GLICLAZIDE 60 MG MR TABLETS | TAJ PHARMA

TAJ PHARMA GLICLAZIDE 60 MG MR TABLETS FOR EXPORTS
Active substance(s): TAJ PHARMA GLICLAZIDE

Package : Information for the user
TAJ PHARMA GLICLAZIDE 60 mg MR Tablets, modified release tablets
TAJ PHARMA GLICLAZIDE
Read all of this carefully before you start taking this medicine because it contains important
information for you.
 Keep this page bookmarked. You may need to read it again.•
 If you have any further questions, ask your doctor or pharmacist.•
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if•
their signs of illness are the same as yours.
 If you get any of the side effects gets serious talk to your doctor or pharmacist. This includes any•
possible side effects not listed in this leaflet.

What is in this

1. What Gliclazide 60 mg MR is and what it is used for
2. What you need to know before you take TAJ PHARMA GLICLAZIDE 60 mg MR
3. How to take TAJ PHARMA GLICLAZIDE 60 mg MR
4. Possible side effects
5. How to store TAJ PHARMA TAJ PHARMA GLICLAZIDE 60 mg MR
6. Contents of the pack and other information

 

 

 

 

 

 

 

 

 

What TAJ PHARMA TAJ PHARMA GLICLAZIDE 60 mg MR is and what it is used for
What you need to know before you take TAJ PHARMA TAJ PHARMA GLICLAZIDE 60 mg MR
How to take TAJ PHARMA TAJ PHARMA GLICLAZIDE 60 mg MR
Possible side effects
How to store TAJ PHARMA GLICLAZIDE 60 mg MR
Contents of the pack and other information

1. What TAJ PHARMA GLICLAZIDE 60 mg MR is and what it is used for
TAJ PHARMA GLICLAZIDE 60 mg MR is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to
the sulphonylurea group).
TAJ PHARMA GLICLAZIDE 60 mg MR is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet,
exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

2. What you need to know before you take TAJ PHARMA GLICLAZIDE 60 mg MR
Do not take TAJ PHARMA GLICLAZIDE 60 mg MR:
- if you are allergic to TAJ PHARMA GLICLAZIDE or any of the other ingredients of TAJ PHARMA GLICLAZIDE 60 mg MR (listed in
section 6), or to other medicines of the same group (sulphonylurea), or to other related medicines
(hypoglycaemic sulphonamides);
- if you have insulin-dependent diabetes (type 1);
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a
diabetic pre-coma or coma;
- if you have severe kidney or liver disease;
- if you are taking medicines to treat fungal infections (miconazole, see Section “Taking other
medicines”);
- if you are breastfeeding (see Section “Pregnancy and breastfeeding”).

Warnings and precautions
You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This
means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where
necessary, reduce weight.
During TAJ PHARMA GLICLAZIDE treatment regular monitoring of your blood (and possibly urine) sugar level and also your
glycated haemoglobin (HbA1c) is necessary.
1


In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be
increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting,
- if you are malnourished,
- if you change your diet,
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of TAJ PHARMA GLICLAZIDE,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the
pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
If you have low blood sugar you may have the following symptoms:
headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor
concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor,
sensory disturbances, dizziness, and helplessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart
beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina
pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop
convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may
become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar,
e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea.
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember
that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar
does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in
time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain
medicines (e.g. those acting on the central nervous system and beta blockers).
If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily
switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when TAJ PHARMA GLICLAZIDE has not yet sufficiently reduced
the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special
stress situations). These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and
reduced performance.
If these symptoms occur, you must contact your doctor or pharmacist.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate
dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and
breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this
medicinal product.
TAJ PHARMA GLICLAZIDE 60 mg MR is not recommended for use in children due to a lack of data.

2


Other medicines and TAJ PHARMA GLICLAZIDE 60mg MR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The blood sugar lowering effect of TAJ PHARMA GLICLAZIDE may be strengthened and signs of low blood sugar levels may
occur when one of the following medicines is taken:
-

other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
antibiotics (e.g. sulphonamides, clarithromycin),
medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril,
or enalapril),
medicines to treat fungal infections (miconazole, fluconazole),
medicines to treat ulcers in the stomach or duodenum (H 2 receptor antagonists),
medicines to treat depression (monoamine oxidase inhibitors),
painkiller or antirheumatics (phenylbutazone, ibuprofen),
medicines containing alcohol.

The blood glucose lowering effect of TAJ PHARMA GLICLAZIDE may be weakened and raised blood sugar levels may occur
when one of the following medicines is taken:
medicines to treat disorders of the central nervous system (chlorpromazine),
medicines reducing inflammation (corticosteroids),
medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
TAJ PHARMA GLICLAZIDE 60 mg MR may increase the effects of medicines which reduce blood clotting (e.g. warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the
medical staff you are taking TAJ PHARMA GLICLAZIDE 60 mg MR.
Taking TAJ PHARMA GLICLAZIDE 60 mg MR with food, drink and alcohol
TAJ PHARMA GLICLAZIDE 60 mg MR can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Pregnancy and breastfeeding
TAJ PHARMA GLICLAZIDE 60 mg MR is not recommended for use during pregnancy. If you are pregnant or breast-feeding,
think you may be pregnant or are planning to have a baby while taking this medicine, inform your doctor so
that he may prescribe a more suitable treatment for you.
You must not take TAJ PHARMA GLICLAZIDE 60 mg MR while you are breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too
high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that
you could endanger yourself or others (e.g. when driving a car or using machines). Please ask your doctor
whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia),
- have few or no warning signals of low blood sugar (hypoglycaemia).
TAJ PHARMA GLICLAZIDE 60 mg MR
contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3


3. How to take TAJ PHARMA GLICLAZIDE 60 mg MR
Dose
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood
sugar control may require changed TAJ PHARMA GLICLAZIDE doses.
The recommended dose is half to two tablets (maximum 120 mg) in a single intake at breakfast time. This
depends on the response to treatment.
If a combination therapy of TAJ PHARMA GLICLAZIDE 60 mg MR with metformin, an alpha glucosidase inhibitor,a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 agonist receptor or insulin is initiated your
doctor will determine the proper dose of each medicine individually for you.
If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you
should contact your doctor or pharmacist.
Routes and method of administration
Oral use.
Swallow your half tablet or whole tablet(s) in one piece. Do not chew or crush. The tablet can be divided into
equal doses.
Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day).
You must always eat a meal after taking your tablet(s).
If you take more TAJ PHARMA GLICLAZIDE 60 mg MR than you should
If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department
immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2.
The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a
substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency
services. The same should be done if somebody, e.g. a child, has taken the product unintentionally.
Unconscious patients must not be given food or drink.
It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take TAJ PHARMA GLICLAZIDE 60 mg MR
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of TAJ PHARMA GLICLAZIDE 60 mg MR, take the next dose at the usual time. Do not
take a double dose to make up for a forgotten dose.
If you stop taking TAJ PHARMA GLICLAZIDE 60 mg MR
As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this
medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of
developing complications of diabetes.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see
Section “Warnings and precautions”).
If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an
episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you
should seek immediate medical attention.

4


Liver disorders
There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you
get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your
doctor will decide whether to stop your treatment.
Skin disorders
Skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of tissues such as eyelids,
face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. The rash may
progress to widespread blistering or peeling of the skin.
Blood disorders
Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may
cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These
symptoms usually vanish when the treatment is discontinued.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are
reduced when TAJ PHARMA GLICLAZIDE 60 mg MR is taken with a meal as recommended.
Eye disorders
Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes
in blood sugar levels.
As for other sulphonylureas, the following adverse events have been observed: cases of severe changes in the
number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium
(hyponatraemia), symptoms of liver impairment (e.g. jaundice) have been observed which in most cases
disappeared after withdrawal of the sulphonylurea, but may lead to life-threatening liver failure in isolated
cases.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet.

5. How to store TAJ PHARMA GLICLAZIDE 60 mg MR
Keep out this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister strip. The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What TAJ PHARMA GLICLAZIDE 60 mg MR contains:
The active substance is TAJ PHARMA GLICLAZIDE. Each modified release tablet contains 60 mg of TAJ PHARMA GLICLAZIDE,
The other ingredients are: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, silica
colloidal anhydrous.
What TAJ PHARMA GLICLAZIDE 60 mg MR looks like and contents of the pack:

5


TAJ PHARMA GLICLAZIDE 60 mg MR is a white oblong modified release tablet, scored and engraved ‘DIA 60’ on both faces.
The tablets are available in blister packed in cartons of 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 112,
120, 180 or 500 tablets.

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder
TAJ PHARMACEUTICALS LTD., MUMBAI INDIA

www.tajpharma.com

This leaflet was last revised in 07/2012.

6 Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

FENOFIBRATE MICRO 200MG CAPSULES | TAJ PHARMA

Ref: LTT0039/010816/1/F

®

TAJ PHARMA fenofibrate200mg Capsules
(fenofibrate)

Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist or nurse.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, or pharmacist or nurse.


Your medicine is called TAJ PHARMA fenofibrate200mg Capsules but will be referred to

 

 

 

 

 

 

 

as TAJ PHARMA fenofibratethroughout this leaflet.


What is in this leaflet
1

What TAJ PHARMA fenofibrateis and what it is used for

2

What you need to know before you take Lipantil Micro

3

How to take Lipantil Micro

4

Possible side effects

5

How to store Lipantil Micro

6

Contents of the pack and other information

1

What TAJ PHARMA fenofibrateis and what it is used for

TAJ PHARMA fenofibratebelongs to a group of medicines, commonly known as
‘fibrates’. These medicines are used to lower the level of fats (lipids) in the
blood. For example the fats known as ‘triglycerides’.
TAJ PHARMA fenofibrateis used, alongside a low fat diet and other non-medical
treatments such as exercise and weight loss, to lower levels of fats in the
blood.
TAJ PHARMA fenofibratecan be used in addition to other medicines (called ‘statins’) in
some circumstances when levels of fats in the blood are not controlled with
a statin alone.
TAJ PHARMA fenofibratecan often also increase the amount of a“good” type
of cholesterol, called HDL or high density lipoprotein cholesterol.
It is always essential to continue a low-fat diet during treatment with Lipantil
Micro.

2

What you need to know before you take Lipantil
Micro

Do not take TAJ PHARMA fenofibrateif:
* You are allergic to fenofibrate, or any of the other ingredients of this
medicine (listed in Section 6: Contents of the pack and other information)
* While taking other medicines, you have had an allergic reaction or skin
damage from sunlight or UV light (these medicines include other fibrates
and an anti-inflammatory medicine called ‘ ketopofen
* You have severe liver, kidney or gallbladder problems
* You have pancreatitis (an inflamed pancreas which causes
abdominal pain), which is not caused by high levels of fat in the blood
Do not take Lipantil Mirco if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Lipantil Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking TAJ PHARMA fenofibrateif:
* You have any liver or kidney problems.
* You may have an inflamed liver (hepatitis) - signs include yellowing of the
skin and the whites of the eyes (jaundice) and an increase in liver enzymes
(shown in blood tests)
* You have an under-active thyroid gland (hypo-thyroidism)
* You have diabetes, especially Type 2 diabetes, that is not well controlled
* You have problems with certain proteins in your blood
* You have an alcohol problem
* You are taking other medicines
* You or your family have had muscle problems
* You are over 70 years of age
(Some of the above conditions can lead to high levels of lipids in your blood
and need to be corrected before you start therapy with fenofibrate).
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Lipantil Micro

Your doctor might want to test your blood or urine to check if TAJ PHARMA fenofibrateis
working properly and also if your kidneys, muscles and liver are working
properly.
Effects on muscles
Stop taking TAJ PHARMA fenofibrateand see a doctor straight away if you get
unexplained cramps or painful, tender or weak muscles while taking this
medicine.
* This is because this medicine may cause muscle problems, which may be
serious
* These problems are rare but include muscle inflammation and
breakdown. This can cause kidney damage or even death
Your doctor may do a blood test to check your muscles before and after
starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your doctor if:
* You are over 70 years old
* You have kidney problems
* You have thyroid problems
* You or a close family member has a muscle problem which runs in the
family
* You drink large amounts of alcohol
* You are taking medicines called statins to lower cholesterol - such as
simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
* You have ever had muscle problems during treatment with statins or
fibrates - such as fenofibrate, bezafibrate or gemfibrozil
If any of the above apply to you (or you are not sure), talk to your doctor
before taking Lipantil Micro.
Other medicines and Lipantil Micro
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the
following medicines:
* Anti-coagulants to thin your blood (such as warfarin)
* Other medicines to control fat levels in the blood (such as statins or
fibrates). Taking a statin at the same time as TAJ PHARMA fenofibratemay increase
the risk of muscle problems
* A particular class of medicines to treat diabetes (such as rosiglitazone or
pioglitazone)
* Cyclosporin - used to suppress your immune system
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Lipantil Micro
TAJ PHARMA fenofibratewith food, drink and alcohol
It is important to take the capsule with food - it will not work as well if your
stomach is empty.
Pregnancy, breast-feeding and fertility
* Do not take TAJ PHARMA fenofibrateand tell your doctor if you are pregnant, think
you might be pregnant or are planning to have a baby
* Do not take TAJ PHARMA fenofibrateif you are breast-feeding or planning to
breast-feed your baby
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine will not affect you being able to drive or use tools or
machines.
Important information about some of the ingredients of Lipantil Micro
TAJ PHARMA fenofibratecontains lactose (a type of sugar). If you have been told by
your doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), talk to your doctor before taking this medicine.

3

How to take Lipantil Micro

Always take this medicine exactly as your doctor or pharmacist has told you.
Also, please read the label on the packet. You should check with your doctor
or pharmacist if you are not sure.
Taking this medicine
* Swallow the capsule whole with a glass of water
* Do not open or chew the capsule
* Take the capsule with food - it will not work as well if your stomach is
empty
How much to take
The recommended dose for adults is one capsule of TAJ PHARMA fenofibrate200 mg a
day, taken at mealtimes.
Use in children and adolescents
The use of TAJ PHARMA fenofibrate200mg is not recommended in children under the
age of 18.


Ref: LTT0039/010816/1/B

®

TAJ PHARMA fenofibrate200mg Capsules
(fenofibrate)
Patient Information Leaflet (continued)
People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose.
Ask your doctor or pharmacist about this.
If you take more TAJ PHARMA fenofibratethan you should
If you take more TAJ PHARMA fenofibratethan you should or if someone else has taken
your medicine, contact your nearest hospital casualty department or tell your
doctor immediately.
If you forget to take Lipantil Micro
* If you forget a dose, take the next dose with your next meal
* Then take your next capsule at the normal time
* Do not take a double dose to make up for a forgotten dose
If you are worried about this talk to your doctor
If you stop taking Lipantil Micro
Do not stop taking TAJ PHARMA fenofibrateunless your doctor tells you to, or the
capsules make you feel unwell. This is because abnormal levels of fats in
the blood need treating for a long period of time.
Remember that as well as taking TAJ PHARMA fenofibrateit is also important that you:
* Have a low fat diet
* Take regular exercise
If you have any further questions on the use of this product, ask your doctor
or pharmacist or nurse.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking TAJ PHARMA fenofibrateand see a doctor straight away, if you notice
any of the following serious side effects - you may need urgent medical
treatment:
* Allergic reaction - the signs may include swelling of the face, lips, tongue
or throat, which may cause difficulty in breathing
* Cramps or painful, tender or weak muscles - these may be signs of
muscle inflammation or breakdown, which can cause kidney damage or
even death
* Stomach pain - this may be a sign that your pancreas is inflamed
(pancreatitis)
* Chest pain and feeling breathless - these may be signs of a blood clot in
the lung (pulmonary embolism)
* Pain, redness or swelling in the legs - these may be signs of a blood clot
in the leg (deep vein thrombosis)
* Yellowing of the skin and whites of the eyes (jaundice), or an increase in
liver enzymes - these may be signs of an inflamed liver (hepatitis)
Stop taking TAJ PHARMA fenofibrateand see a doctor straight away, if you notice any of
the side effects above.
Other side effects include:
Common (affects less than 1 in 10 people):
* Diarrhoea
* Stomach pain
* Wind (flatulence)
* Feeling sick (nausea)
* Being sick (vomiting)
* Raised levels of liver enzymes in the blood - shown in tests
Uncommon (affects less than 1 in 100 people)
* Headache
* Gallstones
* Reduced sex drive
* Rash, itching or red patches on the skin
* Increase in ‘creatinine’ produced by the kidneys - shown in tests
* Pancreatitis (inflammation of the pancreas leading to abdominal pain)
* Thromboembolism: pulmonary embolism (blood clot in the lung causing
chest pain and breathlessness), deep vein thrombosis (blood clot in the
leg causing pain, redness or swelling)
* Muscle pain, muscle inflammation, muscle cramps and weakness
Rare (affects less than 1 in 1,000 people):
* Hair loss
* Increase in ‘urea’ produced by the kidneys - shown in tests
* Increased sensitivity of your skin to sunlight, sun lamps and sunbeds
* Drop in haemoglobin (that carries oxygen in the blood) and white blood
cells - shown in tests
* Hepatitis (inflammation of the liver), symptoms of which may be mild
jaundice (yellowing of the skin and whites of the eyes), stomach pain and
itching
* Hypersensitivity (allergic reaction)

Side effect where the chance of it happening are not known
* Severe form of skin rash with reddening, peeling and swelling of the skin
that resembles severe burns
* Long-term lung problems
* Muscle breakdown
* Complications of gallbladder stones
* Jaundice
* Feeling dizzy (vertigo)
* Feeling exhausted (fatigue)
If you get any unusual breathing discomfort, tell your doctor straight away.
If you get any side effects, talk to your doctor, or pharmacist or nurse. This
includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

How to store Lipantil Micro

* Store in the original package.
* Do not store above 30°C
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Lipantil after the expiry date which is stated on the carton and
the blister pack after EXP. The expiry date refers to the last day of that
month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Lipantil should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Lipantil contains:
Each hard capsule contains 200 mg of fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose
monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and
magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127)
and ferric oxide (E 172)
What Lipantil looks like and contents of the pack
Lipantil are gelatin, orange capsules containing white powder.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Lipantil is manufactured by RECIPHARM Fontaine, Rue des Prés Potets
F 21121 Fontaine-les-Dijon, France.
Procured from within the EU by the Product Licence Holder LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,
B98 0RE, UK.

POM

PL 33723/0039

TAJ PHARMA fenofibrate200mg Capsules

Lipantil is a registered trademark of Fournier Industrie et Sante.
Revision date: 01/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.


Ref: LTT0039/010816/2/F

®

Lipanthyl Micro 200mg Capsules
(fenofibrate)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist or nurse.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, or pharmacist or nurse.
Your medicine is called Lipanthyl Micro 200mg Capsules but will be referred
to as Lipanthyl Micro throughout this leaflet.
What is in this leaflet
1

What Lipanthyl Micro is and what it is used for

2

What you need to know before you take Lipanthyl Micro

3

How to take Lipanthyl Micro

4

Possible side effects

5

How to store Lipanthyl Micro

6

Contents of the pack and other information

1

What Lipanthyl Micro is and what it is used for

Lipanthyl Micro belongs to a group of medicines, commonly known as
‘fibrates’. These medicines are used to lower the level of fats (lipids) in the
blood. For example the fats known as ‘triglycerides’.
Lipanthyl Micro is used, alongside a low fat diet and other non-medical
treatments such as exercise and weight loss, to lower levels of fats in the
blood.
Lipanthyl Micro can be used in addition to other medicines (called ‘statins’)
in some circumstances when levels of fats in the blood are not controlled
with a statin alone.
Lipanthyl Micro can often also increase the amount of a“good” type
of cholesterol, called HDL or high density lipoprotein cholesterol.
It is always essential to continue a low-fat diet during treatment with
Lipanthyl Micro.

Your doctor might want to test your blood or urine to check if Lipanthyl Micro
is working properly and also if your kidneys, muscles and liver are working
properly.
Effects on muscles
Stop taking Lipanthyl Micro and see a doctor straight away if you get
unexplained cramps or painful, tender or weak muscles while taking this
medicine.
* This is because this medicine may cause muscle problems, which may be
serious
* These problems are rare but include muscle inflammation and
breakdown. This can cause kidney damage or even death
Your doctor may do a blood test to check your muscles before and after
starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your doctor if:
* You are over 70 years old
* You have kidney problems
* You have thyroid problems
* You or a close family member has a muscle problem which runs in the
family
* You drink large amounts of alcohol
* You are taking medicines called statins to lower cholesterol - such as
simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
* You have ever had muscle problems during treatment with statins or
fibrates - such as fenofibrate, bezafibrate or gemfibrozil
If any of the above apply to you (or you are not sure), talk to your doctor
before taking Lipanthyl Micro.
Other medicines and Lipanthyl Micro
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the
following medicines:
* Anti-coagulants to thin your blood (such as warfarin)
* Other medicines to control fat levels in the blood (such as statins or
fibrates). Taking a statin at the same time as Lipanthyl Micro may
increase
the risk of muscle problems
* A particular class of medicines to treat diabetes (such as rosiglitazone or
pioglitazone)
* Cyclosporin - used to suppress your immune system
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Lipanthyl Micro
Lipanthyl Micro with food, drink and alcohol
It is important to take the capsule with food - it will not work as well if your
stomach is empty.

2

What you need to know before you take Lipanthyl
Micro

Do not take Lipanthyl Micro if:
* You are allergic to fenofibrate, or any of the other ingredients of this
medicine (listed in Section 6: Contents of the pack and other information)
* While taking other medicines, you have had an allergic reaction or skin
damage from sunlight or UV light (these medicines include other fibrates
and an anti-inflammatory medicine called ‘ ketopofen
* You have severe liver, kidney or gallbladder problems
* You have pancreatitis (an inflamed pancreas which causes
abdominal pain), which is not caused by high levels of fat in the blood
Do not take Lipanthyl Mirco if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Lipanthyl Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Lipanthyl Micro if:
* You have any liver or kidney problems.
* You may have an inflamed liver (hepatitis) - signs include yellowing of the
skin and the whites of the eyes (jaundice) and an increase in liver enzymes
(shown in blood tests)
* You have an under-active thyroid gland (hypo-thyroidism)
* You have diabetes, especially Type 2 diabetes, that is not well controlled
* You have problems with certain proteins in your blood
* You have an alcohol problem
* You are taking other medicines
* You or your family have had muscle problems
* You are over 70 years of age
(Some of the above conditions can lead to high levels of lipids in your blood
and need to be corrected before you start therapy with fenofibrate).
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Lipanthyl Micro

Pregnancy, breast-feeding and fertility
* Do not take Lipanthyl Micro and tell your doctor if you are pregnant, think
you might be pregnant or are planning to have a baby
* Do not take Lipanthyl Micro if you are breast-feeding or planning to
breast-feed your baby
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine will not affect you being able to drive or use tools or
machines.
Important information about some of the ingredients of Lipanthyl Micro
Lipanthyl Micro contains lactose (a type of sugar). If you have been told by
your doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), talk to your doctor before taking this medicine.

3

How to take Lipanthyl Micro

Always take this medicine exactly as your doctor or pharmacist has told you.
Also, please read the label on the packet. You should check with your doctor
or pharmacist if you are not sure.
Taking this medicine
* Swallow the capsule whole with a glass of water
* Do not open or chew the capsule
* Take the capsule with food - it will not work as well if your stomach is
empty
How much to take
The recommended dose for adults is one capsule of Lipanthyl Micro 200 mg
a day, taken at mealtimes.
Use in children and adolescents
The use of Lipanthyl Micro 200mg is not recommended in children under the
age of 18.


Ref: LTT0039/010816/2/B

®

Lipanthyl Micro 200mg Capsules
(fenofibrate)
Patient Information Leaflet (continued)
People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose.
Ask your doctor or pharmacist about this.
If you take more Lipanthyl Micro than you should
If you take more Lipanthyl Micro than you should or if someone else has
taken your medicine, contact your nearest hospital casualty department or
tell your doctor immediately.
If you forget to take Lipanthyl Micro
* If you forget a dose, take the next dose with your next meal
* Then take your next capsule at the normal time
* Do not take a double dose to make up for a forgotten dose
If you are worried about this talk to your doctor
If you stop taking Lipanthyl Micro
Do not stop taking Lipanthyl Micro unless your doctor tells you to, or the
capsules make you feel unwell. This is because abnormal levels of fats in
the blood need treating for a long period of time.
Remember that as well as taking Lipanthyl Micro it is also important that
you:
* Have a low fat diet
* Take regular exercise
If you have any further questions on the use of this product, ask your doctor
or pharmacist or nurse.

4

Possible side effects

Like all medicines, This medicine can cause side effects, although not
everybody gets them.
Stop taking Lipanthyl Micro and see a doctor straight away, if you
notice any of the following serious side effects - you may need urgent
medical treatment:
* Allergic reaction - the signs may include swelling of the face, lips, tongue
or throat, which may cause difficulty in breathing
* Cramps or painful, tender or weak muscles - these may be signs of
muscle inflammation or breakdown, which can cause kidney damage or
even death
* Stomach pain - this may be a sign that your pancreas is inflamed
(pancreatitis)
* Chest pain and feeling breathless - these may be signs of a blood clot in
the lung (pulmonary embolism)
* Pain, redness or swelling in the legs - these may be signs of a blood clot
in the leg (deep vein thrombosis)
* Yellowing of the skin and whites of the eyes (jaundice), or an increase in
liver enzymes - these may be signs of an inflamed liver (hepatitis)
Stop taking Lipanthyl Micro and see a doctor straight away, if you notice any
of the side effects above.
Other side effects include:
Common (affects less than 1 in 10 people):
* Diarrhoea
* Stomach pain
* Wind (flatulence)
* Feeling sick (nausea)
* Being sick (vomiting)
* Raised levels of liver enzymes in the blood - shown in tests
Uncommon (affects less than 1 in 100 people)
* Headache
* Gallstones
* Reduced sex drive
* Rash, itching or red patches on the skin
* Increase in ‘creatinine’ produced by the kidneys - shown in tests
* Pancreatitis (inflammation of the pancreas leading to abdominal pain)
* Thromboembolism: pulmonary embolism (blood clot in the lung causing
chest pain and breathlessness), deep vein thrombosis (blood clot in the
leg causing pain, redness or swelling)
* Muscle pain, muscle inflammation, muscle cramps and weakness
Rare (affects less than 1 in 1,000 people):
* Hair loss
* Increase in ‘urea’ produced by the kidneys - shown in tests
* Increased sensitivity of your skin to sunlight, sun lamps and sunbeds
* Drop in haemoglobin (that carries oxygen in the blood) and white blood
cells - shown in tests
* Hepatitis (inflammation of the liver), symptoms of which may be mild
jaundice (yellowing of the skin and whites of the eyes), stomach pain and
itching
* Hypersensitivity (allergic reaction)

Side effect where the chance of it happening are not known
* Severe form of skin rash with reddening, peeling and swelling of the skin
that resembles severe burns
* Long-term lung problems
* Muscle breakdown
* Complications of gallbladder stones
* Jaundice
* Feeling dizzy (vertigo)
* Feeling exhausted (fatigue)
If you get any unusual breathing discomfort, tell your doctor straight away.
If you get any side effects, talk to your doctor, or pharmacist or nurse. This
includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

How to store Lipanthyl Micro

* Store in the original package.
* Do not store above 30°C
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Lipanthyl after the expiry date which is stated on the carton and
the blister pack after EXP. The expiry date refers to the last day of that
month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Lipanthyl should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Lipanthyl contains:
Each hard capsule contains 200 mg of fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose
monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and
magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127)
and ferric oxide (E 172)
What Lipanthyl looks like and contents of the pack
Lipanthyl are gelatin, orange capsules containing white powder.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Lipanthyl is manufactured by RECIPHARM Fontaine, Rue des Prés Potets
F 21121 Fontaine-les-Dijon, France.
Procured from within the EU by the Product Licence Holder LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,
B98 0RE, UK.

POM

PL 33723/0039

Lipanthyl Micro 200mg Capsules

Lipanthyl is a registered trademark of Fournier Industrie et Sante.
Revision date: 01/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.


Ref: LTT0039/010816/3/F

Fenofibrate Micro 200mg Capsules
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist or nurse.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, or pharmacist or nurse.
Your medicine is called Fenofibrate Micro 200mg Capsules but will be
referred to as Fenofibrate Micro throughout this leaflet.
What is in this leaflet
1

What Fenofibrate Micro is and what it is used for

2

What you need to know before you take Fenofibrate Micro

3

How to take Fenofibrate Micro

4

Possible side effects

5

How to store Fenofibrate Micro

6

Contents of the pack and other information

1

What Fenofibrate Micro is and what it is used for

Fenofibrate Micro belongs to a group of medicines, commonly known as
‘fibrates’. These medicines are used to lower the level of fats (lipids) in the
blood. For example the fats known as ‘triglycerides’.
Fenofibrate Micro is used, alongside a low fat diet and other non-medical
treatments such as exercise and weight loss, to lower levels of fats in the
blood.
Fenofibrate Micro can be used in addition to other medicines (called
‘statins’) in some circumstances when levels of fats in the blood are not controlled with a statin alone.
Fenofibrate Micro can often also increase the amount of a“good” type
of cholesterol, called HDL or high density lipoprotein cholesterol.
It is always essential to continue a low-fat diet during treatment with
Fenofibrate Micro.

Your doctor might want to test your blood or urine to check if Fenofibrate
Micro is working properly and also if your kidneys, muscles and liver are
working properly.
Effects on muscles
Stop taking Fenofibrate Micro and see a doctor straight away if you get
unexplained cramps or painful, tender or weak muscles while taking this
medicine.
* This is because this medicine may cause muscle problems, which may be
serious
* These problems are rare but include muscle inflammation and
breakdown. This can cause kidney damage or even death
Your doctor may do a blood test to check your muscles before and after
starting treatment.
The risk of muscle breakdown is higher in some patients. Tell your doctor if:
* You are over 70 years old
* You have kidney problems
* You have thyroid problems
* You or a close family member has a muscle problem which runs in the
family
* You drink large amounts of alcohol
* You are taking medicines called statins to lower cholesterol - such as
simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
* You have ever had muscle problems during treatment with statins or
fibrates - such as fenofibrate, bezafibrate or gemfibrozil
If any of the above apply to you (or you are not sure), talk to your doctor
before taking Fenofibrate Micro.
Other medicines and Fenofibrate Micro
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
In particular tell your doctor or pharmacist if you are taking any of the
following medicines:
* Anti-coagulants to thin your blood (such as warfarin)
* Other medicines to control fat levels in the blood (such as statins or
fibrates). Taking a statin at the same time as Fenofibrate Micro may
increase
the risk of muscle problems
* A particular class of medicines to treat diabetes (such as rosiglitazone or
pioglitazone)
* Cyclosporin - used to suppress your immune system
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Fenofibrate Micro
Fenofibrate Micro with food, drink and alcohol
It is important to take the capsule with food - it will not work as well if your
stomach is empty.

2

What you need to know before you take Fenofibrate
Micro

Do not take Fenofibrate Micro if:
* You are allergic to fenofibrate, or any of the other ingredients of this
medicine (listed in Section 6: Contents of the pack and other information)
* While taking other medicines, you have had an allergic reaction or skin
damage from sunlight or UV light (these medicines include other fibrates
and an anti-inflammatory medicine called ‘ ketopofen
* You have severe liver, kidney or gallbladder problems
* You have pancreatitis (an inflamed pancreas which causes
abdominal pain), which is not caused by high levels of fat in the blood
Do not take Fenofibrate Mirco if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Fenofibrate Micro.
Warnings and Precautions
Talk to your doctor or pharmacist or nurse before taking Fenofibrate Micro if:
* You have any liver or kidney problems.
* You may have an inflamed liver (hepatitis) - signs include yellowing of the
skin and the whites of the eyes (jaundice) and an increase in liver enzymes
(shown in blood tests)
* You have an under-active thyroid gland (hypo-thyroidism)
* You have diabetes, especially Type 2 diabetes, that is not well controlled
* You have problems with certain proteins in your blood
* You have an alcohol problem
* You are taking other medicines
* You or your family have had muscle problems
* You are over 70 years of age
(Some of the above conditions can lead to high levels of lipids in your blood
and need to be corrected before you start therapy with fenofibrate).
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before taking Fenofibrate Micro

Pregnancy, breast-feeding and fertility
* Do not take Fenofibrate Micro and tell your doctor if you are pregnant,
think
you might be pregnant or are planning to have a baby
* Do not take Fenofibrate Micro if you are breast-feeding or planning to
breast-feed your baby
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine will not affect you being able to drive or use tools or
machines.
Important information about some of the ingredients of Fenofibrate
Micro
Fenofibrate Micro contains lactose (a type of sugar). If you have been told
by your doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), talk to your doctor before taking this medicine.

3

How to take Fenofibrate Micro

Always take this medicine exactly as your doctor or pharmacist has told you.
Also, please read the label on the packet. You should check with your doctor
or pharmacist if you are not sure.
Taking this medicine
* Swallow the capsule whole with a glass of water
* Do not open or chew the capsule
* Take the capsule with food - it will not work as well if your stomach is
empty
How much to take
The recommended dose for adults is one capsule of Fenofibrate Micro 200
mg a day, taken at mealtimes.
Use in children and adolescents
The use of Fenofibrate Micro 200mg is not recommended in children under
the age of 18.


Ref: LTT0039/010816/3/B

Fenofibrate Micro 200mg Capsules
Patient Information Leaflet (continued)
People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose.
Ask your doctor or pharmacist about this.
If you take more Fenofibrate Micro than you should
If you take more Fenofibrate Micro than you should or if someone else has
taken your medicine, contact your nearest hospital casualty department or
tell your doctor immediately.
If you forget to take Fenofibrate Micro
* If you forget a dose, take the next dose with your next meal
* Then take your next capsule at the normal time
* Do not take a double dose to make up for a forgotten dose
If you are worried about this talk to your doctor
If you stop taking Fenofibrate Micro
Do not stop taking Fenofibrate Micro unless your doctor tells you to, or the
capsules make you feel unwell. This is because abnormal levels of fats in
the blood need treating for a long period of time.
Remember that as well as taking Fenofibrate Micro it is also important that
you:
* Have a low fat diet
* Take regular exercise
If you have any further questions on the use of this product, ask your doctor
or pharmacist or nurse.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Fenofibrate Micro and see a doctor straight away, if you
notice any of the following serious side effects - you may need urgent
medical treatment:
* Allergic reaction - the signs may include swelling of the face, lips, tongue
or throat, which may cause difficulty in breathing
* Cramps or painful, tender or weak muscles - these may be signs of
muscle inflammation or breakdown, which can cause kidney damage or
even death
* Stomach pain - this may be a sign that your pancreas is inflamed
(pancreatitis)
* Chest pain and feeling breathless - these may be signs of a blood clot in
the lung (pulmonary embolism)
* Pain, redness or swelling in the legs - these may be signs of a blood clot
in the leg (deep vein thrombosis)
* Yellowing of the skin and whites of the eyes (jaundice), or an increase in
liver enzymes - these may be signs of an inflamed liver (hepatitis)
Stop taking Fenofibrate Micro and see a doctor straight away, if you notice
any of the side effects above.
Other side effects include:
Common (affects less than 1 in 10 people):
* Diarrhoea
* Stomach pain
* Wind (flatulence)
* Feeling sick (nausea)
* Being sick (vomiting)
* Raised levels of liver enzymes in the blood - shown in tests
Uncommon (affects less than 1 in 100 people)
* Headache
* Gallstones
* Reduced sex drive
* Rash, itching or red patches on the skin
* Increase in ‘creatinine’ produced by the kidneys - shown in tests
* Pancreatitis (inflammation of the pancreas leading to abdominal pain)
* Thromboembolism: pulmonary embolism (blood clot in the lung causing
chest pain and breathlessness), deep vein thrombosis (blood clot in the
leg causing pain, redness or swelling)
* Muscle pain, muscle inflammation, muscle cramps and weakness
Rare (affects less than 1 in 1,000 people):
* Hair loss
* Increase in ‘urea’ produced by the kidneys - shown in tests
* Increased sensitivity of your skin to sunlight, sun lamps and sunbeds
* Drop in haemoglobin (that carries oxygen in the blood) and white blood
cells - shown in tests
* Hepatitis (inflammation of the liver), symptoms of which may be mild
jaundice (yellowing of the skin and whites of the eyes), stomach pain and
itching
* Hypersensitivity (allergic reaction)

Side effect where the chance of it happening are not known
* Severe form of skin rash with reddening, peeling and swelling of the skin
that resembles severe burns
* Long-term lung problems
* Muscle breakdown
* Complications of gallbladder stones
* Jaundice
* Feeling dizzy (vertigo)
* Feeling exhausted (fatigue)
If you get any unusual breathing discomfort, tell your doctor straight away.
If you get any side effects, talk to your doctor, or pharmacist or nurse. This
includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

How to store Fenofibrate Micro

* Store in the original package.
* Do not store above 30°C
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use Fenofibrate after the expiry date which is stated on the carton
and the blister pack after EXP. The expiry date refers to the last day of that
month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
Fenofibrate should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Fenofibrate contains:
Each hard capsule contains 200 mg of fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: Lactose
monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and
magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127)
and ferric oxide (E 172)
What Fenofibrate looks like and contents of the pack
Fenofibrate are gelatin, orange capsules containing white powder.
Each pack contains 30 capsules.
Manufacturer and Licence Holder
Fenofibrate is manufactured by RECIPHARM Fontaine, Rue des Prés Potets
F 21121 Fontaine-les-Dijon, France.
Procured from within the EU by the Product Licence Holder LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, and repackaged by Lexon (UK) Limited,
B98 0RE, UK.

POM

PL 33723/0039

Fenofibrate Micro 200mg Capsules

Revision date: 01/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?

TAJ PHARMACEUTICALS LTD., MUMBAI

for help.

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.