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1. Lipantil Micro 67mg Capsules
2. Lipantil Micro 67mg Capsules

Document: leaflet MAH BRAND_PLPI 20774-1212 change

• leaflet MAH BRAND_PLPI 15184-0511
• leaflet MAH BRAND_PLPI 15814-0505
• leaflet MAH BRAND_PLPI 18799-1556
• leaflet MAH BRAND_PLPI 20774-1212

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(leaflet continued)

•    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

.....(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)

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•    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.

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.

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•    Keep out of the sight and reach of children.

•    Keep this medicine in the original package

•    Do not store above 30°C.

•    Do not use Lipantil Micro 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.

•    Lipantil Micro 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.

Each hard gelatin capsule contains 67mg of fenofibrate.

Also contains lactose, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate.

The capsule is made of gelatin, titanium dioxide (E171), quinoline yellow (E104) and erythrosine (E127).

Hard gelatin capsules consist of opaque yellow body and cap, unmarked, containing a white .fumler.

Lipantil Micro is available in blister packs of 90 capsules.

Manufactured by Recipharm Fontaine, Rue des Pres-Potets, F21121 Fontaine-les-Dijon, France. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,

Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA.

Lipantil Micro 67mg Capsules PL 20774/1212

Date of preparation 11^th August 2016

Lipantil is a registered trademark of Fournier frrdustrie et Sante

PP4/1212/V4

(fe nofib rate)

i continue a low-fat diet . ~....~....~....~....~.5j_tfftrtg.t_reat_ment with Lipantil Micro.

. 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. Dp_#no_#tjDass jt_#qn to_#qthers₄ It.ma^ harm them, even if their symptoms are the same as yours.

. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, or pharmacist or nurse.

The name of your medicine is Lipantil Micro

67mg Capsules, but will be referred to as

Lipantil Micro throughout the remainder of the

leaflet.

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1.    What Lipantil Micro is and what it is used for

2.    What you need to know before you take Lipantil Micro

3.    Howto take Lipantil Micro

4.    Possible side effects

5.    How to store Lipantil Micro

6.    Contents of the pack and other information

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Lipantil 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’.

Lipantil 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.

Lipantil 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.

Lipantil Micro can often also increase the amount of a ‘good’ type of cholesterol, called HDL or high density lipoprotein cholesterol.

•    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 antiinflammatory medicine called ‘ketoprofen’)

•    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 Micro if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lipantil Micro

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Talk to your doctor or pharmacist or nurse

before taking Lipantil Micro if:

"““T"(?uTave"anyTrveror 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

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(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 Lipantil Micro is working properly and also if your kidneys, muscles and liver are working properly.

Stop taking Lipantil 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 Lipantil Micro.

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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.

If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

•    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

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The recommended dose for adults is one capsule (67mg) three times a day.

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The usual dose for children is one capsule of Lipantil Micro 67mg per 20kg body weight per day. Your doctor will work out the dose that is

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If you have kidney problems, your doctor may ■•‘to+kyewto take a lower dose. Ask your doctor or pharmacist about this.

If you take more Lipantil Micro than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately.

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•    If you forget a dose, take the next dose with your next meal

•    Then take your next capsule at the normal

•    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

•••—••«nzynw9“"these may be signs of an inflamed liver (hepatitis)

Stop taking Lipantil Micro and see a doctor

straight away, if you notice any of the side

effects above.

■¹««¹ • • ¹(affeets 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

Do not stop taking Lipantil 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 Lipantil Micro it is also important that you:

•    Have a low fat diet

•    Take regular exercise

..........(affeets Hess than 1 in 100

people):

•    Headache

•    Gallstones

•    Reduced sex drive

•    Rash, itching or red patches on the skin

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1

   Do not take a double dose to make up for a forgotten dose.

If you are worried about this talk to your doctor.