Lypfen 200 mg capsules

Fenofibrate

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.

• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Lypfen capsules are and what they are used for
  2. What you need to know before you take Lypfen capsules
  3. How to take Lypfen capsules
  4. Possible side effects
  5. How to store Lypfen capsules
  6. Contents of the pack and other information

 1- What Lypfen capsules are and what they are used for

Lypfen contains the active substance Fenofibrate, 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. Lypfen 200mg capsules are used, alongside a low fat diet and other nonmedical treatments such as exercise and weight loss, to lower levels of fats in the blood. Lypfen 200mg capsules can be used in addition to other medicines (statins) in some circumstances when levels of fats in the blood are not controlled with a statin alone.

 2- What you need to know before you take Lypfen capsules

Do not take Lypfen capsules and tell your doctor if:

• You are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Lypfen capsules if:

• You have any liver or kidney problems

• You have kidney disease

• You may have an inflamed liver (hepatitis) – signs include yellowing of the skin and 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 Lypfen).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lypfen capsules.

Your doctor might want to test your blood or urine to check if Lypfen capsules are working properly and also if your kidneys, muscles and liver are working properly.

Effects on muscles

Stop taking Lypfen capsules 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 Lypfen capsules.

Other medicines and Lypfen capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 Lypfen capsules may increase the risk of muscle problems

• A particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)

• Ciclosporin – 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 Lypfen capsules.

Lypfen capsules 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.

Pregnancy, breast-feeding and fertility

• Do not take Lypfen capsules and tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby

• Do not take Lypfen capsules 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.

Lypfen capsules contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains a type of sugar called lactose.

3- How to take Lypfen capsules

Always take this medicine exactly as your doctor or pharmacist has told you. 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 a day, taken at mealtimes.

Use in children and adolescents

The use of Lypfen 200mg capsules is not recommended in children under the age of 18.

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 Lypfen capsules than you should

If you take more Lypfen capsules 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 Lypfen capsules

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

• Then take the 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 Lypfen capsules

Do not stop taking Lypfen capsules 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 Lypfen capsules it is 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.

4- Possible side effects

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

Stop taking Lypfen capsules and tell your doctor immediately if you develop:

• Muscle poisoning: muscle pain, breakdown, inflammation, cramps or weakness, increase in the levels of a certain enzyme within the body (seen in a blood test).

Contact your doctor immediately if you develop:

• An allergic reaction: swelling of the face, lips, tongue or throat, itchy skin rash, narrowing of the airways causing difficulty breathing or swallowing.

• Hepatitis: yellowing of the skin or whites of the eyes (jaundice), itching.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Common (may affect up to 1 in 10 people)

Headache, tiredness, spinning sensation, stomach or intestine disorders such as feeling or being sick, stomach pains, diarrhoea and wind. Skin rash, itching, a skin rash with pale or red irregular raised patches with severe itching, sensitivity to sunlight or artificial light (e.g. sun beds) which may include reddening of the skin, blisters or lumps.

Uncommon (may affect up to 1 in 100 people)

Increased levels of a certain enzyme within the body (seen in a test), muscle toxicity (muscle pain, inflammation, cramps and weakness), blood clotting, inflammation of the pancreas causing stomach and back pain.

Rare (may affect up to 1 in 1,000 people)

 Disorder of the nerves causing weakness, tingling and numbness (peripheral neuropathy), hair loss, increase in blood levels of creatinine and urea, loss of sex drive, decreased levels of haemoglobin and white blood cells.

If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

Very rare (may affect up to 1 in 10,000 people)

Lung disease (interstitial pneumopathies), inflammation of the liver (hepatitis) causing yellowing of the skin or whites of the eyes (jaundice) or tiredness, development of gallstones, abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).

5- How to store Lypfen capsules

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
  • Store in the original package. Store below 30°C.
  • Do not use this medicine if you notice any visible signs of deterioration.
  • 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 Lypfen capsules contain

• The active substance is Fenofibrate. Each capsule contains 200mg of the active substance.

• The other ingredients are lactose monohydrate, pregelatinized maize starch, sodium lauryl sulfate, crospovidone, povidone, magnesium stearate, colloidal silicon dioxide and filled in Hard Gelatine

Capsule.

What Fenofibrate capsules look like and contents of

the pack

Lypfen 200 mg capsule: Hard-shell gelatin capsule with orange opaque cap and orange opaque body filled with white to off-white powder, imprinted “JS28” on cap and “200” on body. 

Lypfen 200 mg capsule available in blister packs containing 30 capsules.