200 mg hard fenofibrate capsules
What Lipanthyl is and what it is used for
Lipanthyl belongs to a group of medicines, commonly known as fibrates. These drugs are used to lower the fat content ( lipids ) in the blood. For example, the fats called triglycerides are.
Lipanthyl is used in conjunction with a low-fat diet and other non-medical treatments
for example exercise and weight loss, to lower blood fat levels.
Lipanthyl can be used as a supplement to other drugs (called statins) in certain circumstances when one statin alone does not provide adequate control of your blood fat levels.
What you need to know before taking Lipanthyl
Do not take Lipanthyl if:
- you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6).
- you while you are taking other medicines have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and anti-inflammatory substance called ketoprofen ).
- you have severe liver, kidney or gallbladder disease.
- you have pancreatitis ( inflammation of the pancreas that causes abdominal pain) that is not caused by high levels of fat in the blood.
Do not take Lipanthyl if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lipanthyl.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Lipanthyl if:
- you have some liver or kidney problems
- you may have a liver inflammation ( hepatitis ) – signs include yellow skin and eyes (jaundice) and an increase in liver enzymes (shown in blood samples)
- you have an underactive thyroid gland ( hypothyroidism )
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lipanthyl.
Effects on muscles:
Stop taking Lipanthyl and contact your doctor immediately if you experience unexplained cramps or painful, sore, or weak muscles while taking this medicine.
This is because this medicine can cause muscle problems, which can be serious. These problems are rare but include inflammation and muscle breakdown. This can cause kidney damage or even death.
Your doctor may take a blood test to check your muscles before and after starting treatment.
The risk of muscle breakdown is greater in some patients. Tell your doctor if any of the following apply to you:
- you are older than 70 years
- you have kidney problems
- you have thyroid problems
- you drink large amounts of alcohol
- you or a close family member has a hereditary muscle disease
- 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.
Other drugs and Lipanthyl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you should talk to your doctor or pharmacist if you are taking any of the following medicines:
- blood-thinning drugs (eg warfarin )
- other medicines used to control the levels of fat in the blood (eg statins or fibrates). Taking a statin at the same time as Lipanthyl may increase the risk of muscle problems.
- certain medicines for diabetes (eg rosiglitazone, pioglitazone)
- ciclosporin (an immunosuppressant)
If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking Lipanthyl
Lipanthyl with food, drink and alcohol
It is important to take the capsule with a meal, it will not work as well if the stomach is empty.
Pregnancy, breastfeeding and fertility
- Do not take Lipanthyl and tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
- Do not take Lipanthyl if you are breast-feeding or planning to breast-feed your baby.
If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine does not affect your ability to drive or use tools or machines.
Lipanthyl contains lactose and sodium
Lipanthyl contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, it is essential ‘sodium-free’.
How to take Lipanthyl
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will determine the appropriate dose for you depending on your condition, your current treatment, and what risk factors you have.
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 the stomach is empty.
How much to take
The recommended dose is 1 capsule (200 mg) daily.
People with kidney problems
If you have kidney problems, your doctor may ask you to take a lower dose. Ask your doctor or pharmacist about this.
Use for children and adolescents
The use of Lipanthyl is not recommended for people under 18 years of age.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lipanthyl and contact a doctor immediately, if you get any of the following serious side effects – you may need urgent medical treatment:
- allergic reactions. Signs may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing.
- cramps or aching, sore or weak muscles. This can be a sign of muscle inflammation and muscle breakdown which can lead to kidney damage or even death.
- abdominal pain. This may be a sign that your pancreas is inflamed ( pancreatitis ).
- chest pain and shortness of breath. It may be a sign of a blood clot in the lung ( pulmonary embolism )
- pain, redness or swelling in the legs. This may be a sign 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. This may be a sign of hepatitis .
Stop taking Lipanthyl and contact your doctor immediately if you notice any of the side effects listed above.
Other side effects include:
Common (affects less than 1 patient in 10):
- diarrhea
- abdominal pain
- gases
- nausea
- vomiting
- elevated levels of various liver enzymes in the blood, as shown in tests
- elevated levels of homocysteine (too much of this amino acid in the blood has been associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established).
Uncommon (affects less than 1 patient in 100):
- headache
- gallstone
- decreased sexual drive
- rash, itching or red spots on the skin
- increase in creatinine (the substance is excreted by the kidneys), shown in tests.
Rare in less than 1 in 1,000 patients):
- hair loss
- increase in urea (a substance excreted by the kidneys), shown in tests.
- increased skin sensitivity to sunlight, sun lamps and solarium
- decrease in hemoglobin (carries oxygen in the blood) and decrease in white blood cells , shown in tests.
Side effects are where the frequency is unknown
- severe form of rash with reddening flaking and swelling of the skin resembling severe burns.
- long-term problems with the lungs. If you get any unusual discomfort while breathing, contact your doctor immediately
- feeling of exhaustion.
How to store Lipanthyl
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
No special temperature instructions.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Medicines 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.
Contents of the pack and other information
Content declaration
- The active substance is fenofibrate. Each Lipanthyl 200 mg capsule contains 200 mg of fenofibrate.
- The other ingredients are lactose monohydrate , sodium lauryl sulphate, pregelatinised maize starch, crospovidone and magnesium stearate. The capsule is made of gelatin, titanium dioxide (E171), red iron oxide (E 172), yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Lipanthyl 200 mg capsules are ocher-colored and hard.
The capsule is supplied in a blister pack of 28/30/90/100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer
Recipharm Fontaine
Rue des Prés Potets
21121 Fontaines Les Dijon
France
Delpharm L’Aigle
Industrial Zone No. 1
Route Crulai
61300 L’Aigle
France