Lipanthil supra 160

Package leaflet: Information for the patient

Lipanthyl Supra 160, 160 mg, coated tablets
Fenofibrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Lipanthyl Supra 160 is and what it is used for
2. Important information before taking Lipanthyl Supra 160
3. How to take Lipanthyl Supra 160
4. Possible side effects
5. How to store Lipanthyl Supra 160
6. Contents of the pack and other information

1. What Lipanthyl Supra 160 is and what it is used for

Lipanthyl Supra 160 belongs to a group of medicines known as fibrates. These medicines are used to lower the levels of fats (lipids) in the blood. An example of such fats are triglycerides.
Lipanthyl Supra 160 is used together with a low-fat diet and other non-medical treatments such as physical exercise and weight loss, all aimed at reducing blood fat levels.
In certain cases, Lipanthyl Supra 160 may be used in addition to other medicines (statins such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin) when blood fat levels cannot be controlled with statins alone.

2. Important information before taking Lipanthyl Supra 160

When not to take Lipanthyl Supra 160

• if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to products containing peanuts or peanut oil or soy lecithin
• if in the past the patient experienced photosensitivity or skin damage during treatment with other medicines (such as other fibrates or the anti-inflammatory drug ketoprofen)
• if the patient has severe liver, kidney or gallbladder disease
• if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of certain types of fats in the blood

Lipanthyl Supra 160 must not be taken if any of the above apply to the patient. If in doubt, consult a doctor or pharmacist before taking
Lipanthyl Supra 160.
Warnings and precautions
Before starting Lipanthyl Supra 160, discuss with a doctor or pharmacist if:

• the patient has liver or kidney disease
• the patient has hepatitis – symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests)
• the patient has hypothyroidism (reduced activity of the thyroid gland) If any of the above warnings apply (or if in doubt), consult a doctor or pharmacist before starting treatment with Lipanthyl Supra 160.

Effect on muscles
Immediately stop taking the medicine and contact a doctor if unexpected muscle cramps, pain, tenderness or weakness occur while taking this medicine.

• This medicine may cause muscle disorders, which can be serious.
• These disorders are rare but include inflammation of muscles and muscle breakdown. This may lead to kidney damage or even death. The doctor may order blood tests to check muscle function before and during treatment.

The risk of muscle breakdown may be higher in certain patients. Inform the doctor if:

• the patient is over 70 years old
• the patient has kidney disease
• the patient has thyroid disease
• the patient or a family member has a history of inherited muscle disorders
• the patient drinks large amounts of alcohol
• the patient is taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
• the patient has previously experienced muscle disorders while taking statins or fibrates such as fenofibrate, bezafibrate or gemfibrozil If any of the above warnings apply (or if in doubt), consult a doctor before starting treatment with Lipanthyl Supra 160.

Lipanthyl Supra 160 and other medicines
Tell the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if the patient is taking:

• anticoagulant medicines used to thin the blood (e.g. warfarin)
• other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin together with Lipanthyl Supra 160 may increase the risk of muscle damage
• a medicine from the group used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressive medicine) If any of the above apply (or if in doubt), consult a doctor or pharmacist before starting treatment with Lipanthyl Supra 160.

Lipanthyl Supra 160 with food, drink and alcohol
Swallow the tablet with a glass of water. It is important to take the medicine during a meal, as it will be less effective if taken on an empty stomach.
Pregnancy, breastfeeding and fertility

• Do not take Lipanthyl Supra 160 and inform the doctor if pregnant, suspect pregnancy or plan to become pregnant.
• Do not take Lipanthyl Supra 160 during breastfeeding. Consult a doctor or pharmacist before using this medicine.

Driving and using machines
Lipanthyl Supra 160 has no influence on the ability to drive and use machines.
Lipanthyl Supra 160 contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Lipanthyl Supra 160 contains soy lecithin. If allergic to peanuts or soy, this medicine should not be used.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Lipanthyl Supra 160

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your medical condition, current
treatment, and individual risk factors.

Taking the medicine

• Swallow the tablet whole with a glass of water.
• Do not chew the tablet.
• Take the tablet with a meal – absorption of the medicine is poorer when taken on an empty stomach.

How much medicine to take
The recommended dose is 1 coated tablet of 160 mg daily.
Patients currently taking 200 mg fenofibrate capsules (1 capsule daily) may switch to 1 tablet of 160 mg daily without dose adjustment.

Patients with renal impairment
In patients with renal impairment, your doctor may reduce the dose. In such cases, consult your doctor or pharmacist. Lipanthyl Supra 160 is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).

Elderly patients
For elderly patients without renal impairment, the recommended dose is the same as for adults.

Patients with hepatic impairment
Lipanthyl Supra 160 is not recommended in patients with hepatic impairment due to lack of clinical data in this population.

Use in children and adolescents
Lipanthyl Supra 160 is not recommended for use in children and adolescents under 18 years of age.

Taking more Lipanthyl Supra 160 than recommended
If you take more Lipanthyl Supra 160 than recommended, or if the medicine is accidentally taken by someone else, contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Lipanthyl Supra 160

• If you miss a dose, take the next dose with the following meal.
• Then continue with your usual dose at the scheduled time.
• Do not take a double dose to make up for a missed dose. If in doubt, consult your doctor.

Stopping treatment with Lipanthyl Supra 160
Do not stop treatment without consulting your doctor, unless the medicine causes adverse effects. Elevated cholesterol levels require long-term treatment.
Remember that in addition to taking Lipanthyl Supra 160, it is equally important to:

• follow a diet low in fat
• perform regular physical exercise

If treatment is discontinued and your doctor does not advise otherwise, do not keep any unused tablets. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the serious adverse reactions listed below occur, stop taking Lipanthyl Supra 160 and contact your doctor immediately – prompt treatment may be necessary:

Uncommon: may occur in up to 1 in 100 patients

• Muscle cramps, muscle pain, tenderness or weakness – these may be symptoms of muscle inflammation or breakdown, which could lead to kidney damage or even death
• Abdominal pain – these may be symptoms of pancreatitis
• Chest pain and shortness of breath – these may be symptoms of blood clots in the lungs (pulmonary embolism)
• Pain, redness and swelling in the legs – these may be symptoms of blood clots in the legs (deep vein thrombosis)

Rare: may occur in up to 1 in 1000 patients

• Allergic reaction, symptoms may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
• Yellowing of the skin and whites of the eyes (jaundice) or increased liver enzymes – these may be symptoms of liver inflammation

Frequency not known: frequency cannot be estimated from the available data

• Severe skin rash with redness, peeling and swelling of the skin resembling severe burns
• Chronic lung disease

If any of the above-mentioned adverse reactions occur, stop taking Lipanthyl Supra 160 and contact your doctor immediately.

Other adverse reactions
If any of the following adverse reactions occur, contact your doctor or pharmacist:

Common: may occur in up to 1 in 10 patients

• Diarrhea
• Abdominal pain
• Bloating with passing of wind
• Nausea
• Vomiting
• Increased liver enzyme activity in blood – detected in laboratory tests
• Increased homocysteine levels in blood (excess of this amino acid in blood is associated with increased risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established)

Uncommon: may occur in up to 1 in 100 patients

• Headache
• Gallstones
• Decreased libido
• Rash, itching or hives
• Increased creatinine excretion by the kidneys – detected in laboratory tests

Rare: may occur in up to 1 in 1000 patients

• Hair loss
• Increased urea excretion by the kidneys – detected in laboratory tests
• Increased sensitivity of the skin to sunlight, sunbed lamps and tanning beds
• Decreased haemoglobin levels (the pigment carrying oxygen in blood) and decreased white blood cell count – detected in laboratory tests

Frequency not known: frequency cannot be estimated from the available data

• Muscle breakdown
• Complications related to gallstones
• Feeling of fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lipanthyl Supra 160

Keep this medicine out of sight and reach of children.
Store in the original packaging, at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the carton after: Expiry. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Lipanthyl Supra 160 contains

• The active substance is 160 mg of micronized fenofibrate.
• The other ingredients are: sodium lauryl sulfate, monohydrate lactose, povidone (K25), microcrystalline cellulose, colloidal anhydrous silica, crospovidone, sodium stearyl fumarate.
• Film-coat composition (Opadry OY B 28920): polyvinyl alcohol, titanium dioxide (E 171), talc, soybean lecithin, xanthan gum.

What Lipanthyl Supra 160 looks like and contents of the pack
Lipanthyl Supra 160 is available as film-coated tablets.
Pack contains 30 tablets.
Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Manufacturer
Recipharm Fontaine
Rue des Pres Potets
21121 Fontaine les Dijon
France
Delpharm L’Aigle
Zone Industrielle No. 1
Route de Crulai
61300 L’Aigle
France
For further information, contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00