Lipanthyl supra 215 mg

Package leaflet: Information for the patient

Lipanthyl Supra 215 mg, 215 mg, coated tablets
Fenofibrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet

1. What Lipanthyl Supra 215 mg is and what it is used for
2. Important information before taking Lipanthyl Supra 215 mg
3. How to take Lipanthyl Supra 215 mg
4. Possible side effects
5. How to store Lipanthyl Supra 215 mg
6. Contents of the pack and other information

1. What Lipanthyl Supra 215 mg is and what it is used for

Lipanthyl Supra 215 mg contains 215 mg of the active substance fenofibrate, which 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 215 mg is used in combination with a low-fat diet and other non-medical treatments, such as physical exercise and weight loss, aimed at reducing blood fat levels.

2. Important information before taking Lipanthyl Supra 215 mg

When not to take Lipanthyl Supra 215 mg

• 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 peanuts, peanut oil, or soy lecithin and its derivatives
• if the patient has previously experienced allergy or skin damage due to sunlight or UV radiation while taking other medicines (e.g. other fibrates or a non-steroidal anti-inflammatory drug called 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 blood fat levels

If any of the above situations apply, Lipanthyl Supra 215 mg should not be used. If in doubt, consult a doctor or pharmacist before taking Lipanthyl Supra 215 mg.

Warnings and precautions

Before starting Lipanthyl Supra 215 mg, consult your doctor, pharmacist, or nurse if:

• you have liver or kidney disease
• you have symptoms indicating liver inflammation: yellowing of the skin or whites of the eyes (jaundice) and elevated liver enzymes (shown in blood tests)
• you have reduced thyroid gland activity (hypothyroidism)

If any of the above apply (or if you are unsure), consult your doctor or pharmacist before taking Lipanthyl Supra 215 mg.

Effect on muscles

Immediately stop taking Lipanthyl Supra 215 mg and contact your doctor if you experience unexpected muscle cramps, pain, tenderness, or weakness during treatment.

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

The risk of muscle breakdown may be higher in certain patients. Inform your 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 consumes 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 during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil)

If any of the above apply (or if you are unsure), consult your doctor before starting Lipanthyl Supra 215 mg.

Lipanthyl Supra 215 mg and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor or pharmacist if you are taking:

• oral anticoagulants (e.g. warfarin)
• other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin together with Lipanthyl Supra 215 mg may increase the risk of muscle damage
• certain medicines used to treat diabetes (such as rosiglitazone, pioglitazone)
• cyclosporine – an immunosuppressant medicine

If any of the above apply (or if you are unsure), consult your doctor or pharmacist before taking Lipanthyl Supra 215 mg.

Lipanthyl Supra 215 mg with food, drink, and alcohol

It is important to take the medicine during a meal, as the medicine will not work properly if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

• Do not take Lipanthyl Supra 215 mg and inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• Do not take Lipanthyl Supra 215 mg while breastfeeding or if you are planning to breastfeed. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Lipanthyl Supra 215 mg has no effect on the ability to drive or operate machinery.

Lipanthyl Supra 215 mg contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

Lipanthyl Supra 215 mg contains sunset yellow (E110) lake and Allura red AC (E129) lake. These excipients may cause allergic reactions.

Lipanthyl Supra 215 mg contains soybean oil. Patients with hypersensitivity to peanuts or soy should not take this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Lipanthyl Supra 215 mg

Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Your doctor will determine the appropriate dose based on your condition, current therapy, and individual risk factors.

How to take the medicine

• Swallow the tablet whole with a glass of water.
• Do not crush or chew the tablet.
• Take the tablet during a meal. The medicine does not work properly if taken on an empty stomach.

Dosage

The recommended dose is one 160 mg tablet of Lipanthyl Supra 160 per day.
However, your doctor may increase the dose to 215 mg per day, i.e. one tablet of Lipanthyl Supra 215 mg (higher dose).
For patients currently taking one capsule containing 267 mg of fenofibrate (Lipanthyl 267M), your doctor may switch them to one tablet of Lipanthyl Supra 215 mg.

Patients with kidney disease
In case of kidney disease, your doctor may reduce the dose. If you have any questions, contact your doctor or pharmacist.

Use in children and adolescents
Lipanthyl Supra 215 mg is not recommended for use in children and adolescents under 18 years of age.

Taking more than the recommended dose of Lipanthyl Supra 215 mg
If you take more than the prescribed dose, or if someone else accidentally takes the medicine, contact your doctor immediately or go to the emergency department of your nearest hospital.

Missed dose of Lipanthyl Supra 215 mg

• If you miss a dose, take the next dose with your next meal.
• Take the next tablet at your usual 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 215 mg
Do not stop treatment unless advised by your doctor or if the medicine causes discomfort.
Abnormal blood fat levels require long-term treatment.
Remember that while taking Lipanthyl Supra 215 mg, the following are important:

• a low-fat diet
• regular physical activity

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 following serious adverse reactions occur, stop taking Lipanthyl Supra 215 mg and contact your doctor immediately – prompt treatment may be necessary:

• allergic reaction, symptoms may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing
• muscle cramps or pain, tenderness to touch or muscle weakness – these may be symptoms of inflammation or breakdown of muscles, which may lead to kidney damage or even death
• abdominal pain – these may be symptoms of inflammation of the pancreas (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)
• yellowing of the skin and whites of the eyes (jaundice), or increased liver enzymes – these may be symptoms of liver inflammation. If any of the above symptoms occur, stop taking Lipanthyl Supra 215 mg immediately and contact your doctor.

Other adverse reactions include:
Common (occurring in fewer than 1 in 10 patients)

• diarrhoea
• abdominal pain
• bloating with passing of wind
• nausea
• vomiting
• increased liver enzyme activity in blood – detected in laboratory tests
• increased blood homocysteine levels – although a causal relationship has not been established, high levels of this amino acid in blood are associated with increased risk of coronary heart disease, stroke and peripheral vascular disease

Uncommon (occurring in fewer than 1 in 100 patients)

• headache
• gallstones
• decreased libido
• rash, itching or hives
• increased creatinine excretion by the kidneys – detected in laboratory tests

Rare (occurring in fewer than 1 in 1,000 patients)

• hair loss
• increased urea excretion by the kidneys – detected in laboratory tests
• increased sensitivity to sunlight, sunbed lamps and tanning beds
• decreased haemoglobin concentration (oxygen-carrying pigment in blood) and decreased white blood cell count – detected in laboratory tests

Adverse reactions for which frequency is not known

• severe skin rash with redness, peeling and swelling of the skin resembling severe burns
• chronic lung disease. If unexpected breathing difficulties occur, contact your doctor immediately
• feeling of fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 of 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 directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lipanthyl Supra 215 mg

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from moisture.
No special temperature storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 215 mg contains

• The active substance is fenofibrate. Each Lipanthyl Supra 215 mg tablet contains 215 mg of fenofibrate.
• The other ingredients are: lactose monohydrate, sodium lauryl sulfate, povidone K25, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate.
• Film-coating ingredients: polyvinyl alcohol, titanium dioxide (E171), talc, soya lecithin, xanthan gum, sunset yellow (E110) lake, Allura red AC (E129) lake, indigotine (E132) lake.

What Lipanthyl Supra 215 mg looks like and contents of the pack
Lipanthyl Supra 215 mg is an orange-red, elongated film-coated tablet, embossed with "215" on one side.
The pack contains 30 film-coated tablets.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Poland

Manufacturer
Astrea Fontaine
Rue des Pres Potets
21121 Fontaine les Dijon
France

Delpharm L’Aigle
Zone Industrielle No. 1
Route de Crulai
61300 L’Aigle
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Ireland: Lipantil Supra 215 mg
Czech Republic: Lipanthyl S 215 mg
Slovakia, Poland: Lipanthyl Supra 215 mg

For more detailed information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Poland
tel. +48 22 546 64 00