Lipanthil Supra 215 mg

Package Leaflet: Information for the Patient

Lipanthyl Supra 215 mg, 215 mg, coated tablets

Fenofibrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lipanthyl Supra 215 mg and what is it 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 is Lipanthyl Supra 215 mg and what is it 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 level of fats (lipids) in the blood. Examples of such fats include 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, which aim to lower the level of fats in the blood.

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 or arachidic oil or soy lecithin and their derivatives
• if the patient has had an allergic reaction or skin damage due to sunlight or UV radiation while taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen)
• if the patient has severe liver, kidney, or gallbladder disease
• if the patient has pancreatitis (a disease that causes abdominal pain), which is not caused by high levels of fats in the blood. If any of the above situations apply to the patient, they should not take Lipanthyl Supra 215 mg. In case of doubts, consult a doctor or pharmacist before taking Lipanthyl Supra 215 mg.

Warnings and Precautions

Before starting to take Lipanthyl Supra 215 mg, the patient should discuss it with their doctor, pharmacist, or nurse if:

• they have liver or kidney disease
• they have symptoms of liver inflammation: yellowing of the skin and whites of the eyes (jaundice) and increased levels of liver enzymes (shown by blood tests)
• they have reduced thyroid function (hypothyroidism). If any of the above situations apply to the patient (or in case of doubts), they should consult a doctor or pharmacist before taking Lipanthyl Supra 215 mg.

Muscle Effects

The patient should stop taking Lipanthyl Supra 215 mg immediately and contact their doctor if they experience unexpected muscle cramps or pain, muscle tenderness to touch, or muscle weakness while taking the medicine.

• The medicine may cause muscle diseases, which can be severe.
• These diseases are rare but include muscle inflammation and muscle breakdown. This can cause kidney damage and even death. The doctor may order a blood test to check the condition of the muscles before and after starting treatment.

The risk of muscle breakdown may be higher in some patients. The patient should inform their doctor if:

• they are over 70 years old
• they have kidney disease
• they have thyroid disease
• they or a family member have had hereditary muscle disorders
• they drink large amounts of alcohol
• they are taking cholesterol-lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin)
• they have had muscle diseases while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil). If any of the above situations apply to the patient (or in case of doubts), they should consult a doctor before starting to take Lipanthyl Supra 215 mg.

Lipanthyl Supra 215 mg and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. In particular, they should inform their doctor or pharmacist about taking medicines such as:

• oral blood thinners (e.g., warfarin)
• other medicines used to control the level of fats in the blood (such as statins or fibrates). Taking a statin at the same time as Lipanthyl Supra 215 mg may increase the risk of muscle damage
• certain medicines used to treat diabetes (such as rosiglitazone, pioglitazone)
• cyclosporine - an immunosuppressive medicine. If any of the above situations apply to the patient (or in case of doubts), they should consult a 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 with a meal, as it will not work as well if taken on an empty stomach.

Pregnancy, Breast-feeding, and Fertility

• The patient should not take Lipanthyl Supra 215 mg and should inform their doctor if they are pregnant, think they may be pregnant, or plan to become pregnant.
• The patient should not take Lipanthyl Supra 215 mg while breast-feeding or if they plan to breast-feed. They should consult a doctor or pharmacist before taking this medicine.

Driving and Using Machines

The medicine does not affect driving or using machines. Lipanthyl Supra 215 mg contains lactose(a type of sugar). If the doctor has told the patient that they have an intolerance to some sugars, they should contact their doctor before taking the medicine.

Lipanthyl Supra 215 mg Contains Orange Yellow S (E110) Lake and Allura Red AC (E129) Lake

(E129) lake. These excipients may cause allergic reactions. Lipanthyl Supra 215 mg contains soybean oil. Patients with an allergy to peanuts or soy should not take this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to Take Lipanthyl Supra 215 mg

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist. The doctor will determine the appropriate dose of the medicine based on the patient's condition, current therapy, and personal risk.

How to Take the Medicine

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

How Much to Take

The recommended dose is 1 tablet of 160 mg of Lipanthyl Supra 160 per day. However, the doctor may increase the dose to 215 mg per day, i.e., 1 tablet of Lipanthyl Supra 215 mg (higher dose). For patients currently taking one capsule containing 267 mg of fenofibrate (Lipanthyl 267M), the doctor may replace it with one tablet of Lipanthyl Supra 215 mg.

Patients with Kidney Disease

In case of kidney disease, the doctor may reduce the dose. If the patient has any questions, they should consult a 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

In case of taking a higher dose than recommended, or accidental ingestion of the medicine by another person, the patient should immediately contact a doctor or go to the emergency room of the nearest hospital.

Missing a Dose of Lipanthyl Supra 215 mg

• If a dose is missed, the patient should take the next dose with the next meal.
• The next tablet should be taken at the usual time.
• The patient should not take a double dose to make up for the missed dose. In case of doubts, they should consult a doctor.

Stopping Treatment with Lipanthyl Supra 215 mg

The patient should not stop treatment unless their doctor decides to or if the medicine causes bad side effects. Abnormal levels of fats in the blood require long-term treatment. The patient should remember that during treatment with Lipanthyl Supra 215 mg, it is important to:

• follow a low-fat diet
• engage in regular physical activity. If the patient has any further doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Lipanthyl Supra 215 mg can cause side effects, although not everybody gets them.

If the Patient Experiences Any of the Following Serious Side Effects, They Should Stop Taking Lipanthyl Supra 215 mg and Contact Their Doctor Immediately – They May Need Urgent Medical Treatment:

• allergic reaction, symptoms may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing
• muscle cramps or pain, muscle tenderness to touch, or muscle weakness - these may be symptoms of muscle inflammation or muscle breakdown, which can cause 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 of 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 levels of liver enzymes - these may be symptoms of liver inflammation. If the patient experiences any of the above symptoms, they should stop taking Lipanthyl Supra 215 mg and contact their doctor immediately.

Other Side Effects Include:

Common(occurring in less than 1 in 10 patients)

• diarrhea
• abdominal pain
• bloating with gas
• nausea
• vomiting
• increased activity of liver enzymes in the blood - found in laboratory tests
• increased levels of homocysteine in the blood (high levels of this amino acid in the blood are associated with a higher risk of coronary heart disease, stroke, and peripheral vascular disease, although a causal relationship has not been established yet)

Uncommon(occurring in less than 1 in 100 patients)

• headache
• gallstones
• decreased sex drive
• rash, itching, or hives
• increased levels of creatinine excreted by the kidneys - found in laboratory tests

Rare(occurring in less than 1 in 1000 patients)

• hair loss
• increased levels of urea excreted by the kidneys - found in laboratory tests
• increased sensitivity to sunlight, sunlamps, and sunbeds
• decreased levels of hemoglobin (the protein that carries oxygen in the blood) and decreased white blood cell count - found in laboratory tests

Side Effects with Unknown Frequency

• severe skin rash with redness, peeling, and swelling of the skin, resembling severe burns
• chronic lung diseases. If the patient experiences unexpected breathing difficulties, they should contact their doctor immediately
• feeling tired

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to Store Lipanthyl Supra 215 mg

The medicine should be stored out of sight and reach of children. Store in the original package to protect from moisture. There are no special precautions for storage temperature. 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 month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 tablet of Lipanthyl Supra 215 mg 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.
• The tablet coating contains: polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin, xanthan gum, orange yellow S (E110) lake, Allura Red AC (E129) lake, indigo carmine (E132) lake.

What Lipanthyl Supra 215 mg Looks Like and Contents of the Pack

Lipanthyl Supra 215 mg is available as orange-red, elongated, coated tablets with "215" embossed on one side. The pack contains 30 coated tablets.

Marketing Authorization Holder

Viatris Healthcare Sp. z o.o. ul. Postępu 21B 02-676 Warsaw

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 Authorized 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 Information, Contact the Marketing Authorization Holder:

Viatris Healthcare Sp. z o.o. ul. Postępu 21B 02-676 Warsaw tel. 22 546 64 00 Date of Last Revision of the Leaflet:02/2024