Lipanthil Supra 160

Package Leaflet: Information for the Patient

Lipanthyl Supra 160, 160 mg, Film-Coated Tablets

Fenofibrate

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

Lipanthyl Supra 160 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 160 is used in combination with a low-fat diet and other non-drug treatments, such as physical exercise and weight loss, to lower the level of fats in the blood.

In some cases, Lipanthyl Supra 160 may be used in addition to other medicines (statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin), if the level of fats in the blood cannot be controlled by statins alone.

2. Important information before taking Lipanthyl Supra 160

When not to take Lipanthyl Supra 160

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to products containing peanuts or arachidic oil or soy lecithin
• if you have had an allergic reaction to sunlight or UV radiation or skin damage (with medicines such as other fibrates or the anti-inflammatory medicine ketoprofen) in the past
• if you have severe liver, kidney, or gallbladder disease
• if you have pancreatitis (a disease that causes stomach pain), which is not caused by high levels of a certain type of fat in the blood

Do not take Lipanthyl Supra 160 if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Lipanthyl Supra 160.

Warnings and precautions

Before starting to take Lipanthyl Supra 160, discuss it with your doctor or pharmacist if:

• you have liver or kidney disease
• you have liver inflammation - symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests)
• you have hypothyroidism (reduced thyroid activity) If any of the above warnings apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lipanthyl Supra 160.

Muscle effects

Stop taking the medicine and contact your doctor immediately if you experience unexpected muscle cramps or pain, muscle tenderness or weakness while taking this medicine.

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

The risk of muscle breakdown may be higher in some patients. Tell your doctor if:

• you are over 70 years old
• you have kidney disease
• you have thyroid disease
• you or a family member have had hereditary muscle disorders
• you drink large amounts of alcohol
• you are taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin
• you have had muscle disorders while taking statins or fibrates - such as fenofibrate, bezafibrate, or gemfibrozil If any of the above warnings apply to you (or if you are unsure), consult your doctor before taking Lipanthyl Supra 160.

Lipanthyl Supra 160 and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Especially, inform your doctor or pharmacist about taking medicines such as:

• blood-thinning medicines (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 160 may increase the risk of muscle damage
• a medicine used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporin (an immunosuppressant) If any of the above warnings apply to you (or if you are unsure), consult your doctor or pharmacist before taking 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 with a meal, as it will work less well if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

• Do not take Lipanthyl Supra 160 and inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Do not take Lipanthyl Supra 160 while breastfeeding. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Lipanthyl Supra 160 has no effect on driving or using machines.

Lipanthyl Supra 160 contains lactose(a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Lipanthyl Supra 160 contains soy lecithin. If you are allergic to peanuts or soy, do 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 160

Always take this medicine exactly as your doctor or pharmacist has told you.

If you are unsure, consult your doctor or pharmacist.

Your doctor will determine the appropriate dose of the medicine, depending on your condition, current therapy, and personal risk.

How to take the medicine

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

How much to take

The recommended dose is one 160 mg film-coated tablet per day.

Patients who are taking capsules containing 200 mg of fenofibrate (one capsule per day) can start taking one 160 mg tablet per day without modifying the dosage.

Patients with kidney problems

In patients with kidney problems, your doctor may reduce the dose. If you have such disorders, consult your doctor or pharmacist. In patients with severe kidney problems (creatinine clearance <20 ml min), the medicine is contraindicated.< p>

Patients over 65 years old

In elderly patients without kidney problems, the recommended dose is the same as for adults.

Patients with liver problems

In patients with liver problems, Lipanthyl Supra 160 is not recommended due to the lack of clinical data for this group.

Use in children and adolescents

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

Overdose of Lipanthyl Supra 160

If you have taken more than the recommended dose of Lipanthyl Supra 160 or if someone else has taken your medicine, contact your doctor or the nearest hospital emergency department immediately.

Missed dose of Lipanthyl Supra 160

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

Stopping treatment with Lipanthyl Supra 160

Do not stop treatment without consulting your doctor, unless the medicine is causing you harm. High cholesterol must be treated for a long time.

Remember that, in addition to taking Lipanthyl Supra 160, it is also important to:

• follow a low-fat diet
• perform regular physical exercise If you stop taking the medicine and your doctor does not decide otherwise, do not store unused tablets. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lipanthyl Supra 160 can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Lipanthyl Supra 160 and contact your doctor immediately - you may need urgent medical treatment:

Uncommon:may affect up to 1 in 100 people

• muscle cramps or pain, muscle tenderness or weakness - these can be symptoms of muscle inflammation or breakdown, which can cause kidney damage or even death
• stomach pain - these can be symptoms of pancreatitis
• chest pain and shortness of breath - these can be symptoms of blood clots in the lungs (pulmonary embolism)
• pain, redness, and swelling of the legs - these can be symptoms of blood clots in the legs (deep vein thrombosis)

Rare:may affect up to 1 in 1,000 people

• allergic reaction, symptoms may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzyme activity - these can be symptoms of liver inflammation

Frequency not known: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 you experience any of the above side effects, stop taking Lipanthyl Supra 160 and contact your doctor immediately.

Other side effects

If you experience any of the following side effects, contact your doctor or pharmacist:

Common:may affect up to 1 in 10 people

• diarrhea
• stomach pain
• bloating with gas
• nausea
• vomiting
• increased liver enzyme activity in the blood - confirmed by laboratory tests
• increased homocysteine levels 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)

Uncommon:may affect up to 1 in 100 people

• headache
• gallstones
• decreased sex drive
• rash, itching, or hives
• increased creatinine levels in the blood - confirmed by laboratory tests

Rare:may affect up to 1 in 1,000 people

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

Frequency not known:cannot be estimated from the available data

• muscle breakdown
• complications related to gallstones
• feeling tired

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Lipanthyl Supra 160

Keep this medicine out of the sight and reach of children.

Store in the original package, at a temperature below 30°C.

Do not use this medicine after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, lactose monohydrate, povidone (K25), microcrystalline cellulose, colloidal anhydrous silica, crospovidone, sodium stearyl fumarate.
• The tablet coating (Opadry OY B 28920) contains: polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

What Lipanthyl Supra 160 looks like and contents of the pack

Lipanthyl Supra 160 is available as film-coated tablets.

The pack contains 30 tablets.

Marketing authorization 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 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