Lipanthil 200m

Package Leaflet: Information for the Patient

Lipanthyl 200M, 200 mg, Capsules

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.
• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lipanthyl 200M and what is it used for
• 2. Important information before taking Lipanthyl 200M
• 3. How to take Lipanthyl 200M
• 4. Possible side effects
• 5. How to store Lipanthyl 200M
• 6. Contents of the pack and other information

1. What is Lipanthyl 200M and what is it used for

Lipanthyl 200M 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 200M 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 200M 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 200M

When not to take Lipanthyl 200M

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if you have had an allergic reaction to sunlight or UV radiation, or skin damage (with other fibrates or with 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 abdominal pain), which is not caused by high levels of a certain type of fat in the blood

Do not take Lipanthyl 200M if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Lipanthyl 200M.

Warnings and precautions

Before starting to take Lipanthyl 200M, discuss it with your doctor or pharmacist if:

• you have liver or kidney disease
• you have hepatitis: 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 200M.

Muscle effects

Stop taking the medicine and consult your doctor immediately if you experience unexpected muscle cramps, pain, tenderness, or weakness while taking Lipanthyl 200M.

• 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. Inform your doctor if:

• you are over 70 years old
• you have kidney disease
• you have thyroid disease
• you drink large amounts of alcohol
• you or a family member have had hereditary muscle disorders
• 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 or pharmacist before taking Lipanthyl 200M.

Lipanthyl 200M and other medicines

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

• blood-thinning medicines (such as 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 200M may increase the risk of muscle damage
• medicines 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 200M.

Lipanthyl 200M with food, drink, and alcohol

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 200M and inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Do not take Lipanthyl 200M while breastfeeding. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Lipanthyl 200M has no effect on driving or using machines. Lipanthyl 200M 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. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Lipanthyl 200M

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose of the medicine, depending on your condition, current treatment, and personal risk.

How to take the medicine

• Swallow the capsule whole with a glass of water.
• Do not open or chew the capsule.
• Take the capsule with a meal - absorption of the medicine is reduced on an empty stomach.

How much to take

The recommended daily dose is 1 capsule of 200 mg once a day.

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 patients over 65 years old without kidney problems, the recommended dose is the same as for adults.

Patients with liver problems

In patients with liver problems, Lipanthyl 200M is not recommended due to the lack of clinical data for this group.

Use in children and adolescents

Lipanthyl 200M is not recommended for use in children and adolescents under 18 years old.

Overdose

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

Missed dose

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

Stopping treatment

Do not stop treatment without consulting your doctor, unless the medicine makes you feel unwell. High cholesterol must be treated for a long time. Remember that, in addition to taking Lipanthyl 200M, it is also important to:

• follow a low-fat diet
• perform regular physical exercise If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Lipanthyl 200M and contact your doctor immediately - you may need urgent medical treatment:

Uncommon:may affect up to 1 in 100 people

• muscle cramps, pain, tenderness, or weakness - these can be symptoms of muscle inflammation or breakdown, which can cause kidney damage or even death
• abdominal pain - this can be a symptom 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 can include swelling of the face, lips, tongue, or throat, which can cause difficulty breathing
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzyme activity - these can be symptoms of hepatitis

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 200M 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
• abdominal 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
• fatigue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 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 200M

Keep the medicine out of the sight and reach of children. Store in the original package, at a temperature below 25°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 200M contains

• The active substance is 200 mg of micronized fenofibrate.
• The other ingredients are: lactose monohydrate, maize starch, sodium lauryl sulfate, crospovidone, magnesium stearate. Capsule shell: titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), gelatin.

What Lipanthyl 200M looks like and contents of the pack

Lipanthyl 200M is available as capsules. The pack contains 30 capsules.

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 further 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