Lipanthyl 267m

Package leaflet: Information for the patient

Lipanthyl 267M, 267 mg, capsules
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, ask 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Lipanthyl 267M is and what it is used for
2. Important information before taking Lipanthyl 267M
3. How to take Lipanthyl 267M
4. Possible side effects
5. How to store Lipanthyl 267M
6. Contents of the pack and other information

1. What Lipanthyl 267M is and what it is used for
Lipanthyl 267M belongs to a group of medicines generally known as fibrates. These medicines are used to lower levels of fats (lipids) in the blood. An example of such fats are triglycerides. Lipanthyl 267M is used together 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 267M

When not to take Lipanthyl 267M

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if in the past, when taking other medicines, you experienced photosensitivity or skin damage caused by sunlight or UV light (such medicines include other fibrates or the anti-inflammatory drug ketoprofen)
• if you have severe liver, kidney or gallbladder disease
• if you have pancreatitis (a condition causing abdominal pain) not caused by high levels of certain fats in the blood

Do not take Lipanthyl 267M if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Lipanthyl 267M.

Warnings and precautions
Before starting to take Lipanthyl 267M, talk to 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 activity of the thyroid gland)
  If any of the above warnings apply to you (or if you are in any doubt), consult your doctor or pharmacist before starting to take Lipanthyl 267M.

Effect on muscles
Stop taking the medicine immediately and contact your doctor if you experience unexpected muscle cramps or pain, tenderness or weakness while taking Lipanthyl 267M.

• This medicine may cause muscle disorders, which can be serious.
• These disorders are rare, but include myositis (inflammation of the muscles) and rhabdomyolysis (breakdown of muscle tissue). This may lead to kidney damage or even death. Your doctor may order blood tests to check muscle status before and after starting treatment.

The risk of muscle breakdown may be higher in certain 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 has had inherited muscle disorders
• you are taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
• you previously experienced 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 in any doubt), consult your doctor or pharmacist before starting to take Lipanthyl 267M.

Lipanthyl 267M 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:

• 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 267M may increase the risk of muscle damage
• a medicine used in the treatment of diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressive medicine)
  If any of the above warnings apply to you (or if you are in any doubt), consult your doctor or pharmacist before starting to take Lipanthyl 267M.

Lipanthyl 267M with food, drink and alcohol
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 267M and inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant.
• Do not take Lipanthyl 267M during breastfeeding. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Lipanthyl 267M has no effect on the ability to drive or operate machinery.

Lipanthyl 267M contains lactose (a type of sugar). If you have previously been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to take Lipanthyl 267M

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your condition, current treatment, and
personal risk factors.

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 poorer when taken on an empty stomach.

How much medicine to take
The recommended daily dose is 1 capsule of 200 mg once daily.
Your doctor may increase the dose to 1 capsule of 267 mg once daily.

Patients with renal impairment
In patients with renal impairment, your doctor may reduce the dose. In such cases, consult your doctor or pharmacist. Lipanthyl 267M 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 267M is not recommended for patients with hepatic impairment due to lack of clinical data in this patient group.

Use in children and adolescents
Lipanthyl 267M is not recommended for use in children and adolescents under 18 years of age.

Taking more Lipanthyl 267M than recommended
If you take more than the recommended dose or if someone else accidentally takes this medicine, contact your doctor or the nearest hospital emergency department immediately.

Missed dose of Lipanthyl 267M

• If you miss a dose, take the next dose with the next 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 267M
Do not stop treatment without consulting your doctor, unless the medicine causes you discomfort. Elevated cholesterol levels require long-term treatment.
Remember that in addition to taking Lipanthyl 267M, the following are equally important:

• adopting a diet low in fat
• regular physical exercise

If you have any further doubts about using 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 267M and contact your doctor immediately – prompt treatment may be necessary:

Uncommon: may occur in up to 1 in 100 patients

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

Rare: may occur in up to 1 in 1,000 patients

• 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 enzymes – 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 resembling severe burns
• Chronic lung disease

If any of the above-mentioned adverse reactions occur, stop taking Lipanthyl 267M 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
• Flatulence with passage of wind
• Nausea
• Vomiting
• Increased liver enzyme activity in blood – detected in laboratory tests
• Increased blood homocysteine concentration (elevated levels of this amino acid in blood are associated with higher 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 1,000 patients

• Hair loss
• Increased urea excretion by the kidneys – detected in laboratory tests
• Increased skin sensitivity to sunlight, sunlamps and sunbeds
• Decreased haemoglobin concentration (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 symptoms 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, phone: +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 267M

Keep this medicine out of sight and reach of children.
Store in the original packaging, 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lipanthyl 267M contains

• The active substance is 267 mg of micronized fenofibrate.
• The other ingredients are: monohydrate lactose, gelatinized starch, sodium lauryl sulfate, crospovidone, magnesium stearate. Composition of the gelatin capsule shell: lower part (ivory colour): titanium dioxide (E 171), iron oxide yellow (E 172), gelatin; upper part (orange colour): titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), gelatin.

What Lipanthyl 267M looks like and contents of the pack
Lipanthyl 267M is available in the form of capsules.
The pack contains 30 capsules.
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 more detailed information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00