Lipanthil Nt 145

Package Leaflet: Information for the Patient

Lipanthyl NT 145, 145 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.
• 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 Leaflet

• 1. What is Lipanthyl NT 145 and what is it used for
• 2. Important information before taking Lipanthyl NT 145
• 3. How to take Lipanthyl NT 145
• 4. Possible side effects
• 5. How to store Lipanthyl NT 145
• 6. Contents of the pack and other information

1. What is Lipanthyl NT 145 and what is it used for

Lipanthyl NT 145 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 NT 145 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 NT 145 may be used in addition to other medicines (statins) if the level of fats in the blood cannot be controlled by statins alone.

2. Important information before taking Lipanthyl NT 145

When not to take Lipanthyl NT 145

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information)
• if you are allergic to peanuts or arachidic oil or soy lecithin and soy products
• if you have had an allergic reaction or skin damage due to sunlight or UV radiation while taking other medicines (such as other fibrates or the anti-inflammatory medicine ketoprofen)
• 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 fats in the blood

If any of the above applies to you, do not take Lipanthyl NT 145. If you are in doubt, consult your doctor or pharmacist before taking Lipanthyl NT 145.

• In case of doubt, consult your doctor or pharmacist before taking Lipanthyl NT 145.

Warnings and precautions

Before starting to take Lipanthyl NT 145, discuss it with your doctor or pharmacist if:

• you have liver or kidney disease
• you have had symptoms of liver inflammation: yellowing of the skin and whites of the eyes (jaundice), increased levels of liver enzymes (shown by blood tests), abdominal pain, and itching
• you have reduced thyroid function (hypothyroidism). If any of the above applies to you (or if you are in doubt), consult your doctor or pharmacist before taking Lipanthyl NT 145.

Effect on muscles

Stop taking Lipanthyl NT 145 and contact your doctor immediately if you experience:

• unexpected muscle spasms
• muscle pain, muscle tenderness to touch, or muscle weakness while taking Lipanthyl NT 145. 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.

Your doctor may order a blood test to check the condition of your muscles 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 diseases while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil). If any of the above applies to you (or if you are in doubt), consult your doctor before starting to take Lipanthyl NT 145.

Lipanthyl NT 145 and other medicines

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

• oral 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 or another fibrate at the same time as Lipanthyl NT 145 may increase the risk of muscle damage
• certain medicines used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporin (an immunosuppressant). If any of the above applies to you (or if you are in doubt), consult your doctor or pharmacist before taking Lipanthyl NT 145.

Pregnancy, breastfeeding, and fertility

• Tell your doctor if you are pregnant, think you may be pregnant, or plan to have a baby. Due to the lack of sufficient experience with the use of Lipanthyl NT 145 during pregnancy, Lipanthyl NT 145 may only be taken if your doctor considers it absolutely necessary.

It is not known whether the active substance of Lipanthyl NT 145 passes into breast milk. For this reason, do not take Lipanthyl NT 145 while breastfeeding or if you plan to breastfeed.

• Do not take Lipanthyl NT 145 while breastfeeding or if you plan to breastfeed.

Driving and using machines

The medicine does not affect driving or using machines.

Lipanthyl NT 145 contains lactose, sucrose, and soybean oil

• Lipanthyl NT 145 contains sugars called lactose and sucrose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
• Lipanthyl NT 145 contains soybean oil. Patients with hypersensitivity to peanuts, arachidic oil, or soy should not take this medicine.
• The product contains less than 1 mmol (23 mg) of sodium per tablet, which means the product is considered "sodium-free".

3. How to take Lipanthyl NT 145

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose of the medicine based on your condition, current therapy, and personal risk.

How to take the medicine

The tablet can be taken with or without food, at any time of the day.

• Swallow the tablet whole with a glass of water.
• Do not crush or chew the tablet.

Remember that during treatment with Lipanthyl NT 145, it is important to:

• follow a low-fat diet
• engage in regular physical activity

How much to take

The recommended dose is one tablet per day. Patients who have been taking one 200 mg capsule of Lipanthyl 200M or one 160 mg tablet of Lipanthyl Supra 160 may switch to one 145 mg tablet of Lipanthyl NT 145.

Patients with kidney disease

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

Use in children and adolescents

Lipanthyl NT 145 is not recommended for use in patients under 18 years of age.

Taking more than the recommended dose of Lipanthyl NT 145

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

Missing a dose of Lipanthyl NT 145

• If you miss a dose, take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Lipanthyl NT 145

Do not stop treatment unless your doctor tells you to. Abnormal levels of fats in the blood require long-term treatment. If your doctor advises you to stop treatment, do not store the tablets unless your doctor tells you to. 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 NT 145 and contact your doctor immediately – you may need urgent medical treatment.

Uncommon:may affect up to 1 in 100 people

• muscle spasms or muscle pain, muscle tenderness to touch, or muscle weakness - these can be symptoms of muscle inflammation or muscle 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 levels of liver enzymes - 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 NT 145 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 activity of liver enzymes in the blood - shown by 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)

Uncommon:may affect up to 1 in 100 people

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

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

• hair loss
• increased levels of urea excreted by the kidneys - shown by laboratory tests
• increased sensitivity of the skin to sunlight, sunlamps, and sunbeds
• decreased levels of hemoglobin (the protein that carries oxygen in the blood) and decreased white blood cell count - shown 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. 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 NT 145

Keep the medicine out of the sight and reach of children. Store the medicine at a temperature below 30°C. 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 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 NT 145 contains

• The active substance is fenofibrate. Each tablet of Lipanthyl NT 145 contains 145 mg of fenofibrate.
• The other ingredients are: hypromellose, sodium docusate, sucrose, sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose with colloidal silicon dioxide, crospovidone, magnesium stearate. The coating contains: polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin, xanthan gum.

What Lipanthyl NT 145 looks like and contents of the pack

• Lipanthyl NT 145 is available in the form of white, elongated, coated tablets with "145" engraved on one side and the Fournier logo on the other.
• Lipanthyl NT 145 is packaged in 30 tablets.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Manufacturer

Astrea Fontaine, Rue des Prés Potets, 21121 Fontaine-lés-Dijon, France, Mylan Laboratories SAS, Route de Belleville, Lieu-dit Maillard, 01400 Châtillon-sur-Chalaronne, France, Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary. For more detailed information, please contact the local representative of the marketing authorization holder: Viatris Healthcare Sp. z o.o., tel. 22 546 64 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

MRP procedure No. DE/H/0497/001:

Germany:Lipidil 145 ONE

• Austria: Lipanthyl Nanopartikel 145 mg
• Belgium: Lipanthylnano 145 mg
• Luxembourg: Lipanthylnano 145 mg
• Czech Republic: Lipanthyl NT 145 mg
• Finland: Lipanthyl Penta 145 mg
• France: Lipanthyl 145 mg
• Greece: Lipidil NT 145 mg
• Hungary: Lipidil 145 mg
• Ireland: Lipantil supra 145 mg
• Italy: Fulcrosupra 145 mg
• Poland: Lipanthyl NT 145
• Slovakia: Lipanthyl NT 145 mg
• Spain: Secalip 145 mg

MRP procedure No. DE/H/0498/001:

• Germany: Xafenor 145 mg
• Portugal: Supralip 145 mg

MRP procedure No. DE/H/0500/001:

• Germany: Liperial 145 mg
• France: Fenofibrate Fournier 145 mg
• Italy: Liperial 145 mg

Date of last revision of the leaflet: