Lipanthyl nt 145

Patient Information Leaflet

Important! Keep this leaflet, as the packaging information is in a foreign language!
Lipanthyl NT 145 (Secalip 145 mg)
145 mg, coated tablets
Fenofibrate
Lipanthyl NT 145 and Secalip 145 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Lipanthyl NT 145 belongs to a group of medicines known as fibrates. These medicines are used to lower levels of fats (lipids) in the blood. An example of such fats is triglycerides. Lipanthyl NT 145 is used in combination with a low-fat diet and other non-medical treatment methods, such as physical exercise and weight loss, aimed at reducing blood fat levels.
In certain cases, Lipanthyl NT 145 may be used as an add-on to other medicines (statins) when blood fat levels cannot be controlled with statins alone.

2. Information before taking Lipanthyl NT 145

When not to take Lipanthyl NT 145

• if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information)
• if the patient is allergic to peanuts, peanut oil, or soy lecithin and its derivatives
• if the patient has previously experienced an allergic reaction or skin damage due to sunlight or UV radiation while taking other medicines (e.g. other fibrates or a non-steroidal anti-inflammatory drug called ketoprofen)
• if the patient has severe liver, kidney, or gallbladder disease
• if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of fats in the blood

If any of the above situations apply, Lipanthyl NT 145 must not be taken. If in doubt, consult a doctor or pharmacist before taking Lipanthyl NT 145.

Warnings and precautions
Before starting Lipanthyl NT 145, consult a doctor or pharmacist if:

• the patient has liver or kidney disease
• symptoms indicating liver inflammation have occurred: yellowing of the skin or whites of the eyes (jaundice), increased liver enzymes (shown by blood tests), abdominal pain, or itching
• the patient has reduced thyroid function (hypothyroidism)

If any of the above situations apply (or if in doubt), consult a doctor or pharmacist before taking Lipanthyl NT 145.

Effect on muscles
Immediately stop taking Lipanthyl NT 145 and contact a doctor if:

• unexpected muscle cramps
• muscle pain, tenderness to touch, or muscle weakness occur during treatment

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 and even death.

The doctor may order blood tests to monitor muscle status before and during treatment.
The risk of muscle breakdown may be higher in certain patients. Inform the doctor if:

• the patient is over 70 years old
• the patient has kidney disease
• the patient has thyroid disease
• the patient or a family member has a history of inherited muscle disorders
• the patient consumes large amounts of alcohol
• the patient is taking cholesterol-lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin)
• the patient has previously experienced muscle disorders while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil)

If any of the above situations apply (or if in doubt), consult a doctor before starting Lipanthyl NT 145.

Lipanthyl NT 145 and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor or pharmacist if the patient is taking:

• oral anticoagulants (e.g. warfarin)
• other medicines used to control blood lipid levels (such as statins or fibrates). Taking a statin or another fibrate together with Lipanthyl NT 145 may increase the risk of muscle damage
• certain medicines used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressive medicine)

If any of the above situations apply (or if in doubt), consult a doctor or pharmacist before taking Lipanthyl NT 145.

Pregnancy, breastfeeding, and fertility

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant. Due to insufficient experience with the use of Lipanthyl NT 145 during pregnancy, Lipanthyl NT 145 should be used only if clearly needed and considered essential by the doctor.
• It is not known whether the active substance of Lipanthyl NT 145 passes into breast milk. Therefore, Lipanthyl NT 145 should not be taken during breastfeeding or if the patient is planning to breastfeed.

Driving and using machines
Lipanthyl NT 145 has no influence on the ability to drive or operate machinery.

Lipanthyl NT 145 contains lactose, sucrose, soya oil, and sodium

• Lipanthyl NT 145 contains sugars called lactose and sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• Lipanthyl NT 145 contains soya oil. Patients with hypersensitivity to peanuts, peanut oil, or soya should not take this medicine.
• The product contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the product is considered "sodium-free".

3. How to take Lipanthyl NT 145

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your condition, current
treatment, and individual risk factors.
How to take the medicine
The tablet may be taken with or without food, at any time of day.

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

Please remember that during treatment with Lipanthyl NT 145, the following are important:

• a diet low in fat
• regular physical activity

Dosage
The recommended dose is one tablet per day.
Patients who have previously taken 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 problems, your doctor may reduce the dose. If you have any questions, contact your doctor or pharmacist.
Use in children and adolescents
Lipanthyl NT 145 is not recommended for use in individuals under 18 years of age.
Taking more Lipanthyl NT 145 than recommended
If you take more than the recommended dose, or if the medicine is accidentally taken by someone else, contact your doctor immediately or go to the emergency department of the nearest hospital.
Missed dose of Lipanthyl NT 145

• If you miss a dose, take the next dose at your usual time.
• Do not take a double dose to make up for the missed dose.
• Stopping treatment with Lipanthyl NT 145 Do not stop treatment unless instructed by your doctor or if the medicine causes discomfort. Abnormal blood fat levels require long-term treatment. If your doctor advises stopping treatment, do not keep the tablets unless otherwise instructed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the serious adverse reactions listed below occur, stop taking Lipanthyl NT 145 and contact your doctor immediately – prompt treatment may be necessary.

Not very common: may occur in up to 1 in 100 patients

• Muscle cramps or muscle pain, tenderness or weakness – these may be symptoms of muscle inflammation or muscle breakdown, which could lead to 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)

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 – these 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 of the skin resembling severe burns
• Chronic lung disease

If any of the above adverse reactions occur, stop taking Lipanthyl NT 145 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
• Bloating with flatulence
• 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 increased risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established)

Not very common: may occur in up to 1 in 100 patients

• Headache
• Gallstones
• Decreased libido
• Skin rash, itching or urticaria
• 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 tanning beds
• Decreased hemoglobin concentration (the oxygen-carrying pigment 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 associated with gallstones
• Feeling of fatigue

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 not exceeding 30°C.
Do not use this medicine after the expiry date stated on the packaging. 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. This will help protect the environment.

4. Contents of the packaging 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, monohydrate lactose, microcrystalline cellulose silicon dioxide, crospovidone, magnesium stearate. The coating contains: polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

What Lipanthyl NT 145 looks like and contents of the pack

• Lipanthyl NT 145 is a white, oblong film-coated tablet, embossed with "145" on one side and the Fournier logo on the other.
• Lipanthyl NT 145 is packed in packs of 30 tablets.

For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Lacer S.A.
Boters, 5
08290 Cerdanyola del Vallès
Barcelona
Spain
Manufacturer:
Astrea Fontaine
Rue Des Prés Potets
Fontaine Les Dijon 21121
France
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
Mylan Hungary Kft.
Mylan utca 1. Koppanymonostor
Komárom, 2900
Hungary
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Relabeled in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Spanish Marketing Authorisation Number (country of export): 651465.8
Parallel Import Authorisation Number: 153/21
This medicinal product is authorised for marketing in the European Economic Area countries 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