Lipanthil Nt 145

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging 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 trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, which aim to lower the level of fats in the blood.
Lipanthyl NT 145 may be used as an addition to other medicines (statins), if the level of fats in the blood cannot be controlled using only statins.

2. Important 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, arachidic oil, or soy lecithin and their derivatives
• if the patient has 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 the patient has severe liver, kidney, or gallbladder disease
• if the patient has pancreatitis (a disease that causes abdominal pain), which is not caused by high levels of fats in the blood

If any of the above situations apply to the patient, they should not take Lipanthyl NT 145. In case of doubts, the patient should consult a doctor or pharmacist before taking Lipanthyl NT 145.

• 145. In case of doubts, the patient should consult a doctor or pharmacist before taking Lipanthyl NT 145.

Warnings and precautions

Before starting to take Lipanthyl NT 145, the patient should discuss it with their doctor or pharmacist if:

• they have liver or kidney disease
• they have 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
• they have reduced thyroid function (hypothyroidism) If any of the above situations apply to the patient (or in case of doubts), they should consult a doctor or pharmacist before taking Lipanthyl NT 145.

Effect on muscles

The patient should stop taking Lipanthyl NT 145 immediately and contact their doctor if:

• they experience unexpected muscle cramps
• they have muscle pain, muscle tenderness to the touch, or muscle weakness while taking the medicine 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.

The doctor may order a blood test to check the condition of the muscles before and after starting treatment.
The risk of muscle breakdown may be higher in some patients. The patient should inform their doctor if:

• they are over 70 years old
• they have kidney disease
• they have thyroid disease
• they or a family member have had hereditary muscle disorders
• they consume large amounts of alcohol
• they are taking cholesterol-lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin)
• they have had muscle diseases while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil) If any of the above situations apply to the patient (or in case of doubts), they should consult a doctor before starting to take Lipanthyl NT 145.

Lipanthyl NT 145 and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take. In particular, they should inform their doctor or pharmacist about taking medicines such as:

• oral blood thinners (e.g., warfarin)
• other medicines used to maintain a healthy 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)
• cyclosporine (an immunosuppressive medicine) If any of the above situations apply to the patient (or in case of doubts), they should consult a doctor or pharmacist before taking Lipanthyl NT 145.

Pregnancy, breastfeeding, and fertility

• The patient should inform their doctor if they are pregnant, think they 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, the medicine should only be taken if the doctor considers it absolutely necessary.
• It is not known whether the active substance of Lipanthyl NT 145 passes into breast milk. For this reason, the medicine should not be taken during breastfeeding or if the patient plans to breastfeed.

Driving and using machines

The medicine does not affect driving or using machines.

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

• Lipanthyl NT 145 contains sugars called lactose and sucrose. If the patient has been diagnosed with intolerance to some sugars, they should contact their 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

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The doctor will determine the correct dose of the medicine based on the patient's condition, current therapy, and personal risk.

Using the medicine

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

• The patient should swallow the tablet whole and drink a glass of water.
• The patient should not crush or chew the tablet.

It is essential to remember that during treatment with Lipanthyl NT 145:

• a low-fat diet
• regular physical activity

How much to take

The recommended dose is one tablet per day.
Patient who have been taking one 200 mg capsule of Lipanthyl 200M or one 160 mg tablet of Lipanthyl Supra 160 can switch to one 145 mg tablet of Lipanthyl NT 145.
Patients with kidney diseaseThe doctor may reduce the dose in case of kidney disease. In case of questions, the patient should contact their doctor or pharmacist.

Use in children and adolescents

Lipanthyl NT 145 should not be used in patients under 18 years of age.

Taking more than the recommended dose of Lipanthyl NT 145

In case of taking a higher dose than recommended, or accidental ingestion of the medicine by another person, the patient should immediately contact their doctor or go to the emergency room of the nearest hospital.

Missing a dose of Lipanthyl NT 145

• In case of missing a dose, the patient should take the next dose at the usual time.
• The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Lipanthyl NT 145

The patient should not stop treatment unless their doctor decides to. Abnormal levels of fats in the blood require long-term treatment. If the doctor recommends stopping treatment, the patient should not store the tablets unless the doctor decides otherwise.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lipanthyl NT 145 can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, the patient should stop taking Lipanthyl NT 145 and contact their doctor immediately – prompt treatment may be necessary.

Uncommon:may affect up to 1 in 100 people

• muscle cramps or muscle pain, muscle tenderness to the touch, or muscle weakness - these may be symptoms of muscle inflammation or muscle breakdown, which can cause 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 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 levels of liver enzymes - these may be symptoms of liver inflammation

Frequency not known:frequency cannot be estimated

• severe skin rash with redness, peeling, and swelling of the skin, resembling severe burns
• chronic lung disease

If the patient experiences any of the above side effects, they should stop taking Lipanthyl NT 145 and contact their doctor immediately.

Other side effects

In case of any of the following side effects, the patient should contact their 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 - shown 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 yet)

Uncommon:may affect up to 1 in 100 people

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

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

• hair loss
• increased urea levels in the blood - shown 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 - shown by laboratory tests

Frequency not known:frequency cannot be estimated

• muscle breakdown
• complications related to gallstones
• feeling tired

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lipanthyl NT 145

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 30°C.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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, 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 available in the form of white, elongated, coated tablets with "145" embossed on one side and the Fournier logo on the other.
• Lipanthyl NT 145 is packaged in 30 tablets.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
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 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 651465.8
Parallel import authorization number: 153/21

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 revision of the leaflet: 27.09.2023

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