Lipanor

Leaflet accompanying the packaging: patient information

LIPANOR, 100 mg, capsules

Ciprofibrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lipanor and what is it used for

Lipanor belongs to a group of medicines called fibrates. These medicines are used to reduce the level of fats (lipids) in the blood. Examples of such fats include triglycerides. Lipanor is used in combination with a low-fat diet and other non-pharmacological treatments, such as physical exercise and weight loss, which aim to reduce the level of fats in the blood.

2. Important information before taking Lipanor

When not to take Lipanor

• if the patient is allergic to ciprofibrate or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if the patient is pregnant, plans to become pregnant, or suspects she may be pregnant (see the section "Pregnancy and breastfeeding" below).
• if the patient is breastfeeding or plans to breastfeed (see the section "Pregnancy and breastfeeding" below).
• if the patient has severe kidney or liver function disorders.
• if the patient is taking other fibrates (such as clofibrate, bezafibrate, fenofibrate, or gemfibrozil) used to treat high lipid levels in the blood.

Do not take the medicine if any of the above conditions apply to the patient. In case of doubts, consult a doctor or pharmacist before taking Lipanor.

Warnings and precautions

Before starting to take Lipanor, discuss it with your doctor or pharmacist if:

• the patient has unexplained muscle pain, muscle tenderness, or muscle weakness.
• the patient has kidney or liver function disorders.
• the patient has hypothyroidism.
• the patient regularly consumes large amounts of alcohol.
• the patient is over 70 years old.
• the patient or their family members have a history of hereditary muscle disorders.
• the patient has experienced muscle disorders while taking other fibrates (lipid-lowering medicines).
• the medicine is used in children.

In case of doubts whether any of the above conditions apply to the patient, consult a doctor or pharmacist before starting to take Lipanor.

Blood tests

Taking Lipanor may affect the results of some blood tests. During treatment, the doctor may order blood tests to assess liver function. If the patient is to have other blood tests, they should inform the person performing the test that they are taking Lipanor.

Lipanor and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This is because Lipanor may interact with other medicines. Also, some medicines may interact with Lipanor. Inform your doctor if the patient is taking any of the following medicines:

• fibrates (such as clofibrate, bezafibrate, fenofibrate, or gemfibrozil) used to treat high lipid levels in the blood.
• statins (such as simvastatin, atorvastatin, pravastatin, fluvastatin, or rosuvastatin) used to treat high lipid levels in the blood.
• warfarin - used to thin the blood.
• metformin - used to treat diabetes.
• contraceptives (used to prevent pregnancy) or hormone replacement therapy (HRT).

Lipanor and alcohol

One of the side effects of taking Lipanor is muscle disorders. Consuming large amounts of alcohol may increase the risk of such disorders. Therefore, limit alcohol consumption while taking Lipanor. Consult a doctor for detailed advice.

Pregnancy and breastfeeding

Do not take Lipanor if:

• the patient is pregnant, plans to become pregnant, or suspects she may be pregnant,
• the patient is breastfeeding or plans to breastfeed.

If the patient is pregnant, breastfeeding, or suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Driving and operating machinery

While taking Lipanor, the patient may experience dizziness, drowsiness, and fatigue. If such symptoms occur, do not drive vehicles, use tools, or operate machinery.

Lipanor contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Lipanor contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Lipanor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking the medicine

Take the medicine orally. It is important to follow a suitable diet while taking Lipanor. If you feel that the effect of the medicine is too strong or too weak, consult your doctor. Do not change the dose of the medicine yourself.

How much medicine to take

The recommended dose is 1 capsule once a day. Do not take more than 1 capsule a day.

Taking more than the recommended dose of Lipanor

If you take more than the recommended dose of Lipanor, contact your doctor or go to the nearest hospital immediately. Take the packaging of the medicine with you so that the doctor knows what medicine has been taken.

Missing a dose of Lipanor

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Lipanor treatment

Take Lipanor for as long as your doctor tells you to. Do not stop taking Lipanor just because you feel better. If you stop taking the medicine, your condition may worsen. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Lipanor and contact your doctor or go to the nearest hospital immediately (you may need urgent medical attention) if you experience:

• Muscle disorders, such as muscle cramps, muscle pain, or muscle tenderness. This can lead to kidney failure.

Contact your doctor immediately if you experience any of the following side effects:

• An allergic reaction. Symptoms may include: rash (which may be itchy and lumpy), itching, and sensitivity to sunlight.
• Shortness of breath.
• Liver disorders, which may cause yellowing of the eyes or skin (jaundice).
• Severe pain in the right upper abdomen, which may radiate to the back - this may be a sign of a gallstone or biliary colic.

The following side effects have been observed during Lipanor treatment:

Common(may affect up to 1 in 10 people):

• headache,
• dizziness,
• drowsiness,
• nausea,
• vomiting,
• diarrhea,
• indigestion,
• abdominal pain,
• rash,
• hair loss,
• muscle pain,
• fatigue. Frequency not known(frequency cannot be estimated from the available data):
• pneumonia, pulmonary fibrosis,
• liver function disorders,
• cholestasis (bile stagnation),
• gallstones,
• liver cell breakdown (cytolysis),
• hives,
• itching,
• sensitivity to sunlight,
• eczema,
• muscle disorders (muscle damage, muscle inflammation, muscle breakdown),
• erectile dysfunction,
• easy bruising, which may be a sign of blood disorders (low platelet count).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipanor

Do not store above 25°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. 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 packaging and other information

What Lipanor contains

• The active substance of the medicine is ciprofibrate. Each capsule contains 100 mg of ciprofibrate.
• The other ingredients are: corn starch and lactose. Capsule ingredients: gelatin, titanium dioxide, yellow iron oxide, black iron oxide.

What Lipanor looks like and contents of the packaging

Greenish-olive colored cap and ivory colored body gelatin capsules, containing a fine white to off-white powder. Pack size: 30 capsules (3 blisters of 10 capsules).

Responsible entity

Sanofi Winthrop Industrie, 82, Avenue Raspail, 94250 Gentilly, France

Manufacturer

Sanofi-Winthrop Industrie, 1, rue de la Vierge, Ambarès et Lagrave, 33565 Carbon Blanc Cedex, France, Opella Healthcare Poland Sp. z o.o., Branch in Rzeszów, ul. Lubelska 52, 35-233 Rzeszów. For more information, contact the local representative of the responsible entity: Sanofi Sp. z o.o., ul. Marcina Kasprzaka 6, 01-211 Warsaw, Tel.: +48 22 280 00 00

Date of last revision of the leaflet: