Lipanor

Package leaflet: Information for the patient

LIPANOR, 100 mg, capsules
Ciprofibratum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet ((logo of the marketing authorization holder))

1. What Lipanor is and what it is 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 pack and other information

1. What Lipanor is and what it is used for

Lipanor belongs to a group of medicines called fibrates. These medicines are used to reduce the levels of fats (lipids) in the blood. An example of such fats are triglycerides. Lipanor is used in combination with a low-fat diet and other non-pharmacological treatment approaches, such as physical exercise and weight reduction, aimed at lowering blood fat levels.

2. Important information before taking Lipanor

When not to take Lipanor

• if the patient is allergic to cyprolbrate 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, planning to become pregnant, or suspects she may be pregnant (see section "Pregnancy and breastfeeding" below).
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding" below).
• if the patient has severe impairment of kidney or liver function.
• if the patient is currently taking other fibrates (such as clofibrate, bezafibrate, fenofibrate or gemfibrozil), used to treat high blood lipid levels.

Do not take this medicine if any of the above conditions apply to you. In case of doubt, consult your doctor or pharmacist before taking Lipanor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lipanor if:

• the patient experiences unexplained muscle pain, tenderness or weakness.
• the patient has impaired kidney or liver function.
• the patient has hypothyroidism.
• the patient regularly consumes large amounts of alcohol.
• the patient is over 70 years old.
• the patient or members of their family have inherited muscle disorders.
• the patient has previously experienced muscle-related problems while taking other fibrates (medicines used to reduce blood lipid levels).
• the medicine is to be used in children.

If in doubt whether any of the above conditions apply, consult your doctor or pharmacist before starting treatment with Lipanor.

Blood tests

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

Lipanor with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is because Lipanor may affect the action of other medicines, and some medicines may affect the action of 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 blood lipid levels.
• statins (such as simvastatin, atorvastatin, pravastatin, fluvastatin, rosuvastatin), used to treat high blood lipid levels.
• warfarin – used to thin the blood.
• metformin – used to treat diabetes.
• contraceptive medicines (used to prevent pregnancy) or hormone replacement therapy (HRT).

Lipanor and alcohol

One of the adverse effects associated with Lipanor is muscle-related disorders. Consuming large amounts of alcohol may increase the risk of such disorders. Therefore, alcohol intake should be limited during treatment with Lipanor. Consult your doctor for specific advice.

Pregnancy and breastfeeding

Do not take Lipanor if:

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

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Lipanor contains lactose

If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Lipanor contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to take Lipanor

This medicine should always be taken as directed by the physician. In case of any doubts,
consult your doctor or pharmacist.
Administration of the medicine
The medicine should be taken orally.
It is important to follow an appropriate 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 dosage of the medicine on your own.
Dosage
The recommended dose is 1 capsule once daily.
Do not take more than 1 capsule per day.
Overdose of Lipanor
In case of taking more than the recommended dose of Lipanor, contact your doctor immediately
or go to the nearest hospital. Bring the medicine package with you so that the doctor knows
which medicine has been taken.
Missed dose of Lipanor
If a patient forgets to take a dose, they should take it as soon as they remember.
However, if it is almost time for the next dose, the missed dose should be skipped.
Do not take a double dose to make up for the missed dose.
Discontinuation of Lipanor
Lipanor should be taken until the doctor decides to discontinue it. Do not stop taking Lipanor
just because the patient feels better. Discontinuing the medicine may lead to worsening of the patient's condition.
In case of any further doubts regarding 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 everybody will experience them.
The use of Lipanor must be discontinued and immediate contact with a doctor must be made or
the patient must go to the nearest hospital (urgent treatment may be required) if the patient
experiences:

• Muscle-related disorders such as muscle cramps, muscle pain or tenderness. These may lead to kidney failure.

Immediate contact with a doctor is required if the patient experiences any of the
following adverse reactions:

• Allergic reaction. Symptoms may include: rash (which may be itchy and raised), itching, and photosensitivity.
• Shortness of breath.
• Liver-related disorders which may cause yellowing of the eyes or skin (jaundice).
• Severe pain in the upper right abdomen, possibly radiating to the back – this may be a symptom of biliary colic or gallstones.

The following adverse reactions have been observed during treatment with Lipanor:
Common (may occur in up to 1 in 10 people):

• headache,
• dizziness,
• drowsiness,
• nausea,
• vomiting,
• diarrhoea,
• indigestion,
• abdominal pain,
• rash,
• hair loss,
• muscle pain,
• fatigue.

Frequency unknown (frequency cannot be estimated from available data):

• lung inflammation, pulmonary fibrosis,
• liver function disorders,
• cholestasis (bile stasis),
• gallstones,
• liver cell breakdown (cytolysis),
• urticaria,
• pruritus,
• photosensitivity,
• skin eruption (eczema),
• muscle-related disorders (muscle damage, myositis, rhabdomyolysis),
• erectile dysfunction,
• easy bruising, which may be a sign of blood-related disorders (low platelet count).

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, the patient should inform their 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to 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 pack. 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 practices help protect the environment.

6. Contents of the pack and other information

What Lipanor contains

• The active substance is cyprofillate. Each capsule contains 100 mg of cyprofillate.
• Other ingredients are: maize starch and lactose. Capsule composition: gelatin, titanium dioxide, yellow iron oxide, black iron oxide.

What Lipanor looks like and contents of the pack
Olive-green capped and ivory-bodied gelatin capsules containing a fine powder ranging from white to off-white. Pack size: 30 capsules (3 blisters of 10 capsules each).

Marketing Authorisation Holder
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 detailed information, please contact the local representative of the Marketing Authorisation Holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00