Pitamet

PACKAGE LEAFLET: INFORMATION FOR THE USER

PITAMET, 1 mg, film-coated tablets
PITAMET, 2 mg, film-coated tablets
PITAMET, 4 mg, film-coated tablets
pitavastatin
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. This medicine may harm others, 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.

Leaflet contents:

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

1. What PITAMET is and what it is used for

PITAMET contains an active substance called pitavastatin. It belongs to a group of medicines known as "statins". PITAMET is used to correct blood lipid (fat) levels and can be taken by both children aged 6 years and older and adults. Abnormal lipid levels, particularly high cholesterol, may sometimes lead to heart attack or stroke.
PITAMET has been prescribed for the patient due to lipid imbalance when changes in diet and lifestyle have not provided sufficient improvement. While taking PITAMET, the patient should continue a cholesterol-lowering diet and maintain lifestyle modifications.

2. Important information before taking PITAMET

When not to take PITAMET:

• if the patient is allergic (hypersensitive) to pitavastatin, any other statin, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding;
• if the patient is of childbearing age and is not using effective methods of contraception (see "Pregnancy and breastfeeding");
• if the patient has liver problems;
• if the patient is taking cyclosporine – used after organ transplantation;
• if the patient has recurrent or unexplained muscle pain.

If the patient has any doubts, they should speak with their doctor or pharmacist before starting PITAMET.

Warnings and precautions

Before starting PITAMET, discuss with your doctor or pharmacist if:

• the patient has respiratory failure (serious breathing problems);
• the patient has ever had kidney problems;
• the patient has had liver problems. In some people, "statins" may affect the liver. The doctor usually performs blood tests (liver function tests) before and during treatment with PITAMET;
• the patient has ever had thyroid problems;
• the patient or members of their family have had muscle problems;
• the patient has had muscle problems while taking other cholesterol-lowering medicines (e.g. statins or fibrates);
• the patient drinks excessive amounts of alcohol;
• if the patient is taking or has taken within the last 7 days a medicine called fusidic acid (used for bacterial infections), taken orally or by injection. Concomitant use of fusidic acid and PITAMET may cause serious muscle problems (rhabdomyolysis);
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

If any of the above apply to the patient (or if the patient is unsure), they should contact their doctor or pharmacist before taking PITAMET. The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and treatment with other medicines may be necessary for diagnosis and treatment of this condition.

Patients with diabetes or those at risk of developing diabetes will remain under close medical supervision while taking this medicine. Patients with high levels of blood sugar and fats, overweight, and high blood pressure may be at increased risk of developing diabetes.

Children and adolescents

PITAMET should not be given to children under 6 years of age.

Girls of childbearing age should receive advice on contraception before starting PITAMET.

PITAMET and other medicines

Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or plans to take any other medicines, including those obtained without a prescription and herbal supplements. Some medicines may interfere with each other. In particular, inform the doctor or pharmacist if the patient is taking:

• other medicines called "fibrates" – such as gemfibrozil and fenofibrate;
• erythromycin or rifampicin – types of antibiotics used for infections;
• warfarin or other medicines used to thin the blood;
• antiviral medicines for HIV, called "protease inhibitors" (e.g. ritonavir, lopinavir, darunavir, atazanavir) and "non-nucleoside reverse transcriptase inhibitors" (e.g. efavirenz);
• niacin (vitamin B3);
• if the patient needs to take fusidic acid orally due to a bacterial infection, treatment with PITAMET must be temporarily discontinued. The doctor will inform the patient when it is safe to resume PITAMET. Concomitant use of PITAMET and fusidic acid may, in rare cases, cause muscle weakness, tenderness, or muscle pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4;
• if the patient is taking medicines containing glecaprevir and pibrentasvir, used in the treatment of hepatitis C virus infection. The doctor may adjust the dose of pitavastatin.

If the patient is taking any of the above medicines (or is unsure), they should contact their doctor or pharmacist before taking PITAMET.

PITAMET with food and drink

PITAMET can be taken with or without food.

Pregnancy, breastfeeding, and fertility

PITAMET is contraindicated during pregnancy and breastfeeding. If the patient is planning to become pregnant, she should consult her doctor before starting PITAMET. Women of childbearing potential must use an effective method of contraception during treatment with PITAMET. If a patient becomes pregnant while taking PITAMET, she should stop taking the medicine and contact her doctor immediately. If the patient is pregnant or breastfeeding, she should contact her doctor or pharmacist before taking any medicine.

Driving and operating machinery

PITAMET is not expected to affect the ability to drive or operate machinery. However, if dizziness or drowsiness occurs while taking PITAMET, the patient should not drive, operate machinery, or use tools.

PITAMET contains lactose

PITAMET contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take the medicine PITAMET

This medicine should always be taken as directed by the physician. In case of doubts,
consult the doctor or pharmacist.
Taking the medicine
The tablet should be swallowed whole with water, during a meal or regardless of meals.
The medicine can be taken at any time of day. However, it is advisable to take the tablet at the
same time each day.
Only the 4 mg tablet: the score line on the 4 mg coated tablet is intended solely for splitting
the tablet if the patient has difficulty swallowing it whole.
Dosage

• The usual initial dose of the medicine is 1 mg once daily. After several weeks, the physician may decide to increase the dose. The maximum dose for adults and children over 10 years of age is 4 mg per day.
• If the patient has liver problems, they should not take more than 2 mg per day.

Use in children and adolescents

• The maximum dose for children under 10 years of age is 2 mg per day.
• If necessary, the tablet may be dispersed in a glass of water to form a suspension immediately before administration, then rinse the glass with the same volume of water and drink immediately. Tablets should not be dispersed in fruit juices or milk.
• PITAMET is not recommended for use in children under 6 years of age.

Other important information during treatment with PITAMET

• In case of hospitalization or treatment for another condition, inform the medical staff that you are taking PITAMET.
• The physician may perform regular checks of cholesterol levels.
• Do not discontinue treatment with PITAMET without prior consultation with the physician. Cholesterol levels may increase.

Overdose of PITAMET
In case of ingestion of a dose higher than recommended, contact a physician or go to the hospital immediately. Bring the medicine packaging with you.
Missed dose of PITAMET
Do not be alarmed; simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur during treatment with this medicine:
If any of the following adverse reactions occur, stop taking PITAMET and contact a doctor immediately – immediate medical intervention may be necessary:

• allergic reaction – may present as: difficulty breathing, swelling of the face, tongue or throat, difficulty swallowing, severe itching of the skin (with raised lumps);
• unexplained muscle pain or weakness, especially if accompanied by general malaise, fever or red-brown coloured urine. PITAMET may rarely (in less than 1 in 1000 people) cause unpleasant symptoms affecting the muscular system. If these symptoms are ignored, they may lead to serious conditions such as muscle breakdown (rhabdomyolysis), which may result in kidney problems;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• liver problems, which may cause yellowing of the skin and eyes (jaundice);
• pancreatitis (severe abdominal and back pain).

Other adverse reactions include:
Common (affects less than 1 in 10 people)

• joint pain, muscle pain;
• constipation, diarrhoea, indigestion, nausea;
• headache.

Uncommon (affects less than 1 in 100 people)

• muscle cramps;
• feeling weak, tired, general malaise;
• swelling of ankles, feet or fingers;
• abdominal pain, dry mouth, nausea, loss of appetite, altered taste;
• pale skin, weakness or shortness of breath (anaemia);
• itching or rash;
• ringing in the ears;
• dizziness or drowsiness, insomnia (other sleep disorders, including nightmares);
• need to urinate more frequently (frequency);
• tingling sensation and reduced sensation in fingers and toes, legs and face.

Rare (affects less than 1 in 1000 people)

• redness of the skin, inflamed, red, itchy skin;
• blurred vision;
• sore tongue;
• unpleasant sensation or discomfort in the stomach;
• breast enlargement in men (gynaecomastia).

Adverse reactions of unknown frequency (frequency cannot be determined from available data)

• persistent muscle weakness;
• lupus-like syndrome (including rash, joint disorders and effects on blood cell count);
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing);
• ocular myasthenia (a disease causing weakness of eye muscles). You should speak to your doctor if you experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible adverse reactions

• memory loss;
• sexual dysfunction;
• depression;
• diabetes. The risk of developing diabetes is higher in people who have high levels of blood sugar and fats, are overweight and have high blood pressure. Your doctor may monitor your condition while you are taking this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store PITAMET medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister packs and the outer carton following “Expiry date (EXP)”. The expiry date refers to the last day of the specified month.
Store blister packs in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What PITAMET contains
The active substance is pitavastatin. Each coated tablet contains pitavastatin as the calcium salt equivalent to 1 mg, 2 mg or 4 mg of pitavastatin.
The other ingredients are: monohydrate lactose (see section 2 “PITAMET contains lactose”), low-substituted hydroxypropylcellulose, hypromellose 606, magnesium hydroxide, magnesium stearate, hypromellose 2910, titanium dioxide (E171), polyethylene glycol 400.

What PITAMET looks like and contents of the pack
PITAMET 1 mg, coated tablets, white, cylindrical, biconvex, without a breakline, marked “P1” on one side, approximately 6 mm in diameter.
PITAMET 2 mg, coated tablets, white, cylindrical, biconvex, without a breakline, marked “P2” on one side, approximately 7 mm in diameter.
PITAMET 4 mg, coated tablets, white, cylindrical, biconvex, with a breakline on one side and marked “P4” on the other side, approximately 9 mm in diameter. The breakline is intended solely to facilitate breaking the tablet if the patient has difficulty swallowing it whole.

PITAMET is available in blister packs containing 7, 28 or 30 coated tablets, and in unit dose blister packs of 7 x 1, 28 x 1, 30 x 1 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva B.V.,
Swensweg 5,
2031 GA Haarlem,
The Netherlands

Manufacturer:
LABORATORIOS CINFA, S.A.,
Carretera Olaz-Chipi, 10, Polígono Industrial Areta
31620 Huarte,
Spain

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

For further information about this medicine and its trade names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
ul. Emilii Plater 53,
00-113 Warszawa,
tel. (22) 345 93 00