Pitamet

PACKAGE LEAFLET: INFORMATION FOR THE USER

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, as you may need to read it again.
• 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 adverse reactions 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, as well as 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 to follow 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 contraceptive methods (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 to take PITAMET.
Warnings and precautions
Before starting to take PITAMET, discuss with the doctor or pharmacist if:

• the patient has respiratory failure (serious breathing problems);
• the patient has ever had kidney problems;
• the patient has 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 experienced muscle problems while taking other cholesterol-lowering medicines (e.g. statins or fibrates);
• the patient consumes 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), 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 gravis (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 statements apply to the patient (or 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 additional 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 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 with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without prescription and herbal preparations. Some medicines may interfere with each other's action. 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 oral fusidic acid for a bacterial infection, treatment with PITAMET must be interrupted. The doctor will inform the patient when they can resume PITAMET. Concomitant use of PITAMET and fusidic acid may, in rare cases, cause muscle weakness, tenderness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• if the patient is taking medicines containing glecaprevir and pibrentasvir, medicines used to treat 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 plans to become pregnant, she should consult her doctor before starting PITAMET. Women of childbearing age must use an effective method of contraception during treatment with PITAMET. If the 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 using machines
PITAMET is not expected to affect the ability to drive or use machines. 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 previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take PITAMET

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Taking the medicine
The tablet should be swallowed whole with water, during or regardless of meals.
PITAMET can be taken at any time of day. However, it is recommended to take the tablet at approximately the same time each day.
Tablet 4 mg only: The score line on the 4 mg coated tablet is intended solely for ease of swallowing in patients who have difficulty swallowing the tablet whole. The tablet may be divided along the score line if necessary.

Dosage

• The usual initial dose of this medicine is 1 mg of pitavastatin (using another product containing pitavastatin) once daily. After several weeks, your doctor may decide to increase the dose. The maximum dose for adults and children over 10 years of age is 4 mg daily.
• If the patient has liver problems, the daily dose should not exceed 2 mg.

Use in children and adolescents

• The maximum dose for children under 10 years of age is 2 mg daily.
• If necessary, the tablet may be dispersed in a glass of water to form a suspension immediately before administration. The glass should then be rinsed with an equal volume of water, which should also be consumed immediately. Tablets should not be dissolved in fruit juices or milk.
• PITAMET is not recommended for use in children under 6 years of age.

Other important information while taking PITAMET

• If hospitalization or medical treatment for another condition becomes necessary, inform the medical staff that you are taking PITAMET.
• Your doctor may perform regular checks of your cholesterol levels.
• Do not stop taking PITAMET without first consulting your doctor, as cholesterol levels may rise.

If you take more PITAMET than you should
If you take more PITAMET than recommended, contact your doctor or go to a hospital immediately. Bring the medicine package with you.

If you forget to take PITAMET
Do not be concerned. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

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.
The following adverse reactions may occur during treatment with this medicine:
If any of the following adverse reactions occur, stop taking PITAMET and contact your 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 bumps);
• unexplained muscle pain or weakness, especially if accompanied by general malaise, fever or red-brown coloured urine. PITAMET may in rare cases (in less than 1 person in 1000) cause unpleasant symptoms affecting the muscular system. If these symptoms are neglected, they may lead to serious disorders 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 (occurs in less than 1 person in 10)

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

Uncommon (occurs in less than 1 person in 100)

• 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 often (frequency of urination);
• tingling sensation and reduced sensation in fingers of hands and feet, legs and face.

Rare (occurs in less than 1 person in 1000)

• redness of the skin, infected, red, itchy skin;
• worsening of vision;
• tongue pain;
• unpleasant sensation or discomfort in the stomach;
• enlargement of breasts in men (gynaecomastia).

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

• persistent muscle weakness;
• lupus-like syndrome (including rash, joint disorders and effects on blood cell counts);
• 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 that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible adverse reactions

• memory loss;
• sexual disorders;
• diabetes. The risk of developing diabetes is higher in people with high blood levels of sugar and fats, overweight and high blood pressure. Your doctor may monitor your condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at 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 provide more information on the safety of this medicine.

5. How to store PITAMET

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the outer carton following “Expiry date (EXP)”. The expiry date refers to the last day of the specified month.
Store blisters in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures will 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 calcium salt equivalent to 2 mg or 4 mg of pitavastatin.
Other ingredients are: monohydrate lactose (see section 2 “PITAMET contains lactose”), hydroxypropylcellulose low-substituted, hypromellose 606, magnesium hydroxide, magnesium stearate, hypromellose 2910, titanium dioxide (E171), polyethylene glycol 400.

What PITAMET looks like and contents of the pack
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, marked “P4” on the other side, approximately 9 mm in diameter. The breakline is intended solely for splitting the tablet if the patient has difficulty swallowing it whole.

PITAMET is available in blisters containing 7, 28 or 30 coated tablets, and in unit dose blisters 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

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 Warsaw,
tel. (22) 345 93 00