Pitamet

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

PITAMET, 2 mg, coated tablets

PITAMET, 4 mg, coated tablets

Pitavastatin

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

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

Table of contents of the leaflet:

• 1. What is PITAMET and what is it 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 is PITAMET and what is it used for

PITAMET contains the active substance pitavastatin. It belongs to a group of medicines called "statins". PITAMET is used to correct lipid levels in the blood and can be taken by children from 6 years of age and adults. An inappropriate lipid level, especially cholesterol, can sometimes lead to a heart attack or stroke. PITAMET has been prescribed for you because you have a lipid imbalance and changing your diet and lifestyle has not provided sufficient improvement. While taking PITAMET, you should continue to follow a cholesterol-lowering diet and maintain lifestyle changes.

2. Important information before taking PITAMET

When not to take PITAMET:

• if you are allergic (hypersensitive) to pitavastatin, any other statin or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if you are of childbearing age and do not use effective methods of contraception (see "Pregnancy and breastfeeding");
• if you have liver problems;
• if you are taking cyclosporine - used after organ transplantation;
• if you have recurring or unexplained muscle pain.

If you have any doubts, you should discuss them with your doctor or pharmacist before starting to take PITAMET.

Warnings and precautions

Before starting to take PITAMET, you should discuss it with your doctor or pharmacist if:

• you have respiratory failure (severe breathing problems);
• you have ever had kidney problems;
• you have had liver problems. In some people, "statins" can affect the liver. Your doctor will usually perform blood tests (liver function tests) before and during treatment with PITAMET;
• you have had thyroid problems;
• you or your family members have had muscle problems;
• you have had muscle problems while taking other cholesterol-lowering medicines (e.g. statins or fibrates);
• you drink excessive amounts of alcohol;
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (used for bacterial infections), orally or by injection. Taking fusidic acid and PITAMET at the same time may cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

If any of the above statements apply to you (or you are not sure), you should contact your doctor or pharmacist before taking PITAMET. You should also inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary. People with diabetes or at risk of developing diabetes will be under close medical supervision while taking this medicine. People with high blood sugar and lipid levels, 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. Before starting to take PITAMET, adolescent girls should receive advice on contraception.

PITAMET and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription and herbal preparations. Some medicines may interfere with each other's proper functioning. In particular, you should inform your doctor or pharmacist if you are 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;
• 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 you need to take fusidic acid orally for a bacterial infection, you will need to stop taking PITAMET. Your doctor will tell you when you can restart taking PITAMET. Taking PITAMET and fusidic acid at the same time may, in rare cases, cause muscle weakness, muscle tenderness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• if you are taking medicines containing glecaprevir and pibrentasvir, medicines used to treat hepatitis C. Your doctor may change the dose of pitavastatin.

If you are taking any of the above medicines (or are not sure), you should contact your 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 you plan to become pregnant, you should consult your doctor before starting to take PITAMET. Women of childbearing age must use effective contraception while taking PITAMET. If you become pregnant while taking PITAMET, you should stop taking the medicine and contact your doctor immediately. If you are pregnant or breastfeeding, you should contact your doctor or pharmacist before taking any medicine.

Driving and using machines

PITAMET is not expected to affect your ability to drive or use machines. However, if you experience dizziness or drowsiness while taking PITAMET, you should not drive, operate machinery, or use tools.

PITAMET contains lactose

PITAMET contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking PITAMET.

3. How to take PITAMET

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking the medicine

Swallow the tablet whole with water, during or without meals. You can take the medicine at any time of the day. However, try to take the tablet at the same time every day. Only the 4 mg tablet: the score line on the 4 mg coated tablet is only for breaking the tablet if you have difficulty swallowing it whole.

Dosage

• The usual starting dose of PITAMET is 1 mg of pitavastatin (using another product containing pitavastatin) once a day. After a few weeks, your doctor may decide to increase the dose. The maximum dose for adults and children over 10 years of age is 4 mg per day.
• If you have liver problems, you should not take more than 2 mg per day.

Use in children and adolescents

• The maximum dose in children under 10 years of age is 2 mg per day.
• The tablet can be dissolved in a glass of water just before taking, and then the glass should be rinsed with the same amount of water and taken immediately. The 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 you are hospitalized or treated for another condition, you should inform the medical staff that you are taking PITAMET.
• Your doctor may perform regular cholesterol checks.
• You should not stop taking PITAMET without consulting your doctor first. Your cholesterol level may increase.

Taking a higher dose of PITAMET than recommended

If you have taken more PITAMET than you should, you should contact your doctor or go to the hospital immediately. Take the medicine pack with you.

Missing a dose of PITAMET

Do not worry, just take the next dose at the right time. Do not take a double dose to make up for a forgotten dose. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, PITAMET can cause side effects, although not everybody gets them. The following side effects may occur while taking this medicine:

If you experience any of the following side effects, stop taking PITAMET and contact your doctor immediately – immediate medical attention may be necessary:

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

Other side effects include:

Common (affects less than 1 in 10 people)

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

Uncommon (affects less than 1 in 100 people)

• muscle spasms;
• feeling weak, tired, unwell;
• swelling of the ankles, feet, or fingers;
• abdominal pain, dry mouth, nausea, loss of appetite, altered taste;
• pale skin, weakness, or shortness of breath (anemia);
• itching or rash;
• ringing in the ears;
• dizziness or drowsiness, insomnia (other sleep disorders, including nightmares);
• need to urinate more often (frequent urination);
• feeling of numbness and reduced sensation in the fingers of the hands and feet, and on the face.

Rare (affects less than 1 in 1000 people)

• redness of the skin, inflamed, red, itchy skin;
• worsening vision;
• tongue pain;
• unpleasant feeling or discomfort in the stomach;
• breast enlargement in men (gynecomastia).

Side effects with unknown frequency(frequency cannot be estimated from available data)

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

Other possible side effects

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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. By reporting side effects, you can help 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 packs and carton after "EXP". The expiry date refers to the last day of the month. Store the blisters in the original package 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. This will help protect the environment.

6. Contents of the pack and other information

What PITAMET contains

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

What PITAMET looks like and contents of the pack

PITAMET, 2 mg, coated tablets, white, cylindrical, biconvex, without a score line, marked "P2" on one side and a diameter of about 7 mm. PITAMET, 4 mg, coated tablets, white, cylindrical, biconvex, with a score line on one side, marked "P4" on the other side and a diameter of about 9 mm. The score line is only for breaking the tablet if you have difficulty swallowing it whole. PITAMET is available in blisters containing 7, 28, or 30 coated tablets, and in single-dose blisters of 7 x 1, 28 x 1, 30 x 1 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

LABORATORIOS CINFA, S.A., Carretera Olaz-Chipi, 10, Polígono Industrial Areta, 31620 Huarte, Spain For more information about this medicine and its names in other EU countries, please contact the representative of the marketing authorization holder: Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00

Date of leaflet approval: July 2024