Pitamet

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

PITAMET, 2 mg, coated tablets

PITAMET, 4 mg, coated tablets

pitavastatin

You should carefully read the contents of the leaflet before taking this medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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 both 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 the patient due to lipid balance disorders, when diet and lifestyle changes have not brought 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 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 does not use 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 experiences recurring or unexplained muscle pain.

If the patient has any doubts, they should talk to their doctor or pharmacist before starting to take PITAMET.

Warnings and precautions

Before starting to take PITAMET, the patient should discuss it with their doctor or pharmacist if:

• the patient has respiratory failure (severe breathing problems);
• the patient has ever had kidney problems;
• the patient has had liver problems. In some people, "statins" can affect the liver. The doctor usually performs blood tests (liver function tests) before and during treatment with PITAMET;
• the patient has had thyroid problems;
• the patient or their family members have had muscle problems;
• the patient has had 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 in bacterial infections), orally or by injection. Taking fusidic acid and PITAMET at the same time may cause serious muscle problems (rhabdomyolysis).
• if the patient has or has 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 the 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. In order to diagnose and treat this condition, additional tests and medications may be necessary. People with diabetes or those 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription and herbal preparations. Some medicines may interfere with each other's proper functioning. In particular, the doctor or pharmacist should be informed if the patient is taking:

• other medicines called "fibrates" - such as gemfibrozil and fenofibrate;
• erythromycin or rifampicin - types of antibiotics used in 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 the patient needs to take fusidic acid orally due to a bacterial infection, it will be necessary to stop taking PITAMET. The doctor will inform the patient when they can resume 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 the patient is taking medicines containing glecaprevir and pibrentasvir, medicines used to treat hepatitis C. The doctor may change 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, they should consult their doctor before starting to take PITAMET. Women of childbearing age must use effective contraception while taking PITAMET. If the patient becomes pregnant while taking PITAMET, they should stop taking the medicine and contact their doctor immediately. If the patient is pregnant or breastfeeding, they should contact their doctor or pharmacist before taking any medicine.

Driving and using machines

It is not expected that PITAMET will affect the ability to drive or use machines. However, if the patient experiences dizziness or drowsiness while taking PITAMET, they should not drive, operate machinery, or use tools.

PITAMET contains lactose

PITAMET contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking PITAMET.

3. How to take PITAMET

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Taking the medicine

The tablet should be swallowed whole, with a glass of water, during a meal or independently of meals. The medicine can be taken at any time of day. However, the patient should try to take the tablet at the same time every day. Only the 4 mg tablet: the dividing line on the 4 mg coated tablet is intended solely for breaking the tablet if the patient has difficulty swallowing it whole.

Dosage

• The usual initial dose of the medicine is 1 mg of pitavastatin (using another product containing pitavastatin) once a day. After a few weeks, the 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 the patient has liver problems, they 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 administration, and then the glass should be rinsed with the same amount of water and drunk 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

• In the event of hospitalization or treatment for another disease, the patient should inform the medical staff that they are taking PITAMET.
• The doctor may perform regular cholesterol level checks.
• The patient should not stop taking PITAMET without consulting their doctor first. Cholesterol levels may increase.

Taking a higher dose of PITAMET than recommended

If the patient has taken a higher dose of PITAMET than recommended, they should contact their doctor or go to the hospital immediately. They should take the medicine packaging with them.

Missing a dose of PITAMET

The patient should not worry, but take the next dose at the right time. They should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their 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 when taking this medicine:

If any of the following side effects occur, the patient should stop taking PITAMET and contact their doctor immediately – immediate medical attention may be necessary:

• allergic reaction - may be manifested by: difficulty breathing, swelling of the face, tongue, or throat, difficulty swallowing, severe skin itching (with raised bumps);
• 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 people) 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 (occurs in less than 1 in 10 people)

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

Uncommon (occurs in less than 1 in 100 people)

• muscle spasms;
• feeling weak, tired, general malaise;
• 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 decreased sensation in the fingers, hands, and feet, as well as on the face.

Rare (occurs in 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 the 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). The patient should talk to their doctor if they experience muscle weakness in the hands or feet, 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. The doctor may monitor the patient's condition while taking this medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should consult their 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 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, more information can be collected on the safety of the medicine.

5. How to store PITAMET

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blisters and the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month. The blisters should be stored in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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, in an amount 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 dividing line, marked "P2" on one side and a diameter of about 7 mm. PITAMET, 4 mg, coated tablets, white, cylindrical, biconvex, with a dividing line on one side, marked "P4" on the other side and a diameter of about 9 mm. The dividing line is intended solely for breaking the tablet if the patient has 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 the medicine and its names in other EU countries, the patient should 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