Pitipix

Package Leaflet: Information for the Patient

Pitipix, 1 mg, film-coated tablets

Pitipix, 2 mg, film-coated tablets

Pitipix, 4 mg, film-coated tablets

Pitavastatinum

Read the package leaflet carefully before taking the 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Pitipix and what is it used for

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

2. Important information before taking Pitipix

When not to take Pitipix

• if you are allergic to pitavastatin 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 are not using effective contraception (see "Pregnancy, breastfeeding and fertility"),
• if you have liver problems,
• if you are taking cyclosporine - used after organ transplantation,
• if you have recurring or unexplained muscle pain. If you are unsure, you should discuss this with your doctor or pharmacist before starting Pitipix.

Warnings and precautions

Before starting Pitipix, discuss with your doctor or pharmacist:

• you have severe respiratory failure (serious 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 a blood test (liver function test) before and during treatment with Pitipix.
• 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 consume excessive amounts of alcohol,
• if you are taking or have taken fusidic acid (used for bacterial infections) orally or by injection in the last 7 days. Taking fusidic acid and Pitipix at the same time may cause serious muscle problems (rhabdomyolysis).
• if you are taking glecaprevir and pibrentasvir, medicines used to treat hepatitis C virus infection. Your doctor may need to change the dose of pitavastatin.
• 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 can 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 unsure), you should contact your doctor or pharmacist before taking Pitipix. You should also inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition. People with diabetes or at risk of developing diabetes will be closely monitored by their doctor 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

Pitipix should not be given to children under 6 years of age. Before starting Pitipix, adolescent girls should receive advice on contraception.

Pitipix with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, 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, 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,
• HIV 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 due to a bacterial infection, you will need to temporarily stop taking Pitipix. Your doctor will tell you when you can restart Pitipix. Taking Pitipix 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 glecaprevir and pibrentasvir (medicines used to treat hepatitis C virus infection). Your doctor may need to change the dose of Pitipix.

If any of the above situations apply to you (or you are unsure), you should contact your doctor or pharmacist before taking Pitipix.

Pitipix with food and drink

Pitipix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pitipix is contraindicated during pregnancy and breastfeeding. If you are planning to become pregnant, you should consult your doctor before starting Pitipix. Women of childbearing age must use effective contraception while taking Pitipix. If you become pregnant while taking Pitipix, 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

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

Pitipix contains lactose

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

3. How to take Pitipix

This medicine should always be taken exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Taking the medicine

Swallow the tablet whole with water, with or without food. You can take the medicine at any time of day. However, try to take the tablet at the same time each day.

Dosage

• The usual starting dose of Pitipix is 1 mg once daily. After a few weeks, your doctor may decide to increase the dose. The maximum dose for adults and children over 10 years is 4 mg once daily.
• If you have liver problems, you should not take more than 2 mg daily.

Use in children and adolescents

• The maximum dose in children under 10 years is 2 mg once daily.
• The tablet can be dissolved in a glass of water to make a suspension, just before taking, and then rinse the glass with the same amount of water and drink it immediately. Do not dissolve the tablets in fruit juice or milk.
• Pitipix is not recommended for use in children under 6 years of age.

Other important information while taking Pitipix

• If you are hospitalized or treated for another condition, tell your doctor that you are taking Pitipix.
• Your doctor may perform regular cholesterol checks.
• Do not stop taking Pitipix without consulting your doctor first. Your cholesterol levels may increase.

Taking more than the recommended dose of Pitipix

If you have taken more than the recommended dose of Pitipix, contact your doctor or go to the hospital immediately. Take the medicine package with you.

Missing a dose of Pitipix

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

4. Possible side effects

Like all medicines, Pitipix can cause side effects, although not everybody gets them.

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

• allergic reaction - may cause difficulty breathing, swelling of the face, lips, tongue, or throat, difficulty swallowing, severe itching of the skin (with raised lumps),
• unexplained muscle pain or weakness, especially if accompanied by general feeling unwell, fever, or brownish-colored urine. Pitipix may rarely (in less than 1 in 1,000 people) cause unpleasant muscle symptoms. If left untreated, these 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:

• Frequent (in less than 1 in 10 people):
• joint pain, muscle pain,
• constipation, diarrhea, indigestion, nausea,
• headache.

Uncommon (in less than 1 in 100 people):

• muscle spasms,
• feeling weak, tired, or 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,
• numbness or reduced sensation in fingers and toes, legs, and face.

Rare (in less than 1 in 1,000 people):

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

Frequency not known (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).

Tell your doctor if you experience muscle weakness in your 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. In people with high blood sugar and lipid levels, overweight, and high blood pressure, there is a higher risk of developing diabetes. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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. You can also report side effects 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 Pitipix

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. 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 Pitipix contains

• The active substance is pitavastatin. Each film-coated tablet contains 1 mg of pitavastatin (as pitavastatin calcium). Each film-coated tablet contains 2 mg of pitavastatin (as pitavastatin calcium).

Each film-coated tablet contains 4 mg of pitavastatin (as pitavastatin calcium).

• The other ingredients (excipients) are: Core of the tablet: lactose monohydrate, hypromellose 5 cP, hydroxypropylcellulose low-substituted, and magnesium stearate. Coating of the tablet: hypromellose 6 cP, titanium dioxide (E 171), talc, propylene glycol (E 1520), yellow iron oxide (E 172) - only for1 mg and 2 mg tablets, and red iron oxide (E 172) - only for2 mg and 4 mg tablets. See section 2 "Pitipix contains lactose".

What Pitipix looks like and contents of the pack

1 mg, film-coated tablets: brownish-yellow, round, biconvex film-coated tablets with "1" engraved on one side of the tablet. Tablet dimensions: diameter approximately 6 mm. 2 mg, film-coated tablets: brown-orange, round, biconvex film-coated tablets with "2" engraved on one side of the tablet. Tablet dimensions: diameter approximately 7 mm. 4 mg, film-coated tablets: brownish-red, round, biconvex film-coated tablets with "4" engraved on one side of the tablet. Tablet dimensions: diameter approximately 9 mm. Pitipix is available in packs containing: 7, 28, 30, 56, 60, 84, 90, or 100 tablets in blisters, in a cardboard box, 7, 28, 56, or 84 tablets in calendar blisters, in a cardboard box, 7×1, 28×1, 30×1, 56×1, 60×1, 84×1, 90×1, or 100×1 tablet in perforated unit dose blisters, in a cardboard box, 7×1, 28×1, 56×1, or 84×1 tablet in perforated unit dose calendar blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more information on this medicine, contact your local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Tel. 22 57 37 500

Date of last revision of the leaflet: