Pitipix

Leaflet attached to the packaging: patient information

Pitipix, 1 mg, film-coated tablets

Pitipix, 2 mg, film-coated tablets

Pitipix, 4 mg, film-coated tablets

Pitavastatinum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 adults.

Abnormal lipid levels, particularly cholesterol, can sometimes lead to heart attack or stroke.

Pitipix has been prescribed to the patient due to lipid balance disorders, and dietary changes and lifestyle modifications have not provided sufficient improvement. During treatment with Pitipix, the patient should continue to follow a cholesterol-lowering diet and maintain lifestyle changes.

2. Important information before taking Pitipix

When not to take Pitipix

• if the patient is allergic to pitavastatin 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, breastfeeding, and fertility"),
• 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 doubts, they should consult their doctor or pharmacist before starting Pitipix.

Warnings and precautions

Before starting Pitipix, the patient should discuss the following with their doctor or pharmacist:

• the patient has severe respiratory failure (serious breathing problems),
• the patient has ever had kidney problems,
• the patient has ever had liver problems. In some people, "statins" can affect the liver. The doctor usually performs a blood test (liver function test) before and during treatment with Pitipix.
• the patient has ever 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 fusidic acid (used for bacterial infections) orally or by injection in the last 7 days. Concurrent use of fusidic acid and Pitipix may cause serious muscle problems (rhabdomyolysis).
• if the patient is taking glecaprevir and pibrentasvir, medicines used to treat hepatitis C virus. The doctor may need to change the dose of pitavastatin.
• 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 eye muscle weakness), as statins can sometimes exacerbate symptoms of the disease or lead to 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 Pitipix. The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.

Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients 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 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 available without a prescription and herbal preparations. Some medicines can interfere with each other's proper functioning. In particular, the patient should inform their doctor or pharmacist if they 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 the patient needs to take fusidic acid orally due to a bacterial infection, it may be necessary to temporarily stop taking Pitipix. The doctor will inform the patient when they can resume taking Pitipix. Concurrent use of Pitipix and fusidic acid 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 glecaprevir and pibrentasvir (medicines used to treat hepatitis C virus). The doctor may need to change the dose of Pitipix.

If any of the above situations apply to the patient (or they are unsure), they should contact their 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 the patient is trying to become pregnant, they should consult their doctor before starting Pitipix. Women of childbearing age must use effective contraception while taking Pitipix. If the patient becomes pregnant while taking Pitipix, 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

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

Pitipix contains lactose

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

3. How to take Pitipix

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 water, during or outside 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.

Dosage

• The usual starting dose of Pitipix is 1 mg once daily. After a few weeks, the doctor may decide to increase the dose. The maximum dose for adults and children over 10 years is 4 mg once daily.
• If the patient has liver problems, they 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, immediately 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.
• Pitipix is not recommended for use in children under 6 years of age.

Other important information while taking Pitipix

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

Taking a higher dose of Pitipix than recommended

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

Missing a dose of Pitipix

The patient should not worry, just 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, Pitipix can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking Pitipix and contact their 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 itching of the skin (with raised lumps),
• unexplained muscle pain or weakness, especially if accompanied by general malaise, fever, or brownish-red urine. Pitipix may rarely (in less than 1 in 1,000 people) cause unpleasant muscle symptoms. If left untreated, 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:

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

Uncommon (in less than 1 in 100 people):

• muscle cramps,
• 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 (frequent urination),
• feeling of numbness and reduced sensation in the fingers of the hands and feet, legs, and face.

Rare (in less than 1 in 1,000 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).

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 eye muscle weakness).

The patient should talk to their doctor if they experience weakness in their 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. In people with high blood sugar and lipid levels, overweight, and high blood pressure, there is a higher risk of developing diabetes. 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 this leaflet, they should tell their doctor or pharmacist. Side effects can be reported 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Pitipix

The medicine should be stored out of 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 precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pitipix contains

• The active substance of Pitipix 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 the engraving "1" 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 the engraving "2" 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 the engraving "4" 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 about this medicine, the patient should contact their 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: