Pitipix

Package leaflet: Information for the patient

Pitipix, 1 mg, coated tablets
Pitipix, 2 mg, coated tablets
Pitipix, 4 mg, coated tablets
Pitavastatinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Pitipix is and what it is 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 Pitipix is and what it is used for

Pitipix contains an active substance called pitavastatin. It belongs to a group of medicines known as "statins". Pitipix is used to correct blood lipid (fat) levels and can be taken by both children aged 6 years and older and adults.
Abnormal lipid levels, especially high cholesterol, may sometimes lead to heart attack or stroke.
Pitipix has been prescribed for you due to a lipid disorder, and changes in diet and lifestyle have not provided sufficient improvement. While taking Pitipix, you should continue to follow a cholesterol-lowering diet and maintain lifestyle modifications.

2. Important information before using 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 is not using 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 has recurrent or unexplained muscle pain. If the patient is in doubt, they should speak to their doctor or pharmacist before starting Pitipix.

Warnings and precautions
Before starting to take Pitipix, discuss with your doctor or pharmacist if:

• the patient has severe respiratory insufficiency (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 will usually perform a blood test (liver function test) before and during treatment with Pitipix.
• the patient has ever had thyroid problems,
• the patient or a family member has ever 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,
• the patient is taking or has taken within the last 7 days an oral or injectable medicine called fusidic acid (used for bacterial infections). Concomitant use of fusidic acid and Pitipix may cause serious muscle problems (rhabdomyolysis).
• the patient is taking medicines containing glecaprevir and pibrentasvir, used to treat hepatitis C virus infection. The doctor may adjust the dose of pitavastatin.
• the patient has or has had myasthenia (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 or lead to the development of myasthenia (see section 4).

If any of the above apply to the patient (or if 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 possibly additional medicines may be
necessary for diagnosis and treatment of this condition.
Patients with diabetes or 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 increased risk of developing diabetes.
Children and adolescents
Pitipix must not be given to children under 6 years of age.
Adolescent girls should receive advice on contraception before starting Pitipix.
Pitipix and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines they plan to take, including those obtained without a 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 due to a bacterial infection, temporary discontinuation of Pitipix treatment will be necessary. The doctor will inform the patient when they can resume taking Pitipix. Concomitant use of Pitipix and fusidic acid may, in rare cases, cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information about 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 consider it necessary to change the dose of Pitipix.

If any of the above situations apply to the patient (or if 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 an effective method of 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 operate machinery. However, if dizziness or
drowsiness occurs while taking Pitipix, the patient should not drive, operate machinery or use tools.
Pitipix contains lactose
Pitipix contains lactose (a type of sugar). If the patient has previously been diagnosed with an
intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Pitipix

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Taking the medicine
The tablet should be swallowed whole with water, during or independently of meals.
Pitipix can be taken at any time of day. However, it is advisable to take the tablet at the same time each day.
Dosage

• The usual initial dose is 1 mg 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 per day.
• 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 per day.
• If necessary, the tablet may be dispersed in a glass of water immediately before administration. The glass should then be rinsed with the same amount of water, which should also be immediately consumed. Tablets must not be dispersed in fruit juices or milk.
• Pitipix is not recommended for use in children under 6 years of age.

Other important information during treatment with Pitipix

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

If you take more Pitipix than you should
If you take more Pitipix than recommended, contact your doctor immediately or go to the nearest hospital. Bring the medicine package with you.
If you forget to take Pitipix
Do not be alarmed; simply 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse symptoms occur, stop taking Pitipix 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 skin itching (with raised lumps),
• unexplained muscle pain or weakness, especially if accompanied by general malaise, fever or reddish-brown coloured urine. Pitipix may, in rare cases (less than 1 in 1,000 people), cause unpleasant symptoms affecting the muscular system. If left untreated, these may lead to serious conditions 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 (affects less than 1 in 10 people):

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

Uncommon (affects less than 1 in 100 people):

• muscle cramps,
• feeling of weakness, fatigue, 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 frequently (frequency),
• tingling sensation and reduced sensation in fingers and toes, legs and face.

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

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

Frequency not known (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).

Talk to your doctor if the patient experiences weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathing difficulties.
Other possible adverse reactions

• memory loss,
• sexual dysfunction,
• depression,
• diabetes. In individuals with high levels of sugar and fats in the blood, obesity and high blood pressure, the risk of developing diabetes is increased. Your doctor may monitor your condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform 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 Warsaw
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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pitipix

Keep this medicine 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 stated month.
No special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system 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 Pitipix contains

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

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

• The other components (excipients) are: Tablet core: monohydrate lactose, hypromellose 5 cP, low-substituted hydroxypropylcellulose, and magnesium stearate. Tablet coating: hypromellose 6 cP, titanium dioxide (E 171), talc, propylene glycol (E 1520), yellow iron oxide (E 172) – only for 1 mg and 2 mg tablets, and red iron oxide (E 172) – only for 2 mg and 4 mg tablets. See section 2 "Pitipix contains lactose".

What Pitipix looks like and contents of the pack
1 mg, coated tablets: brownish-yellow, round, biconvex coated tablets with the engraved mark "1" on one side of the tablet. Tablet dimensions: diameter approximately 6 mm.
2 mg, coated tablets: brown-orange, round, biconvex coated tablets with the engraved mark "2" on one side of the tablet. Tablet dimensions: diameter approximately 7 mm.
4 mg, coated tablets: brownish-red, round, biconvex coated tablets with the engraved mark "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 blister packs, in a cardboard box,
• 7, 28, 56 or 84 tablets in calendar blister packs, in a cardboard box,
• 7×1, 28×1, 30×1, 56×1, 60×1, 84×1, 90×1 or 100×1 tablet in perforated, single-dose blisters, in a cardboard box,
• 7×1, 28×1, 56×1 or 84×1 tablet in perforated, single-dose calendar blister packs, in a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: +48 22 57 37 500