PITAVASTATIN KRKA 4 mg FILM-COATED TABLETS

1. What is Pitavastatina Krka and what is it used for

Pitavastatina Krka contains a substance called pitavastatina. It belongs to a group of medicines called ‘statins’. Pitavastatina is used to correct blood fat (lipid) levels and can be taken by children from 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

You have been prescribed pitavastatina because you have an imbalance of fats, and changes in your diet and lifestyle have not been enough to correct it. You should continue with a low-cholesterol diet and lifestyle changes while taking pitavastatina.

2. What you need to know before you take Pitavastatina Krka

Do not take Pitavastatina Krka:

• if you are allergic to pitavastatina or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.
• if you are a woman and can become pregnant, and you are not using a reliable contraceptive method (see ‘Pregnancy, breast-feeding and fertility’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after organ transplants.
• if you have repeated or unexplained muscle pain.

If you are in doubt, consult your doctor or pharmacist before taking pitavastatina.

Warnings and precautions

Consult your doctor or pharmacist before taking pitavastatina.

• if you have severe respiratory problems (serious breathing problems).
• if you have ever had kidney problems.
• if you have ever had liver problems. ‘Statins’ can affect the liver in some people. Your doctor will usually do blood tests (to see how your liver is working) before and during treatment with pitavastatina.
• if you have ever had thyroid problems.
• if you or a family member have a history of muscle problems.
• if you have previously had muscle problems when taking other medicines to lower cholesterol (e.g. statins or fibrates).
• if you drink a lot of alcohol.
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and pitavastatina can cause serious muscle problems (rhabdomyolysis).
• if you are taking medicines that contain glecaprevir and pibrentasvir, medicines used to treat hepatitis C. Your doctor may need to change your dose of pitavastatina.
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes make the disease worse or trigger myasthenia (see section 4).

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before taking pitavastatina. Also, inform your doctor or pharmacist if you experience constant muscle weakness. You may need additional tests and medicines to diagnose and treat this problem.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Children and adolescents

Pitavastatina should not be given to children under 6 years of age.

Before taking pitavastatina, adolescent girls should receive guidance and advice on contraceptives.

Other medicines and Pitavastatina Krka

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Some medicines can interfere with how others work. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines called ‘fibrates’, such as gemfibrozil and fenofibrate.
• erythromycin or rifampicin, antibiotics used for infections.
• warfarin or any other medicine used to thin the blood.
• HIV medicines 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 oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with pitavastatina. The use of pitavastatina with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before taking pitavastatina.

Taking Pitavastatina Krka with food and drinks

You can take pitavastatina with or without food.

Pregnancy, breast-feeding, and fertility

Do not take pitavastatina if you are pregnant or breast-feeding. If you want to become pregnant, inform your doctor before starting to take pitavastatina. If you are a woman who can become pregnant, you must use a reliable contraceptive method while taking pitavastatina. If you become pregnant while taking pitavastatina, stop taking pitavastatina and contact your doctor immediately.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pitavastatina is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking pitavastatina, do not drive or use machines or tools.

Pitavastatina Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Pitavastatina Krka

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.

Taking this medicine

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

How much to take

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

Use in children

• The maximum dose in children under 10 years is 2 mg a day.
• If necessary, the tablets can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink immediately. Do not use fruit juices or milk to disperse the tablets.
• Pitavastatina is not recommended for use in children under 6 years of age.

Other things you need to know while taking this medicine

• If you go to the hospital or receive treatment for another problem, tell the medical staff that you are taking pitavastatina.
• Your doctor may do regular blood tests to check your cholesterol levels.
• Do not stop taking pitavastatina without talking to your doctor first. Your cholesterol levels might increase.

If you take more Pitavastatina Krka than you should

If you take more pitavastatina than you should, talk to your doctor or go to the hospital immediately. Take the medicine pack with you.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pitavastatina Krka

Do not worry, take the next dose at the right time. Do not take a double dose to make up for forgotten doses.

If you have any doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking this medicine and contact your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Allergic reaction: some of the signs are difficulty breathing, swelling of the face, lips, tongue, or throat, problems swallowing, intense itching of the skin (with hives).
• Unexplained muscle pain or weakness, especially if you feel unwell, have a fever, or if your urine is brownish-red. In rare cases (less than 1 in 1,000), pitavastatina can cause unpleasant muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems.
• Breathing problems, including persistent coughing and/or difficulty breathing or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (severe abdominal and back pain).

Other side effects include:

Common (affect less than 1 in 10 people)

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

Uncommon (affect less than 1 in 100 people)

• muscle spasms
• weakness, tiredness, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, altered taste
• pale skin and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares)
• increased need to urinate (urinary frequency)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

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

• redness of the skin, rash, and itching
• vision problems
• tongue pain
• unpleasant or uncomfortable feeling in the stomach
• breast enlargement in men (gynecomastia)

Side effects of unknown frequency

• constant muscle weakness
• Lupus-like syndrome (with rash, joint problems, and effects on blood cells)
• severe myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects

• memory loss
• sexual dysfunction
• depression
• diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatina Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Pitavastatina Krka

• The active substance is pitavastatina.

Each film-coated tablet contains 1 mg of pitavastatina (as pitavastatina calcium).

Each film-coated tablet contains 2 mg of pitavastatina (as pitavastatina calcium).

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

• The other ingredients are:

Core of the tablet:lactose monohydrate, hypromellose 5 cP, hydroxypropylcellulose, and magnesium stearate.

Coating:hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) – only for the 1 mg and 2 mg tabletsand red iron oxide (E172) – only for the 2 mg and 4 mg tablets.

See section 2 “Pitavastatina Krka contains lactose”.

Appearance of the product and pack contents

1 mg film-coated tablets: film-coated tablets, round, biconvex, yellowish-brown in color, and engraved with “1” on one side. Tablet size: approximately 6 mm in diameter.

2 mg film-coated tablets: film-coated tablets, round, biconvex, orange-brown in color, and engraved with “2” on one side. Tablet size: approximately 7 mm in diameter.

4 mg film-coated tablets: film-coated tablets, round, biconvex, reddish-brown in color, and engraved with “4” on one side. Tablet size: approximately 9 mm in diameter.

Pitavastatina Krka is available in packs containing:

• 7, 28, 30, 90, and 100 tablets in blisters,
• 7 x 1, 28 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

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

Manufacturer

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

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Date of last revision of this leaflet: August 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).