Pitavastatin Krka 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the User

Pitavastatin Krka 1 mg film-coated tablets EFG

Pitavastatin Krka 2 mg film-coated tablets EFG

Pitavastatin Krka 4 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Pitavastatin Krka is and what it is used for
2. What you need to know before taking Pitavastatin Krka
3. How to take Pitavastatin Krka
4. Possible side effects
5. How to store Pitavastatin Krka

Pack contents and additional information

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

Pitavastatin Krka contains a substance called pitavastatin. It belongs to a group of medicines known as 'statins'. Pitavastatin is used to correct levels of fatty substances (lipids) in the blood and can be taken by both children from the age of 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

Your doctor has prescribed pitavastatin because you have an imbalance of fats, and changes in diet and lifestyle have not been sufficient to correct it. You should continue with a cholesterol-lowering diet and lifestyle changes while taking pitavastatin.

2. What you need to know before starting to take Pitavastatin Krka

Do not take Pitavastatin Krka:

• if you are allergic to pitavastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding.
• if you are a woman who could become pregnant and you are not using an effective method of contraception (see 'Pregnancy, breastfeeding and fertility').
• if you currently have liver problems.
• if you are taking cyclosporine, a medicine used after organ transplantation.
• if you have recurrent or unexplained muscle pain.

If you have any doubts, consult your doctor or pharmacist before starting to take pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pitavastatin:

• if you have severe respiratory insufficiency (serious breathing problems).
• if you have ever had kidney problems.
• if you have previously had liver problems. Statins may affect the liver in some people. Your doctor will usually perform blood tests (to check how your liver is functioning) before and during treatment with pitavastatin.
• if you have ever had thyroid problems.
• if you or a family member has a history of muscle problems.
• if you have previously experienced muscle problems while taking other cholesterol-lowering medicines (e.g. statins or fibrates).
• if you drink large amounts of alcohol.
• if you are currently taking or have taken within the last 7 days a medicine containing fusidic acid, taken orally or by injection (used to treat bacterial infection). The combination of fusidic acid and pitavastatin may cause serious muscle problems (rhabdomyolysis).
• if you are taking medicines containing glecaprevir and pibrentasvir, medicines used to treat hepatitis C. Your doctor may need to adjust your dose of pitavastatin.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin. Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

While you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Children and adolescents

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

Before taking pitavastatin, adolescents should receive guidance and counseling regarding contraception.

Other medicines and Pitavastatin Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the effectiveness of others. Specifically, inform 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 to treat infections.
• warfarin or any other medicine used to prevent blood clotting.
• medicines for HIV called 'protease inhibitors' (e.g. Ritonavir, lopinavir, darunavir) 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 must stop taking this medicine. Your doctor will advise you when you can restart treatment with pitavastatin. Taking pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin.

Taking Pitavastatin Krka with food and drink

You may take pitavastatin with or without food.

Pregnancy, breastfeeding and fertility

Do not take pitavastatin if you are pregnant or breastfeeding. If you are planning to become pregnant, inform your doctor before starting to take pitavastatin. If you are a woman who could become pregnant, you must use an effective method of contraception while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking it immediately and contact your doctor.

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

Driving and using machines

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

Pitavastatin Krka contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pitavastatin Krka

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

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

How much to take

• To begin with, the usual dose is 1 mg once daily. After a few weeks, your doctor may decide to increase your dose. The maximum dose in adults and children over 10 years of age is 4 mg per day.
• If you have liver problems, you must not take more than 2 mg per day.

Use in children

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

Other things you need to know while taking this medicine

• If you go to hospital or receive treatment for another condition, inform medical staff that you are taking pitavastatin.
• Your doctor may perform regular blood tests to monitor your cholesterol levels.
• Do not stop taking pitavastatin without first talking to your doctor. Your cholesterol levels may rise.

If you take more Pitavastatin Krka than you should

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

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

If you forget to take Pitavastatin Krka

Don't worry. Take the next dose at the correct time. Do not take a double dose to make up for missed doses.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking this medicine and see a doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• Allergic reaction: some signs include difficulty breathing, swelling of the face, lips, tongue or throat, trouble swallowing, severe skin itching (with hives).
• Unexplained muscle pain or weakness, especially if you do not feel well, have a fever, or your urine is reddish-brown. In rare cases (in fewer than 1 in 1,000 people), pitavastatin may cause muscle-related side effects. If these effects are not investigated, they may lead to serious problems such as abnormal breakdown of muscle (rhabdomyolysis), which can cause kidney problems.
• Breathing problems including persistent cough and/or shortness of breath or fever.
• Liver problems that may cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (severe abdominal and back pain).

Other adverse effects include:

Common (affects fewer than 1 in 10 people)

• Joint pain, muscle pain
• Constipation, diarrhoea, indigestion, nausea
• Headache

Uncommon (affects fewer than 1 in 100 people)

• Muscle spasms
• Weakness, fatigue or malaise
• Swelling of the ankles, feet or fingers
• Stomach pain, dry mouth, vomiting, loss of appetite, taste disturbances
• Paleness and weakness or shortness of breath (anaemia)
• 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 sensation in the fingers, toes, legs and face

Rare (affects fewer than 1 in 1,000 people)

• Redness of the skin, skin rash and itching
• Visual impairment
• Tongue pain
• Unpleasant sensation or discomfort in the stomach
• Enlargement of the breasts in men (gynaecomastia)

Adverse effects of unknown frequency

• Persistent muscle weakness
• Lupus-like syndrome (with rash, joint disorders and effects on blood cells)
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

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

Other possible adverse effects

• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Krka

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 indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin Krka

• 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 excipients are:

Tablet core: Monohydrate lactose, hypromellose 5 cP, low-substituted hydroxypropylcellulose, and magnesium stearate.

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

See section 2 “Pitavastatin Krka contains lactose”.

Nature of the product and contents of the pack

1 mg film-coated tablets: Film-coated, round, biconvex tablets, brownish-yellow in colour, marked with the number “1” on one side. Tablet dimensions: approximate diameter 6 mm.

2 mg film-coated tablets: Film-coated, round, biconvex tablets, brownish-orange in colour, marked with the number “2” on one side. Tablet dimensions: approximate diameter 7 mm.

4 mg film-coated tablets: Film-coated, round, biconvex tablets, brownish-red in colour, marked with the number “4” on one side. Tablet dimensions: approximate diameter 9 mm.

Pitavastatin 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 single-dose perforated blisters.

Only certain pack sizes may be commercially available.

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

For more information about this medicinal product, patients should contact the local representative of the Marketing Authorisation Holder:

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

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

Date of the last revision of this leaflet: August 2023

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