Pitavastatin Sandoz 2 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pitavastatin Sandoz 1 mg film-coated tablets EFG

Pitavastatin Sandoz 2 mg film-coated tablets EFG

Pitavastatin Sandoz 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, consult 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, since it could 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 Sandoz is and what it is used for
2. What you need to know before taking Pitavastatin Sandoz
3. How to take Pitavastatin Sandoz
4. Possible side effects
5. How to store Pitavastatin Sandoz
6. Contents of the pack and other information

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

Pitavastatin Sandoz 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 Sandoz

Do not take Pitavastatin Sandoz

• if you are allergic to pitavastatin, to any other statin, 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 repeated 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 Sandoz:

• 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 have a history of muscle disorders,
• if you previously experienced muscle problems while taking other cholesterol-lowering medicines (e.g., statins or fibrates),
• if you have or have had myasthenia gravis (a disease causing generalized muscle weakness that, 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 you consume large amounts of alcohol,
• if you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and pitavastatin may cause serious muscle problems (rhabdomyolysis).

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 and 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 increases if you have high levels of blood sugar and fats, are overweight, or have high blood pressure.

Children and adolescents

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

Before taking pitavastatin, adolescent girls should receive guidance and counseling on contraception.

Other medicines and Pitavastatin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal products. 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 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 must stop taking this medicine. Your doctor will advise you when you can restart pitavastatin treatment. Taking pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4,
• 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 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 Sandoz 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 plan to become pregnant, inform your doctor before starting 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pitavastatin is not expected to affect your ability to drive or operate machinery. However, if you feel dizzy or drowsy while taking pitavastatin, do not drive or operate machinery or tools.

Pitavastatin Sandoz 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 Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, 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

• Initially, 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 should not take more than 2 mg per day.

Use in children and adolescents

• The maximum dose in children under 10 years of age is 2 mg per day.
• If necessary, tablets may be dispersed in a glass of water immediately before taking; then rinse the glass with more water and drink it 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 Pitavastatin Sandoz

• If you go to hospital or are receiving treatment for another condition, inform the medical staff that you are taking pitavastatin.
• Your doctor may carry out 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 Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a hospital, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. Take the medicine packaging with you.

If you forget to take Pitavastatin Sandoz

Do not worry; take your next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask 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 experience 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 (angioedema) (frequency cannot be estimated from available data), intense itching of the skin (with hives),
• unexplained muscle pain or weakness, especially if you feel unwell, have a fever, or your urine is red-brown in color. In rare cases (in less than 1 in 1,000 people), pitavastatin may cause unpleasant muscle effects. If these are not investigated, they may lead to serious problems such as abnormal muscle breakdown (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 less than 1 in 10 people)

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

Uncommon (affects less 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)
• sensation of numbness and reduced sensitivity in the fingers, toes, legs and face.

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

• skin redness, hives and skin itching
• deterioration of vision
• sore tongue
• unpleasant sensation or discomfort in the stomach
• breast enlargement in men (gynaecomastia).

Frequency not known (cannot be estimated from available data)

• persistent muscle weakness
• lupus-like syndrome (including rash, joint disorders and effects on blood cells),
• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects muscles used for breathing),
• ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs 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, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect 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 Sandoz

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin Sandoz

• The active substance is pitavastatin.

Pitavastatin Sandoz 1 mg: Each film-coated tablet contains calcium pitavastate equivalent to 1 mg of pitavastatin.

Pitavastatin Sandoz 2 mg: Each film-coated tablet contains calcium pitavastate equivalent to 2 mg of pitavastatin.

Pitavastatin Sandoz 4 mg: Each film-coated tablet contains calcium pitavastate equivalent to 4 mg of pitavastatin.

• The other excipients are:

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

Coating:

Pitavastatin Sandoz 1 mg: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, and yellow iron oxide (E172).

Pitavastatin Sandoz 2 mg: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172), and red iron oxide (E172).

Pitavastatin Sandoz 4 mg: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, and red iron oxide (E172).

Appearance of the product and contents of the pack

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

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

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

The film-coated tablets are packed in PVC/PVDC/Alu blisters contained in a cardboard carton.

Pack sizes:

Blister: 7, 28, 30, 90 and 100 film-coated tablets.

Unit-dose blister packs: 7 x 1, 28 x 1, 30 x 1, 90 x 1 or 100 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

This medicinal product is authorized in the European Economic Area member states under the following names:

Greece: Pitavastatin/Sandoz

Portugal: Pitavastatina Sandoz

Date of the most recent revision of this leaflet: March 2026.

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