Pitavastatin Teva-Ratiopharm 4 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pitavastatin Teva-ratiopharm 1 mg film-coated tablets EFG

Pitavastatin Teva-ratiopharm 2 mg film-coated tablets EFG

Pitavastatin Teva-ratiopharm 4 mg film-coated tablets EFG

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

• Keep this leaflet; 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

5 Storage of Pitavastatin Teva-ratiopharm

1. Contents of the pack and other information

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

Pitavastatina Teva-ratiopharm 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 and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

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

2. What you need to know before taking Pitavastatin ratiopharm

Do not take Pitavastatin Teva-ratiopharm:

• 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 are not using an effective method of contraception (see "Pregnancy and breastfeeding").
• 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 this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine if:

• you have severe respiratory insufficiency (serious breathing problems).
• you have ever had kidney problems.
• you have previously had liver problems. Statins may affect the liver in some people. Your doctor will usually carry out blood tests (to check how your liver is functioning) before and during treatment with pitavastatin.
• you have ever had thyroid problems.
• you or a family member has a history of muscle problems.
• you have previously experienced muscle problems while taking other cholesterol-lowering medicines (e.g., statins or fibrates).
• you drink large amounts of alcohol.
• 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 you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia gravis (see section 4).

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before starting 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 you for diabetes or 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 counseling and advice regarding contraception.

Other medicines and Pitavastatin Teva-ratiopharm

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 using this medicine. Your doctor will advise you when you can restart pitavastatin treatment. Using pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis).

For further information on 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 Teva-ratiopharm 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 plan 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 experience dizziness or drowsiness while taking pitavastatin, do not drive or operate machinery or tools.

Pitavastatin Teva-ratiopharm 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 Pitavastatina ratiopharm

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

Taking 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.

For the 4 mg tablet only: The score line on the 4 mg film-coated tablet is only to help you split the tablet if you have difficulty swallowing it whole.

How much to take

• The usual starting 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, the tablets may be dispersed in a glass of water immediately before administration; 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 Pitavastatina Teva-ratiopharm

• If you go to hospital or receive treatment for another condition, inform 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 Pitavastatina Teva-ratiopharm 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 or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Pitavastatina Teva-ratiopharm

Do not worry; take the next dose at the correct 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, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects may occur with this medicine:

Stop taking Pitavastatin Teva-ratiopharm and contact your 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, severe skin rash (with hives).
• unexplained muscle pain or weakness, especially if you do not feel well, have a fever, or if your urine is red-brown in color. In rare cases (in fewer than 1 in 1,000 people), pitavastatin may cause bothersome muscle effects. If these are not investigated, they may lead to serious problems such as abnormal breakdown of muscles (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, altered taste.
• paleness, 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).
• sensation of numbness and reduced sensitivity in the fingers, hands, feet, legs and face.

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

• redness of the skin, hives and skin itching.
• deterioration of vision.
• tongue pain.
• unpleasant sensation or discomfort in the stomach.
• enlargement of the breasts in males (gynecomastia).

Adverse effects with unknown frequency (cannot be estimated from available data)

• 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 arm or leg weakness 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin ratiopharm

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

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

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin Teva-ratiopharm

• The active substance is pitavastatin. Each film-coated tablet contains calcium pitavastatin equivalent to 1 mg, 2 mg or 4 mg of pitavastatin.
• The other ingredients are: monohydrate lactose (see section 2, "Pitavastatin Teva-ratiopharm contains lactose"); low-substituted hydroxypropylcellulose; hypromellose 606; hypromellose 2910; magnesium hydroxide; magnesium stearate; titanium dioxide (E 171); macrogol 400.

Appearance of the product and contents of the pack

Pitavastatin Teva-ratiopharm 1 mg film-coated tablets EFG:

White, cylindrical, biconvex film-coated tablets without a score mark, bearing the logo “P1” on one side and approximately 6 mm in diameter.

Pitavastatin Teva-ratiopharm 2 mg film-coated tablets EFG:

White, cylindrical, biconvex film-coated tablets without a score mark, bearing the logo “P2” on one side and approximately 7 mm in diameter.

Pitavastatin Teva-ratiopharm 4 mg film-coated tablets EFG:

White, cylindrical, biconvex film-coated tablets, scored on one side and bearing the logo “P4” on the other side, approximately 9 mm in diameter. The score mark on the 4 mg tablet is only intended to assist in splitting the tablet if you have difficulty swallowing it whole.

Pitavastatin Teva-ratiopharm is supplied in blisters, in pack sizes of 7, 28 and 30 film-coated tablets, and in single-dose perforated blisters, in pack sizes of 7x1, 28x1 and 30x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10,

Polígono Industrial Areta,

Huarte (Navarra), 31620,

Spain

Date of latest review of this leaflet: March 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85141/P_85141.html