PITAVASTATIN TEVA 4 MG FILM-COATED TABLETS EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pitavastatin Teva 1 mg film-coated tablets EFG

Pitavastatin Teva 2 mg film-coated tablets EFG

Pitavastatin Teva 4 mg film-coated tablets EFG

Read all of this 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of this leaflet

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

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

Pitavastatin Teva 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 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 to follow a cholesterol-lowering diet and maintain lifestyle changes while taking Pitavastatin Teva.

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

Do not take Pitavastatin Teva:

• 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 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 perform blood tests (to check how your liver is functioning) before and during treatment with pitavastatin.
• you have ever had thyroid problems.
• you or a member of your family has a history of muscle disorders.
• you have previously experienced muscle problems when 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).
• you have or have had myasthenia gravis (a disease causing 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 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 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 increases 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, adolescent girls should receive counseling and advice regarding contraception.

Other medicines and Pitavastatin Teva

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 known as “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 treatment with pitavastatin. Taking pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis).

For further information about rhabdomyolysis, see section 4.

• If you are taking medicines containing glecaprevir and pibrentasvir, 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 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 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 feel dizzy or drowsy while taking pitavastatin, do not drive or operate machinery or tools.

Pitavastatin Teva contains lactose

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

3. How to take Pitavastatin Teva

Follow exactly the instructions given by your doctor 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 each day.

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

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 for 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 for 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 Pitavastatin Teva

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

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

Do not worry; take your next dose at the correct time. Do not take a double dose to make up for missed 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 experiences them.

The following adverse effects may occur with this medicine:

Stop taking Pitavastatin Teva 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, intense skin itching (with rash).
• unexplained muscle pain or weakness, especially if you do not feel well, have a fever, or your urine is red-brown in color. In rare cases (in fewer 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, altered taste.
• 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, rash and itching.
• deterioration of vision.
• tongue pain.
• unpleasant sensation or discomfort in the stomach.
• enlargement of the breast in males (gynaecomastia).

Adverse effects of 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 worsening weakness in your 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, or 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 can 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 Teva

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 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 have any doubts, ask your pharmacist how to properly 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 Teva

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

Description of the product and contents of the pack

Pitavastatin Teva 1 mg film-coated tablets EFG:

White, cylindrical, biconvex, film-coated tablets without a breakline, marked with the logo “P1” on one side and with a diameter of approximately 6 mm.

Pitavastatin Teva 2 mg film-coated tablets EFG:

White, cylindrical, biconvex, film-coated tablets without a breakline, marked with the logo “P2” on one side and with a diameter of approximately 7 mm.

Pitavastatin Teva 4 mg film-coated tablets EFG:

White, cylindrical, biconvex, film-coated tablets with a breakline on one side and marked with the logo “P4” on the other side, with a diameter of approximately 9 mm. The breakline on the 4 mg tablet is intended only to facilitate splitting the tablet if you have difficulty swallowing it whole.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10,

Polígono Industrial Areta,

Huarte (Navarra), 31620,

Spain

For further information on this medicinal product, contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.

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

Alcobendas, 28108 – Madrid

Spain

Date of the most recent review of this product information: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)