PITAVASTATIN TEVA-RATIOPHARM 4 mg FILM-COATED TABLETS

2. What you need to know before you take Pitavastatin ratiopharm

Do not take Pitavastatin Teva-ratiopharm:

• if you are allergic to pitavastatin 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 and breast-feeding”).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after organ transplantation.
• if you have repeated or unexplained muscle pain.

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• you have severe respiratory problems (severe breathing problems).
• you have ever had kidney problems.
• 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 pitavastatin.
• you have ever had thyroid problems.
• you or a family member have a history of muscle problems.
• you have previously had muscle problems when taking other cholesterol-lowering medicines (e.g. statins or fibrates).
• you drink a lot of alcohol.
• you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and pitavastatin can cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease that causes general 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 worsen the disease or cause myasthenia to appear (see section 4).

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before taking pitavastatin. Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary 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 your blood, are overweight, and 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 guidance and advice on contraceptives.

Other medicines and Pitavastatina Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription or herbal products. Some medicines can interfere with others. 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).

For more information on rhabdomyolysis, see section 4.

• 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 pitavastatin.

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

Taking Pitavastatina Teva-ratiopharm with food and drinks

You can take pitavastatin with or without food.

Pregnancy, breast-feeding, and fertility

Do not take pitavastatin if you are pregnant or breast-feeding. If you want to become pregnant, inform your doctor before taking pitavastatin. If you are a woman who can become pregnant, you must use a reliable contraceptive method while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking pitavastatin and consult 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 using this medicine.

Driving and using machines

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

Pitavastatina Teva-ratiopharm contains lactose

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

3. How to take Pitavastatin ratiopharm

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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.

Only for the 4 mg tablet: the score line on the 4 mg film-coated tablet is only to help you break the tablet if you have difficulty swallowing it whole.

How much to take

• To start with, the normal 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 and adolescents

• 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.
• Pitavastatin is not recommended for use in children under 6 years of age.

Other things you need to know while taking Pitavastatina Teva-ratiopharm

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

If you take more Pitavastatina Teva-ratiopharm than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pitavastatina Teva-ratiopharm

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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur with this medicine:

Stop taking Pitavastatina Teva-ratiopharm and contact your doctor immediately if you experience any of the following serious side effects, as you may need urgent medical attention:

• allergic reaction - some of the signs are: difficulty breathing, swelling of the face, lips, tongue, or throat, problems swallowing, intense skin itching (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), pitavastatin 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.
• respiratory problems including persistent cough 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, taste disturbance.
• pallor 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).
• feeling of numbness and reduced sensitivity in the fingers and toes, legs, and face.

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

• skin redness, rash, and itching.
• vision loss.
• tongue pain.
• unpleasant feeling or discomfort in the stomach.
• breast enlargement in males (gynecomastia).

Side effects of unknown frequency (cannot be estimated from available data)

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

Tell 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 your 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Pitavastatin ratiopharm

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 and blister after “EXP”. The expiry date refers to the last day of that month.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatina Teva-ratiopharm

• 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: lactose monohydrate (see section 2 “Pitavastatina 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

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

White, cylindrical, biconvex film-coated tablets without a score line, with the logo “P1” on one face, approximately 6 mm in diameter.

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

White, cylindrical, biconvex film-coated tablets without a score line, with the logo “P2” on one face, approximately 7 mm in diameter.

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

White, cylindrical, biconvex film-coated tablets with a score line on one face, with the logo “P4” on the other face, approximately 9 mm in diameter. The score line on the 4 mg tablet is only to help you break the tablet if you have difficulty swallowing it whole.

Pitavastatina Teva-ratiopharm is available in blisters, in pack sizes of 7, 28, and 30 film-coated tablets, and in unit-dose blisters, in pack sizes of 7x1, 28x1, and 30x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10,

Polígono Industrial Areta,

Huarte (Navarra), 31620,

Spain

Date of last revision of this leaflet:March 2023

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

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