PITAVASTATIN PENSA 4 mg FILM-COATED TABLETS

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

Do not take pitavastatin:

• 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 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 pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before taking pitavastatin:

• if you have severe respiratory problems (severe breathing difficulties).
• if you have ever had kidney problems.
• if 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.

if you have ever had thyroid problems.

• if you or a family member have a history of muscle problems.
• if you have previously had muscle problems when taking other cholesterol-lowering medicines (e.g. statins or fibrates).
• if you drink a lot of alcohol.
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth 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 (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. Tests and additional medication 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 sugar and fat levels 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 counseling and advice on contraceptives.

Other medicines and pitavastatin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can interfere with how well other medicines work.

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.

medicines for HIV 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 will need to stop using this medicine. Your doctor will tell you when you can restart treatment with pitavastatin. The use of pitavastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking medicines containing glecaprevir or 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 pitavastatin with food and drinks

You can take pitavastatin with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take pitavastatin if you are pregnant or breast-feeding.

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 contact your doctor immediately.

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.

Pitavastatin Pensa contains lactose

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

3. How to take Pitavastatin Pensa

Follow exactly the instructions of your doctor or pharmacist. 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.

The tablets of Pitavastatin Pensa 4 mg are scored. The score line is only to help you break the tablet if you have difficulty swallowing it whole.

How much to take

• To start with, the usual 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

• 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 pitavastatin

• 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 rise.

If you take more pitavastatin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take pitavastatin

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

4. Possible side effects

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

Stop taking pitavastatin and contact your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Allergic reaction: some of the signs are difficulty breathing, swelling of the face, lips, tongue, or throat, problems swallowing, intense itching of the skin (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 lead to 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).
• Rare side effects (affecting less than 1 in 1,000 people):

Increased breast size in men (gynecomastia)

• Side effects of unknown frequency:

Lupus-like syndrome (with rash, joint disorders, and effects on blood cells)

Other side effects include:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 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
• pale skin 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)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

Rare (may affect up to 1 in 1,000 people)

• redness of the skin, rash, and itching of the skin
• vision problems
• tongue pain
• unpleasant sensation or discomfort in the stomach

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

• Constant muscle weakness.
• 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).

Consult 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 sugar and fat levels 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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Pensa

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

Store in the original package (blister) to protect from light.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Pitavastatin Pensa

• The active substance is pitavastatin calcium.
• The other excipients are:

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

Coating: Opadry Y-1-7000: hypromellose, titanium dioxide (E171), macrogol.

Appearance of the product and pack contents

Pitavastatin Pensa 4 mg film-coated tablets are cylindrical, biconvex, white, scored on one side, and have the logo ‘P4’ on the other side.

They are available in packs of 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Date of last revision of this leaflet:March 2023

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