Pitavastatin Pensa 4 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pitavastatin pensa 4 mg film-coated tablets EFG

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

• Keep this leaflet, as 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 must not be given 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 pensa is and what it is used for
2. What you need to know before taking Pitavastatin pensa
3. How to take Pitavastatin pensa
4. Possible side effects
5. How to store Pitavastatin pensa
6. Contents of the pack and other information

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

This medicine contains a substance called pitavastatin. It belongs to a group of medicines known as 'statins'. Pitavastatina pensa is used to correct levels of fatty substances (lipids) in the blood and can be taken by both children aged 6 years and older and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

Your doctor has prescribed Pitavastatina pensa 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 pensa.

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

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 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 pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pitavastatin:

• 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 have previously experienced muscle problems while taking other cholesterol-lowering medicines (e.g., statins or fibrates).
• if you drink 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 infections). The combination of fusidic acid and pitavastatin may cause serious muscle problems (rhabdomyolysis).
• if 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 condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (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 is higher 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 temporarily 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 or 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 with food and drink

You may take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

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. Do not take pitavastatin if you are pregnant or breastfeeding.

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 without delay.

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 pensa contains lactose

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

3. How to take Pitavastatin pensa

Follow exactly the administration instructions for this medicine as indicated by your doctor. 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.

Pitavastatina pensa 4 mg tablets are scored. The score line is only intended to facilitate breaking 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 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

• 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 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 pitavastatin

• If you go to hospital or receive treatment for another condition, inform medical staff that you are taking pitavastatin.
• Your doctor may perform 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 than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take pitavastatin

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. This medicine may cause the following adverse effects:

Stop taking pitavastatin 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, intense skin itching (with hives).
• Unexplained muscle pain or weakness, especially if you do not feel well, have fever, or your urine is reddish-brown. In rare cases (in fewer than 1 in 1,000 people), pitavastatin may cause bothersome muscle effects. If these effects are not investigated, they may lead to serious problems such as abnormal breakdown of muscle (rhabdomyolysis), which can cause kidney problems. Respiratory 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).
• Rare adverse effects (affecting fewer than 1 in 1,000 people):

? Enlargement of the breasts in males (gynecomastia)

• Adverse effects with unknown frequency:

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

Other adverse effects include:

Frequent (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, 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 (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 sensation in the fingers, toes, legs and face

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

• Redness of the skin, skin rashes and itching
• Deterioration of vision
• Tongue pain
• Unpleasant sensation or discomfort in the stomach

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

• Persistent muscle weakness.
• 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 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 the 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 Medicinal Products: https://www.notificaram.es By reporting adverse 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 packaging (blister) to protect from light.

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

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

6. Contents of the pack and other information

Composition of Pitavastatin pensa

• The active substance is calcium pitavastatin.
• The other ingredients 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 contents of the pack

Pitavastatin pensa 4 mg film-coated tablets EFG are cylindrical, biconvex, white tablets, scored on one side and marked with 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 the most recent review of this leaflet: March 2023

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