Pitavastatin Cinfa 2 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

pitavastatin cinfa 1 mg film-coated tablets EFG

pitavastatin cinfa 2 mg film-coated tablets EFG

pitavastatin cinfa 4 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What pitavastatin cinfa is and what it is used for

This medicine 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 aged 6 years and older and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

You have been prescribed pitavastatin 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 pitavastatin.

2. What you need to know before starting to take pitavastatin cinfa

Do not take pitavastatin cinfa:

• 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 recurrent 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 problems.
• 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 a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and pitavastatin may cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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 (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 and 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 should not be given to children under 6 years of age.

Adolescent girls should receive counseling and advice on contraception before starting pitavastatin.

Taking pitavastatin cinfa with other medicines

Inform your doctor or pharmacist if you are currently using or have recently used 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 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 more 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 the dose of your pitavastatin treatment.

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 cinfa 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, consult your doctor or pharmacist before taking any 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 cinfa contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take pitavastatin cinfa

Follow exactly the instructions for use of this medicine given 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.

Pitavastatin cinfa 4 mg tablets are scored. The score 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, the tablets may 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.
• 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 the 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 cinfa than you should

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

If you forget to take pitavastatin cinfa

Do not worry; take your next dose at the correct 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 adverse effects

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

Stop taking pitavastatin 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 itching (with hives).
• 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 bothersome muscle effects. If these are not investigated, they may lead to serious problems such as abnormal breakdown of muscle (rhabdomyolysis), which may 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).
• Lupus-like syndrome (with rash, joint disorders and effects on blood cells).
• Breast enlargement in men (gynecomastia).

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Joint pain, muscle pain
• Constipation, diarrhoea, 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 disturbances
• Paleness and weakness or breathlessness (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)
• Numbness and reduced sensation in the fingers of the hands and feet, legs and face

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

• Skin redness, hives and skin itching
• Visual impairment
• Tongue pain
• Unpleasant sensation or discomfort in the stomach

Adverse effects of 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 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 adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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 cinfa

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

Store in the original packaging to protect it from light.

This medicine does not require any special storage temperature.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to your pharmacy’s SIGRE point. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of pitavastatin cinfa

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

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

Coating: Opadry Y-1-7000 (hypromellose, titanium dioxide (E-171) and macrogol).

Appearance of the product and contents of the pack

Pitavastatin cinfa 1 mg film-coated tablets EFG are cylindrical, biconvex, white, unmarked tablets with the logo “P1” on one side.

Pitavastatin cinfa 2 mg film-coated tablets EFG are cylindrical, biconvex, white, unmarked tablets with the logo “P2” on one side.

Pitavastatin cinfa 4 mg film-coated tablets EFG are cylindrical, biconvex, white, scored tablets with the logo “P4” on one side and a score line on the other. The score line is provided only to facilitate breaking the tablet if you have difficulty swallowing it whole.

The tablets are packed in packs of 28.

Marketing Authorization Holder and 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: May 2023

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

Pitavastatin cinfa 1 mg film-coated tablets EFG

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84971/P_84971.html

QR code link: https://cima.aemps.es/cima/dochtml/p/84971/P_84971.html

Pitavastatin cinfa 2 mg film-coated tablets EFG

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84972/P_84972.html

QR code link: https://cima.aemps.es/cima/dochtml/p/84972/P_84972.html

Pitavastatin cinfa 4 mg film-coated tablets EFG

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84973/P_84973.html

QR code link: https://cima.aemps.es/cima/dochtml/p/84973/P_84973.html