PITAVASTATIN GEPREM 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pitavastatina Geprem 1 mg film-coated tablets EFG

Pitavastatina Geprem 2 mg film-coated tablets EFG

Pitavastatina Geprem 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Pitavastatina Geprem and what is it used for
2. What you need to know before you take Pitavastatina Geprem
3. How to take Pitavastatina Geprem
4. Possible side effects
5. Storage of Pitavastatina Geprem
6. Contents of the pack and further information

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

This medicine contains a substance called pitavastatin. It belongs to a group of medicines called ‘statins’. Pitavastatin is used to correct blood fat (lipid) levels and can be taken by children from 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

You have been prescribed pitavastatin because you have an imbalance of fats, and changes in your diet and lifestyle have not been enough to correct it. You should continue with a low-cholesterol diet and lifestyle changes while taking pitavastatin.

2. What you need to know before you take Pitavastatina Geprem

Do not take pitavastatin:

• if you are allergic (hypersensitive) to pitavastatin, to any other statin or to any of the other ingredients of pitavastatin (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 transplants.
• 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 problems).
• 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 medicines to lower cholesterol (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 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 persistent muscle weakness. Further tests and medicines may be needed 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 counseling and advice on contraceptives.

Other medicines and Pitavastatina Geprem

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 how others 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.
• HIV medicines called ‘protease inhibitors’ (e.g. ritonavir, lopinavir, darunavir, atazanavir) and ‘non-nucleoside reverse transcriptase inhibitors’ (e.g. efavirenz).
• niacin (vitamin B3).

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 drink

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 are planning 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 see your doctor immediately.

If you are pregnant or breast-feeding, consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Pitavastatina Geprem contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially ‘sodium-free’.

3. How to take Pitavastatina Geprem

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.

How much to take

• The usual starting 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 children under 6 years of age.

Other things you need to know while taking Pitavastatina Geprem

• 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 might increase.

If you take more Pitavastatina Geprem than you should

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

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 Pitavastatina Geprem

Do not worry, take the next dose at the right 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 Pitavastatina Geprem and see your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Allergic reaction: some 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).

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)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

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

• redness of the skin, rash, and itching
• vision problems
• tongue pain
• unpleasant feeling or discomfort in the stomach
• breast enlargement in men (gynecomastia)

Frequency not known

• persistent muscle weakness
• lupus-like syndrome (with rash, joint problems, and effects on blood cells)

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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatina Geprem

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 blister and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pitavastatina Geprem

The active substance is pitavastatin.

Pitavastatina Geprem 1 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 1 mg of pitavastatin.

Pitavastatina Geprem 2 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 2 mg of pitavastatin.

Pitavastatina Geprem 4 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 4 mg of pitavastatin.

The other ingredients are:

Core of the tablet: anhydrous sodium carbonate, anhydrous colloidal silica, microcrystalline cellulose, sodium carboxymethyl starch (potato) and sodium stearyl fumarate.

Coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylate type 1 and sodium lauryl sulfate.

Appearance and packaging

Pitavastatina Geprem is available in packs containing 7, 14, 28, or 56 film-coated tablets.

Not all pack sizes may be marketed.

Pitavastatina Geprem 1 mg: The film-coated tablets are round, white, and approximately 6 mm ± 0.2 mm in diameter.

Pitavastatina Geprem 2 mg: The film-coated tablets are round, white, scored on one side, and approximately 8 mm ± 0.2 mm in diameter.

Pitavastatina Geprem 4 mg: The film-coated tablets are round, white, and approximately 10 mm ± 0.3 mm in diameter.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Pitavastatina Geprem

Portugal: Pitavastatina Biofarmoz

Date of last revision of this leaflet: May 2022

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