Pitavastatin Alter 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pitavastatin Alter 1 mg film-coated tablets EFG

Pitavastatin Alter 2 mg film-coated tablets EFG

Pitavastatin Alter 4 mg film-coated tablets EFG

Read the 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 could 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.

Contents of the leaflet

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

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

Pitavastatina Alter 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.

Your doctor has prescribed Pitavastatina Alter because you have an imbalance of fats, and changes in diet and lifestyle have not been sufficient to correct it. You should continue following a cholesterol-lowering diet and maintain lifestyle changes while taking this medicine.

2. What you need to know before taking Pitavastatina Alter

Do not take Pitavastatina Alter

• 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have severe respiratory insufficiency (serious breathing problems).
• if you have ever had kidney problems.
• if you have ever 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 this medicine.
• if you have ever had thyroid problems.
• if you or a member of your family has 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 consume 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 infection). The combination of fusidic acid and Pitavastatina Alter may cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia gravis (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 this medicine. 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 increases 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.

Before taking pitavastatin, adolescent girls should receive guidance and counseling regarding contraception.

Other medicines and Pitavastatina Alter

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 known as '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 pitavastatin treatment. 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 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 this medicine.

Taking Pitavastatina Alter with food and drinks

You may take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may 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 plan to become pregnant, inform your doctor before starting 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.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, if you experience dizziness or drowsiness while taking pitavastatin, do not drive or operate machinery or tools.

Pitavastatina Alter contains lactose

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

3. How to take Pitavastatin Alter

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take 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.

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 carry out blood tests regularly 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 Alter than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to take Pitavastatin Alter

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 further 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 will experience them. This medicine may cause the following adverse effects:

Stop taking Pitavastatin Alter and seek medical attention 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).

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

• Unexplained muscle pain or weakness, especially if you feel unwell, have a fever, or your urine is red-brown in color. In rare cases (in fewer than 1 in 1,000 people), Pitavastatin Alter may cause unpleasant muscle effects. If these are not investigated, they may lead to serious problems such as abnormal muscle breakdown (rhabdomyolysis), which may cause kidney problems.

• Respiratory problems including persistent cough and/or difficulty breathing or fever.

• Liver problems that may cause yellowing of the skin and eyes (jaundice).

• Pancreatitis (severe abdominal and back pain).

Other adverse 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, 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)
• sensation of numbness and reduced sensitivity in fingers, toes, legs and face

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

• skin redness, hives and skin itching
• deterioration of vision
• tongue pain
• unpleasant sensation or discomfort in the stomach
• enlargement of the breasts in males (gynecomastia)

Adverse effects with unknown frequency (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 blood sugar and fats, 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, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may 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 Alter

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information.

Composition of Pitavastatin Alter

The active substance is pitavastatin.

Pitavastatin Alter 1 mg: Each tablet contains 1 mg of pitavastatin (as calcium pitavastatin).

Pitavastatin Alter 2 mg: Each tablet contains 2 mg of pitavastatin (as calcium pitavastatin).

Pitavastatin Alter 4 mg: Each tablet contains 4 mg of pitavastatin (as calcium pitavastatin).

The other components are: monohydrate lactose, povidone, hydroxypropylcellulose, calcium carbonate, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin.

Appearance of the product and contents of the pack

Pitavastatin Alter 1 mg: Film-coated tablets, round, biconvex, white or almost white, scored on one side. The score line should not be used to split the tablet.

Pitavastatin Alter 2 mg: Film-coated tablets, round, biconvex, white or almost white.

Pitavastatin Alter 4 mg: Film-coated tablets, round, biconvex, white or almost white, scored on one side. The score line should not be used to split the tablet.

PA/Aluminum/PVC-Aluminum blisters. Pack sizes of 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: May 2023

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