Pitavastatin Stada 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pitavastatin Stada 1 mg film-coated tablets EFG

Pitavastatin Stada 2 mg film-coated tablets EFG

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

1. What Pitavastatina Stada 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 from the age of 6 and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

Your doctor has 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 taking Pitavastatin Stada

Do not take Pitavastatin Stada:

• 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 are not using an effective method of contraception (see 'Pregnancy, breastfeeding and fertility').
• 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

Talk to your doctor or pharmacist before starting to take pitavastatin if:

• you have severe respiratory insufficiency (serious breathing problems).
• you have ever had kidney problems.
• 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.
• you have ever had thyroid problems.
• you or a family member have a history of muscle problems.
• you have previously experienced muscle problems when taking other cholesterol-lowering medicines (e.g., statins or fibrates).
• you consume large amounts of alcohol.
• 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 pitavastatin may cause serious muscle problems (rhabdomyolysis).
• you have or have had myasthenia gravis (a disease causing generalized muscle weakness that, 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 disease 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 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 sugar and fats in the blood, 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 counseling and advice regarding contraception.

Other medicines and Pitavastatin Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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.
• antiretroviral medicines for HIV called 'protease inhibitors'.
• niacin (vitamin B3).
• if you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with pitavastatin. Using pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• medicines containing glecaprevir and pibrentasvir, 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.

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 Stada contains lactose

This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Pitavastatin Stada

Follow exactly the instructions given by your doctor for taking this medicine. 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 each 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.

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 and adolescents

• The maximum dose in children under 10 years of age is 2 mg per day.
• The use of pitavastatin is not recommended in children under 6 years of age.

Other things you need to know while taking Pitavastatin Stada

• 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 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 Stada 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, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Pitavastatin Stada

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 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 Stada 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, 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 less than 1 in 1,000 people), pitavastatin may cause unpleasant muscle effects. If these are not investigated, they may lead to serious problems such as abnormal breakdown of muscle (rhabdomyolysis), which can cause kidney problems.

• breathing 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) (frequency not known (frequency cannot be estimated from available data)).

Other adverse effects include:

Common (affects less than 1 in 10 people)

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

Uncommon (affects less than 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, altered taste
• paleness and weakness or shortness of breath (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)
• sensation of numbness and reduced sensitivity in the fingers, toes, legs and face

Rare (affects less than 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 men (gynaecomastia)

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 muscles used for breathing)*

• ocular myasthenia (a disease causing weakness of the eye muscles)*

• Consult your doctor if you experience weakness in the arms or legs 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 fat 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 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 Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Stada

Keep in the original packaging (blister) to protect from light.

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

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin Stada

The active substance is pitavastatin (as calcium pitavastatin).

Each film-coated tablet contains 1 mg of pitavastatin (as calcium pitavastatin).

Each film-coated tablet contains 2 mg of pitavastatin (as calcium pitavastatin).

Each film-coated tablet contains 4 mg of pitavastatin (as calcium pitavastatin).

The other excipients are:

Tablet core:
Lactose monohydrate, low-substituted hydroxypropylcellulose, hypromellose (E464), magnesium hydroxide, magnesium stearate.

Coating:
Opadry Y-1-7000 containing hypromellose (E464), titanium dioxide (E171), polyethylene glycol.

Appearance of the product and contents of the pack

Pitavastatin Stada 1 mg are film-coated tablets, round, biconvex, white in colour, without a breakline, and marked with the logo ‘P1’ on one side.

Pitavastatin Stada 2 mg are film-coated tablets, round, biconvex, white in colour, without a breakline, and marked with the logo ‘P2’ on one side.

Pitavastatin Stada 4 mg are film-coated tablets, round, biconvex, white in colour, with a breakline on one side and marked with the logo ‘P4’ on the other side.

Pitavastatin Stada is available in packs of 7 and 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Laboratorios CINFA, S.A.
Carretera Olaz-Chipi, 10 Polígono Industrial Areta
31620 Huarte (Navarra) Spain

or

STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany

Date of the most recent revision of this leaflet: September 2023

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