PITAVASTATIN STADA 2 mg FILM-COATED TABLETS

1. What is Pitavastatin Stada 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 of age and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

You have been prescribed pitavastatin because you have a fat imbalance, 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 taking Pitavastatin Stada

Do not take Pitavastatin Stada:

• if you are allergic to pitavastatin, any other statin, or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding.
• if you are a woman who can become pregnant and are not using an effective contraceptive method (see 'Pregnancy, breastfeeding, and fertility).
• if you currently have liver problems.
• if you are taking ciclosporin, 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 failure (severe breathing problems).
• you have ever had kidney problems.
• you have ever had liver problems. 'Statins' can affect the liver in some people. Your doctor will usually perform blood tests (to check how your liver is working) 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 had muscle problems when taking other cholesterol-lowering medicines (e.g., statins or fibrates).
• 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) orally or by injection. The combination of fusidic acid and pitavastatin can cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

If any of the above applies to you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin. Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary 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 sugar and fat levels 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 guidance and counseling on contraceptives.

Other medicines and Pitavastatin Stada

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take other medicines, including those obtained without a prescription or herbal products. Some medicines can interfere with the effects of others.

In particular, 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 for infections.
• warfarin or any other medicine used to thin the blood.

• medicines for HIV called 'protease inhibitors'
• niacin (vitamin B3).
• medicines containing glecaprevir and pibrentasvir, used to treat hepatitis C. Your doctor may need to change your dose of pitavastatin.

If any of the above applies to you (or 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 want to become pregnant, inform your doctor before starting to take pitavastatin.

If you are a woman who can become pregnant, you must use an effective contraceptive method while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking pitavastatin and consult your doctor immediately.

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 use machines. However, if you feel dizzy or drowsy while taking pitavastatin, do not drive or use machines or tools.

Pitavastatin Stada contains lactose

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

3. How to take Pitavastatin Stada

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you have any doubts, 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 day. However, try to take the tablet at the same time every 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.

How much to take

• The usual starting dose is 1 mg once a day. After a few weeks, your doctor may decide to increase the 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.
• Pitavastatin is not recommended for use in children under 6 years of age.

Other things you need to know while taking Pitavastatin Stada

• If you go to the hospital or receive treatment for another problem, inform the medical staff that you are taking pitavastatin.
• Your doctor may perform regular cholesterol checks.
• Do not stop taking pitavastatin without talking to your doctor first. Your cholesterol levels may increase.

If you take more Pitavastatin Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating 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 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 Pitavastatin Stada and consult 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, swallowing problems, intense itching of the skin (with hives).

• unexplained muscle pain or weakness, especially if you are not feeling well, have a fever, or if your urine is brownish-red. In rare cases (less than 1 person 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).
• lupus-like syndrome (with rash, joint disorders, and effects on blood cells) (frequency not known).

Other side effects include:

Common (affect less than 1 person in 10)

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

Uncommon (affect less than 1 person in 100)

• muscle spasms
• weakness, fatigue, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, altered taste
• 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 urination frequency
• numbness and reduced sensitivity in the fingers and toes, legs, and face

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

• redness of the skin, hives, and itching
• vision loss
• tongue pain
• unpleasant sensation or discomfort in the stomach
• breast enlargement in men (gynecomastia)

Side effects of unknown frequency (cannot be estimated from available data)

• constant muscle weakness.
• severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing)*
• ocular myasthenia (a disease that causes 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 side effects

• memory loss
• sexual dysfunction
• depression
• diabetes. This is more likely if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Stada

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

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

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Pitavastatin Stada composition

The active substance is pitavastatin (as pitavastatin calcium)

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

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

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

The other ingredients 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), macrogol.

Appearance and package contents

Pitavastatin Stada 1 mg are film-coated tablets, round, biconvex, white, without a score, and with the logo 'P1' on one side.

Pitavastatin Stada 2 mg are film-coated tablets, round, biconvex, white, without a score, and with the logo 'P2' on one side.

Pitavastatin Stada 4 mg are film-coated tablets, round, biconvex, white, scored on one side, and with the logo 'P4' on the other side.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 last revision of this leaflet:September 2023

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