Product Information for the User

Alipza 1 mg, 2 mg and 4 mg Film-Coated Tablets

pitavastatina

Read this 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Table of Contents:

1. What is Alipza and what is it used for
2. What you need to know before taking Alipza
3. How to take Alipza
4. Possible side effects
5. Storage of Alipza

Contents of the pack and additional information

Alipza contains a substance called pitavastatina. It belongs to a group of medications called ‘statins’. Alipza is used to correct levels of fatty substances (lipids)in the blood and it can be taken by both children from 6 years old and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or a cerebral infarction.

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

Do not take Alipza:

• if you are allergic to pitavastatin or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding.
• if you are a woman and may become pregnant, and you are not using an effective contraceptive method (see ‘Pregnancy and breastfeeding’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after an organ transplant.
• if you have repeated or unjustified muscle pain.

Consult your doctor or pharmacist before starting to take Alipza if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alipza if:

• you have severe respiratory failure (serious respiratory 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 see how your liver is working) before and during treatment with Alipza;
• 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;
• you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or injection.The combination of fusidic acid and Alipza can cause severe muscle problems (rhabdomyolysis);
• you have or have had myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

Consult your doctor or pharmacist if any of the above applies to you (or if you are unsure). Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines 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 levels of sugar and fat in your blood, being overweight and high blood pressure.

Children and adolescents

Alipza should not be given to children under 6 years.

Before taking Alipza, adolescents should receive guidance and advice on contraceptives

Other medicines and Alipza

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Some medicines can make others less effective.

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 anticoagulate the blood;

• medicines for HIV 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 fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will tell you when you can restart treatment with Alipza. The use of Alipza with fusidic acid can cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4;
• if you are taking medicines that contain glecaprevir and pibrentasvir, medicines used to treat hepatitis C. Your doctor may need to change your Alipza dose;

Consult your doctor or pharmacist if any of the above applies to you (or if you are unsure).

Alipza with food and drinks

You can take Alipza with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

If you are a woman and may become pregnant, you must use an effective contraceptive method while taking Alipza.If you become pregnant while taking Alipza, stop taking Alipza and see your doctor immediately.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before starting to take any medicine.

Driving and operating machinery

Alipza is not expected to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking Alipza, do not drive or use machines or tools.

Alipza contains lactose

Alipza 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.

FOLLOW EXACTLY THE ADMINISTRATION INSTRUCTIONSFOR THIS MEDICINE AS INDICATED BY YOUR DOCTOR. IF IN DOUBT,CONSULT YOUR DOCTOR OR PHARMACIST AGAIN.

Taking This Medication

Swallow the entire tablet 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

• Initially, the usual dose is 1mg 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 old is 4mg per day.
• If you have liver problems, do not take more than 2mg per day.

Use in Children

• The maximum dose in children under 10years is 2mg per day.
• If necessary, the tablets can be dispersed in a glass of water just before taking them; then rinse the glass with more water and drink it immediately. Do not use fruit juices or milk to disperse the tablets.
• The use of Alipza in children under 6 years old is not recommended.

Other Things You Need to Know While Taking Alipza

• If you go to the hospital or receive treatment for another problem, inform the medical staff that you are taking Alipza.
• Your doctor may perform tests to regularly monitor your cholesterol levels.
• Do not stop taking Alipza without first talking to your doctor. Your cholesterol levels may rise.

If You Take More Alipza Than You Should

If you take more Alipza than you should, inform your doctor or go to the hospital immediately. Bring the medication packaging.

If You Forget to Take Alipza

Do not worry, take the next dose at the correct time.Do not take a double dose to make up for the missed doses..

Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicine can cause the following side effects:

Stop taking Alipza and see your doctor immediately if you observe any of the following severe side effects, as you may need urgent medical treatment:

• Allergic reaction: some signs are difficulty breathing, swelling of the face, lips, tongue, or throat, trouble swallowing, intense skin itching (with rashes).

• Unjustified muscle pain or weakness, especially if you are not feeling well, have a fever, or if your urine is brownish-red in color. In rare cases (in less than 1 person in 1,000), Alipza may cause bothersome muscle effects. If these effects are not investigated, they may cause serious problems such as abnormal muscle rupture (rhabdomyolysis), which can lead to kidney problems.

• Respiratory problems that include persistent cough and/or breathing difficulty or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (intense abdominal and back pain).

Other side effects include:

Frequent (affect less than 1 in 10 people)

• Joint pain, muscle pain
• Constipation, diarrhea, indigestion, nausea
• Headache

Rare (affect less than 1 in 100 people)

• Muscle spasms
• Weakness, fatigue, or discomfort
• Swelling of the ankles, feet, or fingers of the hands
• Abdominal pain, dry mouth, vomiting, loss of appetite, alteration of taste
• Pale skin and weakness or lack of breathing (anemia)
• Itching or skin rash
• Tinnitus in the ears
• Dizziness or somnolence, insomnia (or other sleep disorders, including nightmares)
• Increased frequency of urination
• Sensation of numbness and reduced sensitivity in the fingers of the hands and feet, legs, and face

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

• Redness of the skin, rashes, and skin itching
• Deterioration of vision
• Tongue pain
• Unpleasant sensation or discomfort in the stomach
• Enlargement of the breast in males (gynecomastia)

Unknown frequency (cannot be estimated from available data)

• Constant muscle weakness.

• Syndrome similar to lupus (with rash, joint disorders, and effects on blood cells)
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

• See your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Other possible side effects

• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above25°C. Store the blister pack in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the blister pack and on the box. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Alipza

• The active ingredient ispitavastatina calcium, equivalent to 1mg, 2mg or 4mg of pitavastatina.
• The other components are lactose monohydrate, LS-hydroxypropylcellulose, hypromellose (E464), titanium dioxide (E171), triethyl citrate (E1505), magnesium aluminosilicate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Alipza film-coated tablets are presented in packaging of 7, 28, 30, 90 or 100.Only some sizes of packaging may be commercially available..

The tablets are round, white and have the letters ‘KC’ engraved on one side. To help identify the different concentrations, they are of different sizes and have ‘1’, ‘2’ or ‘4’ engraved on the other side.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Kowa Pharmaceutical Europe GmbH.

Görreshof 151, 53347 Alfter,

Germany.

Responsible manufacturer:

Pierre FabreMédicament Production*,

Rue du Lycée, 45502 Gien Cedex

France

or

Recordati Industria Chimica e Farmaceutica S.p.A.*

Vía M. Civitali, 1, 20148 Milan

Italy

Local Representative:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Last review date of this leaflet: April 2023

Other sources of information

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