LIVAZO 4 mg FILM-COATED TABLETS

1. What is Livazo and what is it used for

Livazo contains a substance called pitavastatin. It belongs to a group of medicines called 'statins'. Livazo 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 Livazo 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 Livazo.

2. What you need to know before taking Livazo

Do not take Livazo:

• if you are allergic to pitavastatin or any of the other components 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 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 are in doubt, consult your doctor or pharmacist before starting to take Livazo.

Warnings and precautions

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

• you have severe respiratory failure (severe breathing problems);
• you have had kidney problems in the past;
• you have had liver problems in the past. '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 Livazo;
• you have had thyroid problems in the past;
• you or a family member have a history of muscle problems;
• you have 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) orally or by injection. The combination of fusidic acid and Livazo can cause serious muscle problems (rhabdomyolysis);

• 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 to appear (see section 4).

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before starting to take Livazo. 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 levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Children and adolescents

Livazo should not be given to children under 6 years of age.

Before taking Livazo, adolescent girls should receive guidance and counseling on contraceptives.

Other medicines and Livazo

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. 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' (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 starting to take Livazo.

Taking Livazo with food and drinks

You can take Livazo with or without food.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and using machines

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

Livazo contains lactose

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

3. How to take Livazo

Follow the instructions for taking this medicine exactly as indicated by your doctor. 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

• Initially, the usual 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 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 can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink again immediately. Do not use fruit juices or milk to disperse the tablets.
• The use of Livazo is not recommended in children under 6 years of age.

Other things you need to know while taking Livazo

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

If you take more Livazo than you should

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

If you forget to take Livazo

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 everyone gets them. This medicine can cause the following side effects:

Stop taking Livazo 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), Livazo 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 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, 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 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 males (gynecomastia)

Frequency not known (cannot be estimated from available data)

• constant muscle weakness

• lupus-like syndrome (with rash, joint disorders, and effects on blood cells)
• 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 levels of sugars and fats in the 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 Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Livazo

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. The expiration date is the last day of the month indicated.

Do not store above 25°C. Keep the blister pack in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Package contents and additional information

Livazo composition

The active ingredient is pitavastatin calcium, equivalent to 1 mg, 2 mg, or 4 mg of pitavastatin.

The other ingredients are lactose monohydrate, LS-hydroxypropylcellulose, hypromellose (E464), titanium dioxide (E171), triethyl citrate (E1505), magnesium aluminometasilicate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and package contents

Livazo film-coated tablets are available in packs of 7, 28, 30, 90, or 100. Not all pack sizes may be marketed.

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 the numbers '1', '2', or '4' engraved on the other side.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kowa Pharmaceutical Europe GmbH.

Görreshof 151, 53347 Alfter

Germany

Manufacturer:

Pierre Fabre Médicament Production*,

Rue du Lycée, 45502 Gien Cedex

France

Or

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

Via M. Civitali, 1, 20148 Milan

Italy

Local representative:

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo (Zaragoza)

Spain

Date of the last revision of this leaflet: April 2023.

Other sources of information

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