Patient Information

Livazo 1 mg, 2 mg and 4 mg film-coated tablets

pitavastatin

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of theleaflet:

1. What is Livazo and what it is used for
2. What you need to know before you start taking Livazo
3. How to take Livazo
4. Possible side effects
5. Storage of Livazo
6. Contents of the pack and additional information

Livazo contains a substance called pitavastatina. It belongs to a group of medications called ‘statins’. Livazo is used to correct the 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 Livazo because you have a fat imbalance, and changes in your diet and lifestyle have not been sufficient to correct it. You must continue with a low-cholesterol diet and lifestyle changes while taking Livazo.

Do not take Livazo:

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

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

Warnings and precautions:

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

• you have severe respiratory insufficiency (serious 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 see how your liver is working) before and during treatment with Livazo;
• 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 medications (e.g. statins or fibrates);
• you drink a lot of alcohol;

• you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Livazo 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 before starting to take Livazo if any of the above applies (or if you are unsure). Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

While you are taking this medication, 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:

Livazo should not be administered to children under 6 years old.

Before taking Livazo, adolescents should receive guidance and advice on contraceptives.

Other medications and Livazo:

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

Specifically, inform your doctor or pharmacist if you are taking any of the following medications:

• other medications called 'fibrates', such as gemfibrozil and fenofibrate;
• erythromycin or rifampicin, antibiotics used to treat infections;
• warfarin or any other medication used to anticoagulate the blood;

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

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

Taking Livazo with food and drinks:

You can take Livazo with or without food.

Pregnancy, breastfeeding, and fertility:

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

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

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

Driving and operating machinery:

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

Livazo contains lactose:

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

Follow the medication administration instructions exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Taking this medication

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

• The usual starting dose is 1 mg once a day. After a few weeks, your doctor may decide to increase your dose. The maximum dose for adults and children over 10 years old is 4 mg per day.
• If you have liver problems, do not take more than 2 mg per day.

Use in children

• The maximum dose for children under 10 years old is 2 mg 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 Livazo in children under 6 years old is not recommended.

Other things you need to know while taking Livazo

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

What to do if you take too much Livazo

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

What to do 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 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 Livazo and see your doctor immediately if you observe 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, 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 dark brown in color. In rare cases (in less than 1 in 1,000 people), Livazo can cause bothersome muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle rupture (rhabdomyolysis), which can lead to kidney problems.

• Respiratory problems that include persistent cough and/or difficulty breathing 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 (affecting less than 1 in 10 people)

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

Rare (affecting less than 1 in 100 people)

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

Rare (affecting 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 problems, 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 your 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 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.

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

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

Composition of Livazo

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

Livazo 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:

Casen Recordati, S.L.

Autovía de Logroño, Km 13,300

50180 Utebo (Zaragoza)

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 for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/