Livazo

1. What is Livazo and what is it used for

Livazo contains the active substance pitavastatin. It belongs to a group of medicines called "statins". Livazo is used to correct blood lipid levels and can be taken by children from 6 years of age and adults.

Abnormal lipid levels, especially high cholesterol, can sometimes lead to heart attack or stroke.

Livazo has been prescribed for you because you have a lipid imbalance and changes in diet and lifestyle have not provided sufficient improvement. While taking Livazo, you should continue to follow a cholesterol-lowering diet and maintain lifestyle changes.

2. Important information before taking Livazo

When not to take Livazo:

• if you are allergic (hypersensitive) 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 of childbearing age and do not use effective contraception (see "Pregnancy and breastfeeding");
• if you have liver problems;
• if you are taking cyclosporine - used after organ transplantation;
• if you have recurring or unexplained muscle pain.

PT/H/2350/001-003/DC

Warnings and precautions

Before starting to take Livazo, discuss it with your doctor or pharmacist if:

• you have respiratory failure (severe breathing difficulties);
• you have ever had kidney problems;
• you have had liver problems. In some people, "statins" can affect the liver. Your doctor will usually perform blood tests (liver function tests) before and during treatment with Livazo;
• you have had thyroid problems;
• you or your family members have had muscle problems;
• you have had muscle problems while taking other cholesterol-lowering medicines (e.g. statins or fibrates);
• you drink excessive amounts of alcohol;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (used for bacterial infections), orally or by injection. Taking fusidic acid and Livazo at the same time may cause serious muscle problems (rhabdomyolysis).
• you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

If any of the above statements apply to you (or you are not sure), you should contact your doctor or pharmacist before taking Livazo. You should also inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

People with diabetes or at risk of developing diabetes will be under close medical supervision while taking this medicine. People with high blood sugar and lipid levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

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

Before starting to take Livazo, adolescent girls should receive advice on contraception.

Livazo and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription and herbal preparations. Some medicines may interfere with each other's proper functioning. In particular, inform your doctor or pharmacist if you are taking:

• other medicines called "fibrates" - such as gemfibrozil and fenofibrate;
• erythromycin, fusidic acid or rifampicin - types of antibiotics used for infections;
• warfarin or other medicines used to thin the blood;
• HIV protease inhibitors (e.g. ritonavir, lopinavir, darunavir, atazanavir) and "non-nucleoside reverse transcriptase inhibitors" (e.g. efavirenz).
• niacin (vitamin B3);

PT/H/2350/001-003/DC

If you are taking any of the above medicines (or are not sure), you should contact your doctor or pharmacist before taking Livazo.

Livazo with food and drink

Livazo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Livazo is contraindicated during pregnancy and breastfeeding.

If you are planning to become pregnant, you should consult your doctor before starting to take Livazo. Women of childbearing age must use effective contraception while taking Livazo. If you become pregnant while taking Livazo, you should stop taking the medicine and contact your doctor immediately. If you are pregnant or breastfeeding, you should contact your doctor or pharmacist before taking any medicine.

Driving and using machines

Livazo is not expected to affect your ability to drive or use machines. However, if you experience dizziness or drowsiness while taking Livazo, you should not drive, operate machinery, or use tools.

Livazo contains lactose

Livazo contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Livazo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking the medicine

Swallow the tablet whole with water, during or outside meals. You can take the medicine at any time of the day. However, try to take the tablet at the same time every day.

Dosage

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

PT/H/2350/001-003/DC

Use in children and adolescents

• The maximum dose in children under 10 years is 2mg once a day.
• The tablet can be dispersed in a glass of water immediately before administration, and then the glass should be rinsed with the same amount of water and taken immediately. The tablets should not be dispersed in fruit juices or milk.
• Livazo is not recommended for use in children under 6 years of age.

Other important information while taking Livazo

• If you are hospitalized or treated for another condition, inform the medical staff that you are taking Livazo.
• Your doctor may perform regular cholesterol level checks.
• Do not stop taking Livazo without consulting your doctor. Your cholesterol level may increase.

Taking too much Livazo

If you have taken more Livazo than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you.

Missing a dose of Livazo

Do not worry, just take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Livazo can cause side effects, although not everybody gets them.

The following side effects may occur while taking this medicine:

If you experience any of the following side effects, stop taking Livazo and contact your doctor immediately – medical attention may be necessary:

• allergic reaction - may manifest as: difficulty breathing, swelling of the face, tongue or throat, difficulty swallowing, severe itching of the skin (with raised bumps);
• unexplained muscle pain or weakness, especially if accompanied by general malaise, fever, or brownish-red urine. Livazo may rarely (in less than 1 in 1000) cause unpleasant muscle symptoms. If these symptoms are neglected, they can lead to serious conditions such as muscle breakdown (rhabdomyolysis), which can lead to kidney problems;
• breathing difficulties, including persistent cough and/or shortness of breath or fever.
• liver problems, which can cause yellowing of the skin and eyes (jaundice);
• pancreatitis (severe abdominal and back pain).

Common (affects less than 1 in 10 people)

• joint pain, muscle pain;
• constipation, diarrhea, nausea, vomiting;
• headache.

PT/H/2350/001-003/DC

Uncommon (affects less than 1 in 100 people)

• muscle cramps;
• feeling weak, tired, unwell;
• swelling of the ankles, feet or fingers;
• abdominal pain, dry mouth, nausea, loss of appetite, altered taste;
• pale skin, weakness or shortness of breath (anemia);
• itching or rash;
• ringing in the ears;
• dizziness or drowsiness, insomnia (other sleep disorders, including nightmares);
• need to urinate more often (frequent urination);
• feeling of numbness and reduced sensation in the fingers of the hands and feet, in the legs, and on the face.

Rare (affects less than 1 in 1000 people)

• redness of the skin, inflamed, red, itchy skin;
• worsening vision;
• tongue pain;
• unpleasant feeling or discomfort in the stomach
• Breast enlargement in men (gynecomastia)

Frequency not known (frequency cannot be estimated from the available data)

• persistent muscle weakness.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cell count)
• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes).
• You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects

• memory loss;
• sexual disorders;
• depression;
• diabetes: in people with high blood sugar and lipid levels, overweight, and high blood pressure, there is a higher risk of developing diabetes. Your doctor may monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Livazo

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

Do not use this medicine after the expiry date stated on the blister packs and carton. The expiry date refers to the last day of the month.

Do not store above 25°C. Store the blisters in the outer packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Livazo contains

• The active substance is pitavastatin calcium, equivalent to 1mg, 2mg, or 4mg of pitavastatin.
• The other ingredients are lactose monohydrate, hypromellose 6 cP, magnesium aluminometasilicate type 1B, magnesium stearate, hypromellose 6 cP, titanium dioxide (E171), triethyl citrate (E1505), colloidal anhydrous silica.

What Livazo looks like and contents of the pack

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

The tablets are round, white, and marked with the letters "KC" on one side. To help distinguish between the strengths, the tablets have different shapes and are marked with the numbers "1", "2", or "4" on the other side.

Marketing authorization holder and manufacturer

Marketing authorization holder in the EU:

Kowa Pharmaceutical Europe GmbH.,

Görreshof 151, 53347 Alfter, Germany

Manufacturer:

Pierre Fabre Médicament Production,

Rue du Lycée, 45502 Gien, France

or

Recordati Industria Chimica e Farmaceutica SpA,

Via M Civitali 1, 20148 Milan, ITALY

Date of last revision of the leaflet:April 2023

Other sources of information

Detailed information on this medicine is available on the website www.urpl.gov.pl