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.

Incorrect lipid levels, especially cholesterol, can sometimes lead to heart attacks or strokes.

Livazo has been prescribed to the patient due to lipid balance disorders, and dietary changes and lifestyle modifications have not provided sufficient improvement. During treatment with Livazo, the patient should continue to follow a cholesterol-lowering diet and maintain lifestyle changes.

2. Important information before taking Livazo

When not to take Livazo:

• if the patient is allergic (hypersensitive) to pitavastatin, any other statin, or any of the other ingredients of this medicine (listed in section 6).
• if the patient is pregnant or breastfeeding;
• if the patient is of childbearing age and does not use effective contraception (see "Pregnancy and breastfeeding");
• if the patient has liver problems;
• if the patient is taking cyclosporine - used after organ transplants;
• if the patient has recurring or unexplained muscle pain.

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Warnings and precautions

Before starting treatment with Livazo, the patient should discuss it with their doctor or pharmacist if:

• the patient has respiratory failure (severe breathing problems);
• the patient has ever had kidney problems;
• the patient has had liver problems. In some people, "statins" can affect the liver. The doctor usually performs blood tests (liver function tests) before and during treatment with Livazo;
• the patient has had thyroid problems;
• the patient or their family members have had muscle problems;
• the patient has had muscle problems while taking other cholesterol-lowering medicines (e.g., statins or fibrates);
• the patient consumes excessive amounts of alcohol;
• if the patient is taking or has taken within 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).
• the patient has or has 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 the patient (or the patient is unsure), they should contact their doctor or pharmacist before taking Livazo. The doctor or pharmacist should also be informed 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 treatment with Livazo, adolescent girls should receive advice on contraception.

Livazo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription and herbal preparations. Some medicines may interfere with each other's proper functioning. In particular, the doctor or pharmacist should be informed if the patient is 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;
• medicines for HIV, called "protease inhibitors" (e.g., ritonavir, lopinavir, darunavir, atazanavir) and "non-nucleoside reverse transcriptase inhibitors" (e.g., efavirenz).
• niacin (vitamin B3);

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If the patient is taking any of the above medicines (or is unsure), they should contact their 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 the patient is trying to become pregnant, they should consult their doctor before starting Livazo. Women of childbearing age must use effective contraception while taking Livazo. If the patient becomes pregnant while taking Livazo, they should stop taking the medicine and contact their doctor immediately. If the patient is pregnant or breastfeeding, they should contact their doctor or pharmacist before taking any medicine.

Driving and using machines

Livazo is not expected to affect the ability to drive or use machines. However, if the patient experiences dizziness or drowsiness while taking Livazo, they should not drive, operate machinery, or use tools.

Livazo contains lactose

Livazo contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Livazo

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.

Taking the medicine

The tablet should be swallowed whole, with water, during or outside meals.

The medicine can be taken at any time of day. However, the patient should try to take the tablet at the same time every day.

Dosage

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

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Use in children and adolescents

• The maximum dose in children under 10 years is 2mg daily.
• The tablet can be suspended 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 suspended in fruit juices or milk.
• Livazo is not recommended for use in children under 6 years of age.

Other important information while taking Livazo

• In case of hospitalization or treatment for another condition, the patient should inform the medical staff that they are taking Livazo.
• The doctor may perform regular cholesterol level checks.
• The patient should not stop taking Livazo without consulting their doctor first. Cholesterol levels may increase.

Taking a higher dose of Livazo than recommended

In case of taking a higher dose of Livazo than recommended, the patient should contact their doctor or go to the hospital immediately. They should take the medicine packaging with them.

Missing a dose of Livazo

The patient should not worry, just take the next dose at the right time. They should not take a double dose to make up for the missed dose.

4. Possible side effects

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

The following side effects may occur when taking this medicine:

If the patient experiences any of the following side effects, they should stop taking Livazo and contact their doctor immediately – immediate 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 people) 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 problems, 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, indigestion, nausea;
• headache.

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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, hands, feet, and 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).
• The patient should talk to their doctor if they experience weakness in their 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. The doctor may monitor the patient's condition while taking this medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported 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, more information can be gathered on the safety of this medicine.

5. How to store Livazo

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blisters 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. The patient should ask their 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 in the form of calcium salt, in an amount equivalent to 1mg, 2mg, or 4mg of pitavastatin.
• The other ingredients are lactose monohydrate, hydroxypropylcellulose low substituted, hypromellose 6 cP, magnesium aluminometasilicate type IB, magnesium stearate, hypromellose 6 cP, titanium dioxide (E171), triethyl citrate (E1505), colloidal silica anhydrous.

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 of the tablets, they have different shapes and are marked with the numbers "1", "2", or "4" on the other side.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Updated leaflet:

April 2023

Other sources of information

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