Livazo

Package Leaflet: Information for the User

Livazo

1 mg, 2 mg and 4 mg film-coated tablets
Pitavastatin
Please read this leaflet carefully before taking Livazo as it contains important information for you.

• Keep this leaflet. 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 the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  Contents of this leaflet:
  1. What Livazo is and what it is used for
  2. What you need to know before taking Livazo
  3. How to take Livazo
  4. Possible side effects
  5. How to store Livazo
  6. Contents of the pack and other information

1. What Livazo is and what it is used for

Livazo contains a substance called pitavastatin. It belongs to a group of medicines called "statins". Livazo is used to lower levels of fats (lipids) in the blood and can be taken by children from the age of 6 years as well as adults. High levels of fats, particularly cholesterol, can sometimes lead to heart attack or stroke.
Your doctor has prescribed Livazo because you have high levels of fats in the blood and changes in diet and lifestyle alone have not been sufficient to correct this imbalance. While taking Livazo, you must continue to follow the diet and lifestyle recommended to lower cholesterol.

2. What you should know before taking Livazo

Do not take Livazo

• if you are allergic (hypersensitive) to pitavastatin, to other statins, or to any of the excipients in Livazo (listed in section 6, "Contents of the pack and other information")
• if you are pregnant or breastfeeding
• if you are a woman of childbearing age and you are not using a reliable method of contraception (see "Pregnancy and breastfeeding")
• if you currently have liver problems
• if you are taking cyclosporine, used after organ transplantation
• if you currently have frequent or unexplained muscle pain. If in doubt, consult your doctor or pharmacist before taking Livazo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Livazo:

• if you have severe respiratory insufficiency (serious breathing problems)
• if you have or have previously had kidney problems
• if you have or have previously had liver problems. In a small number of people, "statins" may affect the liver. Your doctor will usually perform a blood test (liver function test) before and during treatment with Livazo
• if you have or have previously had thyroid problems
• if you or a family member has a history of muscle problems
• if you have previously experienced muscle problems while taking other cholesterol-lowering medicines (e.g. statins or fibrates)
• if you consume excessive amounts of alcohol
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and Livazo may lead to serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases may include the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

If any of the above apply to you (or if you are in doubt), consult your doctor or pharmacist before taking Livazo. Also, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.
If you have diabetes or are at risk of developing diabetes, your doctor will monitor you closely during treatment with this medicine. You may be at risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight, or if you have high blood pressure.
Children and adolescents
Livazo must not be given to children under 6 years of age.
Before taking Livazo, adolescent girls must receive advice and counseling on contraception.
Other medicines and Livazo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal remedies. Some medicines may interact with each other and not work properly.
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, rifampicin, types of antibiotics used to treat infections
• warfarin or other medicines used to thin the blood
• HIV medicines 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 must temporarily stop taking this medicine. Your doctor will tell you when to restart Livazo. Taking Livazo with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolisis). See further information on rhabdomyolysis in section 4.
• if you are taking medicines containing glecaprevir and pibrentasvir, used to treat hepatitis C. Your doctor may need to adjust the dose of Livazo.

If any of the above apply to you (or if you are in doubt), consult your doctor or pharmacist before taking Livazo.
Taking Livazo with food and drink
Livazo can be taken with or without food.
Pregnancy, breastfeeding and fertility
Do not take Livazo if you are pregnant or breastfeeding. If you plan to become pregnant, consult your doctor before taking Livazo.
If you are a woman of childbearing age, you must use a reliable method of contraception during treatment with Livazo. If you become pregnant while taking Livazo, stop taking Livazo immediately and contact your doctor without delay.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Livazo does not affect the ability to drive or operate machinery. However, if you experience dizziness or drowsiness during treatment with Livazo, do not drive or operate machinery or tools.
Livazo contains lactose
Livazo contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Livazo

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to take this medicine
The tablet must be swallowed whole with a glass of water, with or without food. You may take it at any time of day. However, try to take the tablet at the same time each day.
Dosage

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

Use in children and adolescents

• The maximum dose for children under 10 years of age is 2 mg daily.
• If necessary, dissolve the tablets in a glass of water immediately before administration, then rinse the glass with a second volume of water and drink immediately. Do not use fruit juice or milk to dissolve the tablets.
• The use of Livazo is not recommended in children under 6 years of age.

Other important information about treatment with Livazo

• If you are admitted to hospital or are receiving treatment for another condition, inform medical staff that you are taking Livazo.
• Your doctor may perform periodic checks of your cholesterol levels.
• Do not stop taking Livazo without first consulting your doctor, as cholesterol levels may increase.

If you take more Livazo than you should
If you take more Livazo than you should, consult your doctor or go to hospital immediately. Take the medicine pack 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 a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Stop taking Livazo and contact your doctor immediately if you experience any of the
following serious side effects – urgent medical treatment may be required:

• allergic reaction, which may present as: difficulty breathing, swelling of the face, lips, tongue or throat, trouble swallowing, severe itching (with raised lumps)
• unexplained muscle pain or weakness, especially if associated with feeling unwell, fever or dark red-brown coloured urine. In rare cases (less than 1 in 1,000 people), Livazo may cause troublesome muscle effects. If ignored, these may lead to serious problems, such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems
• breathing problems, including persistent cough and/or shortness of breath or fever
• liver problems which may cause yellowing of the skin and eyes (jaundice)
• pancreatitis (severe pain in the abdomen and back)

Other side effects include:
Common (affects less than 1 in 10 people)

• joint pain, muscle pain
• constipation, diarrhoea, indigestion, malaise
• headache

Uncommon (affects less than 1 in 100 people)

• muscle spasms
• feeling weak, tired or unwell
• swelling of the ankles, feet or fingers
• stomach ache, dry mouth, vomiting, loss of appetite, altered taste
• paleness and feeling weak or short of breath (anaemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (other sleep disorders, including nightmares)
• increased need to urinate (increased urinary frequency)
• tingling sensation or reduced sensation in the fingers of the hands and feet, legs and face

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

• skin redness, raised and itchy red rash
• worsening of vision
• pain in the tongue
• unpleasant sensation or discomfort in the stomach
• breast development in men (gynaecomastia)

Side effects of unknown frequency:

• persistent muscle weakness.
• lupus-like syndrome (including rash, joint disorders and effects on blood cells)
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).
• If you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, consult your doctor.

Other possible side effects

• memory loss
• sexual difficulties
• depression
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor may monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Livazo

Do not store above 25°C. Keep the blisters in the outer packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the outer packaging. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Livazo contains
Livazo tablets contain calcium pitavastatin, equivalent to 1 mg, 2 mg or 4 mg of pitavastatin.
The tablets also contain lactose monohydrate, low-substituted hydroxypropylcellulose, hypromellose (E464), titanium dioxide (E171), triethyl citrate (E1505), aluminium magnesium metasilicate, magnesium stearate, and anhydrous colloidal silica.
Description of the appearance of Livazo and the contents of the pack
Livazo film-coated tablets are supplied in packs of 7, 28, 30, 90 or 100 tablets.
Not all pack sizes are commercially available for each dosage strength. The tablets are round, white, with the letters “KC” engraved on one side. To facilitate identification of the different dosage strengths, the tablets vary in size and have the numbers “1”, “2” or “4” engraved on the other side.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Milano, ITALY
Sole Distributor for sale in Italy:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via M. Civitali 1, 20148 Milano.