Product Information for the User

Pitavastatina Sandoz 1 mg Film-Coated Tablets

Pitavastatina Sandoz 2 mg Film-Coated Tablets

Pitavastatina Sandoz 4 mg Film-Coated Tablets

Read this entire 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

6.Contents of the pack and additional information

Pitavastatina Sandoz contains a substance called pitavastatina. It belongs to a group of medicines called ‘statins’. Pitavastatina is used to correct 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, may sometimes cause a heart attack or a cerebral infarction.

You have been prescribed pitavastatina because you have an imbalance of fats, and changes in your diet and lifestyle have not been sufficient to correct it. You must continue with a low-cholesterol diet and changes in your lifestyle while taking pitavastatina.

Do not take Pitavastatina Sandoz:

• if you are allergic to pitavastatina 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, lactation and fertility’).
• if you currently have liver problems.
• if you are taking ciclosporina, a medication used after an organ transplant.
• if you have repeated or unjustified muscle pain.
• if you have any doubts, consult your doctor or pharmacist before starting to take pitavastatina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pitavastatina Sandoz.

• if you have severe respiratory insufficiency (serious respiratory problems).
• if you have ever had kidney problems.
• if you have ever had liver problems. ‘Statins’ can affect the liver in some people. Your doctor will generally perform blood tests (to see how your liver is functioning) before and during treatment with pitavastatina.
• if you have ever had thyroid problems.
• if you or a family member have a history of muscle problems.
• if you have previously had muscle problems when taking other cholesterol-lowering medications (e.g. statins or fibrates).
• if you have or have had myasthenia (a disease that causes generalized 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),
• if you drink a lot of alcohol.
• if 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 pitavastatina can cause severe muscle problems (rhabdomyolysis).

If any of the above cases affect you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatina. Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and 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 sugars and fats in your blood, being overweight, and high blood pressure.

Children and adolescents

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

Before taking pitavastatina, adolescents should receive guidance and counseling on contraceptives.

Other medications and Pitavastatina Sandoz

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription or herbal products. Some medications may make others less effective. In particular, 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 indicate when you can restart the treatment with pitavastatina. The use of pitavastatina 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. The doctor may need to change your pitavastatina dose.

If any of the above cases affect you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatina.

Taking Pitavastatina Sandoz with food and drinks

You can take pitavastatina with or without food.

Pregnancy, lactation and fertility

Do not take pitavastatina if you are pregnant or breastfeeding. If you want to become pregnant, inform your doctor before starting to take pitavastatina. If you are a woman and may become pregnant, you must use an effective contraceptive method while taking pitavastatina.If you become pregnant while taking pitavastatina, stop taking pitavastatina and see your doctor immediately.

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

Driving and operating machinery

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

Pitavastatina Sandoz contains lactose

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 in 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 and adolescents

• The maximum dose in 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 pitavastatina in children under 6 years old is not recommended.

Other things you need to know while taking Pitavastatina Sandoz

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

If you take more Pitavastatina Sandoz than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pitavastatina Sandoz

Do not worry, take the next dose at the correct time. Do not take a double dose to make up for the missed doses.

If you have any other questions about taking this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking this medicine and seek medical attention immediately if you notice any of the following severe side effects, as you may need urgent medical treatment:

• allergic reaction: some signs include difficulty breathing, swelling of the face, lips, tongue, or throat, trouble swallowing (angioedema) (frequency cannot be estimated from available data), intense itching of the skin (with rashes)
• unexplained muscle pain or weakness, especially if you are unwell, have a fever, or if your urine is dark brown in color. In rare cases (in fewer than 1 in 1,000 people), pitavastatin can cause uncomfortable muscle effects. If these effects are not investigated, they can lead to serious problems such as abnormal muscle rupture (rhabdomyolysis), which can cause 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)
• eruption, joint disorders, and effects on blood cells (lupus-like syndrome) (frequency cannot be estimated from available data)
• enlargement of breast tissue in men (gynecomastia) (may affect up to 1 in 1,000 people)

Other side effects include:

Frequent (affecting fewer than 1 in 10 people)

• joint pain, muscle pain
• constipation, diarrhea, indigestion, nausea
• headache.

Rare (affecting fewer than 1 in 100 people)

• muscle spasms
• weakness, fatigue, or malaise
• swelling of the ankles, feet, or fingers
• abdominal pain, dry mouth, vomiting, loss of appetite, altered taste
• pale skin and weakness or shortness of breath (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 fewer than 1 in 1,000 people)

• skin redness, rashes, and itching
• vision deterioration
• lingual pain
• unpleasant or uncomfortable sensation in the stomach
• breast enlargement in men (gynecomastia).

Side effects of unknown frequency

• constant muscle weakness
• lupus-like syndrome (including eruption, joint disorders, 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).

Consult 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, pharmacist, or nurse, 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 and carton after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Pitavastatina Sandoz

• The active principle is pitavastatina.

Each film-coated tablet contains pitavastatina calcium equivalent to 1 mg of pitavastatina.

Each film-coated tablet contains pitavastatina calcium equivalent to 2 mg of pitavastatina.

Each film-coated tablet contains pitavastatina calcium equivalent to 4 mg of pitavastatina.

• The other excipients are:

Core tablet: lactose monohydrate, hypromellose 5 cP, low-substituted hydroxypropylcellulose, and magnesium stearate.

Coating:

1 mg tablets: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, and yellow iron oxide (E172).

2 mg tablets: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172), and red iron oxide (E172).

4 mg tablets: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the package

1 mg film-coated tablets: film-coated tablets, round, biconvex, yellow-brown in color, and marked with the brand "1" on one face. Tablet diameter: approximately 6 mm.

2 mg film-coated tablets: film-coated tablets, round, biconvex, orange-brown in color, and marked with the brand "2" on one face. Tablet diameter: approximately 7 mm.

4 mg film-coated tablets: film-coated tablets, round, biconvex, red-brown in color, and marked with the brand "4" on one face. Tablet diameter: approximately 9 mm.

Film-coated tablets are packaged in PVC/PVDC/Alu blisters packaged in a cardboard box.

Package sizes:

Blister: 7, 28, 30, 90, and 100 film-coated tablets.

Blister (single-dose perforated): 7 x 1, 28 x 1, 30 x 1, 90 x 1, or 100 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

O

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana.

Slovenia

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Portugal Pitavastatina Sandoz

Last review date of this leaflet: April 2023

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ).