Leaflet:information for the user

Pitavastatina ratiopharm 1 mg film-coated tablets

Pitavastatina ratiopharm 2 mg film-coated tablets

Pitavastatina ratiopharm 4 mg film-coated tablets

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 doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,evenifthey are not listed in this leaflet. See section 4.

1.What is Pitavastatina ratiopharm and what it is used for

2.What you need to knowbeforestarting totake Pitavastatina ratiopharm

3.How to take Pitavastatina ratiopharm

4.Possible side effects

5Storage of Pitavastatina ratiopharm

6.Contents of the pack and additional information

Pitavastatina ratiopharm contains a substance called pitavastatina. It belongs to a group of medicines called statins. Pitavastatina 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, may sometimes cause a heart attack or a cerebral infarction.

You have been prescribed this medicine 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 changes in your lifestyle while taking Pitavastatina ratiopharm.

Do not take Pitavastatina ratiopharm:

• 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 and breastfeeding”).
• 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 this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if:

• you have severe respiratory insufficiency (serious respiratory problems).
• you have ever had kidney problems.
• 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.
• 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 consume a lot of alcohol.
• you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used for the treatment of bacterial infection) by mouth or by injection. The combination of fusidic acid and pitavastatina can cause severe muscle problems (rhabdomyolysis).
• 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 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 monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, 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 ratiopharm

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication, including those purchased without a prescription or herbal products. Some medications may make other medications 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 for 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 fusidic acid orally 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. Your doctor may need to change your pitavastatina dosage.

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 ratiopharm with food and drinks

You can take pitavastatina with or without food.

Pregnancy, breastfeeding, 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 ratiopharm contains lactose

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationindicated by your doctor.Consult your doctor or pharmacist again if you are unsure.

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.

Only for the 4 mg tablet: the groove on the coated 4 mg tablet is only to help you break the tablet if you have difficulty swallowing it whole.

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 ratiopharm

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

If you take more Pitavastatina ratiopharm 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 the Toxicological Information Service. Phone 91562 04 20, indicating the medication and the amount taken.

If you forgot to take Pitavastatina ratiopharm

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 the use of thismedication, ask your doctororpharmacist.

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

The following side effects may occur with this medicine:

Stop taking Pitavastatina ratiopharm and see your doctor immediately if you observe any of the following severe side effects, as you may need urgent medical treatment:

• allergic reaction - some of the signs are: difficulty breathing, swelling of the face, lips, tongue, or throat, trouble swallowing, intense skin rash.
• unexplained 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 person in 1,000), pitavastatina may cause uncomfortable muscle effects. If these effects are not investigated, they may 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 may cause yellowing of the skin and eyes (jaundice).
• pancreatitis (intense abdominal and back pain).

Other side effects include:

Frequent (affect less than 1 person in 10)

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

Rare (affect less than 1 person in 100)

• muscle spasms.
• weakness, fatigue, or discomfort.
• swelling of the ankles, feet, or fingers of the hands.
• stomach pain, dry mouth, vomiting, loss of appetite, altered taste.
• pale skin and weakness or lack of breathing (anemia).
• itching or skin rash.
• tinnitus in the ears.
• dizziness or somnolence, insomnia (or other sleep disorders, including nightmares).
• increased frequency of urination.
• sensation of numbness and reduced sensitivity in the fingers of the hands and feet, legs, and face.

Rare (affect less than 1 person in 1,000)

• skin redness, rash, and itching.
• vision deterioration.
• tongue pain.
• unpleasant sensation or discomfort in the stomach.
• enlargement of the breast in males (gynecomastia).

Side effects of unknown frequency (cannot be estimated from available data)

• constant muscle weakness.
• system similar to lupus (with rash, 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 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthecontainer and blister packafter “CAD or EXP”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

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

Composition of Pitavastatina ratiopharm

• The active ingredient is pitavastatina. Each film-coated tablet contains pitavastatina calcium equivalent to 1 mg, 2 mg or 4 mg of pitavastatina.
• The otherexcipientsare: lactose monohydrate (see section 2 “Pitavastatina ratiopharm contains lactose”); low-substitution hydroxypropylcellulose; hypromellose 606; hypromellose 2910; magnesium hydroxide; magnesium stearate; titanium dioxide (E 171), macrogol 400.

Appearance of the product and content of the container

Pitavastatina ratiopharm 1 mg film-coated tablets EFG:

Film-coated white, cylindrical, biconvex, unnotched tablets with the logo “P1” on one face and approximately 6 mm in diameter.

Pitavastatina ratiopharm 2 mg film-coated tablets EFG:

Film-coated white, cylindrical, biconvex, unnotched tablets with the logo “P2” on one face and approximately 7 mm in diameter.

Pitavastatina ratiopharm 4 mg film-coated tablets EFG:

Film-coated white, cylindrical, biconvex, notched on one face and with the logo “P4” on the other face and approximately 9 mm in diameter. The notch on the 4 mg tablet is only to help you break the tablet if you have difficulty swallowing it whole.

Pitavastatina ratiopharm is provided in blisters, in container sizes of 7, 28 and 30 film-coated tablets and in single-dose blisters, in container sizes of 7x1, 28x1 and 30x1 film-coated tablets.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10,

Industrial Estate Areta,

Huarte (Navarra), 31620,

Spain

Last revision date of thisleaflet: March 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)