Product Information for the User

Pitavastatin Cinfa 1 mg Film-Coated Tablets

Pitavastatin Cinfa 2 mg Film-Coated Tablets

Pitavastatin Cinfa 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.

This medicine 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, can 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 pitavastatin cinfa:

• if you are allergic 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 a woman and may become pregnant, and you are not using an effective contraceptive method (see ‘Pregnancy and breastfeeding’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after an organ transplant.
• if you have repeated or unjustified muscle pains.

If you have any doubts, consult your doctor or pharmacist before starting to take pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pitavastatin:

• if you have severe respiratory failure (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 usually perform blood tests (to see how your liver is working) before and during treatment with pitavastatin.
• 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 medicines (e.g. statins or fibrates).
• if you drink a lot of alcohol.
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and pitavastatin can cause severe muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (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 applies to you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin. Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

While you are taking this medicine, your doctor will check if 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

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

Before taking pitavastatin, adolescents should receive guidance and advice on contraceptives.

Taking pitavastatin cinfa with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription or herbal products. Some medicines may make other medicines less effective.

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines called ‘fibrates’, such as gemfibrozil and fenofibrate.
• erythromycin or rifampicin, antibiotics used to treat infections.
• warfarin or any other medicine used to anticoagulate the blood.
• medicines 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 medicine. Your doctor will tell you when you can restart treatment with pitavastatin. Taking pitavastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking medicines that contain glecaprevir and pibrentasvir, medicines used to treat hepatitis C. Your doctor may need to change the dose of your pitavastatin treatment.

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

Taking pitavastatin cinfa with food and drinks

You can take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

Do not take pitavastatin if you are pregnant or breastfeeding. If you want to become pregnant, inform your doctor before starting to take pitavastatin.

If you are a woman and may become pregnant, you must use an effective contraceptive method while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking pitavastatin and see your doctor immediately.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before starting to take any medicine.

Driving and using machines

Pitavastatin is not expected to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking pitavastatin, do not drive or use machines or tools.

Pitavastatin cinfa contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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.

Pitavastatina cinfa 4 mg tablets are scored. The score is only for breaking the tablet if it is difficult to swallow 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

• 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

• Inform the medical staff that you are taking pitavastatina if you go to the hospital or receive treatment for another problem.
• Your doctor may perform tests to control 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 cinfa than you should

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 forgot to take pitavastatina cinfa

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 this medication, ask your doctor or pharmacist.

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

Stop taking pitavastatin and see your doctor immediately if you notice any of the following serious 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, intense skin itching (with rashes).
• 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 fewer than 1 in 1,000 people), pitavastatin can cause uncomfortable muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can lead to 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).
• Lupus-like syndrome (with rash, joint disorders, and effects on blood cells).
• Enlargement of breast tissue in men (gynecomastia).

Other side effects include:

Frequent (can affect up to 1 in 10 people)

• Joint pain, muscle pain
• Constipation, diarrhea, indigestion, nausea
• Headache

Rare (can affect up to 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 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 (can affect up to 1 in 1,000 people)

• Redness of the skin, rashes, and skin itching
• Deterioration of vision
• Tongue pain
• Unpleasant sensation or malaise in the stomach

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

• Constant muscle weakness.
• Severe myasthenia (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 the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.esBy 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.

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Pitavastatin Calcium Composition

• The active ingredient is pitavastatin calcium.
• The other excipients are:

Tablet core: lactose monohydrate, low-substituted hydroxypropylcellulose, hypromellose, magnesium hydroxide, and magnesium stearate.

Coating: Opadry Y-1-7000 (hypromellose, titanium dioxide (E-171), and macrogol).

Product Appearance and Packaging Content

Pitavastatin calcium 1 mg film-coated tablets are cylindrical, biconvex, white, unnotched, and have the logo “P1” on one side.

Pitavastatin calcium 2 mg film-coated tablets are cylindrical, biconvex, white, unnotched, and have the logo “P2” on one side.

Pitavastatin calcium 4 mg film-coated tablets are cylindrical, biconvex, white, notched on one side, and have the logo “P4” on the other side. The notch is only for breaking the tablet if it is difficult to swallow whole.

It is presented in packs of 28 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last Review Date of this Leaflet:May 2023

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

Pitavastatin Calcium 1 mg Film-Coated Tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/84971/P_84971.html

QR Code to:https://cima.aemps.es/cima/dochtml/p/84971/P_84971.html

Pitavastatin Calcium 2 mg Film-Coated Tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/84972/P_84972.html

QR Code to:https://cima.aemps.es/cima/dochtml/p/84972/P_84972.html

Pitavastatin Calcium 4 mg Film-Coated Tablets

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/84973/P_84973.html

QR Code to:https://cima.aemps.es/cima/dochtml/p/84973/P_84973.html