Prospect: information for the patient

Pitavastatin pensa 2 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Pitavastatin pensa and what it is used for

2.What you need to know before starting to take Pitavastatin pensa

3.How to take Pitavastatin pensa

4.Possible adverse effects

5.Storage of Pitavastatin pensa

6.Contents of the package and additional information

This medicationcontains a substance called pitavastatina. It belongs to a group of medications called ‘statins’. Pitavastatina pensa 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 Pitavastatina pensa 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 pensa.

Do not take pitavastatin:

•If you are allergic to pitavastatin, to any other statin, or to 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 have current liver problems.

•If you are taking ciclosporin, a medicine 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 pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pitavastatin:

•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 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 for bacterial infections) by mouth or by 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 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 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 necessary 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 levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Children and adolescents

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

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

Other medicines and pitavastatin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Some medicines may make others 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 for 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. The use of 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 or pibrentasvir, medicines used to treat hepatitis C. Your doctor may need to change your dose of pitavastatin.

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 with food and drink

You can take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take pitavastatin if you are pregnant or breastfeeding.

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.

Driving and operating machinery

Pitavastatin is unlikely to affect your ability to drive or operate machinery. However, if you feel dizzy or drowsy while taking pitavastatin, do not drive or operate machinery or tools.

Pitavastatin contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Medication intake

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

•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

•If you go to the hospital or receive treatment for another problem, inform the medical staff that you are taking pitavastatina.

•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 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

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

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 observe any of the following severe side effects, as you may need urgent medical treatment:

• Allergic reaction: some signs are 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 rupture (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).
• Rare side effects (affecting fewer than 1 in 1,000 people):

? Enlargement of breast tissue in men (gynecomastia)

• Unknown frequency side effects:

? Systemic lupus-like syndrome (with rash, joint disorders, and effects on blood cells)

Other side effects include:

Frequent (can affect up to 1 in 10 people)

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

Infrequent (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 shortness of breath (anemia)
• Itching or skin rash
• Tinnitus 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 (can affect up to 1 in 1,000 people)

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

Unknown frequency side effects (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).

See 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.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 (blister) to protect it from light.

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

Medications should not be disposed of through drains or in the 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pitavastatina pensa

-The active ingredient is pitavastatina calcium.

-The other excipients are:

•The tablet core: lactose monohydrate, low-substitution hydroxypropylcellulose, hypromellose, magnesium hydroxide, and magnesium stearate.

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

Appearance of the product and contents of the packaging

Pitavastatina pensa 2 mg film-coated tablets are cylindrical, biconvex, white, unnotched, and have the logo ‘P2’ on one side.

They are presented in packaging of 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)

Spain

Last review date of this leaflet:March 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/