Product Information for the Patient

Pitavastatina pensa 4 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone 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 product information. See section 4.

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

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

3.How to take Pitavastatina pensa

4.Possible adverse effects

5.Storage of Pitavastatina pensa

6.Contents of the pack 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 pitavastatina:

•If you are allergic to pitavastatina, to any other statin, or to any of the other components of this medication (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 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:

•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 consume a lot of alcohol.

•If you are taking or have taken in the last 7 days a medication containing fusidic acid, (used for the treatment of bacterial infections) 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 is characterized by 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, obesity, 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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some medications may make others 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 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 containing glecaprevir or pibrentasvir, medications used to treat hepatitis C. Your 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 with food and drinks

You can take pitavastatina with or without food.

Pregnancy, breastfeeding, and fertility

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

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 it and see your doctor immediately.

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 contains lactose

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

Follow exactly the administration instructions for 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.

The Pitavastatina pensa 4 mg tablets are scored. The score is only for breaking the tablet if you find it 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

•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 increase.

If you take more pitavastatina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 notice any of the following serious 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 itching of the skin (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 less than 1 person in 1,000), 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 pain in the abdomen and back).
• 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 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
• Pain in the tongue
• Unpleasant sensation or malaise in the stomach

Unknown frequency side effects (cannot be estimated from available data)

• Constant muscle weakness.
• 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).

See your doctor if you experience weakness in the 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 (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 your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pitavastatina pensa

-The active ingredient is pitavastatina calcium.

-The other excipients are:

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

Coating: Opadry Y-1-7000: hypromellose, titanium dioxide (E171), and macrogol.

Appearance of the product and contents of the packaging

Pitavastatina pensa 4 mg film-coated tablets are cylindrical, biconvex, white in color, scored on one side, and with the logo ‘P4’ on the other 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

Date of the last review of this leaflet:March 2023

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