Leaflet: Information for the user

Pitavastatina Kern Pharma 1 mg film-coated tablets

Pitavastatina Kern Pharma 2 mg film-coated tablets

Pitavastatina Kern Pharma 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 questions, consult 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

Pitavastatina Kern Pharma 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 Kern Pharma 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 this medicine.

Do not take Pitavastatina Kern Pharma:

• if you are allergic to pitavastatin, any other statin, or 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 ciclosporin, 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 or have had myasthenia (a disease that causes generalized 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 may sometimes worsen the disease or cause myasthenia (see section 4).
• if you have severe respiratory insufficiency (serious breathing problems).
• if you have ever had kidney problems.
• if you have ever had liver problems. Statins may 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 this medication.
• 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 within 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 Kern Pharma may 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 this medication. 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

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

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

Other medications and Pitavastatina Kern Pharma

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 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 pitavastatin. The use of pitavastatin with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking medications that contain glecaprevir or pibrentasvir, medications used to treat hepatitis C. Your doctor may need to change your pitavastatin dose.

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

Taking Pitavastatina Kern Pharma with food and drinks

You can take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

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

Do not take pitavastatin if you are pregnant or breastfeeding. If you become pregnant while taking pitavastatin, stop taking it and see your doctor immediately.

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 it and see your doctor immediately.

Driving and operating machinery

This medication is not expected 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.

Pitavastatina Kern Pharma contains lactose

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

Follow the administration instructions for this medication 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

• 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 your healthcare provider that you are taking pitavastatina if you are hospitalized or receiving treatment for another condition.
• 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 increase.

If you take more Pitavastatina Kern Pharma 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: 91 562 04 20, consult with your doctor or pharmacist.

If you forget to take Pitavastatina Kern Pharma

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 Pitavastatina Kern Pharma 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 less than 1 in 1,000 people), Pitavastatina Kern Pharma 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).

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 of the hands
• 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
• Enlargement of the breast in males (gynecomastia)

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

• Constant muscle weakness
• Syndrome 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).

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, 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 the 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.

Keep this medication out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the blister pack 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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pitavastatina Kern Pharma

The active ingredient is pitavastatina.

Pitavastatina Kern Pharma 1 mg: Each tablet contains 1 mg of pitavastastina (as pitavastatina calcium).

Pitavastatina Kern Pharma 2 mg: Each tablet contains 2 mg of pitavastastina (as pitavastatina calcium).

Pitavastatina Kern Pharma 4 mg: Each tablet contains 4 mg of pitavastastina (as pitavastatina calcium).

The other components are: lactose monohydrate, povidone, hydroxypropylcellulose, calcium carbonate, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and triacetin (E1518).

Appearance of the product and content of the packaging

Pitavastatina Kern Pharma 1 mg:Coated tablets, round, biconvex, white or off-white, scored on one face.The score should not be used to break the tablet.

Pitavastatina Kern Pharma 2 mg: Coated tablets, round, biconvex, white or off-white.

Pitavastatina Kern Pharma 4 mg: Coated tablets, round, biconvex, white or off-white, scored on one face. The score should not be used to break the tablet.

PA/Aluminum/PVC-aluminum blisters. Packaging of 28 tablets..

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: May 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/.