PITAVASTATIN KERN PHARMA 1 mg FILM-COATED TABLETS

1. What is Pitavastatin Kern Pharma and what is it used for

Pitavastatin Kern Pharma contains a substance called pitavastatin. It belongs to a group of medicines called ‘statins’. Pitavastatin is used to correct blood fat (lipid) levels and can be taken by children from 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

You have been prescribed Pitavastatin Kern Pharma because you have an imbalance of fats, and changes in your diet and lifestyle have not been enough to correct it. You should continue with a low-cholesterol diet and lifestyle changes while taking this medicine.

2. What you need to know before you take Pitavastatin Kern Pharma

Do not take Pitavastatin Kern Pharma:

• 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 breast-feeding.
• if you are a woman who can become pregnant and are not using a reliable contraceptive method (see ‘Pregnancy and breast-feeding’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after organ transplants.
• if you have repeated or unexplained muscle pain.

If you are in any doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have or have had myasthenia (a disease characterized by general muscle weakness that can affect 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 trigger the onset of myasthenia (see section 4).
• if you have severe respiratory insufficiency (severe breathing 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 this medicine.
• 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 medicines to lower cholesterol (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 containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pitavastatin Kern Pharma can cause serious muscle problems (rhabdomyolysis).

If any of the above applies to you (or you are in doubt), consult your doctor or pharmacist before taking this medicine. Also, inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and medication 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 sugars and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

Pitavastatin should not be given to children under 6 years of age.

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

Other medicines and Pitavastatin Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can interfere with how others work.

In particular, tell 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 thin the blood.

• medicines for HIV 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 using 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 containing 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 are in doubt), consult your doctor or pharmacist before taking this medicine.

Taking Pitavastatin Kern Pharma with food and drinks

You can take pitavastatin with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you are a woman who can become pregnant, you must use a reliable contraceptive method while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking pitavastatin and consult your doctor immediately.

Driving and using machines

Pitavastatin Kern Pharma is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or sleepy while taking pitavastatin, do not drive or use machines or tools.

Pitavastatin Kern Pharma contains lactose

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

3. How to take Pitavastatin Kern Pharma

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

How to take this medicine

Swallow the tablet whole with water, with or without food. You can take it at any time of 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 is 4 mg a day.
• If you have liver problems, you should not take more than 2 mg a day.

Use in children

• The maximum dose in children under 10 years is 2 mg a day.
• If necessary, the tablets can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink immediately. Do not use fruit juices or milk to disperse the tablets.
• Pitavastatin is not recommended for use in children under 6 years of age.

Other things you need to know while taking pitavastatin

• If you go to the hospital or receive treatment for another problem, inform the medical staff that you are taking pitavastatin.
• Your doctor may perform regular cholesterol tests.
• Do not stop taking pitavastatin without talking to your doctor first. Your cholesterol levels may increase.

If you take more Pitavastatin Kern Pharma than you should

If you take more pitavastatin than you should, talk to your doctor or go to the hospital immediately. Take the medicine pack with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Pitavastatin Kern Pharma

Do not worry, take the next dose at the right time. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine can cause the following side effects:

Stop taking Pitavastatin Kern Pharma and contact your doctor immediately if you experience 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, swallowing problems, intense itching of the skin (with hives).

• Unexplained muscle pain or weakness, especially if you feel unwell, have a fever, or if your urine is brownish-red. In rare cases (less than 1 in 1,000), Pitavastatin Kern Pharma can cause unpleasant muscle effects. If these effects are not investigated, they can lead to serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems.

• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (severe abdominal and back pain).

Other side effects include:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• muscle spasms
• weakness, tiredness, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, altered taste
• pallor and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares)
• increased need to urinate (urinary frequency)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

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

• redness of the skin, rash, and itching
• vision loss
• tongue pain
• unpleasant feeling or discomfort in the stomach
• breast enlargement in men (gynecomastia)

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

• constant muscle weakness
• lupus-like syndrome (with rash, joint disorders, and effects on blood cells)
• severe myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects

• memory loss
• sexual dysfunction
• depression
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Kern Pharma

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information.

Composition of Pitavastatin Kern Pharma

The active substance is pitavastatin.

Pitavastatin Kern Pharma 1 mg: Each tablet contains 1 mg of pitavastatin (as pitavastatin calcium).

Pitavastatin Kern Pharma 2 mg: Each tablet contains 2 mg of pitavastatin (as pitavastatin calcium).

Pitavastatin Kern Pharma 4 mg: Each tablet contains 4 mg of pitavastatin (as pitavastatin calcium).

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

Appearance of the product and contents of the pack

Pitavastatin Kern Pharma 1 mg: Film-coated tablets, round, biconvex, white or almost white, scored on one side. The score line is not intended to break the tablet.

Pitavastatin Kern Pharma 2 mg: Film-coated tablets, round, biconvex, white or almost white.

Pitavastatin Kern Pharma 4 mg: Film-coated tablets, round, biconvex, white or almost white, scored on one side. The score line is not intended to break the tablet.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet: May 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.