Pitavastatin Kern Pharma 2 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pitavastatin Kern Pharma 1 mg film-coated tablets EFG

Pitavastatin Kern Pharma 2 mg film-coated tablets EFG

Pitavastatin Kern Pharma 4 mg film-coated tablets EFG

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pitavastatin Kern Pharma is and what it is used for
2. What you need to know before taking Pitavastatin Kern Pharma
3. How to take Pitavastatin Kern Pharma
4. Possible adverse effects
5. How to store Pitavastatin Kern Pharma
6. Contents of the pack and other information

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

Pitavastatina Kern Pharma contains a substance called pitavastatin. It belongs to a group of medicines known as 'statins'. Pitavastatin is used to correct levels of fatty substances (lipids) in the blood, and can be taken by both children aged 6 years and older and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

Your doctor has prescribed Pitavastatina Kern Pharma because you have an imbalance of fats, and changes in diet and lifestyle have not been sufficient to correct it. You must continue with a cholesterol-lowering diet and lifestyle changes while taking this medicine.

2. What you need to know before starting to 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 breastfeeding.
• if you are a woman who could 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 cyclosporine, a medicine used after organ transplantation.
• if you currently have repeated or unexplained muscle pain.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• if you have severe respiratory insufficiency (serious breathing problems).
• if you have ever had kidney problems.
• if you have previously had liver problems. Statins may affect the liver in some people. Your doctor will usually perform blood tests (to monitor liver function) 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 disorders.
• if you have previously experienced muscle problems while taking other cholesterol-lowering medicines (e.g., statins or fibrates).
• if you consume large amounts of alcohol.
• if you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Pitavastatin Kern Pharma may cause serious muscle problems (rhabdomyolysis).

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before starting to take this medicine. Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

While you are taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk is higher if you have high levels of blood sugar and fats, are overweight, or 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 counseling and advice regarding contraception.

Other medicines and Pitavastatin Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the effectiveness of others.

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

• other medicines known as 'fibrates', such as gemfibrozil and fenofibrate.

• erythromycin or rifampicin, antibiotics used to treat infections.

• warfarin or any other medicine used to prevent blood clotting.

• HIV medicines known as '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 must stop taking this medicine. Your doctor will advise you when you can restart pitavastatin treatment. Using pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

• If you are taking medicines containing glecaprevir or pibrentasvir, used to treat hepatitis C. Your doctor may need to adjust your dose of pitavastatin.

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before starting to take this medicine.

Taking Pitavastatin Kern Pharma with food and drinks

You may 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 plan to become pregnant, inform your doctor before starting pitavastatin.

If you are a woman who could become pregnant, you must use an effective contraceptive method while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking it immediately and contact your doctor.

Driving and using machines

This medicine 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 use machines or tools.

Pitavastatin Kern Pharma contains lactose

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

3. How to take Pitavastatin Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Taking this medicine

Swallow the tablet whole with water, with or without food. You may take it at any time of day. However, try to take the tablet at the same time every day.

How much to take

• Initially, the usual dose is 1 mg once daily. After a few weeks, your doctor may decide to increase your dose. The maximum dose in adults and children over 10 years of age is 4 mg per day.
• If you have liver problems, you should not take more than 2 mg per day.

Use in children

• The maximum dose in children under 10 years of age is 2 mg per day.
• If necessary, the tablets may 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.
• The use of pitavastatin is not recommended in children under 6 years of age.

Other things you need to know while taking pitavastatin

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

If you take more Pitavastatin Kern Pharma than you should

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

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

If you forget to take Pitavastatin Kern Pharma

Do not worry; take your next dose at the correct time. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

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

Stop taking Pitavastatin Kern Pharma and contact your doctor immediately if you experience any of the following serious adverse effects, as you may require urgent medical treatment:

• Allergic reaction: some signs include difficulty breathing, swelling of the face, lips, tongue or throat, trouble swallowing, intense skin itching (with hives).

• Unexplained muscle pain or weakness, especially if you do not feel well, have fever, or your urine is reddish-brown in color. In rare cases (in fewer than 1 in 1,000 people), Pitavastatin Kern Pharma may cause muscle-related side effects. If these are not investigated, they may lead to serious problems such as abnormal breakdown of muscle tissue (rhabdomyolysis), which can cause kidney problems.

• Respiratory problems including persistent cough and/or shortness of breath or fever.

• Liver problems that may cause yellowing of the skin and eyes (jaundice).

• Pancreatitis (severe abdominal and back pain).

Other adverse 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, fatigue or malaise
• Swelling of the ankles, feet or fingers
• Stomach pain, dry mouth, vomiting, loss of appetite, altered taste
• Paleness, 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 or reduced sensation in the fingers of the hands and feet, legs and face

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

• Skin redness, hives and skin itching
• Visual disturbances
• Tongue pain
• Unpleasant sensation or discomfort in the stomach
• Enlargement of the breasts in men (gynaecomastia)

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

• Persistent muscle weakness
• Lupus-like syndrome (with rash, joint disorders and effects on blood cells)
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or difficulty breathing.

Other possible adverse effects

• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Kern Pharma

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and on the carton after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin Kern Pharma

The active substance is pitavastatin.

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

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

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

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

Appearance of the product and pack contents

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

Blister packs made of PA/Aluminum/PVC-Aluminum. Packs containing 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 the most recent review of this leaflet: May 2023

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