Pitavastatin Kern Pharma 1 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. You may need to read it again.
• If you have any questions, ask 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.

Contents of the leaflet:

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 Pitavastatin Kern Pharma is and what it is used for

Pitavastatin 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 from the age of 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes lead to a heart attack or stroke.

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

2. What you need to know before starting to take Pitavastatina Kern Pharma

Do not take Pitavastatina 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 method of contraception (see 'Pregnancy and breastfeeding').
• if you currently have liver problems.
• if you are taking cyclosporine, a medicine used after organ transplantation.
• if you 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 gravis (a disease causing generalized muscle weakness, which 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 disease 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 drink 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 Pitavastatina 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 and 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 increases 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 Pitavastatina 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 called 'fibrates', such as gemfibrozil and fenofibrate.
• erythromycin or rifampicin, antibiotics used to treat infections.
• warfarin or any other medicine used to thin the blood.
• 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 temporarily 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, medicines 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 Pitavastatina Kern Pharma with food and drink

You may take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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 method of contraception 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 operate machinery or tools.

Pitavastatina Kern Pharma 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.

3. How to take Pitavastatin Kern Pharma

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

How to take 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 each 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 immediately before use; 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 the hospital or receive treatment for another condition, inform the medical staff that you are taking pitavastatin.
• Your doctor may carry out regular blood tests 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 packaging 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

Don't worry. Take the 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 experiences 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 itching of the skin (with hives).

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

• Breathing 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:

Frequent (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 and weakness or breathlessness (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 sensation in the fingers, toes, legs and face

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

• Skin redness, hives and skin itching
• Deterioration of vision
• Tongue pain
• Unpleasant sensation or discomfort in the stomach
• Enlargement of the breasts in men (gynecomastia)

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

• Persistent muscle weakness
• Lupus-like syndrome (with rash, joint disorders and blood cell abnormalities)
• Severe myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the 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 fat in your blood, are overweight, and 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, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 the 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 should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents 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 pitavastate).

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

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

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

Appearance of the medicinal product and contents of the container

Pitavastatin Kern Pharma 1 mg: Film-coated tablets, round, biconvex, white or almost white, with a notch on one side. The notch is not intended to divide the tablet into equal doses.

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 notch on one side. The notch is not intended to divide the tablet into equal doses.

Blister packs made of PA/Aluminum/PVC-aluminum. Pack sizes: 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 revision 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/.