Pitavastatin Normon 4 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pitavastatin Normon 1 mg film-coated tablets EFG

Pitavastatin Normon 2 mg film-coated tablets EFG

Pitavastatin Normon 4 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Pitavastatina Normon 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 and adults. An imbalance of fats, especially cholesterol, may sometimes lead to a heart attack or stroke.

Your doctor has prescribed Pitavastatina Normon because you have an imbalance of fats, and changes in diet and lifestyle have not been sufficient to correct it. You should continue to follow a cholesterol-lowering diet and maintain lifestyle changes while taking Pitavastatina Normon.

2. What you need to know before taking Pitavastatin Normon

Do not take Pitavastatin Normon:

• 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, breastfeeding and fertility').
• 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 pitavastatin.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take pitavastatin:

• if you have severe respiratory insufficiency (severe 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 check how your liver is functioning) before and during treatment with pitavastatin.
• 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 excessive amounts of alcohol.
• if you are currently taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and pitavastatin may cause serious muscle problems (rhabdomyolysis).
• if you are taking medicines containing glecaprevir and pibrentasvir, medicines used to treat Hepatitis C. Your doctor may need to adjust your dose of pitavastatin.
• if you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin. 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 whether you have diabetes or are at risk of 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.

Adolescent girls should receive counseling and guidance on contraception before taking pitavastatin.

Other medicines and Pitavastatin Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal products. 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 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 must stop taking this medicine. Your doctor will advise you when you can restart treatment with pitavastatin. Using pitavastatin together with fusidic acid may, in rare cases, cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

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

Taking Pitavastatin Normon with food and drink

You may take pitavastatin with or without food.

Pregnancy, breastfeeding and fertility

Do not take pitavastatin if you are pregnant or breastfeeding. If you are planning to become pregnant, inform your doctor before starting to take 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.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pitavastatin 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.

Pitavastatin Normon contains lactose

Pitavastatin Normon 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 Normon

Follow exactly the instructions for the use of this medicine given by your doctor or pharmacist. 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

• To begin with, 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 Normon

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

If you take more Pitavastatin Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Pitavastatin Normon

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

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 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, severe skin itching (with hives).

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

• Breathing problems such as 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 (affects less than 1 in 10 people)

• joint pain, muscle pain,
• constipation, diarrhoea, indigestion, nausea,
• headache.

Uncommon (affects less than 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, taste disturbance,
• paleness and weakness or breathlessness (anaemia),
• itching or skin rash,
• ringing in the ears,
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares),
• increased need to urinate (urinary frequency),
• sensation of numbness and reduced sensitivity in the fingers, toes, legs and face.

Rare (affects less than 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 breast in males (gynaecomastia).

Adverse effects of unknown frequency

• persistent muscle weakness.

• lupus-like syndrome (with rash, joint disorders and effects on blood cells).

• worsening of 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, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin Normon

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

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

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin Normon

The active substance is pitavastatin. Each film-coated tablet contains 1 mg, 2 mg, or 4 mg (as calcium pitavastatin).

The other components (excipients) are:

Tablet core: low-substituted hydroxypropylcellulose, hypromellose (E-464), magnesium aluminometasilicate, calcium carbonate, monohydrate lactose, and magnesium stearate.

Tablet coating: monohydrate lactose, hypromellose (E-464), titanium dioxide (E-171), macrogol, and talc.

Appearance of the product and contents of the pack:

The film-coated tablets are white or almost white, round and biconvex, printed with "P1", "P2", or "P4" on one side and plain on the other side.

Pitavastatin Normon 1 mg and 2 mg film-coated tablets are available in blister packs of 7, 28, 30, 90, and 100 film-coated tablets.

Pitavastatin Normon 4 mg film-coated tablets are available in blister packs of 7, 28, or 30 film-coated tablets.

Only certain pack sizes for each concentration may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the most recent review of this leaflet: March 2023

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