PITAVASTATIN NORMON 1 mg FILM-COATED TABLETS

2. What you need to know before you take Pitavastatina Normon

Do not take Pitavastatina Normon:

• if you are allergic to pitavastatina, 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 and can become pregnant, and you are not using a reliable contraceptive method (see ‘Pregnancy, breast-feeding and fertility’).
• 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 have any doubts, consult your doctor or pharmacist before taking pitavastatina.

Warnings and precautions

Consult your doctor or pharmacist before taking pitavastatina:

• if you have severe respiratory problems (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 do blood tests (to see how your liver is working) before and during treatment with pitavastatina.
• if you have ever had thyroid problems.
• if you or a family member have a history of muscle problems.
• if you have had muscle problems when taking other medicines to lower cholesterol (e.g. statins or fibrates).
• if you drink large amounts of alcohol.
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and pitavastatina can 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 change your dose of pitavastatina.
• if you have or have had myasthenia (a disease that causes general 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 can sometimes worsen the disease or cause myasthenia (see section 4).

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking pitavastatina. Also, inform your doctor or pharmacist if you experience constant muscle weakness. You may need tests and additional medication 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 the blood, are overweight, and have high blood pressure.

Children and adolescents

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

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

Other medicines and Pitavastatina Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription, or herbal products. Some medicines can interfere with others.

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 oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with pitavastatina. The use of pitavastatina with fusidic acid can, in rare cases, cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking pitavastatina.

Taking Pitavastatina Normon with food and drinks

You can take pitavastatina with or without food.

Pregnancy, breast-feeding, and fertility

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

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

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pitavastatina is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking pitavastatina, do not drive or use machines or tools.

Pitavastatina Normon contains lactose

Pitavastatina Normon 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 Pitavastatina Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Taking this medicine

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 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 is 2 mg per 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.
• Pitavastatina is not recommended for children under 6 years of age.

Other things you need to know while taking Pitavastatina Normon

• If you go to the hospital or receive treatment for another problem, tell the medical staff that you are taking pitavastatina.
• Your doctor may do tests to check your cholesterol levels regularly.
• Do not stop taking pitavastatina without consulting your doctor first. Your cholesterol levels may increase.

If you take more Pitavastatina Normon than you should

If you have taken more pitavastatina than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Pitavastatina Normon

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

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 pitavastatina 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 person in 1,000), pitavastatina can cause unpleasant muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems.

• Respiratory problems such as 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 are:

Common (affect less than 1 person in 10)

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

Uncommon (affect less than 1 person in 100)

• muscle spasms,
• weakness, tiredness, or discomfort,
• swelling of the ankles, feet, or fingers,
• stomach pain, dry mouth, vomiting, loss of appetite, taste disturbance,
• paleness 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),
• sensation of numbness and reduced sensitivity in the fingers and toes, legs, and face.

Rare (affect less than 1 person in 1,000)

• skin redness, rash, and itching,
• vision problems,
• tongue pain,
• unpleasant sensation or discomfort in the stomach.

• breast enlargement in males (gynecomastia).

Side effects of unknown frequency

• constant muscle weakness.

• lupus-like syndrome (with rash, joint problems, and effects on blood cells).
• severe myasthenia (a disease that causes general muscle weakness that, in some cases, affects the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult 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 the 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatina Normon

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

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

This medicine does not require any special storage conditions.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatina Normon

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

The other ingredients (excipients) are:

Core of the tablet: hypromellose (E-464), magnesium aluminometasilicate, calcium carbonate, lactose monohydrate, and magnesium stearate.

Coating of the tablet: lactose monohydrate, 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, engraved with “P1, P2, or P4” on one face and flat on the other face.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of last revision of this leaflet:March 2023

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