Package Leaflet: Information for the User

Pitavastatina Normon 1 mg Film-Coated Tablets

Pitavastatina Normon 2 mg Film-Coated Tablets

Pitavastatina Normon 4 mg Film-Coated Tablets

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Pitavastatina Normon contains a substance called pitavastatina. It belongs to a group of medicines called ‘statins’. Pitavastatina is used to correct the levels of fatty substances (lipids) in the blood and it can be taken by both children from 6 years old and adults. An imbalance of fats, especially cholesterol, may cause a heart attack or a cerebral infarction in some cases.

You have been prescribed Pitavastatina Normon because you have an imbalance of fats, and changes in your diet and lifestyle have not been sufficient to correct it. You must continue with a low-cholesterol diet and changes in your lifestyle while taking Pitavastatina Normon.

Do not take Pitavastatina Normon:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take pitavastatina:

• If you have severe respiratory insufficiency (serious respiratory 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 functioning) 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 previously had muscle problems when taking other cholesterol-lowering medications (e.g. statins or fibrates).
• If you consume excessive amounts of alcohol.
• If you are taking or have taken within the last 7 days a medication containing fusidic acid, (used for the treatment of bacterial infections) by mouth or injection. The combination of fusidic acid and pitavastatina can cause severe muscle problems (rhabdomyolysis).
• If you are taking medications containing glecaprevir and pibrentasvir, medications used to treat Hepatitis C. Your doctor may need to change your pitavastatina dose.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (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 cases apply to you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatina. Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While you are taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in your blood, obesity, and high blood pressure.

Children and adolescents

Pitavastatina should not be administered to children under 6 years old.

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

Other medications and Pitavastatina Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those purchased without a prescription, or herbal products. Some medications may make other medications less effective.

In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• Other medications called ‘fibrates’, such as gemfibrozil and fenofibrate.
• Erythromycin or rifampicin, antibiotics used for infections.
• Warfarin or any other medication used to anticoagulate the blood.
• Medications for HIV/AIDS 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 taking this medication. Your doctor will indicate when you can restart the treatment with pitavastatina. The use of pitavastatina with fusidic acid can cause, in rare cases, muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

Taking Pitavastatina Normon with food and drinks

You can take pitavastatina with or without food.

Pregnancy, breastfeeding and fertility

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

If you are a woman and may become pregnant, you must use an effective contraceptive method while taking pitavastatina. If you become pregnant while taking pitavastatina, stop taking pitavastatina and see your doctor immediately.

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Pitavastatina is not expected to affect your ability to drive or operate machinery. However, if you feel dizzy or drowsy while taking pitavastatina, do not drive or operate machinery or tools.

Pitavastatina Normon contains lactose

Pitavastatina Normon contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Medication Intake

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

Other Things You Need to Know While Taking Pitavastatina Normon

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

If You Take MorePitavastatina NormonThan You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If You Forget to TakePitavastatina Normon

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

This medicine may cause the following side effects:

Stop taking pitavastatin and see your doctor immediately if you notice 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, trouble swallowing, intense skin itching (with rashes).

• Unjustified muscle pain or weakness, especially if you are not feeling well, have a fever, or if your urine is dark brown. In rare cases (in less than 1 person in 1,000),pitavastatinmay cause bothersome muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle rupture (rhabdomyolysis), which can lead to kidney problems.

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

Other side effects are:

Frequent (affect less than 1 person in 10)

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

Less frequent (affect less than 1 person in 100)

• Muscle spasms,
• weakness, fatigue, or discomfort,
• swelling of the ankles, feet, or fingers,
• stomach pain, dry mouth, vomiting, loss of appetite, alteration of taste,
• pale skin and weakness or lack of breathing (anemia),
• itching or skin rash,
• tinnitus in the ears,
• dizziness or somnolence, insomnia (or other sleep disorders, including nightmares),
• increased urination frequency,
• sensation of numbness and reduced sensitivity in the fingers of the hands and feet, legs, and face.

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

• Redness of the skin, rashes, and skin itching,
• Deterioration of vision,
• Tongue pain,
• Unpleasant or uncomfortable sensation in the stomach.

• Enlargement of the breast in men (gynecomastia).

Side effects of unknown frequency

• Constant muscle weakness.

• Syndrome similar to lupus (with rash, joint disorders, and effects on blood cells).
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

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

Other possible side effects

• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears after CAD on the packaging and blister. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Pitavastatina Normon

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

The other components (excipients) are:

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

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

Appearance of the product and content of the packaging:

The film-coated tablets are white or almost white, round, and biconvex, with “P1, P2 or P4” printed on one face and flat on the other face.

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

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

Only some sizes of packaging for each concentration may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Last review date of this leaflet: March 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).