Pitavastatin TECNIGEN 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pitavastatin TecniGen 1 mg film-coated tablets EFG

Pitavastatin TecniGen 2 mg film-coated tablets EFG

Pitavastatin TecniGen 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, 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 these adverse effects are not listed in this leaflet. See section 4.

Package leaflet:

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

1. What Pitavastatin TecniGen is and what it is used for

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

Your doctor has prescribed pitavastatin 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 pitavastatin.

2. What you need to know before starting to take Pitavastatin TecniGen

Do not take pitavastatin if:

• you are allergic (hypersensitive) to pitavastatin, to any other statin, or to any of the other
  components of pitavastatin (see section 6, ‘Contents of the pack and other information’).

• you are pregnant or breastfeeding.

• you are a woman who could become pregnant and you are not using an effective method of contraception (see ‘Pregnancy and breastfeeding’).

• you currently have liver problems.

• you are taking cyclosporine, a medicine used after organ transplantation.

• you have recurrent or unexplained muscle pain.

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

Warnings and precautions

Consult 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 has a history of muscle problems.
• 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 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 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 condition causing weakness of the eye muscles), since 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 and treatments may be required 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 of diabetes is increased if you have high levels of blood sugar and fats, are overweight, and have high blood pressure.

Children and adolescents

Pitavastatin should not be administered to children under 6 years of age.

Before taking pitavastatin, adolescent females should receive counseling and guidance on contraception.

Other medicines and Pitavastatin TecniGen

Inform your doctor or pharmacist if you are currently using or have recently used 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 (anticoagulants).

? medicines for HIV/AIDS called 'protease inhibitors' (for example, ritonavir, lopinavir, darunavir, atazanavir) and 'non-nucleoside reverse transcriptase inhibitors' (for example, 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. Taking pitavastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information about rhabdomyolysis, see section 4.

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

Taking pitavastatin 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 pitavastatin.

If you are a woman of childbearing potential, 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, consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Pitavastatin is not expected to influence the ability to drive or operate machinery. However, if you experience dizziness or somnolence while taking pitavastatin, do not drive or operate machinery or tools.

Pitavastatin TecniGen contains lactose

Pitavastatin contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pitavastatin TecniGen

Follow exactly the instructions for use of this medicine 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

• The usual starting dose is 1 mg once daily. After a few weeks, your doctor may decide to increase your dose. The maximum dose for 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 pediatric patients

• 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 administration; then rinse the glass with additional 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 TecniGen

• If you go to the hospital or receive treatment for another condition, inform the 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 speaking to your doctor. Your cholesterol levels may increase.

If you take more Pitavastatin TecniGen than you should

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

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 TecniGen

Do not worry; take the next dose at the correct 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 will experience them. This medicine may cause the following adverse effects:

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

• Allergic reaction: signs may include difficulty breathing, swelling of the face, lips, tongue or throat, trouble swallowing, or intense itching of the skin (with hives).
• Unexplained muscle pain or weakness, especially if you do not feel well, have fever, or your urine is red-brown in color. In rare cases (less than 1 in 1,000 people), pitavastatin 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.
• 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 pain in the abdomen and back).

Other adverse effects include:

Frequent (affect less than 1 in 10 people)

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

Uncommon (affect fewer than 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
• pallor and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disturbances, including nightmares)
• increased urge to urinate (urinary frequency)
• sensation of numbness and reduced sensitivity in the fingers, toes, legs, and face

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

• redness of the skin, rashes, and itching
• deterioration of vision
• tongue pain
• unpleasant sensation or discomfort in the stomach
• enlargement of the breast in males (gynecomastia)

Adverse effects of unknown frequency

• 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 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 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 reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin TecniGen

This medicine does not require any special storage conditions.

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

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pitavastatin TecniGen

The active substance is pitavastatin.

Pitavastatin TecniGen 1 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 1 mg of pitavastatin.

Pitavastatin TecniGen 2 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 2 mg of pitavastatin.

Pitavastatin TecniGen 4 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 4 mg of pitavastatin.

The other components are: lactose monohydrate, povidone, low-substituted hydroxypropyl cellulose, calcium carbonate, magnesium stearate, hypromellose (E464), titanium dioxide (E171), triacetin.

Appearance of the medicinal product and contents of the container

Pitavastatin TecniGen 1 mg: Film-coated tablets are round, biconvex, white to off-white in colour, with a score on one side and a diameter of approximately 6 mm. The score should not be used to divide the tablet.

Pitavastatin TecniGen 2 mg: Film-coated tablets are round, biconvex, white to off-white in colour, with a diameter of approximately 7 mm.

Pitavastatin TecniGen 4 mg: Film-coated tablets are round, biconvex, white to off-white in colour, with a score on one side and a diameter of approximately 9.5 mm. The score should not be used to divide the tablet.

Presented in blister packs containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturing Responsible Party:

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of latest review of this Package Leaflet: March 2023

Other sources of information

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