Prospecto: information for the user

Pitavastatina TecniGen 1 mg film-coated tablets

Pitavastatina TecniGen 2 mg film-coated tablets

Pitavastatina TecniGen 4 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospectus:

1. What isPitavastatina TecniGenand for what it is used
2. What you need to know before starting to take Pitavastatina TecniGen
3. How to take Pitavastatina TecniGen
4. Possible adverse effects
5. Storage of Pitavastatina TecniGen
6. Contents of the package and additional information

This medication contains a substance called pitavastatina. It belongs to a group of medications called 'statins'. Pitavastatina is used to correct the levels of fatty substances (lipids) in the blood and it can be taken by both children aged 6 years and older and adults. An imbalance of fats, especially cholesterol, may sometimes cause a heart attack or a stroke.

You have been prescribed pitavastatina 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 lifestyle changes while taking pitavastatina.

Do not take pitavastatina:

• if you are allergic (hypersensitive) to pitavastatina, to any other statin, or to any of the other

components of pitavastatina (see section 6. ‘Contents of the pack and special precautions for disposal and other special precautions’).

• if you are pregnant or breastfeeding.
• if you are a woman and may become pregnant, and you are not using an effective contraceptive method (see ‘Pregnancy and lactation’).
• if you currently have liver problems.
• if you are taking ciclosporina, a medicine used after an organ transplant.
• if you have repeated or unjustified muscle pain.

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 generally perform 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 member of your family have a history of muscle problems.
• if you have previously had muscle problems when taking other cholesterol-lowering medicines (e.g. statins or fibrates).
• if you drink a lot of alcohol.
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used for the treatment of bacterial infection) by mouth or by injection. The combination of fusidic acid and pitavastatina can cause severe muscle problems (rhabdomyolysis).
• 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 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 cases affect 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. Further tests and additional medicines may be necessary 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 your blood, being overweight, and high blood pressure.

Children and adolescents

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

Before taking pitavastatina, adolescents should receive guidance and advice on contraceptives

Other medicines and Pitavastatina TecniGen

Inform your doctor or pharmacist if you are using or have used recently other medicines, even those acquired without a prescription or herbal products. Some medicines may make others less effective.

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 for infections.
• warfarin or any other medicine used to anticoagulate 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 have to take oral fusidic acid to treat a bacterial infection you will have to stop using this medicine. Your doctor will indicate when you can restart the treatment with pitavastatina. The use of pitavastatina with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis see section 4.

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

Taking pitavastatina with food and drinks

You can take pitavastatina with or without food.

Pregnancy, lactation, 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, consult your doctor or pharmacist before starting to take any medicine.

Driving and operating machinery

Pitavastatina is not expected 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 TecniGen contains lactose

Pitavastatina contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Taking this medication

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 for 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 for 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 TecniGen

• 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 first talking to your doctor. Your cholesterol levels may rise.

If you take more Pitavastatina TecniGen than you should

If you take more pitavastatina than you should, inform your doctor or go to the hospital immediately. Bring the medication packaging.

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

If you forget to take Pitavastatina TecniGen

Do not worry, take the next dose at the correct 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 Pitavastatina TecniGen and seek medical attention immediately if you observe any of the following severe side effects, as you may need urgent medical treatment:

• Allergic reaction: some signs include difficulty breathing, swelling of the face, lips, tongue, or throat, trouble swallowing, intense skin itching (with rashes).
• Unexplained muscle pain or weakness, especially if you are not feeling well, have a fever, or if your urine is dark brown in color. In rare cases (in less than 1 person in 1,000), pitavastatina may cause bothersome muscle effects. If these effects are not investigated, they may cause serious problems such as abnormal muscle rupture (rhabdomyolysis), which can lead to kidney problems.
• Respiratory problems that include persistent cough and/or difficulty breathing or fever.
• Liver problems that may cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (intense abdominal and back pain). Other side effects include:

Frequent (affecting less than 1 person in 10)

• Joint pain, muscle pain
• Constipation, diarrhea, indigestion, nausea
• Headache

Rare (affecting less than 1 person in 100)

• Muscle spasms
• Weakness, fatigue, or discomfort
• Swelling of the ankles, feet, or fingers of the hands
• Abdominal pain, dry mouth, vomiting, loss of appetite, altered taste
• Pale skin and weakness or shortness of breath (anemia)
• Itching or skin rash
• Tinnitus in the ears
• Dizziness or somnolence, insomnia (or other sleep disorders, including nightmares)
• Increased frequency of urination
• Sensation of numbness and reduced sensitivity in the fingers of the hands and feet, legs, and face

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

• Redness of the skin, rashes, and skin itching
• Deterioration of vision
• Tongue pain
• Unpleasant sensation or discomfort in the stomach
• Enlargement of the breast in males (gynecomastia)

Side effects of unknown frequency

• Constant muscle weakness.
• Syndrome similar to lupus (with rash, joint problems, 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).

Consult 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, pharmacist, or nurse, 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 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.

This medication does not require special conditions for conservation.

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

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

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pitavastatina TecniGen

The active ingredient is pitavastatina.

Pitavastatina TecniGen 1 mg: Each film-coated tablet contains pitavastatina calcium equivalent to 1 mg of pitavastatina.

Pitavastatina TecniGen 2 mg: Each film-coated tablet contains pitavastatina calcium equivalent to 2 mg of pitavastatina.

Pitavastatina TecniGen 4 mg: Each film-coated tablet contains pitavastatina calcium equivalent to 4 mg of pitavastatina.

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

Appearance of the product and contents of the packaging

Pitavastatina TecniGen 1 mg: The film-coated tablets are round, biconvex, white to off-white in color, with a notch on one face and approximately 6 mm in diameter. The notch should not be used to break the tablet.

Pitavastatina TecniGen 2 mg: The film-coated tablets are round, biconvex, white to off-white in color, and approximately 7 mm in diameter.

Pitavastatina TecniGen 4 mg: The film-coated tablets are round, biconvex, white to off-white in color, with a notch on one face and approximately 9.5 mm in diameter. The notch should not be used to break the tablet.

It is presented in packaging with blisters containing 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this Prospecto: March 2023

Other sources of information

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