Product Information for the User

Pitavastatina Krka 1 mg Film-Coated Tablets

Pitavastatina Krka 2 mg Film-Coated Tablets

Pitavastatina Krka 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

Contents of the pack and additional information

Pitavastatina Krka contains a substance called pitavastatina. It belongs to a group of medicines called ‘statins’. Pitavastatina is used to correct 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 changes in your lifestyle while taking pitavastatina.

Do not take Pitavastatina Krka:

• if you are allergic to pitavastatina or any of the other ingredients of this medicine (listed in section 6).
• 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, lactation and fertility’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after an organ transplant.
• if you have repeated or unjustified muscle pains.

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 family member 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 injection. The combination of fusidic acid and pitavastatina may cause severe muscle problems (rhabdomyolysis).
• if you are taking medicines that contain glecaprevir and pibrentasvir, medicines 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause it to appear (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.

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

Other medicines and Pitavastatina Krka

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine. Some medicines may make others stop working properly. In particular, 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/AIDS 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 fusidic acid orally 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 may 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 Krka 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, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and operating machines

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 Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Follow the administration instructions for this medication exactly 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 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 this medication

• Inform the medical staff that you are taking pitavastatina if you go to the hospital or receive treatment for another condition.
• Your doctor may perform tests to monitor your cholesterol levels regularly.
• Do not stop taking pitavastatina without talking to your doctor first. Your cholesterol levels may increase.

If you take more Pitavastatina Krka than you should

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

For overdose, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pitavastatina Krka

Do not worry, take the next dose at the correct time. Do not take a double dose to compensate for the missed doses.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

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

Stop taking this medicine 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 itching of the skin (with rashes).
• Unexplained muscle pain or weakness, especially if you are unwell, have a fever, or if your urine is dark brown in color. In rare cases (in less than 1 in 1,000 people), pitavastatin may cause uncomfortable muscle effects. If these effects are not investigated, they can lead to serious problems such as abnormal muscle rupture (rhabdomyolysis), which can cause kidney problems.
• Respiratory problems that include persistent cough and/or difficulty breathing or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (intense abdominal and back pain).

Other side effects include:

Frequent (affecting less than 1 in 10 people)

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

Rare (affecting less than 1 in 100 people)

• Muscle spasms
• Weakness, fatigue, or malaise
• Swelling of the ankles, feet, or fingers
• Abdominal pain, dry mouth, vomiting, loss of appetite, altered taste
• Pale skin and weakness or shortness of breath (anemia)
• Itching or skin rash
• Tinnitus (ringing 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 hands and feet, legs, and face

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

• 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.

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

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Pitavastatina Krka

• The active ingredient is pitavastatina.

Each film-coated tablet contains 1 mg of pitavastatina (as pitavastatina calcium).

Each film-coated tablet contains 2 mg of pitavastatina (as pitavastatina calcium).

Each film-coated tablet contains 4 mg of pitavastatina (as pitavastatina calcium).

• The other excipients are:

Core of the tablet:Lactose monohydrate, hypromellose 5 cP, hydroxypropylcellulose and magnesium stearate.

Coating:Hypromellose 6 cP, titanium dioxide (E171),talco, propylene glycol, yellow iron oxide (E172) –only for 1 mg and 2 mg tablets andred iron oxide (E172) –only for 2 mg and 4 mg tablets.

See section 2 “Pitavastatina Krka contains lactose”.

Appearance of the product and contents of the package

1 mg film-coated tablets:Film-coated tablets, round, biconvex, yellow-brown in color and have the mark “1” engraved on one of the faces. Tablet size: approximately 6 mm in diameter.

2 mg film-coated tablets:Film-coated tablets, round, biconvex, orange-brown in color and have the mark “2” engraved on one of the faces. Tablet size: approximately 7 mm in diameter.

4 mg film-coated tablets:Film-coated tablets, round, biconvex, red-brown in color and have the mark “4” engraved on one of the faces. Tablet size: approximately 9 mm in diameter.

Pitavastatina Krka is available in packages containing:

• 7, 28, 30, 90 and 100 film-coated tablets in blisters,
• 7 x 1, 28 x 1, 30 x 1, 90 x 1 or 100 x 1film-coated tablets in perforated unit-dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Last revision date of this leaflet: August 2023

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).