Patient Information

Pitavastatina Stada 1 mg Film-Coated Tablets

Pitavastatina Stada 2 mg Film-Coated Tablets

Pitavastatina Stada 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.

This medication contains a substance called pitavastatina. It belongs to a group of medications 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 cerebral infarction.

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 Stada:

• if you are allergic to pitavastatina, any other statin, or any of the other components of this medication (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, breastfeeding, and fertility’).
• if you currently have liver problems.
• if you are taking ciclosporina, a medication used after organ transplantation.
• if you have recurring 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).
• you have ever had kidney problems.
• 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 functioning) before and during treatment with pitavastatina.
• you have ever had thyroid problems.
• you or a family member have a history of muscle problems.
• you have previously had muscle problems when taking other cholesterol-lowering medications (e.g. statins or fibrates).
• you consume a lot of alcohol.
• you are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and pitavastatina can cause severe muscle problems (rhabdomyolysis).
• you have or have had myasthenia (a disease characterized by 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 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 blood sugar and fat levels, obesity, and high blood pressure.

Children and adolescents

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

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

Other medications and Pitavastatina Stada

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

Specifically, 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 to treat infections.
• warfarin or any other medication used to anticoagulate the blood.

• medications for HIV called ‘protease inhibitors’
• niacin (vitamin B3).
• if you need to take oral fusidic acid 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 muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• medications containing glecaprevir and pibrentasvir, used to treat Hepatitis C. Your doctor may need to change your pitavastatina dose.

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

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, consult your doctor or pharmacist before starting to take any 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 Stada contains lactose

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

Follow the medication administration instructions exactly as indicated by your doctor. If you are unsure, 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.
• 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.

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 and adolescents

• The maximum dose in children under 10 years old is 2 mg per day.
• Pitavastatina is not recommended for children under 6 years old.

Other things you need to know while taking Pitavastatina Stada

• If you are hospitalized or receiving 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 increase.

If you take more Pitavastatina Stada 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 or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pitavastatina Stada

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

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

Stop taking Pitavastatina Stada and see your doctor immediately if you observe any of the following severe side effects, as you may need urgent medical treatment:

• allergic reaction: some of the signs are 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 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 can 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 that include persistent cough and/or difficulty breathing or fever.
• liver problems that can cause yellowing of the skin and eyes (jaundice).
• pancreatitis (intense pain in the abdomen and back).
• lupus-like syndrome (with rash, joint disorders, and effects on blood cells) (frequency unknown (the frequency cannot be estimated from the available data)

Other side effects include:

Frequent (affects less than 1 person in 10)

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

Rare (affects less than 1 person in 100)

• muscle spasms
• weakness, fatigue, or malaise
• swelling of the ankles, feet, or fingers of the hands
• stomach pain, dry mouth, vomiting, loss of appetite, altered 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 (affects less than 1 person in 1,000)

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

Side effects of unknown frequency (cannot be estimated from the available data)

• constant muscle weakness.
• severe myasthenia (a disease that causes generalized 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 the arms or legs that worsens after periods of activity, double vision, or 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 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.

Store in the original packaging (blister) to protect it from light..

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.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pitavastatina Stada

The active ingredient is pitavastatin (as pitavastatin calcium)

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

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

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

The other excipients are:

Core of the tablet

Lactose monohydrate, low-substituted hydroxypropylcellulose, hypromellose (E464), magnesium hydroxide, magnesium stearate

Coating

Opadry Y-1-7000 containing hypromellose (E464), titanium dioxide (E171), macrogol.

Appearance of the product and content of the container

Pitavastatina Stada 1 mg are film-coated tablets, round, biconvex, white, without a notch, and with the logo ‘P1’ on one side.

Pitavastatina Stada 2 mg are film-coated tablets, round, biconvex, white, without a notch, and with the logo ‘P2’ on one side.

Pitavastatina Stada 4 mg are film-coated tablets, round, biconvex, white, notched on one side, and with the logo ‘P4’ on the other side.

Pitavastatina Stada is available in packs of 7 and 28 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Laboratorios CINFA, S.A.

Carretera Olaz-Chipi, 10 Industrial Estate Areta,

31620 Huarte (Navarra) Spain

Or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Last review date of this leaflet:September 2023

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/