VASPIT 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vaspit 1 mg film-coated tablets EFG

Vaspit 2 mg film-coated tablets EFG

Vaspit 4 mg film-coated tablets EFG

pitavastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What is Vaspit and what is it used for

This medicine contains a substance called pitavastatin. It belongs to a group of medicines called ‘statins’. Pitavastatin is used to correct blood fat (lipid) levels and can be taken by children from 6 years and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

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

2. What you need to know before you take Vaspit

Do not take Vaspit:

• if you are allergic to pitavastatin, to any other statin or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.
• if you are a woman and can become pregnant, and you are not using a reliable contraceptive method (see ‘Pregnancy and breast-feeding’).
• if you currently have liver problems.
• if you are taking ciclosporin - used after organ transplants.
• if you have repeated or unexplained muscle pains.

If you are in doubt, consult your doctor or pharmacist before taking pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before taking pitavastatin:

• if you have severe respiratory problems (serious breathing 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 do blood tests (to see how your liver is working) before and during treatment with pitavastatin.
• 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 medicines to lower cholesterol (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 containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and pitavastatin can cause serious muscle problems (rhabdomyolysis).

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine. Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

If you have or have had myasthenia (a disease with general muscle weakness that includes, in some cases, the muscles used for breathing), or ocular myasthenia (a disease that causes weakness of the eye muscles), since statins can sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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 the blood, are overweight, and have high blood pressure.

Children and adolescents

This medicine should not be given to children under 6 years of age.

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

Other medicines and Vaspit

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription or herbal products. Some medicines can make others stop working properly. In particular, tell 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 thin the blood.
• HIV medicines 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 by mouth to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with pitavastatin. The use of pitavastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking medicines containing glecaprevir and pibrentasvir, medicines used to treat hepatitis C. Your doctor may need to change the dose of your treatment with pitavastatin.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking pitavastatin.

Taking Vaspit with food and drinks

You can take this medicine with or without food.

Pregnancy, breast-feeding, and fertility

Do not take this medicine if you are pregnant or breast-feeding. If you want to become pregnant, inform your doctor before starting to take this medicine.

If you are trying to become pregnant, consult your doctor before taking this medicine. If you are a woman and can become pregnant, you must use a reliable contraceptive method while taking this medicine. If you become pregnant while taking this medicine, stop taking this medicine and consult your doctor immediately. If you are pregnant or breast-feeding, consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking pitavastatin, do not drive or use machines or tools.

Vaspit contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Vaspit

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

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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.

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To start with, the usual dose is 1 mg once a day. After a few weeks, your doctor may decide to increase the dose. The maximum dose in adults and children over 10 years is 4 mg per day.

If you have liver problems, you should not take more than 2 mg per day.

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The maximum dose in children under 10 years is 2 mg per day.

If necessary, the tablets can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink immediately. Do not use fruit juices or milk to disperse the tablets.

The use of this medicine is not recommended in children under 6 years of age.

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If you go to the hospital or receive treatment for another problem, inform the medical staff that you are taking this medicine.

Your doctor may do tests to check your cholesterol levels regularly.

Do not stop taking this medicine without talking to your doctor first. Your cholesterol levels may increase.

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If you take more of this medicine than you should, talk to a doctor or go to the hospital immediately. Take the medicine package with you.

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

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine can cause the following side effects:

Stop taking Vaspit and contact your doctor immediately if you experience 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, swallowing problems, intense itching of the skin (with hives).
• Unexplained muscle pain or weakness, especially if you are unwell, have a fever, or if your urine is brownish-red. In rare cases (less than 1 person in 1,000), pitavastatin can cause unpleasant muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can cause kidney problems.
• Breathing problems, including persistent cough and/or difficulty breathing or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (severe abdominal and back pain).

Other side effects include:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• muscle spasms
• weakness, tiredness, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, taste disturbance
• pale skin and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares)
• increased need to urinate (urinary frequency)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

Rare(may affect up to 1 in 1,000 people)

• redness of the skin, hives, and itching
• vision loss
• 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)

• Persistent muscle weakness.
• Lupus-like syndrome (with rash, joint disorders, and effects on blood cells).
• Myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

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

Other possible side effects

• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vaspit

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage temperature. Keep the blister in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vaspit

• The active substance is pitavastatin. Each film-coated tablet contains pitavastatin calcium equivalent to 1 mg, 2 mg, or 4 mg of pitavastatin.
• The other excipients are: tablet core: lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium aluminometasilicate, hypromellose 2910, magnesium stearate; film coating: Opadry white 03O580007 (hypromellose, titanium dioxide (E171), triethyl citrate (E 1505), anhydrous colloidal silica), yellow iron oxide E172 (2 mg tablets).

Appearance of the product and packaging contents

Vaspit 1 mg film-coated tablets: Film-coated tablets, round, concave, white, engraved with "10" on one side and smooth on the other side, with a diameter of approximately 6 mm.

Vaspit 2 mg film-coated tablets: Film-coated tablets, round, concave, yellow, engraved with "20" on one side and smooth on the other side, with a diameter of approximately 8 mm.

Vaspit 4 mg film-coated tablets: Film-coated tablets, round, concave, white, engraved with "MC" on one side and smooth on the other side, with a diameter of approximately 10.3 mm.

Opaque blisters in boxes of 7, 28, or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Medochemie Ltd,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Manufacturer

Medochemie Ltd,

Factory Az, Agios Athanassios Industrial Area, Michali Irakleous 2,

Agios Athanasios,

4101 Limassol,

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Local representative:

Medochemie Iberia S.A., Spanish branch

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Date of last revision of this leaflet:September 2023.

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