Rozavi^®

Rosuvastatin 10, 20 mg

Film-Coated Tablets for Oral Use

Product leaflet summary

Therapeutic Indications

ROZAVI belongs to a group of medicines called Statins.

You have been prescribed ROZAVI because:

• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. ROZAVI is used in adults, adolescents and children 6 years or older to treat high cholesterol.

You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking ROZAVI.

Or

• You have other factors that increase your risk of having a heart attack, stroke or related health problems.

Heart attack, stroke and other problems can be caused by a disease called atherosclerosis.

Atherosclerosis is due to build of fatty deposits in your arteries.

Dosage and Administration

Take ROZAVI once daily. You can take it at any time of the day with or without food. Try to take your tablet at the same time every day to help you to remember it.

Contraindications

• If you have ever had an allergic reaction to ROZAVI, or to any of its ingredients.
• If you are pregnant or breast-feeding. If you become pregnant while Taking ROZAVI stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking ROZAVI by using suitable contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains.
• If you take a drug called ciclosporin (used, for example, after organ transplants)
• If any of the above applies to you (or you are in doubt), please go back and see your doctor.
• In addition, do not take Rosuvastatin 40 mg (the highest dose):
• If you have moderate kidney problems (if in doubt, please ask your doctor).
• If your thyroid gland is not working properly.
• If you have had any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• If you take other medicines called fibrates to lower your cholesterol.
• If any of the above applies to you (or you are in doubt), please go back and see your doctor.

Pregnancy and Lactation

Do not take ROZAVI if you are pregnant or breast-feeding. If you become pregnant while taking ROZAVI stop taking ROZAVI it immediately and tell your doctor. Women should avoid becoming pregnant while taking ROZAVI by using suitable contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Ability to Drive and Use Machinery

Most people can drive a car and operate machinery while using ROZAVI it will not affect their ability. However, some people feel dizzy during treatment with ROZAVI. If you feel dizzy, consult your doctor before attempting to drive or use machines

Package Presentation:

ROZAVI 20 and 10 mg.

Packs contain 28 film coated tablet