Information about ROSUVA PLUS

Composition:
Each filme coated tablet contains: Rosuvastatin 10 mg (as Rosuvastatin Calcium) and Ezetimibe 10 mg.
Or
Rosuvastatin 20 mg (as Rosuvastatin Calcium) and Ezetimibe 10 mg.
lndication:
As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non HDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Type IIa and IIb).
As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
To reduce LDL-C, total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments or if such treatments are unavailable.
For cardiovascular protection in patients with high risk of CAD.
Contraindication:
Hypersensitivity for Ezetimibe or Rosuvastatin or for any components of Rosuva Plus.
If there is a liver disease.
Pregnancy and lactation .
If there is a renal disease .
In case of using the medicines containing Cyclosporin.
Thyroid gland abnormalities.
The recurrent muscle pain of unknown reason or in case of the occurrence of previous muscle pain during the use of other cholesterol lowering medicines.
Substantial consumption of alcohol.
Warnings:
Rosuva Plus should be used carefully in cases of:
hypersensitivity for medicines.
Kidney disorders.
Liver disorders.
If Fasting blood glucose  levels ranged between 100-125 mg/dl. 
When using medicines as Lopinavir or Ritonavir against HIV.
In case of using medicines containing Fiberates (Gemfiberozil and Fenofibrates).
Children under 10 years age.
Elderly patients (age over 70 years).
Drug-Drug interactions:
If the patient is using one of the following drugs, he must consult the doctor:
Cyclosporine.
Warfarin, Phenprocoumon, acenocoumarol and Fluindione (or other anticoagulants).
Fibrates.
Cholestyramine and Cholestipol.
Erythromycin.
Oral contraceptive.
Lopinavir / Ritonavir (used against HIV infection).
Dosage and Administration:
The patient should be placed on a standard cholesterol lowering diet before receiving Rosuva Plus and should continue on this diet during treatment.
Rosuva Plus can be administered as a single dose at any time of day, with or without food.
Usual dose:
single tablet once daily.
Usage by the children:
Rosuva Plus is not recommended for children.
Renal failure:
No need to titration in patient suffering from mild to moderate renal failure. Rosuva Plus is contraindicated in severe renal failure.
Liver failure:
Rosuva Plus is contraindicated in active liver disease cases.

Overdosage:
In the event of overdose, the doctor or pharmacists should be consulted.
Side Effects:
Rosuva Plus must be stopped in the following cases:
Hypersensitivity reactions (Swelling in the face, lips and tongue,difficulty in swallowing and breathing, Itching).
Muscle bruises, unusual muscle pain for a long time.
Possible side effects:
Hypertension.
Numbness.
Gastritis.
Thrombocytopenia.
Myalgia.
Gallstone.
Cholecystitis (It may lead to an abdominal pain - nausea - vomiting).
Palpitation.
Depression.
Pancreatitis.
Hematuria.
Hepatitis.
Cough.
Abdominal pain.
Diarrhea.
Dyspepsia.
Joints pain.
Anorexia.
Fatigue.
Chest pain.
Dryness in the mouth.
Itching.
Red spots in the skin.
Urticaria.
Muscular pain.
Back pain.
Dizziness.
Bronchitis.
Anemia.
Constipation.
Nausea.
Edemas.

STORAGE:
Store at controlled room temperature not exceeding 25°C. Protect from moisture.
Package:
Rosuva plus 10/10: Packs of 20 F.C tablets.
Rosuva plus 20/10: Packs of 30 F.C tablets.