Rosuvastatin Sandoz

Rosuvastatin Sandoz

rosuvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Firma Vai Hong
Full Prescribing Info
Contents
Rosuvastatin calcium.
Description
Each film-coated tablet also contains the following excipients: Tablet Core: Anhydrous lactose, anhydrous colloidal silica, silicified microcrystalline cellulose, maize starch, talc, sodium stearyl fumarate. Tablet Coat: Hypromellose, mannitol E421, macrogol 6000, talc, titanium dioxide E171, yellow ferric oxide E172, red ferric oxide E172.
Action
Rosuvastatin belongs to a group of drugs called statins (HMG-CoA reductase inhibitors).
Rosuvastatin Sandoz can reduce the low-density lipoprotein (LDL) cholesterol and increase the high-density lipoprotein (HDL) cholesterol. It works by helping to block the body's production of LDL cholesterol and improve the body's ability to remove it from the blood.
For most people, elevated blood cholesterol levels does not produce any symptoms. However, if left untreated, fatty deposits can build up in the walls of the blood vessels causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or stroke. If the cholesterol levels are corrected, risk of having a heart attack or stroke can be reduced.
Indications/Uses
Patients with high cholesterol level. Correct the levels of fatty substance in the blood known as lipids, the most common of which is cholesterol.
Dosage/Direction for Use
Adult: Elevated Blood Cholesterol Levels: Usual Starting Dose: 5 or 10 mg once daily. The choice of the starting dose will depend upon the cholesterol level; the risk level of experiencing a heart attack or stroke; factor that may result to more sensitivity to possible side effects.
Reduce Risk of Heart Attack, Stroke or Related Health Problems: Recommended Dose: 20 mg once daily.
The physician may decide to give the lowest dose (5 mg) if: The patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Pharmacokinetic studies have demonstrated an increase in exposure to rosuvastatin in Asian patients when compared with Caucasians. Initiation of rosuvastatin therapy with 5 mg once daily should be considered in Asian patients; >70 years; moderate renal impairment; risk of muscle aches and pains (myopathy).
The physician will determine further doses to achieve the desired blood cholesterol levels. Thereafter, the dose will be adjusted individually every 4 weeks. Maximum Daily Dose: 40 mg.
Children (10-17 years): Usual Dose: 5 mg once daily. The dose may be increased to find the right amount that best suits the patient. Maximum Daily Dose: 20 mg once daily.
Administration: Swallow each tablet whole with a drink of water at any time of the day and regardless of food intake.
Missed Dose: Do not take a double dose to make up for the missed dose instead, take the next scheduled dose at the correct time.
Contraindications
Hypersensitivity to rosuvastatin or to any of the excipients of Rosuvastatin Sandoz.
Hepatic impairment; severe renal impairment; repeated or unexplained muscle aches or pain (myopathy); ciclosporin (eg, used after organ transplants).
In addition, the 40 mg dose of Rosuvastatin Sandoz is contraindicated in: Repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs; moderate renal impairment; thyroid gland disorders; regular consumption of large amounts of alcohol; if taking fibrates to lower cholesterol; Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
Use in pregnancy & lactation: Rosuvastatin Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rosuvastatin Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rosuvastatin Sandoz by using suitable contraception.
Special Precautions
Renal and hepatic impairment; severe respiratory failure. Repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs; regular consumption of large amounts of alcohol; thryoid gland disorders; if taking fibrates to lower cholesterol (see Contraindications), drugs used for HIV infection eg, lopinavir, ritonavir (see Interactions); Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
If the patient has an intolerance to some sugars (lactose or milk sugar), consult doctor before taking Rosuvastatin Sandoz.
In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, the physician will usually carry out a blood test (liver function test) before and during treatment with Rosuvastatin Sandoz.
Effects on the Ability to Drive or Operate Machinery: Most patients can drive a car and operate machinery while using Rosuvastatin Sandoz- it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin Sandoz. If dizziness occurs, consult the physician before attempting to drive or use machines.
Use in children: If the patient is <10 years, Rosuvastatin Sandoz should not be given. If the patient is <18 years, Rosuvastatin Sandoz 40 mg is not suitable for use.
Use in the elderly: If the patient is >70 years, the physician needs to choose the right starting dose of Rosuvastatin Sandoz that will best suit the patient.
Use In Pregnancy & Lactation
Rosuvastatin Sandoz should not be taken by pregnant and breastfeeding women. If the patient become pregnant while taking Rosuvastatin Sandoz, stop taking it immediately and inform the physician. Women should avoid becoming pregnant while taking Rosuvastatin Sandoz by using suitable contraception.
Side Effects
Stop taking Rosuvastatin Sandoz and seek medical help immediately if any of the following allergic reactions is experienced: Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat; swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing; severe itching of the skin (with raised lumps).
Also, stop taking Rosuvastatin Sandoz and consult the physician immediately if any unusual aches or pains in the muscles which go on for longer than expected period is experienced. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of patients have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life-threatening muscle damage known as rhabdomyolysis.
Common Possible Side Effects (May Affect Between 1/10 and 1/100 Patients): Headache; dizziness; constipation; feeling sick; stomach pain; muscle pain; feeling weak; an increase in the amount of protein in the urine- this usually returns to normal on its own without having to stop taking Rosuvastatin Sandoz (40 mg only); diabetes, mostly in those with blood sugar at the upper end of "normal".
Uncommon Possible Side Effects (May Affect Between 1/100 and 1/1000 Patients): Rash, itching or other skin reactions; an increase in the amount of protein in the urine- this usually returns to normal on its own without having to stop taking Rosuvastatin Sandoz (5, 10 and 20 mg only).
Rare Possible Side Effects (May Affect Between 1/1000 and 1/10,000 Patients): Severe allergic reaction: signs include swelling of the face, lips, tongue and/or throat , difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If an allergic reaction is experienced, stop taking Rosuvastatin Sandoz and seek medical help immediately; muscle damage in adults: as a precaution, stop taking Rosuvastatin Sandoz and consult physician immediately if any unusual aches or pains in the muscles which go on for longer than expected period is experienced; a severe stomach pain (inflamed pancreas); increased liver enzymes in the blood.
Very Rare Possible Side Effects (May Affect <1 in 10,000 Patients): Jaundice (yellowing of the skin and eyes); hepatitis (inflamed liver); traces of blood in urine; damage to the nerves of legs and arms (eg, numbness); joint pain; memory loss.
Side Effects of Not Known Frequency May Include: Diarrhea (loose stools); Stevens-Johnson syndrome (serious blistering of the skin, mouth, eyes and genitals); cough; shortness of breath; oedema (swelling); sleep disturbances, including insomnia and nightmares; sexual difficulties; depression; breathing problems including persistent cough and/or shortness of breath or fever.
Drug Interactions
Ciclosporin (eg, used after organ transplants); warfarin or any other blood-thinning drugs; fibrates and other lipid-lowering drugs (eg, gemfibrozil, fenofibrate); any other drugs used to lower cholesterol (eg, ezetimibe); indigestion remedies (used to neutralize acid in stomach); erythromycin (antibiotic); oral contraceptive (pill); hormone replacement therapy or lopinavir and ritonavir (used for HIV infection, see Precautions).
Storage
Do not store above 25°C. Protect from moisture.
Shelf-Life: 3 months.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
FC tab 5 mg (light brown, round, with "RSV 5" debossed on one side) x 30's. 10 mg (brown, round, with "RSV 10" debossed on one side) x 30's. 20 mg (brown, round, with "RSV 20" debossed on one side) x 30's.
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