Celmantin

Celmantin Special Precautions

rosuvastatin

Manufacturer:

Medochemie

Distributor:

DCH Auriga - Universal
Full Prescribing Info
Special Precautions
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. It is recommended that liver function tests should be performed before the initiation of CELMANTIN, and thereafter when clinically indicated.
While on this medicine, the doctor will closely monitor if there is diabetes or if there is risk of developing diabetes. The patient is likely to be at risk of developing diabetes if high levels of sugars and fats are present in the blood, if overweight and if there is high blood pressure.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.
In JUPITER study, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients.
There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally non-serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
The concomitant use with protease inhibitors is not recommended.
Talk to the doctor or pharmacist before taking CELMANTIN if: Problems with the kidneys are present.
Problems with the liver are present.
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 have been present. Tell the doctor immediately if unexplained muscle aches or pains are present especially if feeling unwell or having a fever. Also tell the doctor or pharmacist if muscle weakness is constantly present.
A medicine called fusidic acid (a medicine for bacterial infection) is being taken or has been taken in the last 7 days orally or by injection. The combination of fusidic acid and CELMANTIN can lead to serious muscle problems (rhabdomyolysis).
Regularly drinking large amounts of alcohol.
Thyroid gland is not working properly.
Other medicines called fibrates are being taken to lower the cholesterol. Read the leaflet carefully, even if other medicines for high cholesterol have been taken before.
Medicines used to treat HIV infection e.g. ritonavir with lopinavir and/or atazanavir are being taken. See Interactions.
Over 70 (as the doctor needs to choose the right start dose of CELMANTIN that is most suitable).
Severe respiratory failure is present.
Of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. The doctor needs to choose the right start dose of CELMANTIN that is most suitable. Pharmacokinetic studies have demonstrated an increase in exposure to rosuvastatin in Asian subjects when compared with Caucasians. Initiation of rosuvastatin therapy with 5 mg once daily should be considered in Asian patients.
If any of the previously mentioned applies (or if unsure), do not take CELMANTIN 40 mg (the highest dose) and check with the doctor or pharmacist before taking any dose of CELMANTIN is actually started.
CELMANTIN with food and drink: CELMANTIN can be taken with or without food.
CELMANTIN contains lactose monohydrate: If intolerance to some sugar is present, contact the doctor before taking this medicinal CELMANTIN.
For a full list of ingredients, see Description.
Driving and using machines: Most people can drive a car and operate machinery while using CELMANTIN - it will not affect their ability. However, some people feel dizzy during treatment with CELMANTIN. If feeling dizzy, consult the doctor before attempting to drive or use machines.
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