Celmantin

Celmantin

rosuvastatin

Manufacturer:

Medochemie

Distributor:

DCH Auriga - Universal
Full Prescribing Info
Contents
Rosuvastatin.
Description
Each film-coated tablet contains 10 mg or 20 mg rosuvastatin as rosuvastatin calcium.
Excipients/Inactive Ingredients: Cellulose Microcrystalline PH-101, Silica Colloidal Anhydrous, Crospovidone Type A, Cellulose Microcrystalline PH-102, Lactose Monohydrate, Magnesium Stearate.
Tablet coating: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Iron oxide red (E172).
Action
CELMANTIN belongs to a group of medicines called statins.
CELMANTIN is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood - 'bad' cholesterol (LDL-C) and 'good' cholesterol (HDL-C).
CELMANTIN can reduce the 'bad' cholesterol and increase the 'good' cholesterol.
It works by helping to block the body's production of 'bad' cholesterol. It also improves the body's ability to remove it from the blood.
For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is 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 a stroke. By lowering the cholesterol levels, the patient's risk of having a heart attack, a stroke or related health problems can be reduced.
The patient needs to keep taking CELMANTIN, even if it has got the cholesterol to the right level, because it prevents the cholesterol levels from creeping up again and causing buildup of fatty deposits. However, the patient should stop if advised by the doctor, or the patient has become pregnant.
Indications/Uses
CELMANTIN has been prescribed because: The patient has a high cholesterol level. This means the patient is at risk from a heart attack or stroke. CELMANTIN is used in adults to treat high cholesterol.
The patient has been advised to take a statin, because changing the diet and doing more exercise were not enough to correct the cholesterol levels. The patient should continue with the cholesterol-lowering diet and exercise while taking CELMANTIN.
The patient has other factors that increase the 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 buildup of fatty deposits in the arteries.
Dosage/Direction for Use
Always take this medicine exactly as advised by the doctor. Check with the doctor or pharmacist if unsure.
The recommended dose in adults is: If the patient is taking CELMANTIN for high cholesterol: Starting dose: The treatment with CELMANTIN must start with the 5-mg or the 10-mg dose, even if the patient has taken a higher dose of a different statin before. The choice of the start dose will depend upon: The cholesterol level; The level of risk the patient has of experiencing a heart attack or stroke; Whether there is a factor that may make the patient more sensitive to possible side effects.
Check with the doctor or pharmacist which start dose of CELMANTIN will be most suitable.
The doctor may decide to give the lowest dose (5 mg) if: Of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian); Over 70 years of age; Moderate kidney problems are present; At risk of muscle aches and pains (myopathy).
Increasing the dose and maximum daily dose: The doctor may decide to increase the dose. This is so that the patient is taking the right amount of CELMANTIN. If the patient started with a 5-mg dose, the doctor may decide to double this to 10 mg, then 20 mg and then 40 mg if necessary. If the patient started on 10 mg, the doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of CELMANTIN is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.
If the patient is taking CELMANTIN to reduce the risk of having a heart attack, stroke or related health problems: The recommended dose is 20 mg daily. However, the doctor may decide to use a lower dose if the patient has any of the factors previously mentioned.
Taking the tablets: Swallow each tablet whole with a drink of water.
Take CELMANTIN once daily. It can be taken at any time of the day.
Try to take the tablet at the same time every day to help in remembering it.
Regular cholesterol checks: It is important to go back to the doctor for regular cholesterol checks to make sure the cholesterol has reached and is staying at the correct level.
The doctor may decide to increase the dose so that the patient is taking the right amount of CELMANTIN.
If the patient forgets to take CELMANTIN: Don't worry, just take the next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If the patient stops taking CELMANTIN: Talk to the doctor if taking CELMANTIN wants to be stopped. The cholesterol levels might increase again if taking CELMANTIN is stopped.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.
Overdosage
If more CELMANTIN is taken than the amount that should be taken, contact the doctor or nearest hospital for advice.
If going into a hospital or receiving treatment for another condition, tell the medical staff that CELMANTIN is being taken.
Contraindications
Do not take CELMANTIN if: Allergic to rosuvastatin, or any of the other ingredients of this medicine (listed in Description).
Pregnant or breast-feeding. If the patient becomes pregnant while taking CELMANTIN, she should stop taking it immediately and tell the doctor. Women should avoid becoming pregnant while taking CELMANTIN by using suitable contraception.
Liver disease is present.
Severe kidney problems are present.
Repeated or unexplained muscle aches or pains are present.
A drug called ciclosporin (used, for example, after organ transplants) is being taken.
If any of the previously mentioned applies (or if in doubt), go back and see the doctor.
In addition, do not take CELMANTIN 40 mg (the highest dose) if: Moderate kidney problems are present (if in doubt, ask the doctor).
Thyroid gland is not working properly.
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 have been present.
Regularly drinking large amounts of alcohol.
Of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
Other medicines called fibrates are being taken to lower the cholesterol.
If any of the previously mentioned applies (or if in doubt), go back and see the doctor.
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.
Use In Pregnancy & Lactation
Do not take CELMANTIN if pregnant or breast-feeding. If the patient becomes pregnant while taking CELMANTIN, she should stop taking it immediately and tell the doctor. Women should avoid becoming pregnant while taking CELMANTIN by using suitable contraception.
Ask the doctor or pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, CELMANTIN can cause side effects, although not everybody gets them.
It is important to be aware of what these side effects may be. They are usually mild and disappear after a short time.
Stop taking CELMANTIN and seek medical help immediately if any of the following allergic reactions are present: 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 CELMANTIN and talk to the doctor immediately if there are any unusual aches or pains in the muscles which go on for longer than might be expected. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely have these gone on to become a potentially life-threatening muscle damage known as rhabdomyolysis.
Common possible side effects (may affect up to 1 in 10 people): Headache; Stomach pain; Constipation; Feeling sick; Muscle pain; Feeling weak; Dizziness.
An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking CELMANTIN tablets (only CELMANTIN 40 mg).
Diabetes. This is more likely if high levels of sugars and fats are present in the blood, if overweight and if there is high blood pressure. The doctor will monitor the patient while taking this medicine.
Uncommon possible side effects (may affect up to 1 in 100 people): 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 CELMANTIN tablets (only CELMANTIN 5 mg, 10 mg and 20 mg).
Rare possible side effects (may affect up to 1 in 1,000 people): 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 the patient thinks he/she is having an allergic reaction, then he/she should stop taking CELMANTIN and seek medical help immediately.
Muscle damage in adults - as a precaution, stop taking CELMANTIN and talk to the doctor immediately if there are any unusual aches or pains in the muscles which go on for longer than expected.
A severe stomach pain (inflamed pancreas).
Increase in liver enzymes in the blood.
Very rare possible side effects (may affect up to 1 in 10,000 people): Jaundice (yellowing of the skin and eyes); Hepatitis (an inflamed liver); Traces of blood in the urine; Damage to the nerves of the legs and arms (such as numbness); Joint pain; Memory loss; Breast enlargement in men (gynaecomastia).
Side effects of unknown frequency may include: Diarrhoea (loose stools); Stevens-Johnson syndrome (serious blistering condition 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; Tendon injury; Constant muscle weakness.
Reporting of side effects: If any side effects are experienced, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. Side effects can also be reported via the national reporting system. By reporting side effects, patients can help provide more information on the safety of this medicine.
Drug Interactions
Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines.
Tell the doctor if taking any of the following: ciclosporin (used for example, after organ transplants), warfarin (or any other drug used for thinning the blood), fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe), indigestion remedies (used to neutralise acid in the stomach), erythromycin (an antibiotic), an oral contraceptive (the pill), hormone replacement therapy, or ritonavir with lopinavir and/or atazanavir (used to treat HIV infection - see Precautions). The effects of these medicines could be changed by CELMANTIN or they could change the effects of CELMANTIN.
If oral fusidic acid needs to be taken to treat a bacterial infection, the patient will need to temporarily stop using CELMANTIN. The doctor will tell when it is safe to restart CELMANTIN. Taking CELMANTIN with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in Side Effects.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Store below 25°C in the original package in order to protect from light.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
FC tab 10 mg (pink, round, biconvex, embossed 'ROS' over '10' on one side and nothing on the other, with diameter 7 mm) x 28's. 20 mg (pink, round, biconvex, embossed 'ROS' over '20' on one side and nothing on the other, with diameter 9 mm) x 28's.
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