Celmantin

Celmantin

rosuvastatin

Manufacturer:

Medochemie

Distributor:

KTZ

Marketer:

Aung Paing Tun
Full Prescribing Info
Contents
Rosuvastatin.
Description
CELMANTIN contains the active substance rosuvastatin.
Each film-coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin as rosuvastatin calcium respectively.
Excipients/Inactive Ingredients: Cellulose Microcrystalline PH-101, Silica Colloidal Anhydrous, Crospovidone Type A, Cellulose Microcrystalline PH-102, Lactose Monohydrate, Magnesium Stearate. Tablet Coating: 5 mg: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Iron oxide yellow (E172); 10 mg: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Iron oxide red (E171); 20 mg: Hypromellose, Titanium dioxide (E171), Lactose monohydrtae, Triacetin, Iron oxide red (E171); 40 mg: 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 can reduce the risk of having a heart attack, a stroke or related health problems. The patient needs to keep CELMANTIN, even if it has got the cholesterol to the right level, because it prevents the cholesterol levels from creeping up again and causing build-up of fatty deposits. However, the patient should stop if the doctor tell the patient to do so, or the patient has become pregnant.
Indications/Uses
The patient has been prescribed CELMANTIN 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, adolescents and children 6 years or older to treat high cholesterol.
The patient has been advised to take a statin, because changing the diet and taking more exercise were not enough to correct the cholesterol levels. The patient should continue with the cholesterol-lowering diet and exercise while taking CELMANTIN or the patient has other factors that increase the risk of having a heart attack, stroke or related problems.
Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to build-up of fatty deposits in the arteries.
Dosage/Direction for Use
Always take the medicine exactly as the doctor has told the patient.
Check with the doctor or pharmacist if the patient is not sure.
The recommended dose in adults is: If the patient is taking for high cholesterol: Starting dose: The treatment with CELMANTIN must start with the 5 mg or 10 mg dose, even if the patient has taken a higher dose of a different statin before. The choice of the starting dose will depend upon: The cholesterol level; The level of risk the patient has of experiencing heart attack or stroke; Whether if the patient has a factor that may make him/her more sensitive to possible side effects.
Check with the doctor or pharmacist which start dose of CELMANTIN will best suit the patient.
The doctor may decide to give the lowest dose (5 mg) if: The patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian); If the patient is over 70 years of age; The patient has moderate kidney problems; The patient is 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 amount of CELMANTIN that is right for him/her. If the patient started with a 5 mg dose, the doctor may decide to double the dose 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 the dose 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 he/she has any of the factors mentioned previously.
Use in children and adolescents aged 6-17 years: The usual starting dose is 5 mg. The doctor may increase the dose to find the right amount of CELMANTIN for the patient. The maximum daily dose is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take the dose once a day. CELMANTIN 40 mg tablet should not be used by children.
Taking the tablets: Swallow each tablet whole with a drink of water.
Take CELMANTIN once daily. The patient can take it at any time of the day.
Try to take the tablet at the same time every day to help the patient remember it.
Regular cholesterol checks: It is important to go back 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 takes 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 the forgotten doses.
If the patient stops taking CELMANTIN: Talk to the doctor if the patient wants to stop taking CELMANTIN. The cholesterol levels might increase again if the patient stops taking CELMANTIN.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
CELMANTIN with food and drink:
The patient can take CELMANTIN with or without food.
Overdosage
If the patient has taken more CELMANTIN than he/she should: Contact the doctor or nearest hospital for advice. If the patient goes to hospital or receives treatment for another condition, tell the medical staff that the patient is taking CELMANTIN.
Contraindications
Do not take CELMANTIN: If the patient is allergic to rosuvastatin, or any of the other ingredients of the medicine listed in Description.
If the patient is pregnant or breast-feeding. If the patient becomes pregnant while taking CELMANTIN by using suitable contraception.
If the patient has liver disease.
If the patient has severe kidney problems.
If the patient has repeated or unexplained muscle aches or pains.
If the patient is taking or has taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and CELMANTIN can lead to serious muscle problems (rhabdomyolysis).
If the patient is taking a drug called ciclosporin (used, for example, after organ transplants).
If any of the previously mentioned condition applies to the patient (or the patient is in doubt), see the doctor.
In addition, do not take CELMANTIN 40 mg (the highest dose): If the patient has moderate kidney problems (if in doubt, ask the doctor).
If the thyroid gland is not working properly.
If the patient has 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 the patient regularly drinks large amounts of alcohol.
If the patient of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
If the patient has taken other medicines called fibrates to lower cholesterol.
If any of the previously mentioned condition applies to the patient (or in doubt), see the doctor.
If the patient is under 6 years old: CELMANTIN should not be given to children younger than 6 years.
Special Precautions
Talk to the doctor or pharmacist before taking CELMANTIN: If the patient has problems with the kidneys.
If the patient has problems with the liver.
If the patient has had repeated or unexplained muscle aches and pains, a personal family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell the doctor immediately if the patient has unexplained muscle aches or pains especially if the patient feels unwell or have a fever. Also tell the doctor or pharmacist if the patient has a muscle weakness that is constant.
If the patient regularly drinks large amount of alcohol.
If the thyroid gland is not working properly.
If the patient is taking other medicines called fibrates to lower the cholesterol. Read the leaflet carefully, even if the patient has taken other medicines for high cholesterol before.
If the patient is taking medicines used to treat the HIV infection e.g. ritonavir with lopinavir and/or atazanavir, see Interactions.
If the patient needs to take oral fusidic acid to treat a bacterial infection he/she will need to temporarily stop using the medicine. The doctor will tell the patient when it is safe to restart CELMANTIN. Taking CELMANTIN with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis).
Use in Children and adolescents:
If the patient is under 6 years old: CELMANTIN should not be given to children younger than 6 years.
If the patient is below 18 years of age: The CELMANTIN 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
If the patient is over 70 (as the doctor needs to choose the right start dose of CELMANTIN to suit the patient).
If the patient has severe respiratory failure.
If the patient is of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. The doctor needs to choose the right start dose of CELMANTIN to suit the patient.
If any of the previously mentioned condition applies to the patient (or if the patient is not sure): Do not take CELMANTIN 40 mg (the highest dose) and check with the doctor or pharmacist before actually start taking any dose of CELMANTIN.
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 doctor will usually carry out this blood test (liver function test) before and during treatment of CELMANTIN.
While the patient is on this medicine, the doctor will monitor the patient closely if he/she has diabetes or is at risk of developing diabetes. The patient is likely to be at risk of developing diabetes if he/she has high levels of sugars and fats in the blood, is overweight and has high blood pressure.
CELMANTIN contains lactose monohydrate. If the patient has been told by the doctor that he/she has intolerance to some sugars, contact the doctor before taking 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 the patient feels 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, 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, this medicine can cause side effects, although not everybody gets them.
It is important that the patient is 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 the patient has any of the following allergic reactions: Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat; Swelling of 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 the patient has any unusual aches or pains in the muscles which go on for longer than expected.
Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people 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 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 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 the patient has high levels of sugars and fats in blood, is overweight and has high blood pressure. The doctor will monitor the patient while taking the medicine.
Uncommon possible side effects (may affect up to 1 in 100 people): Rash, itching or other 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, 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 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 the patient has 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 not known 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; Muscle weakness that is constant.
Reporting of side effects: If the patient gets any side effects talk to the doctor or pharmacist. This includes any possible side effects not listed in the leaflet. The patient can also report side effects via the national reporting system. By reporting side effects the patient can help provide more information on the safety of the medicine.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Tell the doctor if the patient is 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 the HIV infection - see Precautions). The effects of these medicines could be changed by CELMANTIN or they could change the effects of CELMANTIN.
If the patient needs to take oral fusidic acid to treat a bacterial infection he/she will need to temporarily stop using this medicine. The doctor will tell the patient 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 in use.
These measures will help protect the environment.
Storage
Store at 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 2 x 14's.
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