Eurovastin

Eurovastin

rosuvastatin

Manufacturer:

Eurodrug

Distributor:

DCH Auriga - Healthcare
Full Prescribing Info
Contents
Rosuvastatin.
Description
EUROVASTIN film-coated tablets contain rosuvastatin calcium equivalent to 10 mg or 20 mg of rosuvastatin.
Excipients/Inactive Ingredients: Tablet core: microcrystalline cellulose type 102, lactose monohydrate, crospovidone type A, magnesium stearate.
Film coating Opadry II Yellow 31K38097 consisting of: lactose monohydrate, hypromellose (E464), Titanium dioxide (E171), Triacetin (E1518), Quinoline yellow aluminum lake (E104).
Action
EUROVASTIN belongs to a group of medicines called statins.
EUROVASTIN is used to correct the levels of fatty substances in the blood, 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).
EUROVASTIN 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 risk of having a heart attack, a stroke or related health problems can be reduced.
Indications/Uses
The patient has been prescribed EUROVASTIN because he/she has a high cholesterol level. This means that the patient is at risk from a heart attack or stroke.
The doctor has advised the patient to take EUROVASTIN, 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 EUROVASTIN.
EUROVASTIN is also advised if 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 build up of fatty deposits in the arteries.
The patient needs to keep taking EUROVASTIN, even if it has got the cholesterol to the right level, because it prevents the cholesterol levels from increasing again and causing build up of fatty deposits.
However, the patient should stop if advised by the doctor, or the patient has become pregnant.
Dosage/Direction for Use
Always take this medicine exactly as advised by the doctor. Check with the doctor or pharmacist if unsure.
Please note that only EUROVASTIN-10 tablets 10 mg and EUROVASTIN-20 tablets 20 mg are available. Please consider other suitable oral preparation for recommended dosage of 5 mg.
The recommended dose in adults: If taking EUROVASTIN for lowering cholesterol: Starting dose: Treatment with Rosuvastatin must start with the 5-mg or the 10-mg dose, even if a higher dose of a different statin has been taken 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 the patient has a factor that may make him/her more sensitive to possible side effects.
Please check with the doctor or pharmacist which start dose of Rosuvastatin will be most suitable.
The doctor may decide to give the patient the lowest dose (5 mg) if the patient: is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian); is over 70 years of age; has moderate kidney problems; 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 right amount of Rosuvastatin. 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 Rosuvastatin is 40 mg. It is only for patients with high cholesterol levels and patients with a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.
If taking EUROVASTIN 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: Tablets should be swallowed whole with water. EUROVASTIN should be taken once daily at any time of the day. It is advised to take the tablets 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 EUROVASTIN.
If taking EUROVASTIN is forgotten: Just take the next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten tablet.
If taking EUROVASTIN is stopped: Talk to the doctor if wanting to stop taking EUROVASTIN. The cholesterol levels might increase again if taking EUROVASTIN is stopped.
Overdosage
If the patient takes more EUROVASTIN than prescribed, contact the doctor or nearest hospital for advice.
If going into hospital or receiving treatment for another condition, tell the medical staff that EUROVASTIN is being taken.
Contraindications
Do not take EUROVASTIN 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 EUROVASTIN, she should stop taking it immediately and tell the doctor. Women should avoid becoming pregnant while taking EUROVASTIN by using suitable contraception.
There is liver disease.
There are severe kidney problems.
There are repeated or unexplained muscle aches or pains.
Taking a drug called ciclosporin (used for example, after organ transplants).
If any of the previously mentioned applies (or if in doubt), please go back and see the doctor.
In addition, do not take Rosuvastatin 40 mg (the highest dose) if: There are moderate kidney problems (if in doubt, please ask the doctor).
Thyroid gland is not working properly.
There had been 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.
Regularly drinking large amounts of alcohol.
The patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
Taking other medicines called fibrates to lower the cholesterol.
If any of the previously mentioned applies (or if in doubt), please go back and see the doctor.
Special Precautions
Talk to the doctor or pharmacist before taking EUROVASTIN if: There are problems with the kidneys.
There are problems with the liver.
There had been 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. Tell the doctor immediately if unexplained muscle aches or pains are experienced, especially if feeling unwell or having a fever.
Regularly drinking large amounts of alcohol.
Thyroid gland is not working properly.
Taking other medicines called fibrates to lower the cholesterol. Please read the leaflet carefully, even if other medicines for high cholesterol have been taken before.
Taking medicines used to fight the HIV infection e.g. lopinavir/ritonavir, please see Interactions.
Over 70 (as the doctor needs to choose the right start dose of EUROVASTIN to suit the patient).
There is severe respiratory failure.
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 EUROVASTIN to suit the patient.
Taking or have 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 EUROVASTIN can lead to serious muscle problems (rhabdomyolysis).
If any of the previously mentioned applies (or if in doubt), contact the doctor or pharmacist before taking EUROVASTIN.
EUROVASTIN with food and drink: The patient can take EUROVASTIN with or without food.
EUROVASTIN contains lactose: If the patient has an intolerance to some sugars (lactose or milk sugar), contact the doctor before taking EUROVASTIN.
For a full list of ingredients please see Description.
Race: Pharmacokinetic studies have demonstrated an increase in exposure to rosuvastatin in Asian subjects when compared with Caucasians. Initiation of rosuvastatin therapy with 5mg once daily should be considered in Asian patients.
Additional considerations: It is recommended that liver function tests should be performed before the initiation of EUROVASTIN, and thereafter when clinically indicated.
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 with EUROVASTIN.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.
While on this medicine, the doctor will monitor closely the presence of diabetes or 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.
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.
Driving and using machines: Most people can drive a car and operate machinery while taking EUROVASTIN. However, some people feel dizzy during treatment. If feeling dizzy, consult the doctor before attempting to drive or use machines.
Use in Children: If the patient is under 10 years old: EUROVASTIN should not be given to children younger than 10 years.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant, or is planning to have a baby, the doctor or pharmacist should be asked for advice before taking this medicine.
Do not take EUROVASTIN if pregnant or breast-feeding. If the patient becomes pregnant while taking EUROVASTIN, she should stop taking it immediately and tell the doctor. Women should avoid becoming pregnant while taking EUROVASTIN 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 EUROVASTIN and seek medical help immediately if having any of the following allergic reactions: 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).
Stop taking EUROVASTIN and talk to the doctor immediately if having 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 (these may affect between 1 in 10 and 1 in 100 patients): 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 EUROVASTIN tablets (only rosuvastatin 40 mg).
Diabetes. This is more likely if the patient has high levels of sugars and fats in the blood, is overweight, and has high blood pressure. The doctor will monitor the patient while taking this medicine.
Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000 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 EUROVASTIN tablets (only rosuvastatin 5 mg, 10 mg and 20 mg).
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 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 the patient thinks he/she is having an allergic reaction, then taking EUROVASTIN should be stopped and seek medical help immediately.
Muscle damage in adults - as a precaution, stop taking EUROVASTIN and talk to the doctor immediately if having any unusual aches or pains in the muscles which go on for longer than expected.
A severe stomach pain (inflamed pancreas).
Decrease of platelets in the blood (thrombocytopenia).
Increase in liver enzymes in the blood.
Very rare possible side effects (these may affect less than 1 in 10,000 patients): 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 (dry cough and/or shortness of breath or fever); Tendon injury; Permanent 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 listed.
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 lopinavir/ritonavir (used to fight the HIV infection - please see Precautions). The effects of these medicines could be changed by EUROVASTIN or they could change the effect of EUROVASTIN.
If the patient needs to take oral or injectable fusidic acid to treat a bacterial infection, he/she will need to temporarily stop using EUROVASTIN. The doctor will advise when it is safe to restart. Taking EUROVASTIN 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 use this medicine if any visible signs of deterioration are noticed.
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 in the original package in order to protect from light and moisture.
Store in a cool dry place below 30°C.
Shelf Life: 4 years.
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 (yellowish, round, biconvex, debossed "10" on the one side and "
Click on icon to see table/diagram/image
" on the other) x 7's, 28's, 98's. 20 mg (yellowish, round, biconvex, debossed "20" on the one side and "
Click on icon to see table/diagram/image
" on the other) x 7's, 28's, 98's.
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