Rosuvastatin 10 Mg Film Coated Tablets
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Rosuvastatin 5 mg film-coated tablets Rosuvastatin 10 mg film-coated tablets Rosuvastatin 20 mg film-coated tablets Rosuvastatin 40 mg film-coated tablets
Rosuvastatin calcium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Rosuvastatin is and what it is used for
2. What you need to know before you take Rosuvastatin
3. How to take Rosuvastatin
4. Possible side effects
5. How to store Rosuvastatin
6. Contents of the pack and other information
1. What Rosuvastatin is and what it is used for
Rosuvastatin belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin because:
• You have a high cholesterol level. This means you are at risk of having a heart attack or stroke.
You have been advised to take a statin, because changing your diet and exercising more were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin.
Or
• You have other factors that increase your 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 your arteries.
Why is it important to keep taking Rosuvastatin?
Rosuvastatin 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).
• Rosuvastatin can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
• It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves your body’s ability to remove it from your 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 your 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 your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems.
You need to keep taking Rosuvastatin, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from going up again and causing build up of fatty deposits. However, you should stop if your doctor tells you to do so, or you become pregnant.
2. What you need to know before you take Rosuvastatin
Do not take Rosuvastatin
• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin by using suitable contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains (myopathy).
• If you take a medicine called ciclosporin (used, for example, after organ transplants).
If any of the above applies to you (or you are in doubt), talk to your doctor.
In addition, do not take Rosuvastatin 40 mg (the highest dose):
• If you have moderate kidney problems.
• If your thyroid gland is not working properly.
If you have had any repeated or unexplained muscle aches or pains in the past, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before you take Rosuvastatin:
• If you have problems with your kidneys.
• If you have problems with your liver.
If you have had repeated or unexplained muscle aches or pains in the past, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not working properly.
• If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other medicines for high cholesterol before.
• If you take medicines used to fight the HIV infection e.g. lopinavir/ritonavir, please see Other medicines and Rosuvastatin.
• If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin to suit you).
• If you have severe respiratory failure.
• If you are of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of Rosuvastatin to suit you.
If any of the above applies to you (or if you are not sure)
Do not take Rosuvastatin 40 mg (the highest dose) and talk to your doctor or pharmacist before you start taking any dose of Rosuvastatin.
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, your doctor will usually carry out this blood test (liver function test) before and during treatment with Rosuvastatin.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Children and adolescents
Rosuvastatin should not be given to children younger than 10 years of age.
Rosuvastatin 40 mg tablets are not suitable for use in children and adolescents younger than 18 years of age.
Other medicines and Rosuvastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following:
• ciclosporin (used for example, after organ transplants),
• warfarin (or any other medicine 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 your stomach),
• erythromycin (an antibiotic),
• an oral contraceptive (the pill),
• hormone replacement therapy
• lopinavir/ritonavir/atazanavir (used to fight the HIV infection - please see Warnings and precautions)
The effects of these medicines could be changed by Rosuvastatin or they could change the effects of Rosuvastatin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rosuvastatin if you are pregnant or breast-feeding.
If you become pregnant while taking Rosuvastatin stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive a car and operate machinery while using Rosuvastatin - it will not affect their ability to do so. However, some people feel dizzy during treatment with Rosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Rosuvastatin contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Rosuvastatin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual doses in adults
For high cholesterol:
Starting dose
Your treatment with Rosuvastatin must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:
• Your cholesterol level.
• The level of risk you have of experiencing a heart attack or stroke.
• Whether you have a factor that may make you more sensitive to possible side effects.
Please check with your doctor or pharmacist which starting dose of this medicine will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• You are over 70 years of age.
• You have moderate kidney problems.
• You are at risk of muscle aches and pains (myopathy).
Increasing the dose
Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then 20 mg and then 40 mg, if necessary. If you started with 10 mg, your 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.
Maximum daily dose
The maximum daily dose of Rosuvastatin is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke and whose cholesterol levels are not lowered enough with 20 mg doses.
To reduce your risk of having a heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.
Use in children and adolescents (aged 10 to 17 years)
• The usual start dose is 5 mg.
• Your doctor may increase your dose to find the right amount of medicine for you.
• The maximum daily dose is 20 mg. Take your dose once a day. The 40 mg tablet should not be used by children or adolescents.
• Rosuvastatin should not be given to children younger than 10 years of age.
Taking your tablets
Swallow each tablet whole with a drink of water. You can take Rosuvastatin with or without food. The 10, 20 and 40 mg tablets can be divided into equal doses.
Take Rosuvastatin once daily. You can take it at any time of the day.
However, try to take your tablet at the same time every day to help you to remember it.
Regular cholesterol checks
It is important to go back to your doctor for regular cholesterol checks, to make sure your cholesterol has reached and is staying at the correct level.
Your doctor may decide to increase your dose so that you are taking the amount of Rosuvastatin that is right for you.
If you take more Rosuvastatin than you should
Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for any other condition, tell the medical staff that you are taking Rosuvastatin.
If you forget to take Rosuvastatin
Do not worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Rosuvastatin
Talk to your doctor if you want to stop taking Rosuvastatin. Your cholesterol levels might increase again if you stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.
Stop taking Rosuvastatin and seek medical help immediately if you have any of the following signs of an allergic reaction (may affect up to 1 in 1,000 people):
• 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 Rosuvastatin and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than you might expect. Muscle damage in adults may affect up to 1 in 1,000 people. 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 the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin tablets (affects users taking the Rosuvastatin 40 mg tablets)
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are 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 your Rosuvastatin tablets (affects users taking Rosuvastatin 5 mg, 10 mg and/or 20 mg tablets).
Rare possible side effects (may affect up to 1 in 1,000 people):
• 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 your urine
• Damage to the nerves of your legs and arms (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynaecomastia).
Not known (frequency cannot be estimated from the available data):
• 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.
• Peripheral neuropathy (An unusual tingling, weakness or pain in your hands or feet)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rosuvastatin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
HDPE bottle:
Use within 90 days after first opening.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Rosuvastatin contains
• The active substance is rosuvastatin.
Each film-coated tablet contains rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are:
lactose monohydrate, microcristalline celluose, crospovidone, magnesium stearate, hypromellose, triacetin and titanium dioxide (E 171).
Rosuvastatin 5 mg tablets also contain ferric oxide yellow (E 172).
Rosuvastatin 10, 20 and 40 mg tablets also contain ferric oxide red (E 172).
What Rosuvastatin looks like and contents of the pack Rosuvastatin 5 mg
Rosuvastatin 5 mg are yellow coloured, round, biconvex, film-coated tablets with a diameter of approx. 5.7 mm, debossed with “135” on one side and “5” on the other side.
Rosuvastatin 10 mg
Rosuvastatin 10 mg are light pink coloured, round, biconvex, film-coated tablets with a diameter of approx. 7.5 mm, debossed with break line on both sides, separating “11” and “36” on one side and “10” on the other side.
Rosuvastatin 20 mg
Rosuvastatin 20 mg are light pink coloured, round, biconvex, film-coated tablets with a diameter of approx. 9.6 mm, debossed with break line on both sides, separating “11” and “37” on one side and “20” on the other side.
Rosuvastatin 40 mg
Rosuvastatin 40 mg are light pink coloured, oval shape, approx. 12.4 x 6.5 mm biconvex, bevelled edge, film-coated tablets, with break line on both sides.
Rosuvastatin is available in
Aluminium/ OPA/Aluminium/PVC blister packs containing
7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100 or 200 tablets
HDPE bottles, neck finish with child resistant closure and with induction sealing wad containing 30, 90 or 500 (hospital pack, for use on more than one patient) tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way,
Crawley, West Sussex, RH11 7XA,
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
Email: drugsafety@torrentpharma.co.uk
Manufacturer
Torrent Pharma GmbH Sudwestpark 50, 90449 Nurnberg Germany
Heumann Pharma GmbH & Co. Generica KG Sudwestpark 50, 90449 Nurnberg Germany
This medicinal product is authorised in the Member States of the EEA under the following names
Netherlands: Rosuvastatine Torrent 5/10/20/40 mg, filmomhulde tabletten Germany: Rosuvastatin Heumann 5/10/20/40 mg Filmtabletten Lithuania: Rozucor 5/10/20/40 mg plevele dengtos tabletes Romania: Rozucor 5/10/20/40 mg comprimate filmate United Kingdom: Rosuvastatin 5/10/20/40 mg film-coated tablets
This leaflet was last revised in 11/2013.
8044501-7803