Rosuvastatin 10 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Rosuvastatin 5 mg, 10 mg, 20 mg AND 40 mg Film-coated Tablets
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 Film-coated Tablets are and what it is used for
2. What you need to know before you take Rosuvastatin Film-coated Tablets
3. How to take Rosuvastatin Film-coated Tablets
4. Possible side effects
5. How to store Rosuvastatin Film-coated Tablets
6. Contents of the pack and other information
1. What Rosuvastatin Film-coated Tablets are and what it is used for
Rosuvastatin Film-coated Tablets belong to a group of medicines called statins.
You have been prescribed Rosuvastatin Film-coated Tablets because:
• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Film-coated Tablets are used in adults, adolescents and children 6 years or older to treat high cholesterol.
You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin Film-coated Tablets.
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 Film-coated Tablets?
Rosuvastatin Film-coated Tablets are 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 Film-coated Tablets, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have become pregnant.
2. What you need to know before you take Rosuvastatin Film-coated Tablets Do not take Rosuvastatin Film-coated Tablets if you:
• are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6)
• are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin Film-coated Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Film-coated Tablets by using suitable contraception.
• have liver disease
• have severe kidney problems
• have repeated or unexplained muscle aches or pains
• take a drug called ciclosporin (used, for example, after organ transplants).
If any of the above applies to you (or you are in doubt), please go back and see your doctor.
In addition, do not take Rosuvastatin 40 mg Film-coated Tablets (the highest dose) if:
• you have moderate kidney problems (if in doubt, please ask your doctor)
• your thyroid gland is not working properly
• you have 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
• you regularly drink large amounts of alcohol
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian)
• you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Film-coated Tablets if:
• you have problems with your kidneys
• you have problems with your liver
• you have had 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 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.
• you regularly drink large amounts of alcohol
• your thyroid gland is not working properly
• 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
• you take medicines used to treat the HIV or hepatitis C infection eg. ritonavir with lopinavir and/or atazanavir or simeprevir, please see Other medicines and Rosuvastatin Film-coated Tablets
• you take antibiotics containing fusidic acid.If you are 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 Rosuvastatin Film-coated Tablets can lead to serious muscle problems (rhabdomyolysis).
Children and adolescents
If the patient is under 6 years old: Rosuvastatin Film-coated Tablets should not be given to children younger than 6 years.
If the patient is below 18 years of age: Rosuvastatin 40 mg Film-coated Tablets are not suitable for use in children and adolescents below 18 years of age.
• If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin Film-coated Tablets 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 Film-coated Tablets to suit you.
If any of the above applies to you (or if you are not sure):
• do not take Rosuvastatin 40 mg Film-coated Tablets (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin Film-coated Tablets.
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 Film-coated Tablets.
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.
Other medicines and Rosuvastatin Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Rosuvastatin Film-coated Tablets. Taking Rosuvastatin Film-coated Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Tell your doctor if you are taking any of the following:
• ciclosporin (used for example, after organ transplants)
• warfarin or clopidogrel (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 your stomach)
• erythromycin (an antibiotic)
• an oral contraceptive (the pill)
• hormone replacement therapy
• ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including the HIV or hepatitis C infection - please see Warnings and precautions).
The effects of these medicines could be changed by Rosuvastatin Film-coated Tablets or they could change the effect of Rosuvastatin Film-coated Tablets.
Pregnancy and breast-feeding
Do not take Rosuvastatin Film-coated Tablets if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin Film-coated Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Film-coated Tablets 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 Film-coated Tablets - it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin Film-coated Tablets. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Rosuvastatin Film-coated Tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
For a full list of ingredients please see Contents of the pack and other information.
3. How to take Rosuvastatin Film-coated Tablets
Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking Rosuvastatin Film-coated Tablets for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Film-coated Tablets 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 start dose of Rosuvastatin Film-coated Tablets 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)
• are over 70 years of age
• have moderate kidney problems
• are at risk of muscle aches and pains (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin Film-coated Tablets 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 on 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.
The maximum daily dose of Rosuvastatin Film-coated Tablets 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 you are taking Rosuvastatin Film-coated Tablets 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 6-17 years
The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of Rosuvastatin Film-coated Tablets for you. The maximum daily dose of Rosuvastatin Film-coated Tablets is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take your dose once a day. Rosuvastatin 40 mg Film-coated Tablets should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin Film-coated Tablets once daily. You can take it at any time of the day with or without food.
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 Film-coated Tablets that is right for you.
If you take more Rosuvastatin Film-coated Tablets than you should
Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another condition, tell the medical staff that you are taking Rosuvastatin Film-coated Tablets.
If you forget to take Rosuvastatin Film-coated Tablets
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 Film-coated Tablets
Talk to your doctor if you want to stop taking Rosuvastatin Film-coated Tablets. Your cholesterol levels might increase again if you stop taking Rosuvastatin Film-coated Tablets.
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 Film-coated Tablets and seek medical help immediately if you have 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).
Also, stop taking Rosuvastatin Film-coated Tablets 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 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 Film-coated Tablets (only Rosuvastatin Film-coated Tablets 40 mg)
• 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 Film-coated Tablets (only Rosuvastatin Film-coated Tablets 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 you think you are having
an allergic reaction, then stop taking Rosuvastatin Film-coated Tablets and seek medical help immediately
• muscle damage in adults- as a precaution, stop taking Rosuvastatin Film-coated Tablets and talk to your doctor immediately if you have any unusual aches or pains in your 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 your urine
• damage to the nerves of your 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
• muscle weakness that is constant.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Film-coated Tablets
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.
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 Film-coated Tablets contains
The active substance is rosuvastatin.
Rosuvastatin 5, 10, 20 40 mg Film-coated Tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other ingredients are
Tablet core:
Microcrystalline cellulose Lactose monohydrate Crospovidone (type B)
Hydroxypropylcellulose Sodium hydrogen carbonate Magnesium stearate
Film-coating:
Lactose monohydrate Hypromellose 6 Cp Titanium dioxide (E 171)
Triacetin
Iron oxide yellow (E 172) in Rosuvastatin 5 mg Film-coated Tablets
Iron oxide red (E 172) in Rosuvastatin 10 mg, 20 mg and 40 mg Film-coated Tablets
What Rosuvastatin Film-coated Tablets looks like and contents of the pack
Rosuvastatin 5 mg Film-coated Tablets: round, biconvex, yellow tablet.
Rosuvastatin 10 mg Film-coated Tablets: round, biconvex, pink tablet with a score line.
Rosuvastatin 20 mg Film-coated Tablets: round, biconvex, pink tablet with a score line.
Rosuvastatin 40 mg Film-coated Tablets: oval, biconvex, pink tablet with a score line.
Rosuvastatin 10, 20, 40 mg Film-coated Tablets:
The tablets can be divided into equal halves.
Rosuvastatin Film-coated Tablets come in blister packs containing 7, 14, 15, 20, 28, 30, 30 x 1, 42, 50, 50 x 1, 56, 60, 84, 90, 98, 100 and 100 x 1 film-coated tablets and HDPE bottles containing 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-StraBe 3, Blaubeuren 89143, Germany OR1
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb 10000, Croatia
This leaflet was last revised in 07/2016.
PL 00289/2011 PL 00289/2012 PL 00289/2013 PL 00289/2014
Only the actual site of batch release will appear on the printed version of the leaflet.