Rosuvastatin 5mg Film-Coated Tablets
Package leaflet: Information for the patient Rosuvastatin 5mg, 10mg, 20mg and 40mg 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.
- The full name of this medicine is Rosuvastatin 5mg, 10mg, 20mg and 40mg Film-coated Tablets but within the leaflet it will be referred to as Rosuvastatin Tablets.
What is in this leaflet:
1. What Rosuvastatin Tablets are and what they are used for
2. What you need to know before you take Rosuvastatin Tablets
3. How to take Rosuvastatin Tablets
4. Possible side effects
5. How to store Rosuvastatin Tablets
6. Contents of the pack and other information
1. What Rosuvastatin Tablets are and what they are used for
Rosuvastatin Tablets - the active substance is rosuvastatin - belongs to a group of medicines called statins. You have been prescribed Rosuvastatin Tablets because:
- You have a high cholesterol level. This means you are at risk from a heart attack or stroke.
- Rosuvastatin 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 cholesterollowering diet and exercise while you are taking Rosuvastatin 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 buildup of fatty deposits in your arteries.
Why is it important to keep taking Rosuvastatin Tablets
Rosuvastatin 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 Tablets 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 Tablets, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing buildup 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 Tablets
Do not take Rosuvastatin Tablets:
- 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 Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Tablets by using suitable contraception.
- if you have liver disease.
- if you have severe kidney problems.
- if you have repeated, unexplained muscle aches or pains.
- if you 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 Tablets 40mg film-coated (the highest dose):
- if you have moderate kidney problems (if in doubt, please ask your doctor).
- if your thyroid gland is not working properly.
- if 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 c holesterol 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, please go back and see your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatin Tablets:
- 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, 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
- 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 treat infections, including HIV or hepatitis C infection e.g. ritonavir with lopinavir and/or atazanavir, or simeprevir, please see ‘Other medicines and Rosuvastatin Tablets’,
- 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 tablets can lead to serious muscle problems (rhabdomyolysis)
- if you have severe respiratory failure
- if you are of Asian origin i.e. you are a Japanese, Chinese, Filipino, Vietnamese, Korean or Indian.
Your doctor needs to choose the right start dose of Rosuvastatin Tablets to suit you.
- if you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin tablets to suit you).
If any of the above applies to you (or if you are not sure):
- Do not take Rosuvastatin Tablets 40mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin Tablets.
Children and adolescents
- If the patient is under 6 years old: Rosuvastatin Tablets should not be given to children younger than 6 years.
- If the patient is below 18 years of age: The Rosuvastatin Tablets 40mg tablet is not suitable for use in children and adolescents below 18 years of age.
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 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 Tablets
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 medicines:
- ciclosporin (used for example, after organ transplants)
- warfarin (or any other drug used for thinning the blood), or clopidogrel,
- 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
- antiviral medications such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection) - please see “Warnings and precautions”).
The effects of these medicines could be changed by Rosuvastatin Tablets or they could change the effects of Rosuvastatin Tablets.
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 Tablets. Taking Rosuvastatin Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Rosuvastatin Tablets with food and drink
You can take Rosuvastatin Tablets with or without food.
Pregnancy and breast-feeding
Do not take Rosuvastatin Tablets if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin Tablets, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Tablets by using suitable contraception.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Most people can drive a car and operate machinery while using Rosuvastatin Tablets - it will not affect their
ability. However, some people feel dizzy during treatment with Rosuvastatin Tablets. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Rosuvastatin Tablets contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Rosuvastatin Tablets.
3. How to take Rosuvastatin Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Recommended doses in adults
If you are taking Rosuvastatin Tablets for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Tablets must start with the 5mg or the 10mg 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 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)
- You are over 70 years of age
- You have specific type of genetic variation (so called genetic polymorphism) which can lead to increased rosuvastatin level
- You have moderate kidney problems
- You are at risk of muscle aches and pains (myopathy)
- You take rosuvastatin concomitantly with other medical products that may increase the level of rosuvastatin in your blood.
Increasing the dose and maximum daily dose
Your doctor may decide to increase the dose of Rosuvastatin Tablets. This is so that you are taking the amount of Rosuvastatin Tablets that is right for you. If you started with a 5mg dose, your doctor may decide to double this to 10mg, then 20mg and then 40mg if necessary. If you started on 10mg, your doctor may decide to double this to 20mg and then 40mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of Rosuvastatin Tablets is 40mg. This dose is only for patients with high cholesterol levels and a high risk for heart attacks or stroke whose cholesterol levels are not lowered enough with 20mg.
If you are taking Rosuvastatin Tablets to reduce your risk of having a heart attack, stroke or related health problems:
The recommended dose is 20mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.
Recommended doses in children and adolescents aged 6-17 years
The recommended start dose is 5mg. Your doctor may increase your dose to find the right amount of Rosuvastatin Tablets for you. The maximum daily dose of Rosuvastatin Tablets is 10mg for children aged 6 to 9 years and 20mg for children aged 10 to 17 years. Take your dose once a day. Rosuvastatin Tablets 40mg tablet should not be used by children and adolescents.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin 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 Tablets that is right for you.
If you take more Rosuvastatin 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 Tablets.
If you forget to take Rosuvastatin Tablets
Don’t worry; just take your next scheduled dose at the correct time. Do not take a double dose to make up for one you have missed.
If you stop taking Rosuvastatin Tablets
Talk to your doctor if you want to stop taking Rosuvastatin Tablets. Your cholesterol levels might increase again if you stop taking Rosuvastatin 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 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 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 Tablets (only Rosuvastatin Tablets 40mg)
- 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 hives
- 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 (only Rosuvastatin Tablets 5mg, 10mg and 20mg).
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 Tablets and seek medical help immediately
- Muscle damage in adults - as a precaution, stop taking Rosuvastatin T ablets and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected
- Inflamed pancreas that manifests with severe stomach pain
- Increase in liver enzymes in the blood
- Reduction in blood platelets.
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)
- T race s 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 side effects (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 (a problem with the functioning of the nerves outside the spinal cord).
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 the Yellow Card Scheme Website: 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 Tablets
This product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
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 and the blisters. The expiry date refers to the last day of that month.
Do not use this medicine if you notice the visible signs of deterioration (e.g. discolouration).
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 Tablets contains
- The active substance is rosuvastatin (as rosuvastatin zinc). Rosuvastatin Film-coated Tablets contain rosuvastatin zinc equivalent either to 5mg, 10mg, 20mg or 40mg rosuvastatin.
- The other ingredients are:
- core: lactose monohydrate, povidone (E1201), crospovidone Type A and B (E1201), magnesium stearate (E572).
- tablet coat: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350 (E1521), talc (E553b).
What Rosuvastatin Film-coated Tablets look like and contents of the pack
Rosuvastatin Tablets 5mg: Round, slightly biconvex, white or almost white, 6.0 mm diameter tablet, with a stylized ‘E’ engraving on one side and ‘591’ on the other side.
Rosuvastatin Tablets 10mg: Round, slightly biconvex, white or almost white, 7.0 mm diameter tablet, with a stylized ‘E’ engraving on one side and ‘592’ on the other side.
Rosuvastatin Tablets 20mg: Round, slightly biconvex, white or almost white, 9.0 mm diameter tablet, with a stylized ‘E’ and ‘593’ engraved on one side and ‘no engraving on the other side.
Rosuvastatin Tablets 40mg: Oval, slightly biconvex, white or almost white, 8.0 x 15.5 mm diameter tablet, with ‘E 594’ engraved on one side and no engraving on the other side.
Medicine is supplied in cartons containing 28, 56, 84 film-coated tablets in OPA/Al/PVC//Al blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Manufacturer
EGIS Pharmaceuticals PLC Bokenyfoldi ut 118-120., Budapest, 1165 1165 Hungary
EGIS Pharmaceuticals PLC 9900 Kormend, Matyas kiraly u. 65.
9900
Hungary
This leaflet was last revised in August 2016.