Patient leaflet - ROSUVASTATIN JSCH 10 MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– 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
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1. What Rosuvastatin JCSH is and what it is used for
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2. What you need to know before you take Rosuvastatin JCSH
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3. How to take Rosuvastatin JCSH
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4. Possible side effects
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5. How to store Rosuvastatin JCSH
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6. Contents of the pack and other information
1. what rosuvastatin jcsh is and what it is used for
Rosuvastatin JCSH belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin JCSH because:
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– You have a high cholesterol level. This means you are at risk from a heart attack or stroke.
Rosuvastatin JCSH is 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 doing 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 JCSH.
Or
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– 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 it is important to keep taking Rosuvastatin JCSH
Rosuvastatin JCSH 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).
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– Rosuvastatin JCSH can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
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– 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 JCSH, 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 jcsh- if you ever had an allergic reaction to rosuvastatin or any of the other ingredients of this
medicine (listed in section 6).
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– If you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin JCSH
stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin JCSH by using suitable contraception.
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– If you have liver disease.
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– If you have severe kidney problems.
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– If you have repeated or unexplained muscle aches or pains.
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– 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 JCSH 40 mg (the highest dose)
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– If you have moderate kidney problems (if in doubt, please ask your doctor).
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– If your thyroid gland is not working properly.
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– 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 cholesterol-lowering medicines.
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– If you regularly drink large amounts of alcohol.
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– If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
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– 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 JCSH.
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– If you have problems with your kidneys.
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– If you have problems with your liver.
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– 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.
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– If you regularly drink large amounts of alcohol.
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– If your thyroid gland is not working properly.
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– 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.
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– If you take medicines used to treat the HIV infection e.g. ritonavir with lopinavir and/or
atazanavir, please see “Other medicines and Rosuvastatin JCSH”.
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– 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 JCSH can lead to serious muscle problems (rhabdomyolysis), please see Other medicines and Rosuvastatin JCSH.
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– If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin JCSH to
suit you)
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– If you have severe respiratory failure.
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– 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 JCSH to suit you.
If any of the above applies to you (or if you are not sure):
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– Do not take Rosuvastatin JCSH 40 mg (the highest dose) and check with your doctor or
pharmacist before you actually start taking any dose of Rosuvastatin JCSH.
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 JCSH.
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
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– If the patient is under 6 years old: Rosuvastatin JCSH should not be given to children younger
than 6 years.
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– If the patient is below 18 years of age: Rosuvastatin JCSH 40 mg tablet is not suitable for use in
children and adolescents below 18 years of age.
Other medicines and Rosuvastatin JCSH
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 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), fusidic acid (an antibiotic – please see “Warnings and precautions”), an oral contraceptive (the pill), hormone replacement therapy or anti-viral 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 JCSH or they could change the effects of Rosuvastatin JCSH.
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 Crestor. Taking Crestor with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in Section 4.
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 for advice before taking this medicine.
Do not take Rosuvastatin JCSH if you are pregnant or breast-feeding.
If you become pregnant while taking Rosuvastatin JCSH, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin JCSH 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 JCSH – it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin JCSH. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Rosuvastatin JCSH contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (lactose or milk sugar), contact your doctor before taking this medicine.
For a full list of ingredients, please see “
Contents of the pack and other information
”.3. how to take rosuvastatin jcsh
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
If you are taking Rosuvastatin JCSH for high cholesterol:
Starting dose
Your treatment with Rosuvastatin JCSH 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:
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– Your cholesterol level.
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– The level of risk you have of experiencing a heart attack or stroke.
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– 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 JCSH will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
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– You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
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– You are over 70 years of age.
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– You have moderate kidney problems.
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– You 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 JCSH 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 JCSH 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 JCSH 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 dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual start dose is 5 mg per day, and your doctor may gradually increase your dose to find the right amount of Rosuvastatin JCSH for you. The maximum daily dose of Rosuvastatin JCSH is 10 mg or 20 mg for children aged 6 to 17 years depending on your underlying condition being treated.. Take your dose once a day. Rosuvastatin JCSH 40 mg tablet should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin JCSH 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 JCSH that is right for you.
If you take more Rosuvastatin JCSH 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’re taking Rosuvastatin JCSH.
If you forget to take Rosuvastatin JCSH
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 JCSH
Talk to your doctor if you want to stop taking Rosuvastatin JCSH. Your cholesterol levels might increase again if you stop taking Rosuvastatin JCSH.
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 JCSH and seek medical help immediately if you have any of the following allergic reactions:
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– Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat.
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– Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
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– Severe itching of the skin (with raised lumps).
Also, stop taking Rosuvastatin JCSH 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 : may affect up to 1 in 10 people:
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– Headache
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– Stomach pain
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– Constipation
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– Feeling sick
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– Muscle pain
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– Feeling weak
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– Dizziness
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– 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 JCSH tablets (only Rosuvastatin JCSH 40 mg)
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– 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 : may affect up to 1 in 100 people:
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– Rash, itching or other skin reactions
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– 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 JCSH tablets (only Rosuvastatin JCSH 5 mg, 10 mg and 20 mg).
Rare: may affect up to 1 in 1,000 people:
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– 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 JCSH and seek medical help immediately.
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– Muscle damage in adults – as a precaution, stop taking Rosuvastatin JCSH and talk to your
doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected.
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– A severe stomach pain (inflamed pancreas)
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– Increase in liver enzymes in the blood
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Very rare: may affect up to 1 in 10,000 people:
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– Jaundice (yellowing of the skin and eyes)
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– Hepatitis (an inflamed liver)
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– Traces of blood in your urine
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– Damage to the nerves of your legs and arms (such as numbness)
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– Joint pain
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– Memory loss
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– Breast enlargement in men (gynaecomastia)
Not known: frequency cannot be estimated from the available data:
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– Diarrhoea (loose stools)
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– Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals)
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– Cough
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– Shortness of breath
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– Oedema (swelling)
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– Sleep disturbances, including insomnia and nightmares
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– Sexual difficulties
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– Depression
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– Breathing problems, including persistent cough and/or shortness of breath or fever
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– Tendon injury
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– Muscle weakness that is constant
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store rosuvastatin jcsh
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 box and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
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- the active substance is rosuvastatin.
Rosuvastatin JCSH 5 mg film-coated tablets:
Each 5 mg tablet contains 5 mg rosuvastatin equivalent to 5.2 rosuvastatin calcium.
Rosuvastatin JCSH 10 mg film-coated tablets:
Each 10 mg tablet contains 10 mg rosuvastatin equivalent to 10.4 rosuvastatin calcium.
Rosuvastatin JCSH 20 mg film-coated tablets:
Each 20 mg tablet contains 20 mg rosuvastatin equivalent to 20.8 rosuvastatin calcium.
Rosuvastatin JCSH 40 mg film-coated tablets:
Each 40 mg tablet contains 40 mg rosuvastatin equivalent to 41.7 rosuvastatin calcium.
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– The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate anhydrous,
What Rosuvastatin JCSH looks like and contents of the pack
Rosuvastatin JCSH 5 mg film-coated tablets:
Yellow, round (diameter: 6 mm) film-coated tablets.
Rosuvastatin JCSH 10 mg film-coated tablets:
Pink, round (diameter: 7 mm) film-coated tablets.
Rosuvastatin JCSH 20 mg film-coated tablets:
Pink, round (diameter: 9 mm) film-coated tablets scored on one side. The score line is not intended for breaking the tablet.
Rosuvastatin JCSH 40 mg film-coated tablets:
Pink, oval (11.5 × 7 mm) film-coated tablets.
Rosuvastatin JCSH comes in PA/Al/PVC//Al blisters.
Rosuvastatin JCSH 5 mg film-coated tablets and Rosuvastatin JCSH 40 mg film-coated tablets
Pack-sizes:
14, 28, 30, 100 tablets
Rosuvastatin JCSH 10 mg film-coated tablets and Rosuvastatin JCSH 20 mg film-coated tablets
Pack-sizes:
14, 20, 28, 30, 100 tablets
Not all pack-sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
JCSH Pharma Ltd
47 Bloomfield Close, Knaphill, Woking, Surrey,
GU21 2BL, United Kingdom
Manufacturer
ELPEN Pharmaceutical Co. Inc
Site: 95, Marathonos Ave., Pikermi Attica
GR-19009, Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
Rosuvastatin JCSH
This leaflet was last revised in October 2017