5 mg, 10 mg, 20 mg, 40 mg film-coated tablets
rosuvastatin
What Rosuvastatin Accord is and what it is used for
Rosuvastatin Accord belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Accord because:
- You have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Accord is used in adults, adolescents, and children from 6 years of age to treat high cholesterol.
You have been advised to take a statin, as dietary changes and increased exercise were not enough to correct your cholesterol levels. You should continue your cholesterol-lowering diet and exercise while taking Rosuvastatin Accord.
Or
- You have other factors that increase the risk of having a heart attack, stroke, or other health problems related to cardiovascular disease.
- Myocardial infarction, stroke, and other cardiovascular health problems can be caused by a disease called atherosclerosis (atherosclerosis). The cause of atherosclerosis is that fat accumulates in the arteries.
Why is it important to continue taking Rosuvastatin Accord?
- Rosuvastatin Accord is used to correct the concentration of certain fats in the blood, called lipids. The most common of these is cholesterol.
- There are different types of cholesterol in the blood, the “bad” cholesterol ( LDL-C ) and the “good” cholesterol ( HDL-C ).
- Rosuvastatin Accord can reduce the “bad” cholesterol and increase the “good” cholesterol.
- It works by helping your body reduce the production of “bad” cholesterol and improve your body’s ability to remove it from the blood.
- For most people, high cholesterol levels do not affect how they feel because high cholesterol levels do not cause any symptoms. If left untreated, however, fat deposits can accumulate on the walls of blood vessels and make them narrower.
- Sometimes these narrow blood vessels can be blocked and then shut off the blood supply to the heart or brain, which can lead to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.
- You need to continue taking Rosuvastatin Accord even if your cholesterol has reached the right level because it prevents your cholesterol levels from rising again so that fat accumulates. However, you should stop if your doctor advises you to do so, or if you have become pregnant.
Rosuvastatin contained in the Rosuvastatin Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Rosuvastatin Accord
Do not take Rosuvastatin Accord
- if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Accord, stop taking Rosuvastatin Accord immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Accord by using appropriate contraception.
- if you have liver disease.
- if you have severe kidney problems.
- if you have repeated or unexplained muscle aches or pain
- if you are taking a medicine called ciclosporin (used for example in organ transplantation). If you have ever developed a severe skin rash or skin rash, blisters, and/or sores in your mouth after taking Rosuvastatin Accord or other related medicines that belong to a group of medicines called statins.
If any of the above apply to you (or you are not sure), consult a doctor.
Also do not take Rosuvastatin Accord 40 mg (the highest dose)
- if you have moderate kidney problems (ask your doctor if you are unsure).
- if you have thyroid problems.
- if you have had repeated or unexplained muscle aches or pains, previous muscle disease, heredity for muscle disease, or have had muscle pain when using other cholesterol-lowering medicines.
- if you regularly drink large amounts of alcohol.
- if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
- if you are taking another type of cholesterol-lowering drug called fibrates.
If any of the above apply to you (or you are not sure), consult a doctor.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rosuvastatin Accord:
- if you have kidney problems.
- if you have liver problems.
- if you have had repeated or unexplained muscle aches or pains, previous muscle disease, heredity for muscle disease, or have had muscle pain when using other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pain, especially if you feel sick or have a fever. Also, tell your doctor or pharmacist if you have long-term muscle weakness.
- if you regularly drink large amounts of alcohol.
- if you have thyroid problems.
- if you are taking another type of cholesterol-lowering drug called fibrates. Read all of this leaflet carefully even if you have taken other medicines for high cholesterol before.
- If you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see Other medicines and Rosuvastatin Accord.
- if you are taking or have been taking a medicine called fusidic acid (a medicine for bacterial infection ) in the last 7 days, either by mouth or as an injection. The combination of fusidic acid and Rosuvastatin Accord can lead to severe muscle problems ( rhabdomyolysis ), see Other medicines and Rosuvastatin Accord.
- Severe skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Rosuvastatin Accord. Stop using Rosuvastatin Accord and seek medical advice immediately if you notice any of the symptoms described in section 4.
- if you are over 70 years old (then your doctor will need to choose the right starting dose of Rosuvastatin Accord that is right for you).
- if you suffer from severe respiratory failure.
- if you are of Asian origin (Japanese, Chinese, Philippines, Vietnamese, Korean, or Indian) your doctor will need to choose the right starting dose of Rosuvastatin Accord that is right for you.
If any of the above applies to you (or if you are unsure):
- Do not take Rosuvastatin Accord 40 mg (the highest dose one) and talk to your doctor or pharmacist before taking any dose of Rosuvastatin Accord.
In a small number of people, statins can affect the liver. This is detected by a simple test that examines increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin Accord.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to get diabetes if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure.
Children and young people
- If the patient is under 6 years of age: Rosuvastatin Accord should not be given to children under 6 years of age.
- If the patient is under 18 years of age: Rosuvastatin Accord 40 mg tablet is not suitable for children and adolescents under 18 years of age.
Other medicines and Rosuvastatin Accord
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Tell your doctor if you are taking any of the following medicines: regorafenib (used to treat cancer), any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (see Warnings and precautions ): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glekaprevir, pibrentasvir. Ciclosporin (used for example in organ transplantation), blood thinners e.g. warfarin, acenocoumarol, or fluindione (their blood-thinning effect and the risk of bleeding may be increased while taking this medicine), ticagrelor or clopidogrel; fibrates (eg gemfibrozil, fenofibrate), other cholesterol-lowering drugs (eg ezetimibe), certain medicines for heartburn and acid reflux, erythromycin ( antibiotics ), fusidic acid ( antibiotics – see below and Warnings and Precautions), birth control pills or hormone replacement drugs. The effects of these medicines may be affected by Rosuvastatin Accord or they may affect the effect of Rosuvastatin Accord.
If you have to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to take Rosuvastatin Accord again. Use of Rosuvastatin in Accord with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information regarding rhabdomyolysis in section 4.
Pregnancy and breastfeeding
Do not take Rosuvastatin Accord if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Accord, stop taking it immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Accord by using appropriate contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Rosuvastatin Accord does not affect the ability to drive or use machines in most people. However, some people feel dizzy while using Rosuvastatin Accord. If you feel dizzy, talk to your doctor before driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rosuvastatin Accord contains lactose, para-orange, and Allura red
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Rosuvastatin Accord 40 mg film-coated tablets also contain para-orange and Allura red which may cause allergic reactions.
For a complete list of excipients, see Package Contents and Other Information.
How to take Rosuvastatin Accord
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults
If you are taking Rosuvastatin Accord for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Accord should start with 5 mg or 10 mg, even if you have taken a higher dose of another statin before. The choice of dose for you depends on:
- your cholesterol level
- the risk level you have for having a heart attack or stroke
- if you have a factor that may make you more sensitive to possible side effects.
Ask your doctor or pharmacist for advice on which dose of Rosuvastatin Accord is best for you.
Your doctor may decide to give you the lowest dose of one (5 mg):
- if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
- if you are over 70 years old.
- if you have moderate kidney problems.
- if you are at risk for muscle aches and pains ( myopathy ).
Dose increase and maximum daily dose :
Your doctor may decide to increase your dose. This is so that you can take the dose of Rosuvastatin Accord that is right for you. If you started with 5 mg, your doctor may decide to double this dose to 10 mg, then to 20 mg, and then to 40 mg if necessary. If you started with 10 mg, your doctor may decide to double this dose to 20 mg and then to 40 mg if necessary. There will be four weeks between each dose adjustment.
The highest recommended daily dose of Rosuvastatin Accord is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels are not lowered properly by 20 mg.
If you are taking Rosuvastatin Accord to reduce the risk of having a heart attack, stroke, or other cardiovascular health problems:
The recommended dose is 20 mg per day. However, your doctor may decide that you should use a lower dose if you have any of the factors mentioned above.
Use for children and adolescents aged 6–17 years
The usual dose range for children and adolescents aged 6–17 years is 5–20 mg once daily. The usual starting dose is 5 mg daily and your doctor may gradually increase the dose to find the right dose of Rosuvastatin Accord for you. The highest recommended daily dose of Rosuvastatin Accord is 10 mg or 20 mg for children aged 6-17 years, depending on the underlying condition you are being treated for. Take a dose once a day. Rosuvastatin Accord 40 mg tablet should not be used in children.
Tablet intake
Swallow each tablet whole with a glass of water.
Take Rosuvastatin Accord once daily. You can take the tablet any time you want, with or without food. Try to take it at the same time every day so it will be easier to remember.
Regular cholesterol checks
You must see your doctor for regular cholesterol checks to make sure your cholesterol has reached and stays at the right level.
Your doctor may decide to increase your dose so that you take the dose of Rosuvastatin Accord that is right for you.
If you take more Rosuvastatin Accord than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you go to a hospital or receive treatment for any other condition, tell your healthcare provider that you are taking Rosuvastatin Accord.
If you forget to take Rosuvastatin Accord
Do not worry, but take the next dose as planned at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Rosuvastatin Accord
Talk to your doctor if you want to stop taking Rosuvastatin Accord. Your cholesterol levels may rise again if you stop taking Rosuvastatin Accord.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must be aware of what these side effects may be. They are usually mild and disappear after a short time.
Stop taking Rosuvastatin Accord and seek medical help immediately if you get any of the following allergic reactions:
- difficulty breathing, with or without swelling of face, lips, tongue, and/or throat. Rare (may affect up to 1 in 1,000 people).
- swelling of the face, lips, tongue, and/or throat, which may make it difficult to swallow. Rare (may affect up to 1 in 1,000 people).
- severe skin itching (with raised lumps). Rare (may affect up to 1 in 1,000 people).
Also, stop taking Rosuvastatin Accord immediately and talk to your doctor as soon as possible:
- if you get any unusual aches or pains in your muscles that sit in longer than you expected. Rare (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 in rare cases, this has developed into a life-threatening muscle disease, rhabdomyolysis.
- if you get muscle strain
- if you get a lupus-like condition (including skin rash, joint problems, and effects on blood cells ).
- if you get reddish, not raised, target-like, or circular spots on the torso, often with blistering in the middle, skin peeling, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome ).
- if you get a widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Rosuvastatin Accord can cause the following side effects:
Common (may affect up to 1 in 10 people)
- headache
- abdominal pain
- constipation
- nausea
- muscle aches
- impotence
- dizziness
- increased content of protein in the urine. This usually goes back to normal without you having to stop taking Rosuvastatin Accord (Rosuvastatin Accord 40 mg only).
- diabetes. This is more likely if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure. Your doctor will check you while you are taking this medicine.
Uncommon (may affect up to 1 in 100 people)
- rash, itching, or other skin reactions
- increased the content of protein in the urine. This usually returns to normal on its own without you having to stop taking Rosuvastatin Accord (Rosuvastatin Accord 5 mg, 10 mg, and 20 mg only).
Rare (may affect up to 1 in 1,000 people)
- severe abdominal pain (inflamed pancreas )
- increased liver enzymes in the blood
- bleeding or bruising occurs more often than normal due to low platelet levels.
- severe allergic reaction – swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps). If you think you have an allergic reaction, stop taking Rosuvastatin Accord and see a doctor immediately.
- Muscle damage in adults – as a preventative measure, stop taking Rosuvastatin Accord immediately and talk to your doctor as soon as possible if you have any unusual pain or pain in your muscles that lasts longer than expected.
- lupus-like disease (includes skin rash, joint problems, and effects on blood cells ).
Very rare (may affect up to 1 in 10,000 people)
- jaundice (yellowing of the skin and eyes)
- hepatitis (inflammation of the liver)
- traces of blood in the urine
- damage to nerves in legs and arms (eg numbness)
- joint pain
- memory loss
- breast augmentation in men ( gynecomastia ).
Has been reported (occurs in an unknown number of users)
- diarrhea (loose stools)
- cough
- shortness of breath
- edema (swelling)
- sleep disorders (including insomnia and nightmares)
- sexual difficulties
- Depression
- respiratory problems, including persistent cough and/or shortness of breath or fever
- tendon injuries
- long-lasting muscle weakness.
How to store Rosuvastatin Accord
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 label, blister, and carton after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Moisture sensitive. Sensitive to light. The HDPE can be used within 3 months after the first opening.
Do not use this medicine if the package is damaged or appears to have been opened earlier.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium).
- The other ingredients are:
Tablet core
Anhydrous lactose
Microcrystalline cellulose (E460)
Light magnesium
oxide Magnesium stearate (E470b)
Crospovidone type A (E1202)
Film coating 5 mg: hypromellose (E464), triacetin (E1518), titanium dioxide (E172 monoxide ) . 10 mg and 20 mg: hypromellose (E464), triacetin (E1518), titanium dioxide (E171), lactose monohydrate
, red iron oxide (E172), yellow iron oxide (E133), quinoline yellow aluminum lacquer (E104), brilliant blue FCF aluminum lacquer (E133).
40 mg:
hypromellose (E464), triacetin (E1518), titanium dioxide (E171), lactose monohydrate, para-orange FCF aluminum lacquer (E110), Allura red C aluminum lacquer (E129), and brilliant blue FCF aluminum lacquer (E133).
What the medicine looks like and the contents of the pack
This medicine is available in 5 mg, 10 mg, 20 mg, and 40 mg film-coated tablets.
5 mg: Yellow, round, biconvex film-coated tablet, approximately 7.0 mm in diameter, marked with “5” on one side and “R” on the other side.
10 mg: Pink, round, biconvex film-coated tablet, approximately 7.0 mm in diameter, marked with “10” on one side and “R” on the other side.
20 mg: Pink, round, biconvex film-coated tablet, approximately 9.0 mm in diameter, marked with “20” on one side and “R” on the other side.
40 mg: Pink, oval, biconvex film-coated tablet, approximately 11.5 mm long and approximately 6.9 mm wide, marked with “40” on one side and “R” on the other side.
The tablets are packaged in Alu / Alu blisters and HDPE jars (white opaque HDPE jar with white opaque polypropylene seal and white opaque desiccant container with blue print).
Pack sizes:
5 mg: Blister pack: 7, 28, 30, 60, 84, 90 or 98 tablets in blisters.
HDPE jar: 30 or 500 tablets.
10 mg: Blister pack: 7, 28, 30, 60, 84, 90, 98 or 100 tablets in blisters.
HDPE jar: 30 or 500 tablets.
20 mg: Blister pack: 7, 28, 30, 60, 84, 90, 98 or 100 tablets in blisters.
HDPE jar: 30 or 500 tablets.
40 mg: Blister pack: 7, 28, 30, 60, 90, 98 or 100 tablets in blisters.
HDPE jar: 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Ltd
Sage House
319, Pinner Road
North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
ACCORD-UK LTD
WHIDDON VALLEY, BARNSTAPLE, EX32 8NS,
UK