5 mg, 10 mg, 20 mg, 40 mg film-coated tablets
rosuvastatin
What Rosuvastatin Glenmark is and what it is used for
Rosuvastatin Glenmark belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin Glenmark because:
- You have a high cholesterol level. This means that you have an increased risk of having a heart attack or stroke. Rosuvastatin Glenmark is used in adults, adolescents, and children from 6 years of age to treat high cholesterol.
You have been advised to take a statin because 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 Glenmark.
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 it’s important to continue taking Rosuvastatin Glenmark
Rosuvastatin Glenmark is used to correct the concentration of certain lipids 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 ) and the “good” cholesterol ( HDL ).
- Rosuvastatin Glenmark can lower 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 your 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 settle on the walls of your 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 a 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 Glenmark, 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 Rosuvastatin Glenmark 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 taking Rosuvastatin Glenmark
Do not take Rosuvastatin Glenmark:
- if you have ever had an allergic reaction to rosuvastatin or any of the other ingredients.
- if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Glenmark, stop taking Rosuvastatin Glenmark immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosuvastatin Glenmark 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 combination therapy with sofosbuvir / velpatasvir / voxilaprevir (used to treat a viral infection in the liver called hepatitis C).
- if you are taking a medicine called ciclosporin (used for example in organ transplantation).
- if you have ever developed a severe rash or skin rash, blisters, and/or sores in your mouth after taking Rosuvastatin Glenmark or other related medicines.
If any of the above apply to you (or you are not sure) contact your doctor.
Note that you should not take Rosuvastatin Glenmark 40 mg (the highest dose):
- if you have moderate kidney problems (ask a 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) contact your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rosuvastatin Glenmark:
- if you have kidney problems
- if you have liver problems
- if you have had recurrent or unexplained muscle aches or pain, previous muscle disease is hereditary muscle disease, or have had muscle pain when using other cholesterol-lowering drugs. 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 other cholesterol-lowering drugs 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 Glenmark
- 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 Glenmark can lead to serious muscle problems ( rhabdomyolysis ), see “Other medicines and Rosuvastatin Glenmark”.
- if you are over 70 years of age (because your doctor must choose the starting dose of rosuvastatin that suits 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 starting dose of rosuvastatin that suits you.
- Severe skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Rosuvastatin Glenmark. Stop using Rosuvastatin Glenmark and see a doctor immediately if you notice any of the symptoms described in section 4.
If any of the above is true for you (or if you are unsure):
- Do not take Rosuvastatin Glenmark 40 mg (the highest dose one) and consult your doctor or pharmacist before taking any dose of Rosuvastatin Glenmark.
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, doctors will usually take this blood test (liver function test) before and during treatment with Rosuvastatin Glenmark.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at high risk for 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 Glenmark should not be given to children under 6 years of age.
- If the patient is under 18 years of age: Rosuvastatin Glenmark 40 mg tablet is not suitable for children and adolescents under 18 years of age.
Other medicines and Rosuvastatin Glenmark
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:
- cyclosporine (used for example in organ transplantation),
- warfarin , ticagrelor or clopidogrel (or other blood thinners),
- fibrates (eg gemfibrozil, fenofibrate) or other cholesterol-lowering drugs (eg ezetimibe),
- certain medicines for heartburn and acid reflux,
- erythromycin (an antibiotic ), fusidic acid (an antibiotic – see Warnings and Precautions),
- birth control pills,
- regorafenib (used to treat cancer),
- darolutamide (used to treat cancer),
- hormone replacement drugs,
- 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, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grasp, elbasvir, glekaprevir, pibrentasvir.
The effects of these medicines may be affected by Rosuvastatin Glenmark or they may affect the effect of Rosuvastatin Glenmark.
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 Glenmark again. The use of Rosuvastatin Glenmark in combination 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 Glenmark if you are pregnant or breastfeeding. If you become pregnant while taking it, stop taking Rosuvastatin Glenmark immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Glenmark by using appropriate contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive and use machines while taking Rosuvastatin Glenmark without affecting their ability. However, some people may feel dizzy during treatment with Rosuvastatin Glenmark. If you feel dizzy, consult your doctor before attempting to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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. Descriptions 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 Glenmark 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 Rosuvastatin Glenmark.
Rosuvastatin Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
For a complete list of ingredients, see the Contents of the Package and other information.
How to take Rosuvastatin Glenmark
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults
If you are taking Rosuvastatin Glenmark for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Glenmark should start with a dose of 5 mg or 10 mg, even if you have taken a higher dose of another statin before. The choice of starting 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 any side effects.
Ask your doctor or pharmacist for advice on which dose of Rosuvastatin Glenmark is best for you.
Your doctor may decide to give you the lowest dose (5 mg) if:
- you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
- you are over 70 years old
- you have moderate kidney problems
- you are at risk for muscle aches and pains ( myopathy ).
Increase of dose one and a maximum daily dose
Your doctor may decide to increase your dose. This is so that you can take the dose of Rosuvastatin Glenmark 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 start by taking 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 maximum daily dose of Rosuvastatin Glenmark 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 enough by 20 mg.
If you are taking Rosuvastatin Glenmark to reduce the risk of having a heart attack, stroke, or other cardiovascular health problems:
The recommended dose is 20 mg/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 for you. The maximum daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition you are being treated for. Take a dose once a day. Rosuvastatin Glenmark 40 mg tablet should not be used in children.
Tablet intake
Swallow each tablet whole with a glass of water.
Take Rosuvastatin Glenmark once daily. You can take the tablet any time you want, with or without food.
Try to take the same time each day to make it 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 Glenmark that is right for you.
If you take more Rosuvastatin Glenmark than you should
If you have ingested too much medicine, 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 Glenmark.
If you forget to take Rosuvastatin Glenmark
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 Glenmark
Talk to your doctor if you want to stop taking Rosuvastatin Glenmark. Your cholesterol levels may rise again if you stop taking Rosuvastatin Glenmark.
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 Glenmark and seek medical help immediately if you get any of the following allergic reactions:
- difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat
- swelling of the face, lips, tongue, and/or throat that may cause difficulty swallowing
- severe skin itching (with raised lumps).
- reddish, not raised, target-like, or circular spots on the torso, often with blistering in the middle, 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 ).
- widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome ).
Also, stop taking Rosuvastatin Glenmark immediately and contact your doctor:
- if you get any unusual aches or pains in your muscles that sit in longer than you expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects and in rare cases, these have 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 ).
Common side effects (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 Glenmark (Rosuvastatin Glenmark 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 side effects (may affect up to 1 in 100 people):
- skin rash, itching, or other skin reactions
- increased content of protein in the urine. This usually goes back to normal without you having to stop taking Rosuvastatin Glenmark (Rosuvastatin Glenmark 5 mg, 10 mg, and 20 mg only).
Rare side effects (may affect up to 1 in 1,000 people):
- severe allergic reaction – swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe skin itching (with raised lumps). If you think you have an allergic reaction, stop taking Rosuvastatin Glenmark and see a doctor immediately
- muscle damage in adults – as a preventative measure, stop taking Rosuvastatin Glenmark immediately and talk to a doctor as soon as possible if you have any unusual pain or pain in your muscles that lasts longer than expected
- severe abdominal pain (inflamed pancreas )
- increased liver enzymes in the blood
- bleeding or bruising occurs more often than normal due to low platelet levels.
- lupus-like disease (includes skin rash, joint problems, and effects on blood cells )
Very rare side effects (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
- enlargement of the mammary glands in men ( gynecomastia ).
No known frequency (cannot be calculated from the available data):
- 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 Glenmark
- 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/blister/label after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Sensitive to light.
- If the tablets are delivered in a plastic jar, make sure that the lid is properly closed.
- Store the tablets in the original package.
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. Rosuvastatin Glenmark contains either 5 mg, 10 mg, 20 mg, or 40 mg rosuvastatin (as rosuvastatin calcium).
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, sodium bicarbonate, magnesium stearate, hypromellose, triacetin, and titanium dioxide (E171), and red iron oxide (E172).
What the medicine looks like and the contents of the pack
Rosuvastatin Glenmark is supplied in blister packs containing 14, 15, 28, 30, 42, 56, 60, 84, 90, and 98 tablets and in plastic jars of 30, 50, 90, and 100 tablets (not all packs are available in all countries).
The tablets in a plastic jar are supplied with a desiccant to protect the tablets from moisture. The desiccant should not be ingested.
Rosuvastatin Glenmark is available in four tablet strengths:
Rosuvastatin Glenmark 5 mg film-coated tablets are pink film-coated, round tablets about 4.50 mm in size, debossed with “G” on one side of the tablet and “C” on the other side.
Rosuvastatin Glenmark 10 mg film-coated tablets are pink film-coated, round tablets about 5.50 mm in size, debossed with “G” on one side of the tablet and “D” on the other side.
Rosuvastatin Glenmark 20 mg film-coated tablets are pink film-coated, round tablets about 7.00 mm in size, debossed with “G” on one side of the tablet and “O” on the other side.
Rosuvastatin Glenmark 40 mg film-coated tablets are pink, film-coated, oval tablets measuring approximately 11.6 x 7.00 mm, debossed with “G 264” on one side of the tablet and “40” on the other side.
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194 Gröbenzell,
Germany
Manufacturer
Glenmark Pharmaceuticals sro
Fibichova 143, 566 17 Vysoké Mýto
Czech Republic
This medicinal product is authorized in the EEA Member States under the following names:
The Netherlands: Rosuvastatine Glenmark
Spain: Rosuvastatina Viso Pharmacéutica
United Kingdom: Rosuvastatin