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What is Roswera and what it is used for
Roswera belongs to a group of medicines called statins.
Roswera is prescribed to you because:
You have high cholesterol levels. This means there is a risk of getting a heart attack or stroke.
Pink is used in adults, adolescents and children at or above 6 years of age to treat high cholesterol.
If you have high cholesterol levels you are advised to take a statin because changing the diet and doing more exercise is not enough to correct cholesterol levels. You should continue your diet and cholesterol lowering exercises while taking Roswera
There are other factors that increase the risk of heart attack, stroke or heart problems.
Infarction, stroke and other problems can be caused by a disease called atherosclerosis.
Atherosclerosis is due to accumulation of fat deposits in your arteries.
Why is it important to continue taking Pink?
Roswera 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 in the blood - "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).
Pink can reduce the "bad" and increase "good" cholesterol.
It works by helping block the "bad" cholesterol your body produces. It also improves your body's ability to remove it from the blood.
In most people, high cholesterol levels do not change the way they feel because they do not cause symptoms. However, if left untreated, fat deposits thicken the walls of the blood vessels and lead to their narrowing.
Sometimes, these narrow blood vessels can block, which stops the blood supply to the heart or brain leading to a heart attack or stroke. By adjusting cholesterol levels, you can reduce the risk of heart attack, stroke or related heart problems.
You need to continue to take Roswera, even if your cholesterol reaches normal levels, as this prevents a new rise in cholesterol leading to accumulation of fatty deposits. However, you should stop it if your doctor tells you to do so or if you become pregnant.
2. What you need to know before you take Roswera
Do not take Roswera
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 Pink, stop it immediately and call your doctor. Women should avoid becoming pregnant while taking Phozvera by proper contraception.
If you have liver disease.
If you have serious kidney problems.
If you have had recurrent and unexplained pain in the muscles or joints.
If you are taking a medicine called ciclosporin (used for example after an organ transplant).
If you think any of this applies to you (or have any doubts), please go back and consult your doctor.
In addition, do not take Roswera 30 mg or 40 mg (the highest doses)
If you have moderate kidney damage (in case of doubt, please contact your doctor.
If your thyroid does not function properly.
If you have had recurrent and unexplained muscle pains, personal or family history of muscle problems or a history of muscle problems when taking other cholesterol lowering drugs.
If you regularly drink large quantities of alcohol.
If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
If you are taking other medicines called fibrates to lower your cholesterol.
If you think any of the above applies to you (or you suspect), please tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Roswera
If you have kidney problems.
If you have liver problems.
If you have had recurrent and unexplained muscle pains, personal or family history of muscle problems or a history of muscle problems when taking other cholesterol lowering drugs. Instantly contact your doctor if you have unexplained muscle pains, especially if you feel bad or have a fever.
If you regularly drink a lot of alcohol.
If your thyroid does not function properly.
If you are taking other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have already taken other cholesterol lowering medicines.
If you are taking medicines used to fight HIV infection, such as ritonavir with lopinavir and / or atazanavir, please see "Other medicines and Pink".
If the patient is under 6 years of age: Roswera should not be given to children under 6 years of age.
If the patient is under 18 years of age: Pink 30 mg and 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.
If you are aged
If you think any of the above applies to you (or you are not sure):
Do not take Roswera 30 mg and 40 mg (highest dose) and consult your doctor or pharmacist before taking any dosage of Roswera
In a small number of people, statins can affect the liver. This is evidenced by a simple study aimed at detecting elevated levels of hepatic enzymes in the blood. For this reason, your doctor will perform a blood test (liver function test) before and during treatment with Pink
While taking this medicine, your doctor will monitor you closely if you suffer from diabetes or are at risk of developing diabetes. It is more likely that you will be promoted
risk of developing diabetes if you have high blood sugar and fat levels, overweight and have high blood pressure.
Other Drugs and Roswera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking any of the following:
cyclosporin (used for example after organ transplantation),
warfarin or clopidogrel (or other blood thinner),
fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol lowering drug (such as ezetimibe),
medicines for indigestion (used to neutralize acid in the stomach),
erythromycin (an antibiotic),
oral contraceptives (contraceptive pills),
hormone replacement therapy,
ritonavir with lopinavir and / or atazanavir or simneprevirus (used to fight HIV infection - see Warnings and precautions).
If you need to take oral fusidic acid for the treatment of bacterial infections, you should temporarily stop using this medicinal product.
Your doctor will tell you when it is safe to continue using Roswera. Taking Roswerawith Fusidic acid can cause muscle weakness, soreness or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
Roswera with food, drink and alcohol
You can take Pink with or without food.
Pregnancy, breastfeeding and fertility
Do not take Roser if you are pregnant or breast-feeding. If you become pregnant while taking Roswera, stop taking it immediately and tell your doctor. Women should avoid getting pregnant while taking Roswera using appropriate contraception. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive and operate machines while using Roswera - this will not affect their ability. However, some people feel dizzy during treatment with Roswera. If you feel dizzy, talk to your doctor before driving or using machines.
Roswera contains lactose (a type of sugar)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Roswera?
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usual doses in adults
If you take Roswera for increased cholesterol:
Your POWDER treatment should start at a dose of 5 mg or 10 mg, even if you have taken a higher dose than another statin before.
The choice of starting dose depends on:
The level of your cholesterol.
The degree of risk of a heart attack or stroke.
Whether there is a factor that can make you more sensitive to possible side effects.
Not all strengths of Pink tablets may be available.
Please consult with your doctor or pharmacist which dose of Pink is best suited to 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 moderate kidney problems.
- You are at risk of muscle pain (myopathy).
Increased dose and maximum daily dose
To achieve an adequate level of cholesterol, your doctor may gradually increase the dose to a maximum dose of 40 mg once a day. There will be a gap of 4 weeks between each dose adjustment.
The maximum daily dose of Roswera is 40 mg. It is only for patients with high cholesterol levels and a high risk of a heart attack or stroke whose levels are not low enough with lower doses.
If you take Roswera to reduce your risk of getting a heart attack, stroke or related heart problems:
The recommended dose is 20 mg daily. Your doctor, however, may decide to prescribe a lower dose if you have any of the above mentioned factors.
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 a day. The usual starting dose is 5 mg per day, and your doctor may gradually increase your dose to find the right amount of Pink for you. The maximum daily dose of Pink is 10 or 20 mg for children aged 6 to 17 years depending on the treatment of the disease. Take your dose once a day. Pink 30 mg or 40 mg tablets should not be used in children.
Taking the tablets
Swallow each tablet whole with water.
Take Pink once a day. You can take it at any time of the day.
Try taking your tablet at the same time each day. This will help you not forget it.
Regular checks of cholesterol
It is important to return to your doctor for regular cholesterol checks to make sure that the normal cholesterol level is reached and is constantly at the desired level.
Your doctor may decide to increase your dose so that you take the dose of Pink, which is best for you.
If you take more than the necessary dose of Roswera
Contact your doctor or nearest hospital.
If you go to a hospital or treat you for another illness, tell the medical staff that you are taking Roswera
If you forget to take Roswera
Do not worry, just take the next scheduled dose at the right time. Do not take a double dose to make up for the missed dose.
If you stop taking Roswera
Talk to your doctor if you want to stop taking Pink. Your cholesterol levels may increase again if you stop taking Roswera
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 everyone gets them.
It is important to know what these side effects are like. They are usually light and disappear for a short time.
Immediately stop treatment with Roswera and seek medical advice if you notice any of the following side effects:
Difficulty 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 swallowing difficulties.
Severe itching on the skin (rash on the skin).
So stop taking Pink and contact your doctor immediately if you have unusual muscle pains that you do not know the reason or continue longer than you expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people may experience unpleasant effects on their muscles, which rarely lead to life-threatening muscle damage, known as rhabdomyolysis.
Common possible side effects (such as may affect between 1 in 10 and 1 in 100 patients):
Increased urinary protein levels - Normally these values are normalized without having to stop taking Pink tablets (40 mg dose only).
Diabetes. This is more likely to happen if you have high levels of sugar and fat in the blood if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Uncommon possible side effects (those that may affect between 1 in 100 and 1 in 1,000 patients):
Rash, itching or other skin reactions
Increasing the amount of protein in the urine - usually these values are normalized without having to stop taking Pink tablets (only 5 - 20 mg).
Rare possible side effects (such as may affect between 1 in 1,000 and 1 in 10,000 patients):
Severe allergic reaction - Signs are swelling of the face, lips, tongue and / or throat, difficulty in swallowing and breathing, severe itching of the skin (rash). If you think you have an allergic reaction, stop taking Pink and seek medical attention immediately.
Muscular damage in adults - as a precautionary measure, stop taking Rozzera and consult your doctor immediately if you have any unusual pain or muscle pain that lasts longer than expected.
Stomach pain (inflammation of the pancreas).
Enhancement of liver enzymes in the blood.
Reduced platelet count (blood cells), which increases the risk of bleeding or bruising (thrombocytopenia).
Very rare side effects (which may affect less than 1 in 10,000 patients):
Jaundice (yellowing of the skin and eyes).
Hepatitis (inflammation of the liver).
Traces of blood in the urine.
Damage to the nerves of the hands and feet (tingling).
Gynecomastia (breast enlargement in men).
Side effects with an unknown frequency may include:
Diarrhea (rare stools).
How to Store the Roswera?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Store in the original package in order to protect from light.
Do not dispose of medicines in the sewer or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What contains Roswera
The active substance is rosuvastatin.
Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 15 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 30 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium).
The other ingredients are: lactose, microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica in the tablet core and lactose monohydrate, titanium dioxide (E171), macrogol 6000, and basic butyl methacrylate copolymer in the film coating.
What Roswera looks like and what the package contains
5 mg: White, round (7 mm in diameter), slightly biconvex, film-coated tablets with bevelled edges and engraved figure 5 on one side.
10 mg: White, round (diameter 7.5 mm), slightly biconvex, film-coated tablets with bevelled edges and engraved figure 10 on one side.
15 mg: White, round (9 mm in diameter), slightly biconvex, film-coated tablets with bevelled edges and engraved figure 15 on one side.
20 mg: White, round (10 mm diameter), film-coated tablets with bevelled edges.
30 mg: White, biconvex, oblong film-coated tablets scored on both sides (15 mm x 8 mm). The divider is only for ease of breaking for easier swallowing, not for splitting in equal doses.
40 mg: White, biconvex, oblong film-coated tablets (sizes 16 mm x 8.5 mm).
Cartons of 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters are available. Not all pack sizes may be marketed.
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