ROSVERA. 10 mg. 30 tablets
ROSVERA. 10 mg. 30 tablets
ROZVERA WHAT IS AND WHAT IT IS USED FOR?
Rozvera belongs to a group of medicines called statins.
Rozvera is prescribed to you because:
• Do you have high cholesterol levels. This means that there is a risk to get a heart attack or stroke if you have high cholesterol you are recommended to take the articles, because the change of diet and doing more exercise are not enough to correct cholesterol levels. You should continue your diet and exercise to lower cholesterol while taking Rozvera.
- There are other factors that increase the risk of heart attack, stroke, or problems with the heart.
Heart attack, stroke and other problems can be caused by a condition called atherosclerosis.
Atherosclerosis is due to the accumulation of fatty deposits in your arteries.
Why is it important to continue with taking Rozvera? Rozvera is used to adjust the levels of the fatty substances in the blood, called lipids, the most common of which is cholesterol in the blood is different cholesterol - "bad" cholesterol (LDL-C) and "good" cholesterol (HDL -C).
Rozvera can reduce "bad" and increase "good" cholesterol.
It works by helping the blocking of "bad" cholesterol that your body produces. It also improves the ability of your body to remove it from the blood.
In most people, high cholesterol levels do not change the way in which they feel because they do not cause symptoms. However, if left untreated, fatty deposits thickening the walls of blood vessels and lead to narrowing.
Sometimes, these narrowed blood vessels can be blocked to blocked blood supply to the heart or brain, causing heart attack or stroke. By adjusting cholesterol levels, you can reduce your risk of heart attack, stroke or heart related problems.
It is necessary to keep taking Rozvera, even if you arrive normal cholesterol levels, since this prevents the escalation of the cholesterol, leading to the accumulation of fatty deposits. However, you have to stop if your doctor tells you to do or if you become pregnant.
2. BEFORE YOU TAKE ROZVERA
Do not take Rozvera:
If you are allergic (hypersensitive) to rosuvastatin or to any of the excipients of Rozvera
If you are pregnant or breastfeeding. If you become pregnant while taking Rozvera, stop immediately and call your doctor * Women should avoid becoming pregnant while taking Rozvera using adequate contraception
If you have liver disease If you have severe kidney problems
If you have had repeated and unexplained pain in muscles or joints If you are taking a drug called cyclosporine (using eg, after organ transplantation).
If you think any of these apply to you (or you have any) please go back and talk to your doctor.
Moreover, do not take Rozvera 30 mg or 40 mg (the highest dose):
If you have moderate kidney damage (if in doubt, please contact your physician).
- If your thyroid gland is not functioning properly
- If you have had repeated and unexplained muscle pain, personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs.
- If you regularly drink large amounts of alcohol
If you are Asian (Japanese, Chinese, Filipino, Korean and Indian) If you are taking medicines called fibrates to lower cholesterol. If you believe that any of the above applies to you (or suspect), please inform your doctor.
Pay special attention to taking Rozvera:
If you have kidney problems. If you have liver problems.
If you have had repeated and unexplained muscle pain, personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering drugs. Immediately contact your doctor if you have unexplained muscle pain, especially if you feel unwell or have a fever
If you regularly drink large amounts of alcohol. If your thyroid gland is not functioning properly
If you are taking medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have already taken other drugs to lower cholesterol
If you are taking drugs used to fight HIV infection, such as lopinavir / ritonavir, please see "Taking other medicines".
If the patient is under 10 years of age: Rozvera should not be given to children under 10 years.
If the patient is under 18 years of age: Rozvera 30 mg and 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.
If you are aged over 70 years (your doctor should choose the right dose
Rozvera initial intake that is right for you.
If you have severe respiratory failure.
If you are of Asian descent - it's Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor should choose the right dose for initiation of therapy with Rozvera that is right for you.
If you believe that any of the above applies to you (or not sure): Do not take Rozvera 30 mg and 40mg (highest dosage) and consult your doctor or pharmacist before taking any dosage of Rozvera
In a small number of people, statins can affect the liver. This is established by a simple study designed to determine whether increased levels of liver enzymes in the blood. For this reason, your doctor will do a blood test (liver function tests) before and during treatment with Rozvera.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you buy without a prescription. Tell your doctor if you are taking any of the following:
- Cyclosporine (used for example after organ transplantation), warfarin (or other medication to thin the blood), fibrates (such as gemfibrozil, fenofibrate) or any other medicine to lower cholesterol (such as ezetimibe)
- Drugs with indigestion (used to neutralize the acid in the stomach),
- Erythromycin (antibiotic),
- Oral contraceptives (birth control pills), hormone replacement therapy,
lopinavir / ritonavir (used to combat HIV infection - see "Take special care with Rozvera"). The effects of these drugs may be altered by concomitant Rozvera or they may change the effect of Rozvera.
While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk to develop diabetes. More likely it is you to be at increased risk of developing diabetes if you have high levels of sugar and fat in the blood, overweight and have high blood pressure.
Taking Rozvera with food and drink
You can take Rozvera with or without food.
Pregnancy and lactation
Rozvera not take if you are pregnant or breastfeeding. If you become pregnant while taking Rozvera stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rozvera using adequate contraception. Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Most people can not drive or operate machinery while using Rozvera - it will not affect their ability. However, some people feel dizzy during treatment with Rozvera. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.
Important information about some of the ingredients of Rozvera
Rozvera contains lactose (a sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
For a full list of excipients, please see more information below.
3. HOW TO TAKE ROZVERA?
Always take Rozvera as you have been told by your doctor. You should consult with your doctor or pharmacist if you are not sure.
The usual dose in adults
If you take Rozvera for high cholesterol:
Your treatment with Rozvera should start with a dose of 5 or 10 mg, even if you take a higher dose of another statin before. The choice of the starting dose depends on: your cholesterol. The degree of risk of heart attack or stroke.
Whether there is a factor that can make you more sensitive to possible side effects.
Not all concentrations Rozvera may be available, please consult your doctor or pharmacist what starting dose Rozvera most suitable for you.
Your doctor may decide to give you the lowest dose (5 mg), if:
- You are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
- You are over 70 years old.
- You have moderate kidney problems.
- You are at risk of muscle pain (myopathy).
Increasing the dose and maximum daily dose
In order to achieve an adequate level of cholesterol, your doctor may decide to gradually increase the dose to a maximum dose of 40 mg once daily. There will be an interval of 4 weeks between each dose adjustment
The maximum daily dose of Rozvera is 40 mg. It is only for patients with high levels of cholesterol and a higher risk of heart attack or stroke whose levels are not lowered enough with lower doses.
If you take Rozvera to reduce the risk of having a heart attack, stroke or related heart problems:
The recommended dose is 20 mg daily. Your doctor may decide to prescribe a lower dose if you have any of the above factors.
Usual dose for children aged 10-17 years
The usual starting dose is 5 mg. Your doctor may increase your dose to reach the best dose for you Rozvera. The maximum daily dose Rozvera is 20 mg. Take your dose once a day. Rozvera 30 and 40 mg tablets should not be taken by children!
Taking the tablets
Swallow each tablet whole with water.
Take Rozvera daily. You can take it any time of the day. Try to take your tablet at the same time each day. This will help you not to forget.
Regular cholesterol checks
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 on the desired level. Your doctor may decide to increase your dose so that you take Rozvera dose that is best for you.
If you take more dose Rozvera
Contact your doctor or nearest hospital.
If you go into hospital or you are being treated for another illness, tell the medical staff that you are taking Rozvera.
If you forget to take Rozvera
Do not worry, just take your next scheduled dose at the right time. Do not take a double dose to make up for a missed dose.
If you stop taking Rozvera
Talk to your doctor if you should stop taking Rozvera. Values your cholesterol may increase again if you stop taking Rozvera.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rozvera can cause side effects, although not everybody gets them.
It is important to know what they are. They are usually mild and disappear within a short time.
Immediately discontinue Rozvera and seek medical advice in case you notice any of the following side effects:
Difficulty in 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 in swallowing.
Severe itching of the skin (skin rash).
Also Rozvera stop taking and contact your doctor immediately if you have unusual muscle pain, you do not know the cause or last longer than you expect. Muscular symptoms are more common in children and adolescents than in adults. As with other statins very small number of people may experience unpleasant effects on your muscles, which rarely lead to life-threatening muscle damage known as rhabdomyolysis.
Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):
Headache, stomach pain, Constipation, Nausea, Muscle pain, feelings of weakness, dizziness, Increasing the amount of protein in the urine - usually these values are normalized without having to stop taking the tablets Rozvera (only 40 mg dose). Diabetes, particularly those with blood sugar at the upper end of the "norm".
Uncommon possible side effects (these may affect between 1 100 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 the tablets Rozvera (only doses of 5-20 mg).
Rare possible side effects (these 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 swallowing and breathing, severe itching of the skin (rash). If you think you have an allergic reaction, stop taking Rozvera and seek medical advice immediately
- Muscle damage in adults - as a precaution, stop taking Rosvera consult your doctor immediately if you experience any unusual pain or muscle aches that last longer than expected
- Severe stomach pain (inflammation of the pancreas).
- Elevations of liver enzymes in the blood
Very rare side effects (These may affect less than 1 in 10,000 patients):
Jaundice (yellow skin and eyes), hepatitis (liver inflammation) Traces of blood in the urine, nerve damage in the hands and feet (tingling), joint pain, memory loss, gynaecomastia (breast enlargement in men)
Side effects of unknown frequency may include:
diarrhea (loose stools)
Stevens-Johnson syndrome (severe blistering of the skin, mouth, eyes and genitals)
Shortness of breath Edema (swelling)
Sleep disorders, including insomnia and nightmares
Breathing problems including persistent cough and / or shortness of breath or fever
Diabetes. More likely is that to happen if you have high levels of sugar and fat in your blood if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ROZVERA
Keep out of reach of children.
This medicinal product does not require any special storage conditions. Store in the original package to protect from light.
Do not use Rozvera after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste container. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What does Rozvera?
The active agent is rosuvastatin.
Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium) Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium)
Each tablet contains 15 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 30 mg rosuvastatin (as rosuvastatin calcium). Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). The other ingredients are laktoza.bezvodna, microcrystalline cellulose, crospovidone, magnesium stearate and colloidal silica anhydrous in the tablet core, and lactose monohydrate, titanium dioxide (E 171), macrogol 6000 and the basic butylated saiolimer in the film coating.
Rozvera looks like and contents of the pack?
5 mg: white. circular (diameter of 7 mm), slightly biconvex. film-coated tablet with bevelled edges, engraved figure of a 5 th country.
10 mg: White, round (diameter 7.5 mm), slightly biconvex, film-coated tablet with bevelled edges, engraved number 10 on one side.
15 mg: White, round (diameter of 9 mm), slightly biconvex, film-coated tablet with bevelled edges, engraved number 15 on one side.
20 mg: white, round you (diameter of 10 mm), film-coated tablet with bevelled corners. 30 mg: white, biconvex, capsule-like tablets, scored on both sides (15 mm x 8 mm). The score line is only to facilitate breaking for easier swallowing, and not to divide into equal doses.
40 mg: white, biconvex, capsule-like tablets (dimensions 16 mm x 8.5 mm).
Box 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.