ROSWERA 10 mg. 30 tablets
Rozwera belongs to a group of medicines called statins.
Rozwera is prescribed to you because:
• Do you have high cholesterol levels. This means that there is a risk to get heart attack or stroke if you have high cholesterol you are recommended to take the articles, because changing your diet and doing more exercise are not enough to correct cholesterol levels. You should continue your diet and exercise to lower cholesterol while taking Rozwera.
- 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 Rozwera? Rozwera 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 have different types of cholesterol - "bad" cholesterol (LDL-C) and the "good" cholesterol (HDL -C).
Rozwera can reduce 'bad' cholesterol and increase "good" cholesterol.
It works by helping blocking "bad" cholesterol that your body produces. Also improves the ability of your body 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, 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 leading to a heart attack or stroke. Correcting cholesterol levels, you can reduce your risk of heart attack, stroke or related heart problems.
It is necessary to keep taking Rozwera, even if you get normal cholesterol levels, as this prevents the escalation of cholesterol, leading to 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 ROZWERA
Do not take Rozwera:
If you are allergic (hypersensitive) to rosuvastatin or to any of the excipients of Rozwera
If you are pregnant or breast-feeding. If you become pregnant while taking Rozwera, stop immediately and call your doctor * Women should avoid becoming pregnant while taking Rozwera through 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 ciclosporin (used eg after an organ transplant).
If you think any of these apply to you (or you have any doubt), please go back and consult your doctor.
Furthermore, do not take Rozwera 30 mg or 40 mg (the highest dose):
If you have moderate renal impairment (if in doubt, please contact your doctor).
- If your thyroid gland is not functioning normally
- If you have had repeated or 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 of Asian origin (Japanese, Chinese, Filipino, Korean and Indian) If you take other medicines called fibrates to lower your cholesterol. If you believe that any of the above applies to you (or you are in doubt), please tell your doctor.
Pay special attention to taking Rozwera:
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 fever
If you regularly drink large amounts of alcohol. If your thyroid gland is not functioning normally
If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have already taken other drugs to lower cholesterol
If you take medicines used to fight HIV infection, such as lopinavir / ritonavir, please see "Taking other medicines".
If the patient is under 10 years of age: Rozwera should not be given to children under 10 years.
If the patient is under 18 years of age: Rozwera 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 correct dose
Rozwera initial dose that is right for you.
If you have severe respiratory failure.
If you are of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the correct dose for initiation of therapy with Rozwera that is right for you.
If you believe that any of the above applies to you (or are not sure): Do not take Rozwera 30 mg and 40mg (highest dose) and consult your doctor or pharmacist before taking any dose of Rozwera
In a small number of people, statins can affect the liver. This is established by a simple study aimed 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 Rozwera.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you buy without a prescription. Tell your doctor if you are taking any of the following:
- Ciclosporin (used for example, after organ transplants), warfarin (or other medication to thin the blood), fibrates (such as gemfibrozil, fenofibrate) or any other medicine to lower cholesterol (such as ezetimibe)
- Medicines for indigestion (used to neutralize acid in the stomach)
- Erythromycin (antibiotic),
- Oral contraceptives (birth control pills), hormone replacement therapy,
lopinavir / ritonavir (used to fight HIV infection - see "Take special care with Rozwera"). The effects of these drugs may be altered by concomitant Rozwera or they may change the effect of Rozwera.
While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk to develop diabetes. More likely you 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 Rozwera with food and drink
You can take Rozwera with or without food.
Pregnancy and lactation
Rozwera not take if you are pregnant or breast-feeding. If you become pregnant while taking Rozwera stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rozwera 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 Rozwera - it will not affect their ability. However, some people feel dizzy during treatment with Rozwera. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.
Important information about some of the ingredients of Rozwera
Rozwera contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
For a full list of excipients, please see more information below.
3. HOW TO TAKE ROZWERA?
Always take Rozwera 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 Rozwera for high cholesterol:
Your treatment with Rozwera should start with a dose of 5 or 10 mg, even if you have taken 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 may make you more sensitive to possible side effects.
Not all concentrations Rozwera may be available, please consult your doctor or pharmacist which start dose Rozwera most suitable for 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 the age of 70.
- 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 a gap of four weeks between each dose adjustment
The maximum daily dose of Rozwera 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 Rozwera to reduce the risk to get 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 Rozwera. The maximum daily dose Rozwera is 20 mg. Take your dose once a day. Rozwera 30 and 40 mg tablets should not be taken by children!
Swallow each tablet whole with water.
Take Rozwera once 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 go back to your doctor for regular cholesterol checks, to make sure that normal cholesterol level is reached and is constantly on the desired level. Your doctor may decide to increase your dose so you take Rozwera dose that is best for you.
If you take more dose Rozwera
Contact your doctor or nearest hospital.
If you go into a hospital or you are being treated for another illness, tell the medical staff you are taking Rozwera.
If you forget to take Rozwera
Do not worry, just take your next scheduled dose at the right time. Do not take a double dose to make up.
If you stop taking Rozwera
Talk to your doctor if you want to stop taking Rozwera. Values your cholesterol may increase again if you stop taking Rozwera.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rozwera can cause side effects, although not everybody gets them.
It is important to know what they are. They are usually mild and disappear after a short time.
Immediately discontinue Rozwera and seek medical attention if you notice any of the following side effects:
Difficulties 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 stop taking Rozwera and contact your doctor immediately if you have unusual muscle pain, for 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, a very small number of people may experience unpleasant effects on the 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 ache, Constipation, Nausea, Muscle pain, feeling of weakness, dizziness, increase the amount of protein in the urine - usually these values are normalized without having to stop taking the tablets Rozwera (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 in 100 and 1 in 1000 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 Rozwera (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 or breathing, severe itching of the skin (rash). If you think you have an allergic reaction, stop taking Rozwera and seek medical advice immediately
- Muscle damage in adults - as a precaution, stop taking Rosvera consult your doctor immediately if you have any unusual aches or pains in the muscles, which last longer than expected
- Severe stomach pain (inflammation of the pancreas).
- Increased liver enzymes in the blood
Very rare side effects (these can 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, 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 the 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 if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ROZWERA
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light.
Do not use Rozwera after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.