ROZUVISTAT table. 20 mg. 30 tab

ROZUVISTAT table. 20 mg. 30 tab
€ 39.00
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Rozuvistat tablets belong to a group of medicines called statins

ROZUVISTAT table. 20 mg. 30 tab

 
WHAT ROZUVISTAT FILM-COATED TABLETS ARE AND WHAT IT IS USED
Rozuvistat tablets belong to a group of medicines called statins
Rozuvistat tablets are prescribed because:
 have high levels of cholesterol. This means that you are at risk for heart attack or stroke - you are advised to take statins because changing your diet and doing more exercise were not sufficient to correct cholesterol levels. You should continue to cholesterol-lowering diet and exercise while taking Rozuvistat tablets;
 have other factors that increase the risk of heart attack, stroke or related health problems.
 
Heart attacks, strokes and other problems can be caused by a condition called atherosclerosis. Atherosclerosis is due to the formation of fatty deposits in the arteries.

Why is it important to continue taking Rozuvistat tablets?
Rozuvistat tablets is used for adjusting the levels of the fatty substances in the blood, termed lipid, the most common of which is cholesterol.
In the blood, there are different types of cholesterol - "bad" cholesterol (LDL-C) and 'good' cholesterol (HDL-C).
 Rosuvastatin tablets can reduce 'bad' cholesterol and increase "good" cholesterol;
 The drug works by helping block the production of "bad" cholesterol from your body. It improves your body's ability to remove from the blood.
 
In most people, high cholesterol levels did not change the way they feel because they do not produce symptoms. If left untreated, however, the body fat thickening of the walls of blood vessels and lead to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, which can stop blood flow to the heart or brain and cause a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of heart attack, stroke or related health problems.
We need to continue taking Rozuvistat tablets, even after cholesterol has reached the normal level because it will prevent the rise in cholesterol levels you again, causing the formation of fatty deposits. You have to stop it, however, if your doctor tells you to do or if you become pregnant.

2. BEFORE YOU TAKE ROZUVISTAT FILM-COATED TABLETS
Do not take Rozuvistat tablets:
 If you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of Rozuvistat tablets;
 if you are pregnant or breastfeeding. If you become pregnant while taking Rozuvistat tablets, immediately discontinue and contact your doctor. Women should avoid becoming pregnant while taking Rozuvistat tablets using appropriate contraception;
 if you have liver disease;
 if you have severe kidney problems;
 If you have had repeated or unexplained muscle pain;
 if you are taking a drug called cyclosporine (used, for example after organ transplants).
 
If any of the above apply to you (or if in doubt), please inform your doctor.

In addition, do not take Rozuvistat 40 mg (highest dose) tablets:
 if you have moderate to severe kidney problems (if in doubt, ask your doctor)
 if your thyroid gland is not functioning properly;
If you have had repeated or unexplained muscle pain, personal or family history of muscle problems, or a history of muscle problems while taking other cholesterol-lowering drugs;
 if you regularly drink large amounts of alcohol;
 if you are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
 if you take other medicines called fibrates to lower cholesterol.
 
If any of the above apply to you (or if in doubt), please inform your doctor.

Ask your doctor or pharmacist before taking Rozuvistat tablets:
 If you have severe respiratory failure.
 
Take special care with Rozuvistat tablets:

 if you have kidney problems;
 if you have liver problems;
 If you have had repeated or unexplained muscle pain, personal or family history of muscle problems, or a history of muscle problems while taking other cholesterol-lowering drugs. Tell your doctor if you have unexplained muscle pain, especially if you feel unwell or have a fever / chills;
 if you regularly drink large amounts of alcohol;
 if your thyroid gland is not functioning properly;
 if you are taking other medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
 if you are taking drugs used to fight HIV infection, such as lopinavir / ritonavir, please see Taking other medicines;
 if the patient is aged under 10 years: Rozuvistat tablets should not be given to children under the age of 10 years;
 if the patient is under 18 years: 40 mg tablet Rozuvistat tablets is not suitable for use in children and adolescents under 18 years;
 If you are younger than 70 years (it is necessary for your doctor to choose the correct starting dose of Rozuvistat tablets that will be best for you);
 if you are Asian - Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor will need to choose the right starting dose of Rozuvistat tablets that will be best for you.
 
During treatment
If any of the above apply to you (or if in doubt):
 Do not take Rozuvistat tablets 40 mg (highest dose) and refer to your doctor or pharmacist before actually start taking any dosage of Rozuvistat tablets.
 
A small number of people, statins can affect the liver. It opens with a simple study designed to determine whether increased levels of liver enzymes in the blood. For this reason, your doctor will do blood tests (liver function tests) before and during treatment with Rozuvistat tablets.

Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is particularly important to tell your doctor if you are taking any of the following:
 cyclosporin (used, for example, after organ transplants);
 warfarin (or other medication to thin the blood);
 Fibrates (such as gemfibrozil, fenofibrate), or another drug for lowering cholesterol (such as ezetimibe);
 medicines for indigestion (used to neutralize the acid in your stomach), erythromycin (antibiotic);
 oral contraceptive (pill), hormone replacement therapy;
 lopinavir / ritonavir (used to combat HIV infection - please see Take special care with Rozuvistat tablets).
 
The effects of these medicines may be changed by Rozuvistat tablets or they may alter the effect of Rozuvistat tablets.

Taking Rozuvistat tablets with food and drink
You can take Rozuvistat tablets with or without food.

Pregnancy and lactation
Do not take Rozuvistat tablets if you are pregnant or breastfeeding. If you become pregnant while taking Rozuvistat tablets, immediately discontinue and contact your doctor. Women should avoid becoming pregnant while taking Rozuvistat tablets using appropriate contraception.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Most people can not drive or operate machinery while using Rozuvistat tablets - it will not adversely affect your ability to drive or operate machinery. Some people, however, feel dizzy during treatment Rozuvistat tablets. If you feel dizzy, consult your doctor before you drive or operate machinery.

Important information about some of the ingredients of Rozuvistat tablets
This medicine contains lactose. If you were told by your doctor that you have an intolerance to some sugars (lactose or milk sugar), contact your doctor before you start taking Rozuvistat tablets.
For a full list of ingredients please see Additional Information below.

3. HOW TO TAKE ROZUVISTAT FILM-COATED TABLETS
Always take Rozuvistat tablets exactly as your doctor tells you.
If you are not sure, ask your doctor or pharmacist.

Usual adult dose
If you take Rozuvistat tablets for high cholesterol:
Starting dose
Your treatment with Rozuvistat tablets should be initiated at a dose of 5 mg or 10 mg, even if you have previously received a higher dose than other articles. The choice of the starting dose will depend on:
 Cholesterol;
 Level of risk of heart attack or stroke;
 Is there a factor that makes you more susceptible to possible side effects.
 
Please consult your doctor or pharmacist what starting dose of Rozuvistat tablets will be most suitable for you.

Your doctor may decide to recommend the lowest dose (5 mg):
 If you are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
 If you are aged over 70 years;
 If you have moderate to severe kidney problems;
 If you are at risk for muscle pain (myopathy).
 
Increasing dose and maximum daily dose:
Your doctor may decide to increase your dose. This is to take the amount Rozuvistat tablets, which is suitable for you. If you start with a dose of 5 mg, your doctor may decide to double to 10 mg, then 20 mg and, if necessary, to 40 mg. If you start with a dose of 10 mg, your doctor may decide to double to 20 mg and then, if necessary, to 40 mg. There will be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of Rozuvistat tablets is 40 mg. It is only for patients with high cholesterol levels and increased risk of heart attack or stroke whose cholesterol levels are not reduced sufficiently at a dose of 20 mg.
 
If you take Rozuvistat tablets to reduce the risk of heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. Your doctor, however, may choose to use a lower dose, if there is any of the above factors.

The pill
Swallow the tablet whole with a drink of water.
Take Rozuvistat tablets once daily. You can take the tablet at any time of day.
Try to take the tablet at the same time each day will help you remember to take it.

Regular monitoring of cholesterol
It is important to go to the doctor for regular follow-up of cholesterol in order to be sure that your cholesterol is reached and remained at normal levels.
Your doctor may decide to increase your dose to take the amount of Rosuvastatin tablets, which is suitable for you.

If you take an overdose of tablets Rozuvistat
Contact your doctor or nearest hospital for advice.

If you forget to take Rozuvistat tablets
Do not worry, just take the next dose at the right time. Do not take a double dose to make up.

If you stop taking the tablets Rozuvistat
Tell your doctor if you wish to stop taking Rozuvistat tablets. Your cholesterol levels may rise again if you stop taking Rosuvastatin tablets.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Rozuvistat tablets can cause side effects, although not everybody gets them. It is important to know what can be the side effects. They are usually mild and disappear after a short time.

Stop taking Rozuvistat tablets and seek immediate medical attention if you notice any of the following allergic reactions:
 Shortness of breath with or without swelling of the face, lips, tongue and / or throat;
 Swelling of your face, lips, tongue and / or throat that may cause difficulty in swallowing;
 Severe itching of the skin (with bumps on the skin);
 Also, stop taking Rozuvistat tablets and tell your doctor if you have unusual muscle pain, which last longer than expected. Muscular symptoms are more common in children and adolescents than in adults. As with other statins, very few people have experienced the unpleasant effects on muscles that are rarely developed to potentially life-threatening muscle damage known as rhabdomyolysis.
 
Common possible side effects (affect between 1 in 10 and 1 in 100 patients):
 Headache;
 Stomach pain;
 Constipation;
 Nausea;
 Muscle pain;
 Feeling tired;
 Dizziness;
 Increase in amount of protein - usually normalized by itself without the need to stop the acceptance of Rozuvistat tablets (for Rozuvistat 40 mg film-coated tablets);
 Diabetes in patients with increased levels of blood sugar.
 
Uncommon possible side effects (affect between 1 in 100 and 1 in 1000 patients):
 Rash, itching or other skin reactions;
 Increase in amount of protein - usually normalized by itself without the need to stop the acceptance of Rozuvistat tablets (for Rozuvistat 5 mg, 10 mg and 20 mg tablets).
 
Possible rare side effects (affects between 1 in 1,000 and 1 in 10,000 patients):
 Severe allergic reaction - signs include swelling of the face, lips, tongue and / or throat, difficulty in swallowing and breathing, severe itching of the skin (with bumps on the skin). If you think you have an allergic reaction, stop taking Rozuvistat tablets and seek medical attention immediately;
 Muscle injury in adults - as a precaution, stop taking Rosuvastatin tablets and tell your doctor if you have unusual muscle pain, which last longer than expected;
 Severe stomach pain (inflamed pancreas);
 Increase of liver enzymes in blood.
 
Very rare possible side effects (affects less than 1 in 1000 patients):
 Jaundice (yellowing of the skin and whites of the eyes);
 Hepatitis (inflamed liver);
 Traces of blood in the urine;
 Damage to the nerves in the feet and hands (such as numbness);
 Joint pain;
 Memory loss.
 
Side effects of unknown frequency may include:
 Diarrhea (watery stools)
 Stevens-Johnson syndrome (severe blistering of the skin, mouth, eyes and genitals);
 Cough;
 Shortness of breath;
 Edema (swelling);
 Sleep disorders, including insomnia and nightmares;
 Sexual difficulties;
 Depression;
 Breathing problems including persistent cough and / or shortness of breath or fever / chills.
 
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 ROZUVISTAT FILM-COATED TABLETS
Keep out of reach of children.
Rozuvistat not use tablets after the expiry date stated on the label.
Store below 30 ° C 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.

6. ADDITIONAL INFORMATION
What does Rozuvistat tablets
The active substance in tablets Rosuvastatin is rosuvastatin. Rozuvistat tablets containing rosuvastatin calcium, the equivalent of 5 mg, 10 mg, 20 mg or 40 mg of a rosuvastatin.

Excipients:
Rozuvistat 5 mg film-coated tablets: lactose monohydrate, microcrystalline cellulose, sodium citrate, magnesium stearate, crospovidone, 02V82338 Opadry Yellow (hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172));

Rozuvistat 10 mg, 20mg, 40 mg film-coated tablets: lactose monohydrate, microcrystalline cellulose, sodium citrate, magnesium stearate, crospovidone, Opadry pink 03V24082 (hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172)).
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