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What is Aterosad and what it is used for
Aterosad belongs to a group of medicines called statins.
You are prescribed Aterostad because:
• You have a high cholesterol level. This means you are at risk of a heart attack or stroke.
You are advised to take a statin because the change in your diet and the greater physical activity were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and physical activity while taking Atherosada.
• There are other factors that increase the risk of heart attack, stroke or other associated health 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 Aterosad
Aterostad is used to correct blood lipid levels called lipids, the most abundant of which is cholesterol. There are different types of cholesterol found in the blood: "bad" cholesterol (LDL - C) and "good" cholesterol (HDL - C).
• Aterostad may lower "bad" cholesterol and raise "good" cholesterol;
• It works by helping to block the formation of bad cholesterol by your body, and it also improves the ability of your body to remove it from your blood.
Most people do not feel that their cholesterol is elevated because it does not cause any symptoms. However, if it remains untreated, accumulated fat may be delayed in the walls of your blood vessels and this may cause them to narrow.
Sometimes these narrowed blood vessels may become blocked, which may interrupt blood flow to the heart or brain and lead to a heart attack or stroke. By adjusting your cholesterol levels you can reduce the risk of heart attack, stroke or other related health problems.
You should continue to take Atherosada even if it has lowered your cholesterol to the required level because it protects against a new rise in cholesterol and accumulation of fatty deposits. However, you should stop taking Atrostat if your doctor tells you or if you become pregnant.
Atherosstad is used in adults, adolescents and children at or above 10 years of age to treat high cholesterol.
2. What you need to know before taking Atrostat
Do not take Atherosada:
- 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 Atherosada, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Atherosada using appropriate contraception;
- If you have liver disease;
- If you have severe kidney problems;
- If you have recurrent or unexplained muscle pain;
- If you are taking a medicine called ciclosporin (used for example after organ transplantation).
Warnings and precautions
Talk to your doctor or pharmacist before taking Atrostat:
- If you have kidney problems;
- If you have liver problems;
- If you have recurrent or unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol lowering drugs. Tell your doctor immediately if you have unexplained muscle aches, especially if you do not feel well or have fever. Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional studies and medications may be needed to diagnose and cure it;
- If you regularly drink large amounts of alcohol;
- If your thyroid gland does not work properly;
- If you are taking other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even when you have taken these medicines some time ago;
- If you are taking medicines used to treat HIV infection, ritonavir with lopinavir and / or atazanavir, please see "Other medicines and Atherosada";
- If you are over 70 years of age (because your doctor should choose the appropriate starting dose from Atherosada);
- If you have severe respiratory failure;
- If you are of Asian origin - ie. Japanese, Chinese, Filipinos, Vietnamese, Koreans and Indians. Your doctor should choose the appropriate starting dose of Atherosada;
- If you are taking antibiotics containing Fusidic acid, please see the section "Other medicines and Atherosdad".
Children and adolescents
If the patient is under 10 years of age: Atrostat should not be given to children under 10 years of age.
If the patient is under the age of 18: The Atrostat 40 mg tablet is not suitable for use in children and adolescents under the age of 18 years.
If any of the above applies to you (or you are in doubt), please contact your doctor again.
In a small number of people, statins may affect the function of black etc.
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 may be. They are usually mild and subsided for a short time.
Stop taking Atrostat and seek medical attention immediately if you have 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, which can cause difficulty in swallowing.
• Severe skin itching (with rash).
Also stop taking Atrostat and talk to your doctor immediately if you have unusual muscle pains that last longer than you would expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have had unpleasant effects on the muscles and have rarely continued to become potentially life-threatening muscle damage known as rhabdomyolysis.
Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):
• Muscle pain;
• Feeling of weakness;
• Increase in the amount of protein in the urine - usually returning to normal by yourself without having to stop taking your Atherosada tablets;
• Diabetes. It is more likely if you have high levels of sugars and fats in your blood if you are overweight and if you have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Uncommon possible side effects (these 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 - it usually returns to normal by itself, without the need to stop taking your Atherostat tablets (only Atherostat 5 mg, 10 mg and 20 mg only).
Rare possible side effects (these may affect between 1 in 1000 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 rash). If you think you have an allergic reaction, stop taking Atrostat and seek immediate medical attention;
• Muscular impairment in adults - as a precautionary measure, stop taking Atrostat and talk to your doctor immediately if you have any unusual pain in your muscles that lasts longer than expected;
• Severe stomach pain (inflammation of the pancreas);
• Increased hepatic enzymes in the blood;
• Decrease the number of platelets, which increases the risk of bleeding or bruising.
Very rare side effects (these 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 your urine;
• Damaging the nerves of your legs and arms (such as tingling);
• Joint pain;
• Memory loss;
• Breast enlargement in males (gynecomastia).
Side effects with an unknown frequency may include:
• Diarrhea (rare stools);
• Stevens-Johnson syndrome (serious condition with rash of the skin, mouth, eyes, genitals);
• Lack of air;
• Sleep disorders, including insomnia and nightmares;
• Sexual difficulties;
• Breathing problems, including prolonged cough and / or shortness of breath or fever;
• tendon trauma;
• Muscle weakness that is constant.
If any of these side effects become problematic or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Atherosada
Keep out of the reach and sight of children
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in the original package for protection against light.
Do not dispose of medicines in the sewage system 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 Astrostostat contains
The active substance is rosuvastatin, such as rosuvastatin calcium.
What Atherosada looks like and what the package contains
Atestrode 5 mg are white, round, biconvex, film-coated tablets of 5 mm diameter.
Atherosada 10 mg are white, round, biconvex, film-coated tablets of 7 mm diameter.
Atestrode 20 mg are white, round, biconvex, film-coated tablets with a diameter of 9 mm.
The tablets are provided in blister packs of combined oPA-Alu-PVC foil sealed with aluminum foil.
Atherostat 5 mg film-coated tablets:
Available pack sizes of 7, 14, 15, 20, 28, 30, 50, 60, 84, 90, 98, 100, 154, 196, 252 tablets.
Aterostat 10 mg film-coated tablets:
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