ROMAZIC. 5 mg. 30 tablets
ROMAZIC. 5 mg. 30 tablets
What Romazic and what it is used
Romazic belongs to a group of medicines called statins.
Romazic is prescribed to you because:
You have high cholesterol levels. This means that you are at (a) the risk for heart attack or stroke. We recommend you to take your articles, because the change in your diet and strengthen your physical activity is not enough to correct your cholesterol levels. You should continue your diet to lower cholesterol and exercise while taking Romazic;
You have other risk factors that increase your risk for heart attack, stroke or other consequential health problems.
Heart attack, stroke and other problems can be caused by a condition called atherosclerosis.
Atherosclerosis is due to the accumulation of fat in your arteries.
Why is it important to keep taking Romazic?
Romazic is used for adjusting the levels of the fatty substances in the blood, called lipids, such as a large amount of cholesterol is one of them.
In blood are different types of cholesterol - "bad" cholesterol (LDL-C) and 'good' cholesterol (HDL-C).
Romazic lowers "bad" cholesterol and increase "good" cholesterol.
It works by helping to block the production of "bad" cholesterol from your body.
It also improves the ability of your body to remove the "bad" cholesterol from the blood.
In most people, high cholesterol levels do not change the way they feel because it does not cause any symptoms. However, if no treatment is applied on the walls of your blood vessels may accumulate fatty deposits that cause them embarrassment.
Sometimes, these narrowed blood vessels can become blocked, leading to the suspension of the supply of blood to the heart or brain, causing heart attack or stroke.
By reducing your cholesterol levels, you can reduce your risk for heart attack, stroke or other related health problems.
You should continue taking Romazic even if you reach the recommended levels for your cholesterol because it will prevent high cholesterol levels and buildup of fatty deposits.
However, you should stop taking if your doctor recommends that you do or if you become pregnant.
2. Before you take Romazic
You should not take Romazic:
if you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of Romazic;
if you are pregnant or breastfeeding. If you become pregnant while taking Romazic, stop taking the medicine and tell your doctor. Women should avoid becoming pregnant while taking Romazic, use adequate contraception;
if you have liver disease;
if you have severe renal impairment;
If you have repeated and unexplained muscle pain or painful sensations;
if you are taking a drug called cyclosporine (used, eg organ transplantation).
If any of the above conditions apply to you, please consult your doctor.
In addition, do not take Romazic 40 mg (the highest dose):
If you have moderate kidney damage (if in doubt, ask your doctor);
If your thyroid gland is not functioning properly;
If you have repeated or unexplained muscle pain, or painful sensations; have had in the past or someone in your family has had muscle problems, or if you have had muscle problems when taking another medicine to lower cholesterol;
If you regularly consume large amounts of alcohol;
If you are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
If you are taking medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or if you have doubts), please consult your doctor.
Warnings and Precautions
Take special care with Romazic:
If you have kidney problems;
If you have liver problems;
If you have repeated or unexplained muscle pain, or painful sensations; have had in the past or any of your family problems in the muscles or if you had a disease of the muscles when you take other medicines to lower cholesterol. Tell your doctor immediately if you experience unexplained muscle pain or painful sensations, especially if you feel unwell or have a fever;
If you regularly consume large amounts of alcohol;
If your thyroid gland is not functioning properly;
If you are taking medicines called fibrates to lower your cholesterol. Please read this leaflet carefully even if you are taking other medicines for high cholesterol;
If you are taking medicines for HIV infection, such as lopinavir / ritonavir, please refer to the section "Other medicines and Romazic"
If the patient is under 18 years of age Romazic tablets are not suitable for use in children and adolescents under 18 years of age;
If you are aged over 70 years (as your doctor has to choose the appropriate starting dose of Romazic for you);
If you are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor should choose the right starting dose Romazic.
If any of the above applies to you (or if you are not sure), do not take Romazic 40 mg (the highest dose of the drug), and consult your doctor or pharmacist before you start actually taking any dose Romazic.
In a small number of people, statins can cause liver damage. This is established by a simple study which sets elevated levels of liver enzymes in the blood. Therefore doctor will make this blood test (liver function test) generally before the start of treatment and during the treatment with Romazic.
During your treatment with this medicine, your doctor will regularly monitor if you do not have diabetes or are at risk for developing diabetes. You're probably at risk of developing diabetes if you have high levels of sugar and fat in the blood, you are overweight and high blood pressure.
Other medicines and Romazic
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially if you take:
Cyclosporine (used, for example, after organ transplantation);
Warfarin (or any other drug for "thinning" the blood);
Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
Medicines for indigestion (eg drugs to neutralize the stomach acid);
Oral contraceptives (birth control pills);
HRT therapy or lopinavir / ritonavir (used to treat HIV infection - Please see "Warnings and Precautions").
Romazic may alter the effect of these drugs or they may alter the effect of Romazic.
Romazic with food and drink
You can take Romazic with or without food.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Romazic not take if you are pregnant or breastfeeding. If you become pregnant while taking Romazic should immediately stop taking the medicine and tell your doctor.
Women should avoid becoming pregnant while taking Romazic using appropriate means of contraception.
Driving and using machines
Most people can not drive or operate machinery while taking Romazic - it will not affect their ability.
However, some people feel dizzy while taking Romazic. If you experience dizziness, consult your doctor before you drive or operate machinery.
Romazic contains lactose
If your doctor has told you that you have an intolerance to some sugars should be consulted before taking Romazic.
3. How to take Romazic
Always take this medicine exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist. The appropriate dose and treatment duration will be determined by your doctor.
Usual dose for adults
If you take Romazic for high cholesterol:
Your treatment with Romazic should start with a dose of 5 mg or 10 mg, even if you have previously received a higher dose of the other medicine to lower cholesterol (articles). The choice of the starting dose for you depends on:
Your cholesterol level;
The level of risk of getting a heart attack or stroke;
The presence of a factor that can make you more susceptible to possible side effects.
Please consult your doctor or pharmacist what starting dose of Romazic is best suited for you. Your doctor may decide to prescribe the lowest dose (5 mg), if:
You are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
You are over 70 years;
You have moderate kidney damage;
You are exposed to the risk of muscle pain and painful sensations (myopathy).
Increasing dose and maximum daily dose
Your doctor may decide to increase your dose to take the appropriate amount for you Romazic. If you started with a dose of 5 mg, your doctor may decide to double to 10 mg, then 20 mg, then 40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to double to 20 mg and then 40 mg, if necessary. Between each dose adjustment will be a pause of 4 weeks.
The maximum daily dose Romazic is 40 mg.
It is only for patients who have high cholesterol levels, and were exposed to a high risk of heart attack or stroke and their cholesterol is not lowered enough dose of 20 mg.
If you take Romazic to reduce the risk of heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. Your doctor may decide to use a lower dose if you have any of the factors outlined above.
Taking the tablets
Swallow the tablet whole with a glass of water;
Take Romazic once a day. You can take it anytime of the day;
Try to take the tablet at the same time of day to help you remember it.
Regular check of cholesterol
It is important to visit your doctor regularly for a cholesterol test to make sure that your cholesterol is reached and remained within normal limits.
Your doctor may decide to increase your dose to take Romazic amount that is appropriate for you.
If you take more dose Romazic
Seek advice your doctor or nearest hospital.
If you miss a dose of
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 Romazic
Consult your doctor if you should stop taking Romazic. Your cholesterol may rise again if you stop taking Romazic.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they occur, you may need medical attention.
Stop taking Romazic and seek immediate medical attention if you notice any of the following allergic reactions:
Difficulty breathing with or without swelling of the face, lips, tongue and / or throat;
Swelling of face, lips, tongue and / or throat that may cause difficulty in swallowing;
Intense itching of the skin (with the occurrence of the raised formations on the skin).
Also, stop taking Romazic immediately and contact your doctor if you have any unusual pain or painful sensations in the muscles, which last longer than expected. As with other drugs to lower cholesterol (statins), very few people have experienced discomfort in the muscles, as they are rarely continued and turned into potentially life-threatening muscle damage called rhabdomyolysis.
Common possible side effects (affects 1 to 10 users in 100):
Increased amount of protein in the urine - usually returns to normal without having to stop taking your tablets Romazic (only Romazic 40 mg);
Diabetes. This is more likely if you have high levels of sugar and fat in the blood, have obesity and high blood pressure. Your doctor will monitor you during treatment with this medicine.
Uncommon possible side effects (affects 1 to 10 users in 1000):
Rash, itching or other skin reactions;
Increased amount of protein in the urine - usually returns to normal without having to stop taking your tablets Romazic (only Romazic 5 mg, 10 mg and 20 mg).
Rare possible side effects (affects 1 to 10 users in 10,000):
Severe allergic reaction - signs include swelling of the face, lips, tongue and / or throat, difficulty breathing and swallowing, severe itching of the skin (with the appearance of raised growths on the skin). If you think you have an allergic reaction, you should stop taking Romazic and immediately seek medical care;
Muscle damage in adults - as a security measure, stop taking Romazic immediately and contact your doctor if you experience unusual muscle pain or painful sensations that last longer than expected;
Severe stomach pain (inflammation of the pancreas)
Elevations of liver enzymes in the blood;
Decrease the number of blood platelets, which may affect the blood clotting. If you notice bruising or red / purple spots on the skin, you should see your doctor.
Very rare possible side effects (affects less than 1 user in 10,000):
Jaundice (yellowing of the skin or eyes);
Hepatitis (inflammation of liver);
Traces of blood in your urine;
Nerve damage in the feet and your hands (they feel like stiff);
Loss of memory;
Gynecomastia (enlarged breasts in men).
Adverse reactions known (from the available data can not be estimated) may include:
Diarrhea (loose stools);
Stevens-Johnson syndrome (formation of large blisters on the skin, mouth, eyes and genitals);
shortness of breath;
Sleep disorders, including insomnia and nightmares;
Breathing problems including persistent cough and / or shortness of breath or fever;
Muscle weakness, which is permanent.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet.
5. How to store Romazic
Keep out of the reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What does Romazic
The active substance is rosuvastatin (such as rosuvastatin calcium).
Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg of a rosuvastatin.
Other ingredients are:
Tablet core: lactose monohydrate; cellulose, microcrystalline; sodium crospovidone; silica, colloidal anhydrous; magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E 171).
Romazic looks like and contents of pack
Romazic 5 mg: white or off-white, round, biconvex film-coated tablet, engraved with "5" on one side.
Romazic 10 mg: white or off-white, round, biconvex film-coated tablets engraved with "10" on one side.
Romazic 20 mg: white or off-white, round, biconvex film-coated tablets engraved with "20" on one side.
Romazic 40 mg: white or off-white, oval, biconvex film-coated tablets.
Package Contents: 30 tablets.