TINTAROS. 20 mg. 28 tablets

TINTAROS. 20 mg. 28 tablets
€ 25.00
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Tintaros is used to adjust the levels of blood fats, called lipids, the most common of these is cholesterol.
There are different types of cholesterol found in the blood - "bad" cholesterol (LDL-C) and 'good' cholesterol (HDL-C).

TINTAROS. 20 mg. 28 tablets

 
 
What Tintaros and what it is used
Tintaros belongs to a group of medicines called statins.
You have been prescribed Tintaros as:
have high levels of cholesterol. This means that you are at risk of heart attack or stroke. We recommend you to take statins because changing your diet and increased physical activity were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and physical activity while taking Tintaros
or
there are other factors that increase the risk of heart attack, stroke or other related health problems. 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 keep taking Tintaros
Tintaros is used to adjust the levels of blood fats, called lipids, the most common of these is cholesterol.
There are different types of cholesterol found in the blood - "bad" cholesterol (LDL-C) and 'good' cholesterol (HDL-C).
Tintaros can lower "bad" cholesterol and raise "good" cholesterol;
It works by helping to block the formation of "bad" cholesterol. Also improves your body's ability to remove from the blood.
Most people do not feel that their cholesterol is elevated, as it does not cause any symptoms. However, if it remains untreated, accumulate fat can accumulate on the walls of your blood vessels and lead to narrowing them.
Sometimes, these narrowed blood vessels can become blocked, which can interrupt blood flow to the heart or brain and cause a heart attack or stroke. By adjusting the levels of cholesterol, you can lower your risk of heart attack or stroke.
You should continue to take Tintaros even if it is reduced to your cholesterol level necessary because it prevents escalation of cholesterol and accumulation of fatty deposits. However, you should stop taking Tintaros if your doctor tells you to do this or if you become pregnant.

2. What you should know before taking Tintaros
Do not take Tintaros:
If you are allergic to rosuvastatin or to any of the ingredients of this medicine (listed in Section 6);
If you are pregnant or breastfeeding. If you become pregnant while taking Tintaros immediately stop taking it and contact your doctor. Women should avoid becoming pregnant while taking Tintaros using adequate contraception;
If you have liver disease;
If you have severe kidney problems;
If you have repeated or unexplained muscle pain;
If you are taking a drug called cyclosporine (used for example after organ transplantation).
If any of these things apply to you (or if in doubt), please go back to your doctor.

Moreover, do not take Tintaros tablets 40 mg (the highest dose):
If you have moderate to severe kidney problems (if in doubt, ask your doctor);
If your thyroid gland is not functioning properly;
If you had any 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 Asian (Japanese, Chinese, Filipinos, Vietnamese, Koreans and Indians);
If you are taking medicines called fibrates to lower your cholesterol.
If any of these things apply to you (or suspect), please go back to your doctor.

Warnings and Precautions
Consult your doctor or pharmacist before taking Tintaros:
If you have kidney problems;
If you have liver problems;
If you have 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. Tell 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 your cholesterol. Please read this leaflet carefully, even if you are taking these medicines before time;
If you are taking drugs used to combat HIV infection, for example. lopinavir / ritonavir, please refer to "Other medicines and Tintaros"
If the patient is under 10 years of age: Tintaros tablets should not be given to children under the age of 10;
If the patient is under 18 years of age: 40 mg tablet Tintaros not suitable for use in children and adolescents under the age of 18 years;
If you are over 70 years (since your doctor should choose the right starting dose Tintaros);
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 right starting dose Tintaros.
If any of these things apply to you (or not sure):
Do not take Tintaros tablets 40 mg (the highest dose), and consult your doctor or pharmacist before taking any dose of Tintaros.
In a small number of people, statins may affect liver function. This is established via an easy test for the presence of elevated levels of liver enzymes in the blood. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Tintaros.
While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You might be at risk of developing diabetes if you have high levels of sugars and fats in the blood, you are overweight and high blood pressure.

Other medicines and Tintaros
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.

Tell your doctor if you are taking any of the following:
cyclosporine (used for example, after organ transplantation);
warfarin (or any other medicine used to thin the blood);
fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
Medicines for indigestion (used to neutralize stomach acids);
erythromycin (antibiotic);
oral contraceptive pill;
hormone replacement therapy;
lopinavir / ritonavir (used to combat HIV infection - please see "Warnings and Precautions").
Tintaros may alter the effect of these drugs or they may alter the effect of Tintaros.

Tintaros with food and drink
You can take Tintaros with or without food.

Pregnancy and lactation
Tintaros not take if you are pregnant or breastfeeding. If you become pregnant while taking Tintaros immediately stop taking it and contact your doctor. Women should avoid becoming pregnant while taking Tintaros using appropriate birth control.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Most people can drive a car or operate machinery while using Tintaros - it will not affect their ability. However, some people feel dizzy during treatment with Tintaros. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Tintaros contains lactose
If your doctor has told you that you have an intolerance to some sugars (lactose or milk sugar), contact your doctor before taking Tintaros.
For a full list of ingredients please see "Package Contents and additional information" below.

3. How to take Tintaros
Always take this medicine exactly as your doctor tells you. If you are not sure ask your doctor or pharmacist.

Recommended dosage for adults
If you take Tintaros due to high cholesterol
starting dose
Your treatment with Tintaros should start with a dose of 5 mg or 10 mg, even if you take a higher dose of another statin. Your initial choice of dose will depend on:
Your cholesterol;
The level of your risk of getting a heart attack or stroke;
Is there a factor that can make you more sensitive to possible side effects.
Please discuss with your doctor or pharmacist what starting dose of Tintaros would be best for you.

Your doctor may decide to give you the lowest dose (5 mg), if:
You are Asian (Japanese, Chinese, Filipinos, Vietnamese, Koreans and Indians);
You are over the age of 70 years;
You have moderate kidney problems;
You are at risk of muscle pain (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is done so that you can accept Tintaros amount that is appropriate for you. If you started with a dose of 5 mg, your doctor may decide to double to 10 mg, then 20 mg and then to 40 mg, if necessary. If you started with 10 mg, your doctor may decide to double to 20 mg, then 40 mg, if necessary. There will be a distance of four weeks between dose received to date and the new adjusted dose.
The maximum daily dose of Tintaros is 40 mg. It is only for patients with high levels of cholesterol and increased risk of heart attack or stroke, whose cholesterol levels are not lowered sufficiently with 20 mg.

If you take Tintaros to reduce the risk of heart attack, stroke or other related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to prescribe a lower dose if you have any of the above factors.

Usual doses in children aged 10-17 years
The usual starting dose is 5 mg. Your doctor may increase your dose to find the right amount Tintaros for you. The maximum daily dose Tintaros is 20 mg. Take your dose once a day. Tintaros 40 mg should not be used in children.

How to take your tablets
Swallow each tablet whole with liquid or water.

Take Tintaros daily. You can take it anytime of the day. Try to take your tablet at the same time every day, so you can remember it.

Regular cholesterol checks
It is important to sit again with your doctor for regular cholesterol checks to make sure that your cholesterol is reached and held at the proper level.
Your doctor may decide to increase your dose so that you take the amount Tintaros that is appropriate for you.

If you take more than the amount Tintaros
Contact your doctor or nearest hospital for advice.
If you go into hospital for treatment of another condition, tell the medical staff that you are taking Tintaros.

If you forget to take Tintaros
Do not worry, just take your next dose at the right time. Do not take a double dose to make up for a missed dose.

If you stop taking Tintaros
Talk to your doctor if you should stop taking Tintaros. Your cholesterol levels may increase again if you stop taking Tintaros.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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 within a short time.

Stop taking Tintaros and seek medical attention immediately if you experience 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;
Severe itching of the skin (a rash).
Also, stop taking Tintaros and talk to your doctor immediately if you experience unusual muscle pain that 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 have had bad effects on muscles and they rarely have continued to become potentially life-threatening muscle damage known as rhabdomyolysis.

Common possible side effects (may affect up to 1 in 10 patients):
headache;
Stomach pain;
constipation;
nausea;
Muscle pain;
Sense of weakness;
dizziness;
Increase the amount of protein in the urine - usually back to normal by itself without the need to stop taking your tablets Tintaros (only Tintaros 40 mg);
Diabetes. You might be at risk of developing diabetes if you have high levels of sugars and fats in the blood, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Uncommon possible side effects (may affect up to 1 in 100 patients):
Rash, itching or other skin reactions;
Increase the amount of protein in the urine - usually back to normal by itself without the need to stop taking your tablets Tintaros (only Tintaros 5 mg, 10 mg and 20 mg).
Rare possible side effects (may affect up to 1 in 1000 patients):
Severe allergic reaction - signs include swelling of the face, lips, tongue and / or throat, difficulty swallowing and breathing, severe itching of the skin (a rash). If you think you have an allergic reaction, stop taking Tintaros and seek immediate medical attention;
Muscle damage - as a precaution stop taking Tintaros and talk to your doctor if you have any unusual muscle pain that last longer than expected;
Severe stomach pain (inflammation of the pancreas)
Elevation of liver enzymes in the blood;
Reducing the number of platelets in the blood.
Very rare possible side effects (may affect up to 1 in 10,000 patients):
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 (such as numbness);
Joint pain;
Loss of memory;
Gynecomastia (breast enlargement in men and women).
Side effects not known (frequency can not be estimated from available data) may include:
Diarrhea (loose stools);
Stevens-Johnson syndrome (a serious condition with a rash on the skin, mouth, eyes and genitals);
cough;
Shortness of breath;
edema;
Sleep disorders, including insomnia and nightmares;
Sexual difficulties;
depression;
Breathing problems including persistent cough and / or shortness of breath;
Tendon injury.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet.

5. How to store Tintaros
Keep out of reach of children.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the blister / carton after "EXP". Date of 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 medications that are no longer needed you. These measures will help to protect the environment.
Do not use this medicine if you notice any visible signs of deterioration.

6. Contents of the pack and other information
What does Tintaros
The active substance in Tintaros is rosuvastatin. Tintaros tablets containing rosuvastatin calcium, the equivalent of 5 mg, 10 mg, 20 mg and 40 mg of a rosuvastatin.

The other ingredients are:
Core:
cellulose, microcrystalline type 102;
lactose monohydrate;
crospovidone type A;
magnesium stearate.
Coating Opadry II Yellow 31K38097 containing:
lactose monohydrate;
(E464);
titanium dioxide (E 171);
triacetin (E1518);
quinoline yellow aluminum lake (E104).
Tintaros looks like and contents of container
Tintaros is available in blister packs containing 7, 14, 28, 30, 56 and 98 tablets.
Not all pack sizes may be marketed.
 
 
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