ZARANTA 5 mg. 30 tablets

What Zaranta is and what it is used for
Zaranta belongs to a group of medicines called statins.
You have been prescribed for you since:
• You have a high cholesterol level. This means you are at risk of a heart attack or stroke. It is used in adults, adolescents and children at or above 6 years of age to treat high cholesterol.
You are advised to take a statin as changing your diet and doing more exercise is not enough to adjust your cholesterol level. You should continue with your cholesterol-lowering diet and with physical activity while taking Porant.
Either
• There are other factors that increase the risk of heart attack, brain related problems.
Infarction, stroke and other problems can be caused by a disease called arteriosclerosis. Arteriosclerosis is due to accumulation of fat deposits in your arteries.
Why is it important to continue to take Zaranta?
Zerat is used to correct blood lipid levels called lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood - "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).
• Forage may lower "bad" cholesterol and raise "good" cholesterol.
• It works by helping to block the formation of "bad" cholesterol from your body. 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 lowering your cholesterol levels, you can reduce the risk of heart attack, stroke or other related health problems.
You must continue to take Zaranta, 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 Porant if your doctor tells you or if you become pregnant.
2. What you need to know before taking Zaranta
Do not take morning:
- 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 Porant, stop taking the medicine immediately and tell your doctor. Women should avoid becoming pregnant while taking Zaranta using appropriate contraception.
- if you have liver disease.
- if you have severe kidney problems.
- if you have multiple or unexplained muscle pains or painful sensations.
- if you are taking a medicine containing a substance called cyclosporin (used for example after an organ transplant).
If any of the above applies to you (or you suspect), please tell your doctor.
Do not take the 40 mg dose (the highest dose of Zarant) in the following cases:
- if you have moderate kidney problems (if in doubt, ask your doctor).
- if your thyroid gland is not functioning properly.
- if you have multiple or unexplained muscle pains or painful sensations that you have had in the past, or someone in your family has muscle problems or if you have had muscle problems in the past while taking another cholesterol lowering drug.
- if you regularly consume large amounts of alcohol.
- if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian).
- if you are taking other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or if you have any doubts), please contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZARANTA
Take special care with Zaranta
- if you have kidney problems.
- if you have had liver problems in the past.
- if you have multiple or unexplained muscle pains or painful sensations that you have had in the past, or someone in your family has muscle problems or if you have had muscle problems in the past while taking another cholesterol lowering drug. Tell your doctor immediately if you experience unexplained muscle aches or painful sensations and, especially if you feel unwell or feverish. Also, tell your doctor or pharmacist if you have a muscle weakness that is constant.
- if you regularly consume large amounts of alcohol.
- if your thyroid gland is not functioning properly.
- if you are taking other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other high cholesterol medicines before.
- If you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and / or atazanavir, please see section "Other medicines and Zorana" if you are taking antibiotics containing Fusidic acid, please see the section "Other medicines and Rheumatoid arthritis" .
- if you are over 70 years of age (because your doctor should choose the appropriate starting dose of Zaranta for you).
- if you have severe respiratory failure.
- if of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
Your doctor should choose the appropriate starting dose for you.
If any of the above applies to you (or if you are in any doubt), do not take Porant 40 mg (the highest dose) and consult your doctor or pharmacist before taking any dose of Zaranta.
In few people, statins can damage the liver. This is established by laboratory tests to determine levels of enzymes in the blood. Therefore, your doctor will do as usual these liver function tests before and during treatment with Zarant.
While you are taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You may develop diabetes if you have high levels of blood sugars and fats, overweight and high blood pressure.
Children and adolescents
- If the patient is under 6 years of age: Zaranta should not be given to children under 6 years of age.
- If the patient is under 18 years of age: The Zaranta 40 mg tablet is not suitable for use in children and adolescents under the age of 18 years.
Other medications and Zaranta
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines, as itching may change their effect or they may change the effect of the morning:
- Ciclosporin (used for example after organ transplantation, increased blood levels of rosuvastatin);
- Warfarin or clopidogrel (or any other medicine used to dilute blood) when taken together with rosuvastatin may increase the blood thinning effect);
- Fibrates such as gemfibrozil, fenofibrate (used to lower cholesterol, blood levels of rosuvastatin) or any other medicine used to lower cholesterol (such as ezetimibe);
- Treatment of indigestion (for example, gastric acid neutralizing drugs, decreases in blood levels of rosuvastatin);
- Erythromycin (antibiotic, decreases blood levels of rosuvastatin);
- Fusidic acid (antibiotic - please see "Warnings and precautions");
- Oral contraceptives (the "pill", the levels of hormones released from the pill are increased in the blood).
- Hormone replacement therapy (increases in blood levels of hormones).
- Ritonavir with lopinavir and / or atazanavir or tipranavir (antiviral medicines, medicines used to treat HIV infection, blood levels of rosuvastatin are increased).
The morning with food, drinks, and alcohol
You can take the morning with or without food.
Avoid regular consumption of large amounts of alcohol while taking Porant.
Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Zaranta if you are pregnant or breast-feeding. If you become pregnant while taking Zaranta, you should immediately stop taking the medicine and tell your doctor. Women should avoid becoming pregnant while taking Porant using the appropriate contraceptive.
Driving and using machines
Most people can drive and operate machines while using Zaranta - it will not affect their abilities. However, some people feel dizzy while taking Porant. If you feel dizzy, talk to your doctor before driving or using machines.
Porcelain contains lactose
If your doctor has told you that you have an intolerance to some sugars (lactose or milk sugar), you should consult your doctor before taking this medicinal product.
3. How to take Zaranta
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dosage for adults
If you are taking High Cholesterol Force:
Initial dose
Your treatment with Zaranta should start with a daily dose of 5 mg or 10 mg, even when you have previously taken a higher dose of another cholesterol lowering drug (statin). The choice of your initial dose depends on:
- The level of your cholesterol.
- Your risk of heart attack or stroke.
- Whether you have a factor that makes you more prone to possible side effects.
Please discuss with your doctor or pharmacist which initial dose of Zoranta will be most gifting to you.
Your doctor may decide to give you the lowest dose (5 mg) if:
- You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, Indian).
- You are over 70 years of age.
- have moderate kidney problems.
- you have a risk of muscle pain (myopathy).
Dose increase and maximum daily dose
Your doctor may decide to increase your dose in order to take the appropriate amount of Zarathon for you.
There will be a break of four weeks between each dose adjustment.
If you started at a dose of 5 mg daily, your doctor may decide to double it to 10 mg, then to 20 mg and, if necessary, then to 40 mg daily. If you started with a 10 mg dose, your doctor may decide to double it to 20 mg and then, if necessary, to 40 mg. The maximum daily dose of Zarant is 40 mg. It is only for patients who have high cholesterol levels, are at high risk of heart attack or stroke and their cholesterol is not low enough with the 20 mg dose.
If you take Zoran to reduce the risk of a heart attack, stroke or resulting 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 factors mentioned above.
Use in children and adolescents
Recommended doses in children between 6 and 17 years of age
The usual starting dose is 5 mg. Your doctor may decide to increase your dose of Zaranta.
The maximum daily dose of Porant is 10 mg for children from 6 to 9 years of age and 20 mg for children from 10 to 17 years of age.
Take your dose once a day.
Zarant 40 mg tablets should not be used in children below 18 years of age.
Taking the tablets
Swallow the tablet whole with water.
Take the morning once a day. You can take it at any time of the day, with or without food.
Try taking your tablet at the same time of day to make it easier to remember that you should take a tablet.
Regular monitoring of cholesterol levels
It is important to visit your doctor for regular cholesterol testing to make sure your cholesterol has reached and remains within the required limits.
Your doctor may decide to increase your dose in order to take the amount of Zaratha that is right for you.
If you take more than the prescribed dose of Zaranta
Contact your doctor or nearest hospital.
If you go to a hospital or receive treatment for another illness, tell the medical staff that you are taking Zaranta
If you forget to take the morning
Do not worry, just take the next dose on schedule at the right time. Do not take a double dose to make up for the missed dose.
If you stop taking Zaranta
Talk to your doctor if you want to stop taking Poranza. Your cholesterol level may rise again if you stop taking the morning.
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 everyone gets them. It is important to know what these reactions can be. They are usually light and disappear after a short period of time.
Immediately stop taking Zaranta and seek medical advice if any of the following allergic reactions occur:
- Difficulty breathing, with or without swelling of the face, lips, tongue and / or throat.
- Swelling of the face, lips, tongue and / or throat, which may cause difficulty in swallowing.
- Strong skin itching (with "lumps" on the skin).
Immediately stop taking Zaranta and contact your doctor if you have any unusual pain or painful sensations in your muscles that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, very few people experienced unpleasant sensations in the muscles, and they rarely continued and turned into potentially life-threatening muscle damage called rhabdomyolysis.
Common side effects (may affect up to 1 in 10 people):
- Headache;
- Stomach ache;
- Constipation;
- malaise;
- Muscle pain;
- Weakness;
- Dizziness;
- Increased amount of protein in the urine - usually disappears on its own without having to stop taking your tablets on the morning (for Zarant 40 mg only);
- Diabetes. This is possible if you have high levels of blood sugars and fats, overweight and high blood pressure. Your doctor will monitor you while taking this medicine.
Uncommon side effects (may affect up to 1 in 100 people):
- Rash, pruritus and urticaria (hives);
- Appearance of protein in the urine - usually disappears on its own without having to stop taking your tablets for the morning (only for Zarant 5 mg, 10 mg and 20 mg).
Rare side effects (may affect up to 1 in 1,000 people):
- Severe allergic reaction - Signs include swelling of the face, lips, tongue and / or throat, difficulty breathing and swallowing, severe itching of the skin (with rashes). If you think you have an allergic reaction, you should immediately stop taking Poranza and seek medical attention;
- Damage to the muscles in adults - as a precautionary measure, immediately stop taking Zaranta and contact your doctor if you experience unusual pain or painful sensations that last longer than expected;
- Strong upper abdominal pain (inflammation of the pancreas);
- Enhancement of blood enzymes, reflecting hepatic function;
- Decrease in platelet count, which increases the risk of bleeding or bruising.
Very rare side effects (may affect up to 1 in 10,000 people):
- yellowing of the skin and white eyes (jaundice);
- Inflammation of the liver (hepatitis);
- Traces of blood in your urine;
- Nerve damage (polyneuropathy);
- Pain in joints;
- Loss of memory;
- Gynaecomastia (breast enlargement in males).
Not known:
- Depression;
- Sleep disorders, including insomnia and nightmares;
- Cough;
- Diarrhea (rare stools);
- Stevens-Johnson syndrome (serious condition with rash on the skin, mouth, eyes and genital organs);
- Swelling (swelling)
- Sexual difficulties;
- Breathing problems, including prolonged cough and / or shortness of breath or fever;
- numbness, tingling, pain and / or burning sensation in the hands and / or feet (peripheral neuropathy);
- Tendon disorders, sometimes complicated by tearing;
- Muscle weakness that is constant;
Interstitial lung disease.
How to Store the Force
Keep out of the reach and sight of children.
Store in the original package in order to protect from light.
This medicinal product does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
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 Zaranta contains
- The active substance is rosuvastatin.
5 mg film-coated tablets: 5 mg rosuvastatin (as rosuvastatin calcium) in each tablet.
10 mg film-coated tablets: 10 mg rosuvastatin (as rosuvastatin calcium) in each tablet.
ZARTANTA 20 mg film-coated tablets: 20 mg rosuvastatin (as rosuvastatin calcium) in each tablet.
Premature 40 mg film-coated tablets: 40 mg rosuvastatin (as rosuvastatin calcium) in each tablet.
The excipients are:
Tablet core: magnesium stearate, microcrystalline cellulose (12), magnesium hydroxide, crospovudine (type A), lactose monohydrate
Tablet coating: titanium dioxide (E171), macrogol 3350, talc, polyvinyl alcohol.
What does Zaranta look like in what the package looks like?
Day 5 mg film-coated tablets:
White or almost white, round, biconvex film-coated tablet.
On one side there is a concave relief image "SPA".

 

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