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ZARATOR 10 mg coated tablets.
Atorvastatin calcium (trihydrate).
The active ingredient is atorvastatin. Each tablet contains 10 mg of atorvastatin (like calcium trihydrate).
The other ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate and candelilla wax. The coating: opadry white YS-1-7040 (hypromellose, polyethylene glycol, titanium dioxide (E171) and talc) and simethicone emulsion (USP) (simethicone, stearate emulsifiers and sorbic acid).
WHAT IS ZARATOR
ZARATOR - Lipitor belongs to a group of medicines which reduces the levels of cholesterol (lipid-lowering agents / antiatheromatosis).
It is used to lower fats like cholesterol and triglycerides in your blood when a low fat diet and other nonpharmacological measures have been inadequate in patients with:
- hypercholesterolaemia (high cholesterol levels)
- combined hyperlipidaemia (high cholesterol and triglyceride levels)
- heterozygous familial hypercholesterolaemia (genetically determined cholesterol levels)
- homozygous familial hypercholesterolaemia (genetically determined cholesterol levels)
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BEFORE TAKING ZARATOR
Do not take ZARATOR - Lipitor if,
- you are allergic to atorvastatine or any of the ingredients of ZARATOR - Lipitor.
- you have active liver disease or elevations of serum transaminases.
- you have generalized muscular pains (myopathy).
- you are pregnant.
- you are breastfeeding.
- you are a woman of child-bearing potential not using adequate contraceptive measures.
Take special care with ZARATOR - Lipitor
Before you take ZARATOR - Lipitor inform your doctor if:
- you have or have had a disease which affects the liver.
- You experience generalized muscular aches while you take this medication.
Your doctor will inform you when you need to carry out a blood test.
Taking ZARATOR - Lipitor with food and drink:
Avoid drinking alcohol in excess. It may be taken with or without food.
Pregnancy: You should not take ZARATOR - Lipitor during pregnancy unless recommended by your doctor. Women of child-bearing potential should use appropriate contraceptive measures. Contact your doctor immendiately if you fall pregnant whilst on treatment.
Lactation: Do not take ZARATOR - Lipitor if you are breastfeeding.
Geriatric use: The efficacy and safety of ZARATOR - Lipitor in patients over 70, using the recommended dose, is similar to those seen in the general population.
Pediatric use: The therapeutic experience of ZARATOR - Lipitor in children is very limited.
Driving and using machines: There is no evidence suggesting that patients taking ZARATOR - Lipitor will have any impairment of the ability to drive and use machinery.
Taking other medications: Inform your doctor or pharmacist if you are taking or have recently been taking any other medication - either prescription or over-the counter medication.
There are some medicines that may interact with ZARATOR - Lipitor when taken at the same time, increasing the risk of rhabdomyolysis (illness which manifests muscular pain or muscular weakness, sometimes accompanied by fever and discomfort), these are:
- Cyclosporin (medicines used to modulate immune response)
- Fibric acid derivatives (medicines used to reduce cholesterol levels)
- Nicotinic acid derivatives (medicines used to reduce cholesterol levels)
- Macrolide antibiotics (antibiotics used to treat infections)
- Azole antifungal medicines (medicines used to treat fungal infections)
ZARATOR - Lipitor may interact when combined with the following drugs, resulting in the change of plasma concentrations of either drug:
- Antibiotics (like Erythromycin and Clarithromycin)
- Antacid (medication used to reduce the level of acid in the stomach)
- Digoxin (medication to treat heart problems)
- Colestipol (another agent which reduces cholesterol levels)
- Warfarin (medication which reduces the coagulation of the blood)
- Phenazone (medication used to treat pain and fever)
- Cimetidine (medication for stomach or duodenal ulcers)
- Oral contraception
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HOW TO TAKE ZARATOR
Follow the instructions recommended by your doctor. Consult your doctor or pharmacist if you have any questions.
Remember to take your medication.
You doctor will inform you of the duration of the treatment. Do not cease the treatment before time even if you notice an improvement.
The dosage must be established by the doctor depending on each individual's needs. Your doctor should recommend a standard cholesterol-lowering diet before receiving ZARATOR - Lipitor and you should continue on this diet during treatment.
The usual starting dose is 10 mg once a day. Your doctor may increase this if necessary, until you are taking exactly the amount you need. Your doctor can prescribe doses of up to 80 mg per day for you.
ZARATOR tablets should be swallowed, and can be taken once at any time of day, with or without food.
If you take more ZARATOR - Lipitor than you should, inform your doctor or pharmacist immediately.
If overdose or accidental ingestion is suspected contact your local poison control centre
If you miss a dose of ZARATOR - Lipitor
Do not "double-up" the dose to catch up.
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POSSIBLE SIDE EFFECTS
Like all medications, ZARATOR - Lipitor may have side effects.
ZARATOR is generally well-tolerated. Adverse reactions are usually mild and transient. The most frequent adverse effects (1% or more) associated with atorvastatin therapy are: constipation, flatulence, indigestion (dyspepsia), abdominal pain, headache (cephalalgia), nausea, muscle pain (myalgia), weakness (asthenia), diarrhoea and insomnia.
Like in other medicines from this therapeutic group, increases in hepatic enzymes (transaminases) have been seen in some patients taking ZARATOR. These changes were generally mild and transient and discontinuation of treatment was not necessary. Elevations in creatine phosphokinase (CPK) levels occurred in some patients on ZARATOR.
Other less common side effects have been seen in some patients taking ZARATOR - Lipitor, these include: muscle inflammation (myositis), muscle cramps, weakness or tenderness (myopathy, rhabdomyolysis), numbness or tingling in the fingers and toes (paraesthesia), non-inflammatory illnesses related to the nervous system (peripheral neuropathy), inflammation of the pancreas (pancreatitis), liver inflammation (hepatitis), jaundice, anorexia, vomiting, hair loss (alopecia), pruritus, rash, impotence, increase or decrease in blood sugar levels (hyperglycaemia or hypoglycaemia), low blood platelet count (thrombocytopaenia), allergic reactions, (inluding angioneurotic oedema), joint pain (arthralgia) and blistering skin rash.
You should tell your doctor immediately if any of these side effects persist or become bothersome.
Consult your doctor or pharmacist if you experience other symptoms not mentioned in this leaflet.
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STORAGE OF ZARATOR
Keep ZARATOR - Lipitor out of the reach and sight of children.
No special conditions are required for its storage.
Do not use this medication after the expiry date on the package.
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