Atorvastatin Teva

Atorvastatin.

Each tablet contains 10 mg, 20 mg, 40 mg, or 80 mg of atorvastatin as atorvastatin calcium trihydrate.
Excipients/Inactive Ingredients: The other ingredients in the tablet core are microcrystalline cellulose, sodium carbonate anhydrous, maltose, croscarmellose sodium and magnesium stearate.
The other ingredients in the film-coating are hypromellose, hydroxypropyl cellulose, triethyl citrate, polysorbate 80 and titanium dioxide (E171).

Atorvastatin Teva Tablets belong to a group of medicines known as statins, which are lipid (fat) regulating medicines.

Atorvastatin Teva Tablets are used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and lifestyle changes on their own have failed. If patient is at an increased risk of heart disease, Atorvastatin Teva Tablets can also be used to reduce such risk even if his/her cholesterol levels are normal. Patient should maintain a standard cholesterol lowering diet during treatment.

Before starting treatment, the doctor will place patient on a low-cholesterol diet, which he/she should maintain also during therapy with Atorvastatin Teva Tablets.
The recommended starting dose of Atorvastatin Teva Tablets is 10 mg once a day in adults. This may be increased if necessary until patient is taking the amount he/she needs. Adapt the dosage at intervals of 4 weeks or more. The maximum dose of Atorvastatin Teva Tablets is 80 mg once daily for adults.
Use in children and adolescents: The recommended starting dose is 10 mg once a day in children aged 10 years or older. The dose may be increased to a maximum dose of 20 mg once daily.
The use of Atorvastatin Teva Tablets is not recommended in children below 10 years of age.
Atorvastatin Teva Tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.
The duration of treatment with Atorvastatin Teva Tablets is determined by the doctor.
Ask the doctor if patient thinks that the effect of Atorvastatin Teva Tablets are too strong or too weak.
If patient forgets to take Atorvastatin Teva Tablets: If patient forgets to take a dose, just take the next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If patient stops taking Atorvastatin Teva Tablets: If patient has any further questions on the use of this medicine or wish to stop the treatment ask the doctor or pharmacist.

If patient accidentally takes too many Atorvastatin Teva Tablets (more than the usual dose), contact the doctor or nearest hospital for advice.

Do not take Atorvastatin Teva Tablets: If patient is allergic to atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of this medicine (listed in Description); If patient has or ever had a disease that affects the liver; If patient had any unexplained abnormal blood tests for liver function; If patient is a woman able to have children and not using reliable contraception; If patient is pregnant or trying to become pregnant; If patient is breast-feeding.

Talk to the doctor or pharmacist before taking Atorvastatin Teva Tablets: If patient is taking or has taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Atorvastatin Teva Tablets can lead to serious muscle problems (rhabdomyolysis).
If patient had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes.
If patient has kidney problems.
If patient has an under-active thyroid gland (hypothyroidism).
If patient had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems.
If patient had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other '-statin' or '-fibrate' medicines).
If patient regularly drinks a large amount of alcohol.
If patient has a history of liver disease.
If patient is older than 70 years.
While patient is on this medicine a doctor will monitor him/her closely if he/she has diabetes or are at risk of developing diabetes. Patient is likely to be at risk of developing diabetes if he/she has high levels of sugars and fats in the blood, is overweight and has high blood pressure.
Talk to the doctor or pharmacist before taking Atorvastatin Teva Tablets: If patient has severe respiratory failure.
If any of these apply to the patient, blood test will need to be carried out before and possibly during the patient's Atorvastatin Teva Tablets treatment to predict the risk of muscle-related side effects. The risk of muscle-related side effects e.g rhabdomyolysis is known to increase if certain medicines are taken at the same time as atorvastatin (see Interactions).
Also tell the doctor or pharmacist if patient has a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
It is recommended that liver function tests should be performed before the initiation of Atorvastatin Teva Tablets and thereafter when clinically indicated.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.
Co-administration of strong CYP3A4 inhibitors (e.g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) should be avoided if possible. In cases where coadministration of these medicinal products with atorvastatin cannot be avoided, lower starting and maximum doses of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended. In patients taking telaprevir, concomitant use of atorvastatin should be avoided. The dose of atorvastatin should not exceed 40 mg daily when taking with boceprevir and close clinical monitoring is recommended.
Driving and using machines: Normally this medicine does not affect patient's ability to drive or operate machines. However, do not drive if this medicine affects the ability to drive. Do not use any tools or machines if ability to use them is affected by this medicine.

If patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Do not take Atorvastatin Teva Tablets if patient is pregnant, or if she is trying to become pregnant. Do not take Atorvastatin Teva Tablets if patient is able to become pregnant unless she uses reliable contraceptive measures.
Do not take Atorvastatin Teva Tablets if patient is breast-feeding.
The safety of Atorvastatin Teva Tablets during pregnancy and breast-feeding has not yet been proven. Ask the doctor or pharmacist for advice before taking any medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If patent experiences any of the following serious side effects, stop taking the tablets and tell the doctor immediately or go to the nearest hospital accident and emergency department.
Rare: May affect up to 1 in 1,000 people: Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.
Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
Muscle weakness, tenderness or pain (rhabdomyolysis) and particularly, if at the same time, patient feels unwell or has a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems.
Very rare: May affect up to 1 in 10,000 people: If patient experiences problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. He/she should consult the doctor as soon as possible.
Other possible side effects with Atorvastatin Teva Tablets: Common: May affect up to 1 in 10 people: Inflammation of the nasal passages, pain in the throat, nose bleed; allergic reactions; increases in blood sugar levels (if patient has diabetes continue careful monitoring of blood sugar levels), increase in blood creatine kinase; headache; nausea, constipation, wind, indigestion, diarrhoea; joint pain, muscle pain and back pain; blood test results that show the liver function can become abnormal.
Uncommon: May affect up to 1 in 100 people: Anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if patient has diabetes he/she should continue careful monitoring of blood sugar levels); having nightmares, insomnia; dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory; blurred vision; ringing in the ears and/or head; vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain); hepatitis (liver inflammation); rash, skin rash and itching, hives, hair loss; neck pain, muscle fatigue; fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature; urine tests that are positive for white blood cells.
Rare: May affect up to 1 in 1,000 people: Visual disturbance; unexpected bleeding or bruising; cholestasis (yellowing of the skin and whites of the eyes); tendon injury.
Very rare: May affect up to 1 in 10,000 people: An allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse; hearing loss; gynecomastia (breast enlargement in men and women).
Not known (frequency cannot be estimated from the available data) include: Muscle weakness that is constant.
Possible side effects reported with some statins (medicines of the same type): Sexual difficulties; depression; breathing problems including persistent cough and/or shortness of breath or fever; diabetes (This is more likely if patient has high levels of sugars and fats in the blood, is overweight and has high blood pressure. The doctor will monitor the patient while he/she is taking this medicine).
Reporting of side effects: If patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed. By reporting side effects patient can help provide more information on the safety of this medicine.

Other medicines and Atorvastatin Teva Tablets: Tell the doctor or pharmacist if patient is taking, has recently taken or might take any other medicines.
There are some medicines that may change the effect of Atorvastatin Teva Tablets, or their effect may be changed by Atorvastatin Teva Tablets. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side effects, including the important muscle-wasting condition known as rhabdomyolysis described in Side Effects: If patient needs to take oral fusidic acid to treat a bacterial infection he/she will need to temporarily stop using this medicine. The doctor will tell the patient when it is safe to restart Atorvastatin Teva Tablets. Taking Atorvastatin Teva Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in Side Effects.
Medicines used to alter the way the immune system works, e.g. ciclosporin.
Other antibiotics (medicines for bacterial infections) or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.
Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate the heart rhythm e.g. digoxin, verapamil, amiodarone.
Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller) and antacids (indigestion products containing aluminium or magnesium).
Medicines obtained without a prescription: St John's wort.
Atorvastatin Teva Tablets with food, drink and alcohol: See Dosage & Administration for instructions on how to take Atorvastatin Teva Tablets. Note the following: Grapefruit juice: Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin Teva Tablets.
Alcohol: Avoid drinking too much alcohol while taking this medicine. See Precautions for details.

Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask a pharmacist how to throw away medicines the patient no longer use. These measures will help protect the environment.

Dyslipidaemic Agents

C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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