Astellas "Lipitor" 5mg x 100 tablet (100mg x 100 tavlet)

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.

Brand name:Lipitor Tablets 10mg

Active ingredient:Atorvastatin calcium hydrate

Dosage form:white tablet (φ: 6.1mm, thickness: 2.7mm)

Print on wrapping:(Face) リピトール10mg, house-mark + 716, (Back) リピトール10mg, house-mark, company's name

Effects of this medicine

This medicine prevents production of cholesterol in the liver, and thus lowers the cholesterol levels in the blood.

It is usually used for the treatment of hypercholesterolaemia or familial hypercholesterolaemia.

Before using this medicine, be sure to tell your doctor and pharmacist

・If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.

If you have liver or renal disorder.

・If you are pregnant or breastfeeding.

・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

・Your dosing schedule prescribed by your doctor is<<           to be written by a healthcare professional>>

・General dosage regimen:

For hypercholesterolaemia: For adults, take 1 tablet (10mg of atorvastatin) at a time, once daily. The dosage may be adjusted according to the patient's age and symptoms. For severe patients, the dosage may be increased up to a maximum dose of 2 tablets (20 mg) per day.

For familial hypercholesterolaemia: For adults, take 1 tablet (10mg of atorvastatin) at a time, once daily. The dosage may be adjusted according to the patient's age and symptoms. For severe patients, the dosage may be increased up to a maximum dose of 4 tablets (40mg) per day.

In either case, strictly follow the instructions of your doctor/pharmacist.

・If you have missed a dose, take the missed dose as soon as possible before bedtime. DO NOT take double doses to make up for the missed dose.

・If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.

・Do not stop taking the medicine without the instructions of your doctor.

Precautions while taking this medicine

・Strictly follow the instructions on dietary/exercise therapy.

・Intake of grapefruit juice may enhance the effect of this medicine. Refrain from taking the medicine together with grapefruit juice.

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: stomach discomfort, itching, numbness of the fingers, loss of sleep, diarrhoea, heartburn, constipation, headache, general malaise, etc.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

・muscle pain, feeling of weakness, reddish brown urine [rhabdomyolysis, myopathy]

・queasiness/vomiting, general malaise, yellowing of the skin and the whites of the eyes [hepatitis fulminant, hepatitis, hepatic function disorder, jaundice]

・pharynx pain/headache/heaviness of the head, general malaise, bleeding of nose/gums or under the skin [agranulocytosis, pancytopenia, thrombocytopenia]

・fever, loss of appetite, red rash   [oculomucocutaneous syndrome, toxic epidermal necrosis, erythema multiforme]

・dry mouth, excessive drinking/urination, getting tired easily [hyperglycaemia, diabetes mellitus]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

・Keep out of the reach of infants and children. Store away from direct sunlight, heat and humidity.

・Discard the remainder. Do not store them.