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Please read this leaflet carefully before you start to take atorvastatin calcium tablets. It contains important information about your treatment. If you have any questions, or if you are not sure about anything, ask your doctor or pharmacist. Keep this leaflet, you may want to read it again.

The name of your medicine is atorvastatin calcium. It contains atorvastatin calcium trihydrate equivalent to 10, 20 mg of the active ingredient atorvastatin.

What is Atorvastatin Calcium for?

Atorvastatin Calcium belongs to a group of medicines known as lipid regulating medicines (of the type commonly known as statins). It is used to lower fats known as cholesterol and triglycerides in your blood when a low fat diet and other non-medicinal treatments such as exercise and life style changes have failed. Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, if there is too much cholesterol in your blood it can be deposited in the walls of blood vessels leading to the narrowing of these vessels which may eventually become blocked. This is one of the most common causes of heart disease. It is accepted that raised cholesterol levels increase the risk of heart disease. Other factors including high blood pressure, diabetes, increased weight, lack of exercise and smoking will add to the risk of heart disease.

Do you have kidney problems, underactive thyroid gland (hypothyroidism) any muscle disorders (affecting either yourself or other members of your family), previous muscular problems during treatment with other lipid-lowering medicines (e.g. other '-statin' or '-fibrate' medicines), or a history of heavy alcohol consumption. If the answer is 'yes' to any of these questions your doctor will need to carry out a blood test before and possibly during your treatment. These blood tests will be used to predict your risk of muscle-related side effects. A blood test may also be required if you are older than 70 years in order to determine your risk of muscle-related side effects.

If the answer is 'yes' to any of the following questions, do not take Atorvastatin Calcium. Talk to your doctor or pharmacist at once.

Are you pregnant, trying to become pregnant or breast-feeding?
If you are trying to become pregnant your doctor will advise you to stop taking Atorvastatin Calcium about one month before you plan to conceive.

Have you ever had a reaction to Atorvastatin Calcium or to any similar medicines used to lower blood lipids or to any of the inactive ingredients of the medicine?

Do you have or have you had a disease which affects the liver? Have you had any unexplained abnormal blood tests for liver function?

Do you drink excessive amounts of alcohol that might be affecting your liver?

Can you take Atorvastatin Calcium with other medicines?

There are some medicines that may interact with Atorvastatin Calcium, these are:

• Medicines used to modulate immune response, e.g. cyclosporin or antihistamines such as terfenadine, astemizole.
• Macrolide antibiotics, e.g. erythromycin; azole antifungal medicines, e.g. ketoconazole, itraconazole; rifampicin (an antibiotic).
• Medicines to regulate lipid levels, e.g. fibric acid derivatives, niacin, colestipol.
• Some calcium channel blockers used for angina or high blood pressure, e.g. nifedipine; some benzodiazepines used for anxiety and other conditions, e.g. diazepam; medicines to regulate your heart rhythm.
• Digoxin, warfarin, oral contraceptives, antacids, phenytoin (an anti-convulsant for epilepsy).

It is important that you tell your doctor about all the medicines you are taking, including those you have bought without a prescription.

The usual starting dose of Atorvastatin Calcium is 10 mg once a day. This may be increased if necessary by your doctor until you are taking exactly the amount you need. Atorvastatin Calcium tablets should be swallowed, and can be taken at any time of day, with or without food. Do not drink more than one or two small glasses of grapefruit juice per day. Remember to continue with your diet and lifestyle changes while you are taking Atorvastatin Calcium.

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take 2 doses at the same time.

If you accidentally take too many tablets, tell your doctor at once. If you cannot do this, go to the nearest hospital accident and emergency department. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

As with all medicines, Atorvastatin Calcium can sometimes cause side-effects in some individuals. The most commonly reported ones are:

• Nausea, abdominal pain, constipation, wind, indigestion, headache, muscle pain, weakness, diarrhoea and insomnia.

Other less common side-effects have been seen in some patients taking Atorvastatin Calcium or other medicines of this kind. Not all of these effects have necessarily been linked to the use of these medicines. These include:

• Muscle cramps, weakness or tenderness, numbness or tingling in the fingers and toes, impotence, pancreatitis (inflammation of the pancreas leading to stomach pain), hepatitis (liver inflammation), jaundice (yellowing of the skin and whites of the eyes), loss of appetite, vomiting, hair loss, itching, rash (rarely severe blistering rash with associated general illness), chest pain, dizziness, allergic reactions, joint pain.
• Angioneurotic oedema (swelling of the face, tongue and windpipe which can cause great difficulty in breathing). This is a very rare reaction which can be serious if it occurs. You should tell your doctor immediately if it happens.
• Rarely, patients have developed muscle wasting or inflammation, and very rarely this has progressed to become a serious potentially life-threatening condition (called 'rhabdomyolysis'). If you have muscle weakness, tenderness or pain and particularly at the same time, you feel unwell or have a high temperature, stop taking Atorvastatin Calcium and tell your doctor immediately. Consult your doctor as soon as possible if you experience symptoms suggestive of liver complaint (see above).
• Abnormal blood tests, problems with bleeding and bruising, increases in transaminases (a group of enzymes occurring naturally in the blood) which may be a sign of liver problems. Your doctor may want to perform tests periodically to check these.
• Increases and decreases in blood sugar levels have also been seen. If you have diabetes you should continue careful monitoring of your blood sugar levels.

If you get any of these, or any other unusual effects, tell your doctor or pharmacist at once.

• Do not use the medicine after the last day of the month shown in the expiry date. This will be printed on the outside of the pack.
• Remember as with all medicines, keep Atorvastatin Calcium out of reach and sight of children.
• Keep the tablets at normal room temperature in the packaging they come in.

This medicine is for you. Only your doctor can prescribe Atorvastatin Calcium for you. Never give it to anyone else. It may harm them even if their condition is the same as yours.

If you have any further questions about your medicine or your treatment, ask your doctor or pharmacist.

Some Helpful Advice

In addition to taking this medicine as your doctor instructed, there are many other things you can do to help yourself. Your doctor may have explained some of them. The most important steps are the following,

• See your doctor or nurse regularly for check-ups.
• Stop smoking.
• Reduce saturated fats. Replace some saturates with monounsaturates and polyunsaturates
• Take regular physical activity such as walking, swimming or dancing - not violent activities such as squash or weightlifting. Sex is fine as well. Ask your doctor how much you can safely do. If you get chest pain or become breathless, stop and rest.
• Go easy on alcohol.
• Keep to a healthy body weight.
• Relax and laugh!