How does it work?

Lipitor tablets contain the active ingredient atorvastatin, which is a type of medicine called a statin. It works by reducing the production of cholesterol by the liver. Atorvastatin is also available without a brand name, ie as the generic medicine.

For the sake of simplicity, there are two sorts of cholesterol; a 'bad' sort called low density lipoprotein (LDL) and a 'good' sort called high density lipoprotein (HDL). LDL is deposited in the arteries and increases the risk of heart disease by clogging and narrowing the arteries (atherosclerosis), while HDL actually protects the arteries against this.

Atorvastatin decreases the production of LDL cholesterol by blocking the action of the enzyme in the liver (called HMG-CoA reductase) that is responsible for its production. This decreases the amount of cholesterol in the liver cells, which causes them to take up LDL cholesterol from the blood. The decreased cholesterol production and increased removal of LDL cholesterol from the blood ultimately results in lowered blood cholesterol levels.

As the body produces most cholesterol at night, statins are generally more effective if taken at night.

Atorvastatin also causes a small decrease in the production of other 'bad fats' in the blood called triglycerides, and a small increase in the level of HDL cholesterol. This results in lowered levels of 'bad fats' and raised levels of 'good fats' in the blood.

Statins have an important role in the prevention of coronary heart disease. They reduce the risk of excess cholesterol being deposited in the major blood vessels of the heart. Any blockage in the blood vessels limits the amount of blood and therefore oxygen being carried to the heart muscle. This can cause chest pain (angina) and in severe cases can result in a heart attack (myocardial infarction).

Statins also reduce the risk of stroke by decreasing the risk of excess cholesterol being deposited in the blood vessels leading to the brain. These fat deposits can cause blockage and therefore limit blood and oxygen supply to certain parts of the brain.

Atorvastatin is used to lower cholesterol and other bad fats in people who have high levels either due to genetics (familial hypercholesterolaemia) or as a result of diet and lifestyle. This helps to reduce the risk of hardening of the arteries (atherosclerosis) and also the problems described above.

Atorvastatin can also be used to reduce the risk of coronary heart disease in people with type 2 diabetes, regardless of their cholesterol levels. It has been shown to reduce the risk of needing procedures to improve blood supply to the heart, such as a balloon dilation of an arteryor a heart bypass graft. It also reduces the risk of heart attack, stroke and death from heart disease.

It is important to follow a cholesterol-lowering diet and exercise regime while taking atorvastatin. Discuss this with your doctor.

What is it used for?

• High blood cholesterol levels (primary hypercholesterolaemia).
• Inherited high blood cholesterol levels (familial hypercholesterolaemia).
• High levels of any or all of the fats in the blood, such as cholesterol, triglycerides and lipoproteins (mixed hyperlipidaemia).
• Reducing the risk of cardiovascular events such as heart attacks, strokes or needing heart bypass surgery, in people with type 2 diabetes who have at least one other risk factor for heart disease (for example smoking, high blood pressure, diabetic eye disease or diabetic kidney disease). The medicine can be used for this purpose in people who don't currently have evidence of coronary heart disease, irrespective of what their cholesterol levels are.

Warning!

• You should continue to follow a cholesterol-lowering diet during treatment with this medicine. Discuss this with your doctor.
• It is recommended that you avoid drinking excessive amounts of alcohol while taking this medicine.
• You should avoid drinking grapefruit juice while taking this medicine. This is because grapefruit juice can affect the metabolism of atorvastatin and could increase the amount of the medicine in your blood, thus increasing the risk of side effects.
• This medicine may rarely cause liver problems. For this reason your doctor will want you to have blood tests to monitor your liver function (liver function tests) before starting treatment and regularly throughout treatment with this medicine. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine, as these could be signs of a liver problem.
• This medicine may very rarely have side effects on the muscles. For this reason you should inform your doctor immediately if you experience any muscular symptoms such as pain, tenderness, cramps, or weakness while taking this medicine, particularly if it is accompanied by a fever or feeling generally unwell. Your doctor may need to check for side effects on the muscles by taking a blood test to measure the level of a compound called creatinine kinase in your blood. If this is the case, the test should not be done following strenuous exercise.
• Statins may very rarely be associated with a type of lung disease. For this reason, you should consult your doctor if you experience shortness of breath or difficulty breathing, a non-productive cough and deterioration in your general health (eg weight loss, fever, fatigue) while taking this medicine.
• The manufacturer has not studied the effect of this medicine in children aged under 10 years, or in girls who have not yet started their periods. The medicine is not recommended for children under ten years of age. The long-term effects of the medicine in children aged 10 to 18 years have not been studied.

Use with caution in

• People aged over 70 years.
• Decreased kidney function.
• Decreased liver function.
• History of liver disease.
• People who drink large amounts of alcohol.
• Underactive thyroid gland (hypothyroidism).
• Personal or family history of hereditary muscle disorders.
• History of muscular side effects during previous treatment with a statin or fibrate medicine.
• People who have recently had a stroke caused by bleeding in the brain (haemorrhagic stroke).

Not to be used in

• Active liver disease.
• Unexplained raised results in liver function tests.
• Pregnancy.
• Breastfeeding.
• Lipitor tablets contain lactose and are not suitable for people with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should not be used during pregnancy because it may be harmful to a developing foetus. Pregnancy should also be avoided for one month after stopping treatment. Women who could get pregnant should use an effective method of contraception to prevent pregnancy both during treatment with this medicine and for one month after stopping treatment. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Disturbances of the gut such as diarrhoea, constipation, nausea, flatulence or abdominal pain.
• Indigestion.
• Runny or stuffy nose.
• Nose bleeds.
• Muscle, bone or joint pain
• Headache.
• Difficulty sleeping (insomnia).
• Skin reactions such as rash and itch.
• Back pain.
• Dizziness.
• Feeling of weakness.
• Decreased sensitivity to touch or pain, pins and needles sensations.
• Chest pain.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Vomiting.
• Decrease in the number of blood cells called platelets in the blood (thrombocytopenia).
• inflammation of the pancreas (pancreatitis).
• Muscle pain.
• Hair loss (alopecia).
• Loss of appetite.
• Weight gain.
• Liver disorders.
• Changes in blood sugar levels.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
• Hepatitis (inflammation of the liver).
• Muscle breakdown (rhabdomyolysis).
• Inflammation of the muscles (myositis).
• Fever.

Very rare (affect less than 1 in 10,000 people)

• Visual disturbances.
• Serious skin conditions such as Stevens-Johnson Syndrome or toxic epidermal necrolysis.
• Enlargement of the breasts in men.
• Taste changes.

Unknown frequency

• Interstitial lung disease.
• Depression.
• Memory loss.
• Sleep disturbances.
• Sexual problems.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor what medicines you are taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, ask your doctor or pharmacist before taking any new medicines while taking this one, so they can check that the combination is safe.

There may be an increased risk of side effects on the muscles (myopathy) if atorvastatin is taken with any of the following medicines:

• amiodarone
• amlodipine
• azole antifungals, eg itraconazole, ketoconazole, posaconazole
• ciclosporin
• clarithromycin
• daptomycin
• diltiazem
• erythromycin
• ezetimibe
• fibrates for lowering cholesterol, eg bezafibrate, gemfibrozil
• fusidic acid
• niacin (nicotinic acid)
• protease inhibitors for HIV infection, eg nelfinavir, ritonavir
• telithromycin
• verapamil.

If you are prescribed any of the medicines listed above in combination with your atorvastatin, it is important to let your doctor know if you experience any unexplained muscle symptoms, such as pain or tenderness, muscle weakness or muscle cramps.

Atorvastatin may increase the blood level of digoxin. If you are taking both these medicines the amount of digoxin in your blood should be monitored.

The anti-blood-clotting effect of anticoagulants such as warfarin may be affected by atorvastatin. For this reason, if you are taking an anticoagulant your doctor may want to check your blood-clotting time when you start or stop treatment with atorvastatin, and if your atorvastatin dose is altered.

Atorvastatin may slightly increase the blood levels of ethinylestradiol and norethisterone that are found in certain brands of the contraceptive pill. Your doctor should take this into account if you are taking this medicine and need an oral contraceptive.

The following medicines may reduce the amount of atorvastatin in your blood and could make it less effective:

• efavirenz
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

Other medicines containing the same active ingredient

Atorvastatin is also available without a brand name, ie as the generic medicine.