Atorvastatin

• Reduces cholesterol levels
• Take tablet once a day
• Careful with grapefruit or grapefruit juice
• Not to be used while pregnant or breastfeeding

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating medicines. Atorvastatin is used to lower lipids (fats) known as cholesterol and triglycerides in the blood. Treatment is usually combined with a low-fat diet and lifestyle changes.

If you are at an increased risk of heart disease, Atorvastatin can also be used to reduce such risk even if your cholesterol levels are normal.

Atorvastatin tablets should be taken at the same time each day to avoid missing any. The tablets should be swallowed whole without chewing. They can be taken with or without food. 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.

Dosage

The usual starting dose of Atorvastatin tablets is:

• Adults and children aged 10 and above: 10 mg once a day.

If necessary, the dose may be increased until you are taking the amount you need. Your doctor will adapt the dose at intervals of four weeks or more. The maximum dose of Atorvastatin is 80 mg once a day.

Alcohol/driving

Avoid drinking too much alcohol while taking this medicine.

Normally this medicine does not affect your ability to drive. In the unlikely event that you do feel dizzy or sleepy, you should avoid driving.

If you use too much/forget to use/stop using Atorvastatin

If you take more Atorvastatin tablets than you were told to, consult your doctor or pharmacist.

If you miss a dose, do not take a double dose to make up for the forgotten one. Skip the missed dose and take the next tablet at the usual time.

Do not stop using Atorvastatin without consulting a doctor first.

Atorvastatin is not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Atorvastatin contains').
• You have, or have had, a disease which affects the liver.
• You have had any unexplained abnormal blood tests for liver function.
• You are a woman able to have children and not using reliable contraception.
• You are pregnant or trying to conceive.
• You are breastfeeding.

When should this medicine be used with caution?

Talk to your doctor before taking Atorvastatin tablets if:

• You have severe respiratory failure.
• You are taking or have taken in the last seven days a medicine called fusidic acid, orally or by injection. The combination of fusidic acid and Atorvastatin can lead to serious muscle problems (rhabdomyolysis).
• You have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes.
• You have kidney problems.
• You have an underactive thyroid gland (hypothyroidism).
• You have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems.
• You have had previous muscular problems during treatment with other lipid-lowering medicines (e.g., other ‘-statin’ or ‘-fibrate’ medicines).
• You regularly drink large amounts of alcohol.
• You have a history of liver disease.
• You are 70 years or older.

Tell your doctor if any of the following conditions apply to you. You may need to have regular check-ups.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.

Pregnancy and breastfeeding

Do not use Atorvastatin if you are pregnant or breastfeeding.

Other medicines and Atorvastatin

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Medicines that are known to interact with Atorvastatin include:

• Medicines used to alter the way your immune system works such as ciclosporin.
• Certain antibiotics or antifungal medicines (see the package leaflet).
• Other medicines to regulate lipid levels.
• Colestipol.
• Some calcium channel blockers used for angina or high blood pressure.
• Medicines used to regulate heart rhythm.
• Medicines used in the treatment of HIV.
• Some medicines used in the treatment of hepatitis C.
• Ezetimibe.
• Warfarin.
• Oral contraceptives.
• Stiripentol.
• Cimetidine.
• Phenazone.
• Colchicine.
• Indigestion products containing aluminium or magnesium.
• Boceprevir.
• St John’s Wort.
• Oral fusidic acid. You will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart taking Atorvastatin.

For more information on possible interactions, see the package leaflet.

Medicines can cause side effects, although some people may not experience any.

If you experience any of the following serious side effects or symptoms, stop taking your tablets and tell your 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, pain, rupture, and particularly, if at the same time you feel
• unwell or have a high temperature. This may be caused by an abnormal muscle breakdown (rhabdomyolysis). The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it can be life-threatening and lead to kidney problems.

Very rare (may affect up to 1 in 10,000 people):

• If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

Other possible side effects with Atorvastatin 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 you have diabetes continue careful monitoring of your
  blood sugar levels), increase in blood creatine kinase.
• Headache.
• Gastrointestinal problems.
• Joint pain, muscle pain and back pain.
• Abnormal blood test results for liver function.

Uncommon (may affect up to 1 in 100 people):

• Loss of appetite, weight gain, decreases in blood sugar levels.
• 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).
• 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.

For a list of side effects, including rare side effects, please see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed in the package leaflet.

The active substance in Atorvastatin Pfizer is atorvastatin. Each film-coated tablet contains 10, 20, 40 or 80 mg atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients are: sodium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate.

The coating of Atorvastatin tablets contains hypromellose, macrogol 8000, titanium dioxide (E171), talc, simethicone emulsion containing simethicone, stearate emulgators (polyethylene glycol sorbitan tristearate, polyoxyethylene stearate, glycerides), thickening agents (methyl cellulose, xanthan gum), benzoic acid, sorbic acid, sulphuric acid.

The manufacturer of Atorvastatin Pfizer is:

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Read the package leaflet before use. The official package leaflet of Atorvastatin Pfizer is available for download here.