Atorvastatin 10mg, 20mg, 40mg & 80mg film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What atorvastatin is and what it is used for
2. What you need to know before you take atorvastatin
3. How to take atorvastatin
4. Possible side effects
5. How to store atorvastatin
6. Contents of the pack and other information

Do not take atorvastatin if you:

• are hypersensitive (allergic) to atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine – see Section 6 for details.
• have or have ever had a disease which affects the liver.
• have had any unexplained abnormal blood tests for liver function.
• are a woman able to have children and not using reliable contraception.
• are pregnant or trying to become pregnant.
• are breast-feeding.

Warnings and precautions:

The following are reasons why atorvastatin may not be suitable for you.

Talk to your doctor or pharmacist before taking atorvastatin if you have:

• had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes.
• kidney problems.
• an under-active thyroid gland (hypothyroidism).
• had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems.
• had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines).
• had liver disease.

Also take special care with atorvastatin if you:

• regularly drink a large amount of alcohol
• are older than 70 years.

Check with your doctor or pharmacist before taking atorvastatin

• if you have severe respiratory failure.

The above are reasons why atorvastatin may not be suitable for you.

If any of the above reasons apply to you, your doctor will need to carry out a blood test before and possibly during your atorvastatin treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Other medicines and atorvastatin”).

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other Medicines and atorvastatin

There are some medicines that may change the effect of atorvastatin or their effect may be changed by atorvastatin. 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 Section 4:

• Medicines used to alter the way your immune system works, e.g. ciclosporin
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole; rifampin, fusidic acid
• Other medicines to lower blood cholesterol and triglycerides e.g. gemfibrozil, other fibratres, colestipol
• Medicines used for angina or high blood pressure known as “calcium channel blockers” e.g. amlodipine, diltiazem
• Medicines to regulate your 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 (lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (for epilepsy), cimetidine (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.

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Atorvastatin with food and drink

See Section 3 for instructions on how to take atorvastatin. Please 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.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 "Warnings and precautions" for details.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take atorvastatin if you are pregnant or if you are trying to become pregnant.

Do not take atorvastatin if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take atorvastatin if you are breast-feeding. The safety of atorvastatin during pregnancy and breast-feeding has not yet been proven.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Atorvastatin contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you take more atorvastatin than you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take atorvastatin

If you forget to take a dose, just take your next scheduled dose at the correct time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking atorvastatin

If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.

If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Uncommon: affects 1 to 10 users in 1000:

• Inflammation of the pancreas causing abdominal pain and vomiting

Rare: affects 1 to 10 users in 10,000:

• swelling of the face, tongue and windpipe that can cause great difficulty in breathing
• severe, extensive, blistering skin rash
• severe muscle disease: symptoms include muscle weakness, tenderness or pain and if you also feel unwell or have a high temperature then the symptoms may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems.

Very rare: affect less than 1 user in 10,000:

• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• unexpected or unusual bleeding or bruising
• severe liver problems

The following side-effects have also been reported:

Common side effects (affects 1 to 10 users in 100) include:

• inflammation of the nasal passages, pain in the throat, nose bleed
• allergic reactions
• changes in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels)
• headache
• nausea, constipation, wind, indigestion, diarrhoea
• joint pain, muscle pain and back pain
• changes in blood test results that report on your muscles and liver

Uncommon: affects 1 to 10 users in 1000:

• loss of appetite, vomiting, belching, abdominal pain
• weight gain
• nightmares, insomnia
• dizziness, ringing in the ears (tinnitus)
• numbness or tingling in the fingers and toes, reductions of sensation to pain or touch
• change in sense of taste
• loss of memory
• visual disturbance
• liver problems
• skin rash, itching, hives, hair loss
• neck pain, chest pain
• fatigue, feeling unwell, weakness
• fluid retention causing swelling of the extremities
• fever
• a urine test that gives a positive result for the presence of white blood cells

Rare: affects 1 to 10 users in 10,000:

• jaundice (yellowing of skin)
• sore muscle tendons that may rupture

Very rare: affects less than 1 user in 10,000:

• hearing loss
• increase in breast tissue in men

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 you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What Atorvastatin 10mg, 20mg, 40mg and 80mg film-coated tablets contain

The active substance of Atorvastatin 10mg, 20mg, 40mg and 80mg film-coated tablets is atorvastatin.

Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium).

Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium).

Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium).

Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium).

The other excipients are:

Core: Meglumine, Cellulose, microcrystalline (E 460), Lactose monohydrate, Croscarmellose sodium (E 468), Low-substituted hydroxypropyl Cellulose, Silica, colloidal anhydrous, Magnesium stearate (E 572). Coating: Hypromellose (E 464), Macrogol 6000, Titanium dioxide (E 171), Talc and Iron oxide yellow (E 172).

What Atorvastatin 10mg, 20mg, 40mg and 80mg film-coated tablets look like and contents of the pack

Atorvastatin 10 mg film-coated tablets are light yellowish to yellowish film-coated oval biconvex tablets.

Atorvastatin 20 mg film-coated tablets are yellowish to orange-yellow film-coated oval biconvex tablets.

Atorvastatin 40 mg film-coated tablets are orange-yellow to yellow-orange film-coated oval biconvex tablets.

Atorvastatin 80 mg film-coated tablets are yellow-orange film-coated oval biconvex tablets.

Pack sizes: 14, 28, 30, 50, 56, 90, 98, 100 film-coated tablets.

Not all pack sizes may be marketed.

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