What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL30306/0375, PL30306/0374, PL30306/0373.

Atorvastatin 10mg, 20mg and 40mg Film-coated Tablets

PATIENT INFORMATION LEAFLET

Atorvastatin 10mg, 20mg and 40mg 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.
  • The full name of this medicine is Atorvastatin 10mg, 20mg and 40mg Film-coated Tablets but within the leaflet it will be referred to as Atorvastatin tablets.

What is in this leaflet:

1 What Atorvastatin tablets are and what they are used for
2 What you need to know before you take Atorvastatin tablets
3 How to use Atorvastatin tablets
4 Possible side effects
5 How to store Atorvastatin tablets
6 Contents of the pack and other information

1 What Atorvastatin tablets are and what they are used for

Atorvastatin tablets belong to a group of medicines known as statins, which are lipid (fat) regulating medicines.

Atorvastatin tablets are used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin tablets can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.

2 What you need to know before you take Atorvastatin tablets

Do not take Atorvastatin tablets 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 tablets may not be suitable for you. Talk to your doctor or pharmacist before you take Atorvastatin tablets, if you:

  • have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
  • have kidney problems
  • have an under-active thyroid gland (hypothyroidism)
  • have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems
  • have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other statin or fibrate medicines)
  • are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Atorvastatin tablets can lead to serious muscle problems (rhabdomyolysis)
  • regularly drink a large amount of alcohol
  • have a history of liver disease
  • are older than 70 years
  • have severe respiratory failure.

If any of these 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 “Taking other medicines”).

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.

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.

Other medicines and Atorvastatin tablets

There are some medicines that may change the effect of Atorvastatin tablets or their effect may be changed by Atorvastatin tablets.

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
  • If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Atorvastatin tablets. Taking Atorvastatin tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4
  • Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
  • Some calcium channel blockers used for angina or high blood pressure, 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
  • Other medicines known to interact with Atorvastatin tablets include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used 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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Atorvastatin tablets with food, drink and alcohol

See Section 3 for instructions on how to take Atorvastatin tablets. 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 tablets.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care with Atorvastatin tablets” for details

Pregnancy and breast feeding

Do not take Atorvastatin tablets if you are pregnant, or if you are trying to become pregnant.

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

Do not take Atorvastatin tablets if you are breast-feeding.

The safety of Atorvastatin tablets 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.

3 How to take Atorvastatin tablets

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin tablets.

The usual starting dose of Atorvastatin tablets is 10mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin tablets is 80mg once daily for adults and 20mg once daily for children.

Atorvastatin tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

Always take Atorvastatin tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The duration of treatment with Atorvastatin tablets is determined by your doctor.

Please ask your doctor if you think that the effect of Atorvastatin tablets is too strong or too weak.

If you take more Atorvastatin tablets than you should

If you accidently 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 tablets

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 tablets

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

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

Rare: may affect up to 1 in 1000 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 or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which 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 side effects (may affect up to 1 in 10 people) include:

  • 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
  • nausea, constipation, wind, indigestion, diarrhoea
  • joint pain, muscle pain and back pain
  • joint swelling, muscle spasm
  • blood test results that show your liver function can become abnormal.

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

  • anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)
  • having 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)
  • rash, 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.

Rare side effects (may affect up to 1 in 1000 people) include:

  • visual disturbance
  • unexpected bleeding or bruising
  • cholestasis (yellowing of the skin and whites of the eyes)
  • tendon injury.

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

  • an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
  • hearing loss
  • gynecomastia (breast enlargement in men and women).

Not known (cannot be estimated from the available data):

  • Muscle weakness that is constant

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Atorvastatin tablets

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions.

Do not use Atorvastatin tablets after the expiry date which is stated on the pack after {EXP}. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Atorvastatin tablets contain

  • The active substance is atorvastatin as atorvastatin calcium trihydrate. Each 10mg, 20mg or 40mg film-coated tablet contains 10mg, 20mg or 40mg respectively of atorvastatin.
  • The other ingredients are:
    Tablet core: mannitol, cellulose microcrystalline, crospovidone, sodium carbonate anhydrous, povidone, methionine, magnesium stearate. Tablet coating: hypromellose 6 cP, titanium dioxide (E 171), macrogol 6000, talc.

What Atorvastatin tablets look like and contents of the pack

Film-coated tablets.

10mg: White, oval, biconvex 4.9 x 9.1mm film-coated tablets marked with “10 on one side and A on the other”.

20mg: White, oval, biconvex 6.2 x 11.5mm film-coated tablets marked with “20 on one side and A on the other”.

40mg: White, oval, biconvex 7.8 x 14.5mm film-coated tablets marked with “40 on one side and A on the other”.

Pack size: 28

Marketing Authorisation Holder

Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland

Manufacturer

Actavis hf.
Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Iceland

Actavis UK Ltd
Barnstaple
EX32 8NS
UK

This leaflet was last revised in December 2015

If you would like a leaflet with larger text, please contact 01271 385257.

Actavis
Barnstaple
EX32 8NS
UK

50883657 AAAI6179