The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0716 .
Atorvastatin 10 mg Film-coated Tablets
Atorvastatin 20 mg Film-coated Tablets
Atorvastatin 40 mg Film-coated Tablets
Atorvastatin 80 mg Film-coated Tablets
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
Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.
Atorvastatin is 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 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.
Talk to your doctor, pharmacist or nurse before taking Atorvastatin
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 “Other medicines and Atorvastatin”).
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. 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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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:
See section 3 for instructions on how to take Atorvastatin.
Please note the following:
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.
Avoid drinking too much alcohol while taking this medicine. See section 2, “Warnings and precautions” for details.
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.
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.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Atorvastatin contains less than 1 mmol sodium (23 mg) per tablet,that is to say essentially ‘sodium- free’.
Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin.
The usual starting dose of Atorvastatin is 10 mg 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 is 80 mg once a day.
Atorvastatin 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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The duration of treatment with Atorvastatin is determined by your doctor.
Please ask your doctor if you think that the effect of Atorvastatin is too strong or too weak.
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 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 have any further questions on the use of this medicine, or wish to stop your treatment, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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
Very rare: may affect up to 1 in 10,000 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known (frequency cannot be estimated from the available data)
Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath.
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 or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Store below 25ºC. Do not use this medicine after the expiry date which is stated on the carton and blister 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.
What Atorvastatin 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets contain:
The active substance in Atorvastatin film-coated tablets is atorvastatin as atorvastatin calcium trihydrate. Each film-coated tablet contains 10 mg, 20 mg, 40 mg or 80 mg atorvastatin.
The other ingredients are:
Tablet core: Microcrystalline cellulose (E460), Lactose monohydrate, Colloidal anhydrous silica, Croscarmellose sodium (E468), Sodium hydrogen carbonate, Sodium carbonate, anhydrous, Hydroxypropylcellulose (E463), Magnesium stearate (E470b), Butylhydroxyanisole, Butylhydroxytoluene
Film coating: Opadry White YS-1-7040 (Hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc (E553b)
Atorvastatin 10 mg:
White to off white, film-coated oval tablets about 6.1 mm wide and about 8.6 mm long, debossed with ‘A30’ on one side and plain on other side
Atorvastatin 20 mg:
White to off white, film-coated oval tablets about 6.6 mm wide and about 12.1 mm long, debossed with ‘A31’ on one side and plain on other side
Atorvastatin 40 mg:
White to off white, film-coated oval tablets about 8.1 mm wide and about 16.9 mm long, debossed with ‘A32’ on one side and plain on other side
Atorvastatin 80 mg:
White to off white, film-coated oval tablets about 10.8 mm wide and about 21.7 mm long, debossed with ‘A33’ on one side and plain on other side
Atorvastatin is supplied in the pack of:
Cold form blister laminate (structure: oriented polyamide/ aluminium foil/ PVC) with the backing of hard tempered, aluminium foil coated with heat seal lacquer on inner side
Packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets each.
Not all pack sizes may be marketed.
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Bulgaria: ATORVISTAT K 10/20 mg филмирани таблетки
Finland: Atorvastatin Orion 10/20/40/80 mg tabletti, kalvopäällysteinen
France: ATORVASTATINE SUN 10/20/40/80 mg, comprimé pelliculé
Ireland: Atorvastatin 10/20/40/80 mg film-coated tablets
Latvia: Atorvastatin SUN 10/20/40/80mg apvalkotās tabletes
Lithuania: Atorvastatin SUN 10/20/40/80 mg plėvele dengtos tabletės
Poland: Storvas CRT
Romania: Atorvastatin Terapia 10/20/40/80 mg comprimate filmate
Spain: ATORVASTATINA SUN 10-20-40-80 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG
United Kingdom (Northern Ireland): Atorvastatin 10/20/40/80 mg Film-coated Tablets
This leaflet was last revised in September 2023.