Patient Leaflet Updated 15-Sep-2020 | Zentiva
Atorvastatin 30 mg & 60 mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Atorvastatin 30 mg film-coated tablets
Atorvastatin 60 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR
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 lifestyle 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN
Do not take atorvastatin
Warnings and precautions
Talk to your doctor or pharmacist 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.
Other medicines and atorvastatin
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:
Atorvastatin with food, drink and alcohol
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).
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.
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.
3. HOW TO TAKE ATORVASTATIN
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 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.
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 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.
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 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:
Other possible side effects with atorvastatin:
Common side effects (may affect up to 1 in 10 people) include:
Uncommon side effects (may affect up to 1 in 100 people) include:
Rare side effects (may affect up to 1 in 1,000 people) include:
Very rare side effects (may affect up to 1 in 10,000 people) include:
Not known (frequency cannot be estimated from the available data):
Possible side effects reported with some statins (medicines of the same type):
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search the 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.
5. HOW TO STORE ATORVASTATIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
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 contains
The active substance is atorvastatin.
Each film-coated tablet contains either 30 mg or 60 mg atorvastatin (as atorvastatin calcium trihydrate ).
The other ingredients are:
Core: Calcium carbonate; Cellulose, microcrystalline (E 460); Lactose monohydrate; Low-substituted hydroxypropyl cellulose; Povidone K12; Silica, colloidal anhydrous; Magnesium stearate (E 572).
Coating: Hypromellose (E 464); Macrogol 6000; Titanium dioxide (E 171); Talc; Iron oxide yellow (E 172); Lactose monohydrate and Iron oxide red (E 172).
What atorvastatin looks like and contents of the pack
Atorvastatin 30 mg film-coated tablets are light orange, oblong, film-coated tablets with a dimension of approx. 12.1 ± 0.3 mm in length and 6.1 ± 0.3 mm in width. Atorvastatin 60 mg film-coated tablets are orange, oblong, film-coated tablets with a dimension of approx. 15.1 ± 0.3 mm in length and 7.6 ± 0.3 mm in width.
Pack sizes: 28, 30, 50, 60, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is
The manufacturer is
This leaflet was last updated in