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 leaflet can be viewed using the link above.
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 17780/0469.
Atorvastatin Crystalline 10mg 20mg 40mg and 80mg film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Atorvastatin 10mg film-coated tablets
Atorvastatin 20mg film-coated tablets
Atorvastatin 40mg film-coated tablets
Atorvastatin 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 (see section 4).
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
- if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6).
- if you have or have ever had a disease which affects the liver.
- if you have had any unexplained abnormal blood tests for liver function.
- if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.
- if you are a woman able to have children and not using reliable contraception.
- if you are pregnant or trying to become pregnant.
- if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking atorvastatin. The following are reasons why atorvastatin may not be suitable for you:
- if you have severe respiratory failure
- if you 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 can lead to serious muscle problems (rhabdomyolysis)
- if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
- if you have kidney problems
- if you have an under-active thyroid gland (hypothyroidism)
- if you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems
- if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines)
- if you regularly drink a large amount of alcohol
- if you have a history of liver disease
- if you are older than 70 years.
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:
- 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 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.
- Letermovir, a medicine that helps stop you from getting ill from cytomegalovirus.
- Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir etc.
- Some medicines used in the treatment of hepatitis C e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
- Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion products containing aluminium or magnesium).
- Medicines obtained without a prescription: St John’s Wort.
- 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. Taking atorvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis 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 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 is 80mg 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):
- 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 or red-brown discolouration of urine and particularly, if at the same time, you feel unwell or have a high temperature it 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):
- Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).
- 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:
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
- nausea, constipation, wind, indigestion, diarrhoea
- joint pain, joint swelling, muscle pain, muscle spasms, pain in arms and legs and back pain
- blood test results that show your liver function can become abnormal
Uncommon (may affect up to 1 in 100 people):
- 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 (may affect up to 1 in 1,000 people):
- visual disturbance
- unexpected bleeding or bruising
- cholestasis (yellowing of the skin and whites of the eyes)
- tendon injury
Very rare (may affect up to 1 in 10,000 people):
- 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)
Not known (frequency 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
- 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 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 at: 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 10mg film-coated tablet contains 10mg atorvastatin (as atorvastatin calcium trihydrate).
Each 20mg film-coated tablet contains 20mg atorvastatin (as atorvastatin calcium trihydrate).
Each 40mg film-coated tablet contains 40mg atorvastatin (as atorvastatin calcium trihydrate).
Each 80mg film-coated tablet contains 80mg 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.
What atorvastatin looks like and contents of the pack
Atorvastatin 10mg film-coated tablets are white to off white, film-coated, round, biconvex tablets. Diameter of the tablet is approx. 6mm.
Atorvastatin 20mg film-coated tablets are yellowish, film-coated, round, biconvex tablets. Diameter of the tablet is approx. 8mm.
Atorvastatin 40mg film-coated tablets are orange-yellow to yellow-orange, film-coated, round, biconvex tablets. Diameter of the tablet is approx. 10mm.
Atorvastatin 80mg film-coated tablets are yellow-orange film-coated round, biconvex tablets. Diameter of the tablet is approx. 12mm.
10mg: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets
20mg: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets
40mg: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets
80mg: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 200 film-coated tablets
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is
12 New Fetter Lane
The manufacturer is
U kabelovny 130
10237 Prague 10
This leaflet was last updated in January 2021