Atorvastatin 10mg Film Coated Tablets
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Atorvastatin 10 mg film-coated tablets Atorvastatin 20 mg film-coated tablets Atorvastatin 40 mg film-coated tablets
Atorvastatin
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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, pharmacist or nurse.
- 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 of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Atorvastatin Tablets are and what are they used for
2. What you need to know before you take Atorvastatin Tablets
3. How to take 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 ARE THEY USED FOR
Atorvastatin Tablets belongs to a group of medicines known as statins. Statins lower blood lipids such as cholesterol and triglycerides.
Atorvastatin Tablets are advised when a low-fat diet and lifestyle changes have not been adequate to lower blood lipids as recommended.
If you are at an increased risk of heart disease, Atorvastatin Tablets may also be used to reduce such risk even if your blood cholesterol is “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 Tablets 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
• if you have or have ever had a disease that affects the liver
• if you have had any unexplained abnormal blood tests for liver function
• 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, pharmacist or nurse before taking Atorvastatin Tablets.
The following are reasons why Atorvastatin Tablets may not be suitable for you:
• if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous stroke
• 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 a family history of muscle problems
• if you have had previous muscle problems during treatment with other lipid -lowering medicines (i.e. other ‘statin' or ‘fibrate’ medicines)
• if you have a history of liver disease
• if you regularly drink a large amount of alcohol
• if you are older than 70 years
Check with your doctor or pharmacist before taking Atorvastatin Tablets
• if you have severe respiratory failure
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.
The above are reasons why Atorvastatin Tablets 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 treatment with Atorvastatin Tablets especially 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 Tablets”).
Other medicines and Atorvastatin Tablets
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 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, fusidic acid
• Other medicines to lower lipid levels e.g. gemfibrozil, other fibrates, 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, the combination of tipranavir/ ritonavir etc.
• Some medicines used in the treatment of hepatitis C e.g. telaprevir
• Other medicines known to interact with Atorvastatin Tablets include ezetimibe (lowers cholesterol), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant 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) and boceprevir (used to treat liver disease such as hepatitis C)
• 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.
Taking Atorvastatin Tablets with food and drink
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 “Warnings and precautions” 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 breastfeeding 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.
Important information about some of the ingredients of Atorvastatin Tablets
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ATORVASTATIN TABLETS
Before starting treatment, your doctor will advise a low-cholesterol diet: you should continue this diet whilst taking Atorvastatin Tablets.
The usual starting dose of Atorvastatin Tablets 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 Tablets is 80 mg once daily for adults and 20 mg 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) then 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, Atorvastatin Tablets 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.
Uncommon: may affect up to 1 in 100 people:
• Inflammation of the pancreas causing abdominal pain and vomiting
Rare: may affect up to 1 in 1,000 people:
• serious allergic reaction which causes swelling of the face, tongue, throat and windpipe 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
• unexpected or unusual bleeding or bruising
• severe muscle disease: symptoms include muscle weakness, tenderness or pain and particularly if at the same time 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: may affect up to 1 in 10,000 people:
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• if you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of severe liver problems
Not known: frequency cannot be estimated from the available data
• Muscle weakness that is constant
Other possible side effects with Atorvastatin Tablets:
Common side effects (may affect up to 1 in 10 people) include:
• inflammation and pain in the upper airways, pain in the throat, nose bleed
• allergic reactions
• increases in blood sugar (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
• changes in blood test results that show your muscles and liver function can become abnormal
Uncommon side effects (may affect up to 1 in 100 people) include:
• loss of appetite, weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels), vomiting, belching, abdominal pain upper and lower
• nightmares, insomnia
• dizziness, ringing in the ears (tinnitus) and/or head
• 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
• hepatitis (liver inflammation)
• rash, skin rash, itching, hives, hair loss
• neck pain, chest pain, muscle fatigue
• fatigue, feeling unwell, weakness
• fluid retention causing swelling of the extremities, especially in the ankles (oedema)
• fever
• a urine test that gives a positive result for the presence of white blood cells
Rare side effects (may affect up to 1 in 1,000 people) include:
• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• sore muscle tendons that may rupture
Very rare side effects (may affect up to 1 in 10,000 people) include:
• 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
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 out of the reach and sight of children.
Store in the original package in order to protect from moisture. Store below 25oC.
Do not use Atorvastatin Tablets after the expiry date which is stated on the carton label and blister foil after Exp. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Atorvastatin Tablets contains
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin as Atorvastatin calcium hemi-hydrate.
Each film-coated tablet contains 20 mg of atorvastatin as Atorvastatin calcium hemi-hydrate.
Each film-coated tablet contains 40 mg of atorvastatin as Atorvastatin calcium hemi-hydrate.
The other ingredients of Atorvastatin Tablets are: Starch pregelatinized, lactose monohydrate, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, magnesium stearate.
The film-coating of Atorvastatin Tablets contains lactose monohydrate, hypromellose, titanium dioxide (E-171), macrogol 4000 and carnauba wax.
What Atorvastatin Tablets looks like and contents of the pack
Atorvastatin 10, 20 and 40 mg film-coated tablets are white with a round shape, embossed “10”, “20” and “40”, respectively, on one side.
Atorvastatin Tablets are available in blister packs containing 28 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Dexcel®-Pharma Ltd. 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
This medicinal product is authorised in the Member States of the EEA under the following names:
Ireland, UK Atorvastatin 10 mg/20 mg/40 mg film-coated tablets
France, Germany Atorvastatin Dexcel 10 mg/20 mg/40 mg film-coated tablets
This leaflet was last revised in March 2015.
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