Atorvastatin 20 Mg Film Coated Tablets
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Atorvastatin 10/20/40/80 mg film-coated tablets
Atorvastatin
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 use 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 statin, 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN Do not use Atorvastatin:
- if you are allergic to atorvastatin, or to any similar medicines used to lower blood lipids 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 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.
pockets of fluid in the brain
The following are reasons why Atorvastatin may not be suitable for you:
- if you have had a previous stroke with bleeding into the brain, or have small from previous strokes
- if you have kidney problems
- if you have an under-active thyroid gland (hypothyroidism)
history or family history of
- if you have had repeated or unexplained muscle aches or pains, a personal 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.
Check with your doctor or pharmacist before taking Atorvastatin if you have severe respiratory failure.
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.
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”).
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
- Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
- Other medicines known to interact with Atorvastatin 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
Atorvastatin with food, drink and alcohol
See Section 3 for instructions on how to take Atorvastatin. 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.
Alcohol
Avoid drinking too much alcohol while taking this medicine. See Section 2 “Take special care with Atorvastatin” 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 and sucrose
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 USE 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 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.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
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 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
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, 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: affects 1 to 10 users in 10,000:
- 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: affect less than 1 user in 10,000:
• 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 side effects (affects 1 to 10 users in 100) 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
• blood test results that show your liver function can become abnormal
Uncommon side effects (affects 1 to 10 users in 1000) 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 (affects 1 to 10 users in 10,000) include:
• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury
Very rare side effects (affects less than 1 user in 10,000) 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).
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.
Side effects of unknown frequency:
• Muscle weakness that is constant.
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).
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.
This medicinal product does not require any special temperature storage conditions. Store in the original blister packaging.
Do not use this medicine after the expiry date which is stated on the carton or blister foil 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 no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Atorvastatin contains
- The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium).
Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium).
Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium).
Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).
- The other ingredientes are:
Lactose monohydrate, magnesium stearate (E572), sodium laurilsulfate, microcrystalline cellulose, anhydrous colloidal silica, butylhydroxyanisole (E320), crospovidone (E1202), sodium hydrogen carbonate (E500) and sinespum (which consist of sucrose, sorbitan tristearate, polyethylene glycol stearate (E-171), dimeticone, silicon dioxide, 2-Bromo-2-nitropropane-1,3-diol). The coating of Atorvastatin contains Opadry OYL-28900 white (which consists of lactose monohydrate, hypromellose, titanium dioxide (E171) and macrogol 4000).
What Atorvastatin looks like and contents of the pack
The tablets in all strengths 10/20/40 mg are white, round, biconvex, scored and coded with AT1/AT2/AT4 on one side.
The tablets in strength 80 mg are white, oblong, biconvex, scored and coded with AT8 on one side.
Contents:
This medicine is available as 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
All strengths are available in blister packs containing 14 (only for 10mg), 28, 30, 56, 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Galenicum Health S.L Avda Diagonal 123-11a Planta 08005 Barcelona Spain
Telephone: 0034(0)932 011 750 Fax: 0034(0)932 011 751
Email: or@galenicum.com
Manufacturer
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10 - Poligono Industrial Areta
31620 Huarte - Pamplona
Spain
Galenicum Health, S.L.
Avda Cornella 144, 7°-1a Edificio Lekla Esplugues de Llobregat, 08950 Barcelona, Spain.
PL 32854-0023 Atorvastatin 10mg Film-coated Tablets PL 32854-0024 Atorvastatin 20mg Film-coated Tablets PL 32854-0025 Atorvastatin 40mg Film-coated Tablets PL 32854-0026 Atorvastatin 80mg Film-coated Tablets
This leaflet was last revised in February 2015.
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
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