Atorvastatin 20mg Film Coated Tablets
Out of date information, search anotherTEVA UK Ref: 231-30-88245-F LEA ATORVASTATIN TAB A/S TUK <ZAR Version: 1 25 June 2014
REG0070671
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
INTHIS LEAFLET:
1. What Atorvastatin Film-Coated Tablets are and what they are used for
2. Before you take Atorvastatin Film-Coated Tablets
3. How to take Atorvastatin Film-Coated Tablets
4. Possible side effects
5. How to store Atorvastatin Film-Coated Tablets
6. Further information
OWHAT ATORVASTATIN FILM-COATED TABLETS ARE AND WHAT THEY ARE 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.
BEFORE YOU TAKE ATORVASTATIN FILM-COATED TABLETS Do not take Atorvastatin Film-Coated Tablets
• Ifyou are hypersensitive (allergic) to atorvastatin 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
• Ifyou have or have ever had a disease that affects the liver
• Ifyou have had any unexplained abnormal blood tests for liver function
• Ifyou are a woman able to have children and not using reliablecontraception • Ifyou are pregnant or trying to become pregnant • Ifyou are breast-feeding.
Take special care with Atorvastatin Film-Coated Tablets
The following are reasons why Atorvastatin Film-CoatedTablets may not be suitable for you:
• Ifyou have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes • Ifyou have kidney problems • Ifyou have an under-activethyroid gland (hypothyroidism)
• Ifyou have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems
• Ifyou have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other '-statin' or '-fibrate' medicines)
• Ifyou regularly drinka large amount of alcohol • Ifyou have a history of liver disease • Ifyou are older than 70 years.
While you areonthis 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.
Check with your doctor or pharmacist before taking Atorvastatin Film-Coated Tablets
• Ifyou have severe respiratory failure.
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 if certain medicines are taken at the same time as atorvastatin (see section 2 "Taking other medicines"). Taking 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, rifampicin, 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
• Medicinesused inthetreatmentofHIV,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), phenytoin (a painkiller) and antacids (indigestion products containing aluminium or magnesium)
• 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 those obtained without a prescription.
Taking Atorvastatin Film-Coated Tablets with food and drink
See section 3 for instructions on how to take Atorvastatin Film-CoatedTablets. Pleasenotethe 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 Film-CoatedTablets.
Alcohol
Avoid drinking too much alcohol while taking this medicine. See section 2 "Take special care with Atorvastatin Film-CoatedTablets" for details.
Pregnancy and breast-feeding
Do not take Atorvastatin Film-CoatedTablets if you are pregnant orifyouare trying to become pregnant.
Do not take Atorvastatin Film-CoatedTablets ifyou are able to become pregnant unless you use reliable contraceptive measures.
Do not take Atorvastatin Film-CoatedTablets ifyou are breast-feeding.
The safety of Atorvastatin Film-CoatedTablets during pregnancy and breast-feeding 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 ifyourabilitytouse them is affected bythis medicine.
©HOW TO TAKE ATORVASTATIN FILM-COATED TABLETS
Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin Film-CoatedTablets. The usual starting dose of Atorvastatin Film-Coated 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 dosage at intervals of 4 weeks or more.The maximum dose of Atorvastatin Film-CoatedTablets is 80 mg once daily for adults and 20 mg once daily for children.
Atorvastatin Film-CoatedTabletsshould beswallowed whole with a drink ofwater, 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 Film-CoatedTablets exactly as your doctor hastold you.You should checkwith your doctor or pharmacist ifyou are not sure.
The duration of treatment with Atorvastatin Film-Coated Tablets is determined by your doctor. Please askyour doctor ifyou think that the effect of Atorvastatin Film-CoatedTablets is too strong or too weak.
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If you take more Atorvastatin Film-Coated Tablets than you should
If you accidentally take too many Atorvastatin Film-CoatedTablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.
If you forget to take Atorvastatin Film-Coated 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 Film-Coated Tablets If you have any further questions on theuseofthis medicine or wish to stop your treatment, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines, Atorvastatin Film-CoatedTablets 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 ofthe 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 lessthan 1 userin 10,000:
• Ifyou experience problemswith 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 Film-Coated Tablets:
Common side effects (affects 1 to 10 users in 100) include:
• inflammation ofthe 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 (ifyou have diabetesyou should continue careful monitoring ofyour 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 oftaste, loss of memory
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation ofthe 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 ofthe skin and whites ofthe eyes)
• tendon injury.
Very rare side effects (affects lessthan 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 ofthe 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
Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
0HOW TO STORE ATORVASTATIN FILM-COATED TABLETS Keep out of the reach and sight of children.
Store below 30oC.
Do not use Atorvastatin Film-CoatedTablets after the expiry date which is stated on the blister and outer packaging after EXP.The expiry date refers to the last day ofthat month.
Medicines should not be disposed ofvia wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.
6 FURTHER INFORMATION
What Atorvastatin Film-Coated Tablets contain
• The active substance is atorvastatin
Each 10 mg tablet contains 10 mg of atorvastatin as atorvastatin calcium
Each 20 mg tablet contains 20 mg of atorvastatin as atorvastatin calcium
Each 40 mg tablet contains 40 mg of atorvastatin as atorvastatin calcium
Each 80 mg tablet contains 80 mg of atorvastatin as atorvastatin calcium
• The other ingredients in the tablet core are microcrystalline cellulose, sodium carbonate anhydrous, maltose, croscarmellose sodium and magnesium stearate.
The other ingredients in the film-coating are hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80 and titanium dioxide (E171).
What Atorvastatin Film-Coated Tablets look like and the contents of the pack
• 10 mg: Atorvastatin Film-CoatedTablets are white to
off-white, elliptic, biconvex and smooth film-coated tablets.The dimensions of each tablet are approximately 9.7 mm x 5.2 mm.
20 mg: Atorvastatin Film-CoatedTablets are white to off-white, elliptic, biconvex and smooth film-coated tablets.The dimensions of each tablet are approximately 12.5 mm x 6.6 mm.
40 mg: Atorvastatin Film-CoatedTablets are white to off-white, elliptic, biconvex and smooth film-coated tablets.The dimensions of each tablet are approximately 15.6 mm x 8.3 mm.
80 mg: Atorvastatin Film-CoatedTablets are white to off-white, elliptic, biconvex and smooth film-coated tablets.The dimensions of each tablet are approximately 18.8 mm x 10.3 mm.
• Atorvastatin Film-CoatedTablets are available in aluminium-aluminium blisters containing 7, 10, 14,
15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 200 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer
BELMAC, S.A., 50016 Zaragoza, SPAIN.
This leaflet was last revised in 06/2014.
PL 00289/1289-1292
Version 1.3
Approved
88245-F
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