Atorvastatin 10 Mg Film Coated Tablets
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Package leaflet: Information for the user Atorvastatin 10 mg film-coated tablets Atorvastatin 20 mg film-coated tablets Atorvastatin 40 mg film-coated tablets Atorvastatin 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 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 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 take Atorvastatin
• ifyouarehypersensitive (allergic) to atorvastatin or to any similar medicines used to lower blood lipids, peanuts or soya or to any of the other ingredients of the medicine listed in Section 6.
• ifyouhave or have ever had a disease which affects the liver
• ifyouhave had any unexplained abnormal blood tests for liver function
• ifyouarea woman able to have children and not using reliable contraception
• ifyouarepregnant or trying to become pregnant
• ifyouarebreast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Atorvastatin.
The following are reasons why Atorvastatin may not be suitable for you:
• ifyouhave had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
• ifyouhave kidney problems
• ifyouhave an under-active thyroid gland (hypothyroidism)
• ifyouhave had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems
• ifyouhave had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other '-statin' or '-fibrate' medicines)
• ifyouregularly drink a large amount of alcohol
• ifyouhave a history of liver disease
• ifyouareolder than 70 years.
Check with your doctor or pharmacist before taking Atorvastatin
• ifyouhave 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 when certain medicines are taken at the same time (see Section 2 “Other medicines and Atorvastatin”).
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
• Certainantibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid
• Othermedicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Somecalcium 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, the combination of tipranavir/ritonavir etc.
• Somemedicines used in the treatment of hepatitis C e.g. telaprevir
• Othermedicines 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
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Atorvastatin with food and drink
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 “Warnings and precautions” for details
Pregnancy, breast-feeding and fertility
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.
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
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 and soya lecithin. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
3. How to take Atorvastatin
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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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,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, 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):
• Seriousallergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.
• Seriousillness 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.
Black
Bulgaria
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• Muscleweakness, 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 (may affect up to 1 in 10,000 people):
• Ifyouexperience 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 (may affect up to 1in 10 people) include:
• inflammation of the nasal passages, pain in the throat, nose bleed
• allergicreactions
• 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
• jointpain, muscle pain and back pain
• bloodtest results that show your liver function can become abnormal
Uncommon side effects (may affect up to1 in 100 people) 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)
• havingnightmares, 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
• blurredvision
• ringinginthe 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
• neckpain, muscle fatigue
• fatigue,feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
• urinetests that are positive for white blood cells
Rare side effects (may affect up to1 in 1,000 people) include:
• visualdisturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendoninjury
Very rare side effects (may affect up to 1 in 10,000 people)
include:
• anallergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearingloss
• gynecomastia (breast enlargement in men and women).
Possible side effects reported with some statins (medicines of
the same type):
• Sexualdifficulties
• 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Malta
ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira
Website: www.medicinesauthoritv.gov.mt e-mail: postlicensing.medicinesauthority@qov.mt
5. How to store Atorvastatin
Keep this medicine out of the sight and reach of children.
The medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label, carton and blister 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 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 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Each film coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).
Each film coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).
Each film coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).
- The other ingredients are.
Tablet core: Mannitol, copovidone, sodium carbonate
anhydrous, croscarmellose sodium, silicified microcrystalline cellulose (contains Silica, colloidal anhydrous and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, silica colloidal anhydrous, magnesium stearate.
Film coating: Poly vinyl alcohol - part hydrolyzed, titanium dioxide (E171), talc, lecithin (soya), xanthan gum.
What Atorvastatin looks like and contents of the pack
Film-coated tablet
Atorvastatin 10 mg film-coated tablets
White, elliptical [9.8 mm x 5.2 mm], film-coated tablets, debossed with “Y” on one side and “77” on other side.
Atorvastatin 20 mg film-coated tablets
White, elliptical [12.3 mm x 6.5 mm], film-coated tablets, debossed with “Y” on one side and “78” on other side.
Atorvastatin 40 mg film-coated tablets
White, elliptical [15.5 mm x 8.1 mm], film-coated tablets, debossed with “Y” on one side and “79” on other side.
Atorvastatin 80 mg film-coated tablets
White, elliptical [19.4 mm x 10.4 mm], film-coated tablets, debossed with “Y” on one side and “72” on other side.
Atorvastatin film-coated tablets are available in polyamide/ Aluminium foil/ PVC - Aluminium foil blisters packs and HDPE bottle packs with polypropylene closure. Bottle pack contains silica gel as desiccant.
Pack sizes:
Blister pack: 14, 28, 30, 50, 56, 90, 100 and 500 film-coated tablets HDPE bottle pack: 30 and 200 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
UK_ Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
MT_ Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront Floriana FRN 1913 Malta
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
ATopBacraTMH AypoSMHflo 10 mg/ 20 mg/ 40 mg/ 80 mg ^uriMupaHu Ta6neTKu Atorvastatin Aurobindo 10 mg/ 20 mg/
40 mg rmKaAujijiEvo |j£ Aehto ujievio 5iawa
Atorvastatin “Aurobindo” ATORVASTATINE ARROW GE 10 mg/
20 mg/ 40 mg/ 80 mg comprime pellicule Atorvastatin Aurobindo 10 mg/ 20 mg/
40 mg/ 80 mg Filmtabletten Atorvastatin 10 mg/ 20 mg/ 40 mg/ 80 mg film-coated tablets
Atorvastatine Aurobindo 10 mg,/ 20 mg,/ 40 mg,/ 80 mg, filmomhulde tabletten Atorvastatin Vitama Atorvastatina Aurobindo Atorvastatina Aurobindo 10 mg/ 20 mg/ 40 mg/ 80 mg comprimate filmate ATORVASTATINA AUROBINDO 10 mg/
20 mg/ 40 mg/ 80 mg comprimidos recubiertos con pelfcula EFG
Sweden: Atorvastatin Aurobindo 10 mg/ 20 mg/
40 mg/ 80 mg filmdragerade tabletter The United Kingdom: Atorvastatin 10 mg/ 20 mg/ 40 mg/ 80 mg
film-coated tablets