Atorvastatin 10mg Film Coated Tablets
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S. Gonzalez, s. I.
drtesgiaFicas
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
Prueba N.°: 11
Fecha: 22.5.2012
Cliente: BOTICALIA Codigo: ATO PRE [0238,39,40] Edicion: 15.05.2012 Prospecto:
ATORVASTATIN 10/20/40 TABLETS
Tamano: 150 x 540 mm
Plegado: 150 x 33,75 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
Tipografia
Helvetica Condensed Tamano: 9,5 pt.
PATIENT INFORMATION LEAFLET
ATORVASTATIN 10MG FILM COATED TABLETS ATORVASTATIN 20MG FILM COATED TABLETS
ATORVASTATIN 40MG FILM COATED TABLETS
(atorvastatin calcium)
Your medicine is known by any of the above names, but will be referred to as Atorvastatin Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. 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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Atorvastatin Tablets are and what they are used for
2. Before you take Atorvastatin Tablets
3. How to take Atorvastatin Tablets
4. Possible side effects
5. How to store Atorvastatin Tablets
6. Further information
Correcciones □ Aprobado □
Fecha y Firma
Atorvastatin Tablets belong to a group of medicines known as statins, which are lipid (fat) regulating medicines.
Atorvastatin Tablets are 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 Tablets 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.
Anverso / Front
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 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.
Take special care with 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 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.
Check with your doctor or pharmacist before taking Atorvastatin Tablets
• if you 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 Tablets 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”).
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.
Taking 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 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 Tablets 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
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 “Take special care with Atorvastatin Tablets” 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 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 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.
Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with 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.
CC
The duration of treatment with Atorvastatin Tablets is determined by your doctor.
<c Please ask your doctor if you think that the effect of Atorvastatin Tablets is too strong or too weak.
S. Gonzalez, s. I.
drtesgiaFicas
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
Prueba N.°: 11
Fecha: 22.5.2012
If you take more Atorvastatin Tablets 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 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.
Cliente: BOTICALIA Codigo: ATO PRE [0238,39,40] Edicion: 15.05.2012 Prospecto:
ATORVASTATIN 10/20/40 TABLETS
Tamano: 150 x 540 mm
Plegado: 150 x 33,75 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
Tipografia
Helvetica Condensed Tamano: 9,5 pt.
Correcciones □ Aprobado □
Fecha y Firma
Reverso / Back
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.
Rare: affects 1to10 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 Tablets:
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 1to10 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 1to10 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.
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.
• Keep out of the reach and sight of children
• Store in the original packaging
• Do not store above 30°C
• If your tablets show signs of deterioration or discolouration, you should ask your pharmacist what to do.
• Do not use after the last day of the month shown in the expiry date on the carton and blister
What Atorvastatin Tablets contains
Each him coated tablet contains either 10mg, 20mg or 40mg of atorvastatin as atorvastatin calcium trihydrate.
Atorvastatin Tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hyprolose and magnesium stearate,
The coating of Atorvastatin contains hypromellose, macrogol 8000, titanium dioxide E171, talc, simeticone, stearate emulsifi ers and sorbic acid.
What Atorvastatin Tablets looks like and contents of the pack
Each Atorvastatin Tablet is a white, round him coated tablet debossed with ‘10’, ‘20’ or ‘40’ on one side and ‘ATV’ on the other side Atorvastatin Tablets are available as blister packs of 28 tablets.
Who manufactured your medicine
Atorvastatin Tablets are manufactured by Industrias Farmaceuticas Almirall S.L., Ctra. Nacional II, Km.593 08740 Sant Andreu de la Barca, Barcelona, Spain. Procured from within the EU and repackaged by Product Licence Holder Boticalia Ltd, 27 Acton Park, The Vale, London W3 7QE.
Atorvastatin 10mg Film Coated Tablets PL 23038/0238 Atorvastatin 20mg Film Coated Tablets PL 23038/0239 Atorvastatin 40mg Film Coated Tablets PL 23038/0240
POM
Leaflet date: 15.05.2012 ATO PRE