Aspirin 75mg Gastro-Resistant Tablets
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Pack Copy Specification |
Aspirin 75mg Gastro-Resistant Tablets - Leaflet |
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Marketing Authorisation number |
PL 16028/0026 |
<Insert Registered Product Name here>
Aspirin 75mg Gastro-Resistant Tablets
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist or doctor if you need more information or advice.
• You must contact a doctor or pharmacist if your symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
1. WHAT THIS MEDICINE IS FOR
Aspirin 75mg Gastro-Resistant Tablets contain aspirin which belongs to a group of medicines called antiplatelet agents. Platelets are cells in the blood that cause it to clot so anti-platelet agents help prevent blood clotting.
These tablets are used for preventing further heart disease such as heart attacks (myocardial infarctions), or strokes (caused by a blood clot in the brain) in patients who have already suffered from these. They can also be taken following bypass surgery.
The tablets are specially coated (called ‘gastro-resistant’ or ‘enteric-coated’) so that they do not dissolve until they have passed through the stomach.
2. BEFORE YOU TAKE THE MEDICINE
Do not take the Aspirin 75mg Gastro-Resistant Tablets if you:
• are under 16 years old, unless your doctor tells you to
• have or have ever had a stomach ulcer or an ulcer in your intestine
• are allergic to aspirin, to any of the ingredients (listed in section 6), or to ibuprofen or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
• have a stomach ulcer, or have had one
• have kidney or severe liver failure
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Pack Copy Specification |
Aspirin 75mg Gastro-Resistant Tablets - Leaflet |
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Marketing Authorisation number |
PL 16028/0026 |
• suffer from a bleeding disorder (e.g. haemophilia), or are taking medicines to thin your blood.
• have gout
• are taking other NSAID painkillers (for example ibuprofen)
• are pregnant or breast-feeding
• suffer from asthma.
There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.
Talk to your doctor or pharmacist before taking Aspirin 75mg Gastro-Resistant Tablets if you:
• are taking this product for the first time. Your doctor will be able to advise on the relative benefits and risks of long-term treatment with aspirin for you
• suffer from alcohol-related liver disease (noncirrhotic)
• have high blood pressure (your doctor may want to monitor you more closely)
• have allergic disease
• are dehydrated
• have diabetes
• have a condition called glucose-6-phosphate dehydrogenase deficiency
• if you are elderly (your doctor may want to monitor you more closely).
If you drink alcohol (wine, beer, spirits) when you are taking these tablets, it may make your stomach more sensitive to aspirin.
If you are taking other medicines:
You must not take these tablets if you are taking certain other medicines - see section 2 ‘Do not take Aspirin 75mg Gastro-Resistant Tablets if.
Talk to your pharmacist or doctor before you take the tablets if you are taking any regular medication, especially:
• medicines taken to treat diabetes (e.g. metformin or glibenclamide) or insulin
• medicines for water tablets (diuretics e.g. spironolactone)
• medicines to prevent the formation of blood clots (e.g. heparin or warfarin)
• corticosteroids (used for many conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems)
• medicines used to treat high blood pressure or congestive heart failure (e.g. captopril, enalapril or lisinopril)
• methotrexate (a medicine for cancer, skin problems, rheumatic problems, Crohn’s disease)
• probenecid and sulfinpyrazone (medicines for gout)
• acetazolamide (a medicine for the eye disorder glaucoma, epilepsy and water retention)
• metoclopramide (a medicine used to treat the feeling of sickness and being sick)
• phenytoin and sodium valproate (medicines for epilepsy)
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Pack Copy Specification |
Aspirin 75mg Gastro-Resistant Tablets - Leaflet |
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Marketing Authorisation number |
PL 16028/0026 |
• antacids (medicines for acid indigestion) or adsorbents (e.g. kaolin for diarrhoea)
• medicines for depression
• Mifepristone (for termination of pregnancy) - do not take this medicine for 8-12 days after taking mifepristone
• Other non-steroidal anti-inflammatory medicines, including aspirin, ibuprofen (to relieve pain, reduce swollen joints, muscles and ligaments)
• Sulphonamide antibiotics (e.g. co-trimoxazole)
• Zafirluklast (for asthma).
Pregnancy and breastfeeding
Do not take Aspirin 75mg Gastro-Resistant Tablets if you are in the last three months of pregnancy, or you are breastfeeding. Talk to your doctor or pharmacist before taking if you are in the first six months of pregnancy.
Important information about some of the ingredients of your medicine
This product 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 medicinal product.
3. HOW TO TAKE THE MEDICINE
Talk to your doctor before taking these tablets for the first time.
Take the tablets whole with a drink of water.
Do not crush or chew them before you swallow them.
Do not take indigestion remedies just before or straight after you take the tablets.
Adults, the elderly and children over 16 years of age
Dose and how often to take
1 or 2 tablets a day.
A doctor may advise taking a different dose to the usual dose shown above because, sometimes, you will need to take up to four tablets a day to start with. You should always follow your doctor’s instructions about taking your medicine.
Before you decide to stop taking this medicine please consult with your doctor.
DO NOT EXCEED THE STATED DOSE.
Do not give to children under 16 years._
If you take too many tablets: Talk to a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you.
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Pack Copy Specification |
Aspirin 75mg Gastro-Resistant Tablets - Leaflet |
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Marketing Authorisation number |
PL 16028/0026 |
4. POSSIBLE SIDE EFFECTS
Most people take Aspirin 75mg Gastro-Resistant Tablets without any problems, but it can have side effects, like all medicines.
STOP TAKING the tablets and contact your doctor immediately if you develop any of the following symptoms at any time while taking your medicine:
Allergic reactions:
The following reactions may mean you are having an allergic reaction to this medicine:
• asthma, worsening of asthma, unexplained wheezing or shortness of breath
• swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• Also, there may be skin reaction (including hives, rash and itching) - very rarely these can be severe with blistering and peeling skin.
Stomach and bowel problems including:
• stomach discomfort or pain, nausea, indigestion or heartburn, stomach ulcer
• vomit with blood or dark particles (like coffee grounds)
• black tarry stools or blood passed in your stools
• worsening of bowel problems (ulcerative colitis or Crohn’s disease).
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion
• nose bleeds (if a nose bleed is severe or lasts for a long time, talk to your doctor straight away)
• unusual bleeding which may cause blood in the urine, coughing up blood or a stroke due to bleeding in the brain.
• pain in your lower abdomen or back, difficulty in passing urine - this maybe a sign of kidney stones.
Other side effects that may occur include those listed below.
Other stomach and intestine effects including:
• diarrhoea, flatulence (excess wind), constipation and vomiting (being sick).
Nervous system problems including:
• hearing disorders (such as tinnitus, a ringing in the ears), vertigo (a type of dizziness) and mental confusion.
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Pack Copy Specification |
Aspirin 75mg Gastro-Resistant Tablets - Leaflet |
|
Marketing Authorisation number |
PL 16028/0026 |
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. STORING THE MEDICINE
Do not use after the expiry date shown on the pack.
Store the tablets below 25°C in a dry place.
Keep all medicines out of the reach and sight of children.
6. FURTHER INFORMATION
What is in this medicine
The active ingredient is: Aspirin 75mg per tablet.
Other ingredients are: Lactose, starch, sucrose, talc, methacrylic acid-ethyl acrylate copolymer (1:1), polyethylene glycol, hydroxypropylmethylcellulose and titanium dioxide (E171).
What this medicine looks like and contents of the pack
Aspirin 75mg Gastro-Resistant Tablets are small, round white coated tablets and are available in packs containing 12, 14, 16, 28, 32, 56 or 100 tablets (not all packs may be marketed and packs of 32, 56 and 100 tablets are only available from your pharmacist).
Marketing Authorisation Holder:
Galpharm Healthcare Ltd, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom Manufacturer:
Galpharm International Ltd, Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS