Allopurinol 100mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Allopurinol 100mg Tablets Allopurinol 300mg Tablets (Allopurinol)
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, please ask your doctor or pharmacist.
- The 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.
What is in this leaflet
1. What Allopurinol tablets are and what they are used for
2. What you need to know before you take Allopurinol tablets
3. How to take Allopurinol tablets
4. Possible side effects
5. How to store Allopurinol tablets
6. Contents of the pack and other information
1. What Allopurinol tablets are and what they are used for
The name of your medicine is Allopurinol 100mg or 300mg tablets. The active substance is allopurinol.
Allopurinol belongs to a group of medicines called xanthine-oxidase inhibitors.
Allopurinol tablets are used in:
• the management of gout and other conditions associated with too much uric acid in the body, such as kidney disease, metabolic disorders, certain skin diseases, cancer and treatment with diuretics (“water tablets”).
• certain types of kidney stones.
2. What you need to know before you take Allopurinol tablets Do not take Allopurinol tablets if you:
• have ever had an allergic reaction (rash, itching, shortness of breath) to Allopurinol or any of the other ingredients (these are listed in Section 6)
• are currently suffering from an acute attack of gout.
Warnings and Precautions
Check with your doctor or pharmacist before taking your medicine if:
• You have severe liver or kidney disease or kidney problems, you may be given a lower dose.
• Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin.
These serious skin reactions can be more common in people of Han Chinese or Thai origin.
• You have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of, you must not be restarted on Allopurinol tablets at any time.
The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Allopurinol Tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
It is important to let your doctor know if you are taking ANY of the following medicines:
• azathioprine (to treat rheumatoid arthritis and after organ transplants)
• ciclosporin (to treat psoriasis, rheumatoid arthritis or after organ transplants)
• 6-mercaptopurine (used to treat some cancers and bowel diseases)
• cyclophosphamide, doxorubicin, bleomycin or procarbazine (drugs used to treat leukaemias and some cancers)
• adenine arabinoside
• probenecid (used in gout)
• phenytoin (used in epilepsy)
• theophylline (to treat asthma)
• ampicillin or amoxicillin (antibiotics)
• aspirin or related medicines (salicylates)
• drugs to prevent blood from clotting (such as warfarin)
• chlorpropamide (used in diabetes)
• didanosine (antiviral)
• diuretics (water tablets) or ACE inhibitors such as captopril (used in high blood pressure)
• indigestion remedies (should not be taken within 3 hours of taking allopurinol)
Allopurinol tablets with food, drink and alcohol
• Take Allopurinol with food and water.
Pregnancy, breast-feeding and fertility
• Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
• Allopurinol tablets may make you feel dizzy, affect your co-ordination or make you sleepy. Make sure you are not affected before you drive or operate machinery.
Allopurinol tablets contain Lactose and Sodium Starch
Glycolate.
• Allopurinol 100mg Tablets: Each 100mg tablet contains 138.5mg of lactose.
• Allopurinol 300mg Tablets: Each 300mg tablet contains 70.8mg of lactose.
• If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor or pharmacist before taking this medicine.
• Allopurinol tablets 300mg also contains SODIUM STARCH GLYCOLATE. Sodium may be harmful to people on a low sodium diet.
3. How to take Allopurinol tablets
• Always take Allopurinol tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Before starting treatment with allopurinol your doctor may give you an anti-inflammatory drug or colchicine, this helps prevent you getting acute gout attacks.
• If you are taking allopurinol for cancer then treatment with allopurinol will begin before treatment with cancer drugs.
Doses:
Adults:
Starting dose of 100-300mg once a day, this may be increased
to 200-600mg a day in divided doses. A maximum dose of over
900mg a day is rarely needed. g
150 mm
Allopurinol tablets insert two
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Children (usually restricted to metabolic disease or cancer):
10-20mg per kg of body weight a day.
Elderly or patients with kidney disease:
Your doctor may prescribe a smaller dose.
If you take more Allopurinol tablets than you should
• If you have accidentally taken one extra dose, this is unlikely to be a cause for concern. However if you or someone else has taken a large overdose, contact your nearest hospital A&E (casualty department) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
If you forget to take Allopurinol tablets
• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Allopurinol Tablets
• Do not suddenly stop taking these tablets without talking to your doctor. Your symptoms may recur if you stop taking them suddenly. Treatment should continue for as long as your doctor feels it is needed. If you have any further questions on the use of this product, ask your doctor or pharmacist.
| 4. Possible side effects |
Like all medicines, Allopurinol can cause side effects, although not everybody gets them.
Stop taking Allopurinol tablets and contact your doctor at once if you experience the following allergic reactions:
• itchy or flaky skin rash, blistered, peeling skin or sore lips and mouth
• swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• changes in the amounts of blood cells; causing increased bruising, nosebleeds, sore throats or infections.
• fever, swollen lymph glands, joint pain, swollen blood vessels, inflammation of the liver (hepatitis), jaundice (yellowing of the skin or whites of the eyes), kidney damage (blood in the urine) or fits.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Uncommon (may affect up to 1 in 100 people)
• feeling or being sick (occasionally with blood)
• changes in liver function tests
Rare (may affect up to 1 in 1,000 people)
• boils
• fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell
• any changes to your skin, for example ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters or peeling
• Serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder)
Very rare (may affect up to 1 in 10,000 people)
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2)
• weakness, numbness, ‘pin and needles', ‘spinning' sensation, unable to move muscles (paralysis), drowsiness, loss of consciousness
• feeling thirsty, tired and losing weight; these may be signs of diabetes, taste changes, build up of fluid leading to swelling (oedema) high levels of cholesterol in the blood (hyperlipidaemia)
• depression
• hair loss
• cataracts, changes in vision
• blood in the urine, a change in bowel habit
• high temperature, a general feeling of being unwell, headache
• high blood pressure
• enlarged breasts in men and women, difficulty maintaining erection, infertility.
Not known (frequency cannot be estimated from the available data)
• worsening of gout, dizziness, diarrhoea, stomach pain, kidney stones, ‘wet dreams'.
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. How to store Allopurinol tablets
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton or label. The expiry date refers to the last day of that month.
• Securitainers: Store in a cool, dry place and protect from light.
• Blister packs: Do not store above 250C. Keep the blister in the outer carton to protect from light and moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This measures will help protect the environment.
6. Contents of the pack and other information
• Each tablet contains Allopurinol as the active ingredient
• Each Allopurinol 100 mg Tablet contains 100mg of Allopurinol
• Each Allopurinol 300 mg Tablet contains 300mg of Allopurinol
• The other ingredients are: lactose, maize starch, povidone and magnesium stearate. The 300mg tablets also contain sodium starch glycollate.
• Allopurinol 100mg tablets are white, round, biconvex, uncoated tablets marked with ‘100' on one face and ‘BL' on the other.
• Allopurinol 300mg tablets are white, round, biconvex, uncoated tablets marked with ‘300' on one face and ‘BL' on the other.
• Allopurinol 100mg Tablets come in packs of 28, 30, 56, 60, 84, 90 and 250
• Allopurinol 300mg Tablets come in packs of 28, 30, 56, 60 and 100
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Allopurinol 100mg Tablets; PL 17907/0139 Allopurinol 300mg Tablets; PL 17907/0140 This leaflet was last revised in September 2014 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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250 mm
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