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ASACOL FOAM ENEMA

Active substance(s): MESALAZINE / MESALAZINE / MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USERS
Asacol Foam Enema
(mesalazine)


– 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.

your doctor or pharmacist.
1. What Asacol Foam Enema is and what it is used for 4. Possible side effects
2. Before you use Asacol Foam Enema
5. How to store Asacol Foam Enema
3. How to use Asacol Foam Enema
6. Further information
1. WHAT ASACOL FOAM ENEMA IS AND WHAT IT IS USED FOR
Asacol Foam Enema contains the active substance mesalazine (also known as 5-aminosalicylic acid) which
Ulcerative colitis.
Ulcerative colitis is a disease of the large bowel (colon) and back passage (rectum) in which the lining of the
2. BEFORE YOU USE ASACOL FOAM ENEMA
Do not use Asacol Foam Enema if you:
• are allergic (hypersensitivity) to any of the ingredients in the product (see Section 6 on ‘What Asacol
Foam Enema contains’)
• are allergic to aspirin or any other salicylate
• had kidney problems or blood abnormalities while taking other medicines such as sulphasalazine
kidney impairment.

Do not use the foam in children under 2 years of age.
Take special care with Asacol Foam Enema

• Asacol should be used with caution in the elderly.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including those
obtained without a prescription.
(NSAIDs such as ibuprofen, aspirin, Cox-II inhibitors) and
Use of
azathioprine in particular may increase the risk of kidney reactions.
Pregnancy and breast-feeding
Women who are pregnant or breast-feeding should not use Asacol Foam Enema unless advised otherwise
by their doctor. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Asacol Foam Enema is not expected to affect your ability to drive or operate machinery.
3. HOW TO USE ASACOL FOAM ENEMA
Please read these instructions carefully, even if you have used Asacol Foam Enema before, as these
instructions have recently changed.
Asacol Foam Enema should not be swallowed.
Please use the product with care as it may cause staining to clothing and household articles.
DOSE FOR ADULTS AND THE ELDERLY: Please read the pharmacist’s label carefully as your doctor will
have instructed you whether to use one or two doses each day.
This medicine should be delivered to the back passage (rectum) as described below:
1.
shaking the
can vigorously for 15 seconds. Rest for about 30 seconds, and then shake the can
vigorously for another 15 seconds.
2.
dome.
3.
the dome with the spout.
4. Hold the can in the palm of one hand with the dome pointing downwards.This product
must only be dispensed when the can is upside down, with the dome nearest the
ground (if the can is not upside down, the foam will not come out properly).
5.
surface such as a stool or chair, and insert the applicator into the rectum as far as is
comfortable. You can apply a lubricating jelly to the tip of the applicator for comfort if
you wish.
6. To administer one dose, fully push the dome down once and release it. The foam
will not come out of the can until you release the dome. To administer a second
dose, press and release the dome again. Wait for 15 seconds before withdrawing the
applicator. Note, the can will only work properly when held with the dome pointing
downwards.
foam can 7. Remove the applicator and dispose of it in one of the plastic bags provided. Do not
applicator
spout

notch

safety tag
dome

8. Before using the enema again, mix the contents of the can by shaking vigorously for
5 seconds only, before continuing to use the enema as instructed above.
DO NOT use Asacol Foam Enema more than twice in 12 hours.

Do not use this medicine in children under 2 years of age.
treatment too early. Your doctor will normally recommend that you take treatment for between 4 and 6 weeks.
If you use more Asacol Foam Enema than you should
Do not exceed the recommended dose. You should only use as much enema as your doctor has instructed
on the pharmacist’s label. If you use too much, tell your doctor immediately or go to your nearest Accident
& Emergency Department (take the foam enema pack with you if possible).
If you forget to use Asacol Foam Enema
If you forget to use your enema at the required time, take the dose as soon as you remember and continue
using the foam as before. Do not use Asacol Foam Enema more than twice in 12 hours.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Asacol Foam Enema can cause side effects, although not everybody gets them.
Allergic reactions to the enema can occur. Tell your doctor if you get a rash (with or without itching),
any shortness of breath, palpitations (rapid heart beat) or chest pain. These effects will usually
disappear when you stop using the medicine.
Tell your doctor immediately if you experience any of the following symptoms:
• fever, sore throat, mouth or lip ulcers, spots underneath your skin anywhere on your body, including the
genital and anal regions, become very pale, swollen ankles or have unusual bleeding (e.g. unexpected
nosebleeds or bleeding gums)

• bruising more easily or suspect blood abnormalities
• problems with kidney function.
Common side effects:
• diarrhoea
• nausea (feeling sick)
• abdominal pain
• headache.
Rare side effects:
• problems with heart, lung, liver or kidney function
• hair loss
• skin rash

• blood abnormalities
• local irritation at site of application.

Very rare side effects:
• worsening of symptoms of colitis
• Erythema multiforme and Stevens-Johnson syndrome (skin and mucous membrane disease).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
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 ASACOL FOAM ENEMA
Keep out of the reach and sight of children.
Store Asacol Foam Enema below 30ºC (86ºF).
pierce or burn the product, even when it is empty.
Do not use the enema after the expiry date stated on the pack after ‘Exp’. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Asacol Foam Enema contains
The active substance is mesalazine (5-aminosalicylic acid). Each metered dose contains 1g of mesalazine.
The other ingredients are sorbitan oleate, polysorbate 20, emulsifying wax, colloidal anhydrous silica,
sodium metabisulphite (E223), disodium edetate, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), disodium phosphate dodecahydrate, sodium acid phosphate, glycerol (E422),
What Asacol Foam Enema looks like and contents of the pack
Asacol Foam Enema is a white foam. It is supplied in an aerosol can containing 14 metered doses with
14 disposable applicators and 14 disposable plastic bags.
Marketing Authorisation Holder
Allergan Pharmaceuticals International Limited, Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland
Manufacturer
Pharmasol Limited, North Way, Walworth Industrial Estate, Andover, Hampshire, SP10 5AZ, United
Kingdom.
Getting more advice about ulcerative colitis
In addition to advice and information available from your doctor and pharmacist, you may wish to contact
the National Association for Colitis and Crohn’s Disease which offers information, advice and local support
groups: National Association for Colitis and Crohn’s Disease
4 Beaumont House, Sutton Road, St. Albans, Hertfordshire, AL1 5HH
0800 198 5000.
Asacol® is a Trademark
Marketing Authorisation Number: PL 45496/0005
This leaflet was last revised in January 2016

MP00909
79992MD019H

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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