SALOFALK 500MG SUPPOSITORIES

Active substance: MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Salofalk ® Suppositories 500mg
Mesalazine
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.
−  his medicine has been prescribed for you. Do not pass it on to
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others.
It may harm them, even if their symptoms are the same as yours.
− f any of the side effects gets serious, or if you notice any
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side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Salofalk suppositories are and what they are used for
2. Before you use Salofalk suppositories
3. How to use Salofalk suppositories
4. Possible side effects
5. How to store Salofalk suppositories
6. Further information
1.  HAT SALOFALK SUPPOSITORIES 500MG ARE
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AND WHAT THEY ARE USED FOR

Take special care with Salofalk suppositories
Before you start using this medicine you should tell your doctor:
− f you have a history of problems with your lungs, particularly if
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you suffer from bronchial asthma.
− f you have a history of allergy to sulphasalazine, a substance
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related to mesalazine.
− If you suffer with problems of your liver.
− If you suffer with problems of your kidney.
Further precautions
During treatment your doctor may want to keep you under close
medical supervision and you may need to have regular blood and
urine tests.
Using other medicines
Please tell your doctor if you take or use any of the medicines
mentioned below as the effects of these medicines may change
(interactions):
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−  ertain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood, e.g., warfarin)
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–  zathioprine, 6-mercaptopurine or thioguanine (medicines
used to treat immune disorders).
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. It may still be alright for you to use Salofalk
suppositories and your doctor will be able to decide what is suitable
for you.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

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3.  OW TO USE SALOFALK SUPPOSITORIES 500MG
Always take Salofalk suppositories exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.
Method of administration:
This medicine may only be used rectally, so it has to be inserted
through the anus. Do NOT take by mouth.
Dosage:
Adults and elderly
The usual dose is one or two suppositories two to three times daily.
Children
There is little experience and only limited documentation for an
effect in children.
Duration of treatment
Your doctor will decide how long you need to continue the
treatment with this medicine. This will depend on your condition.
To obtain the maximum benefit from this medicine, you should use
Salofalk suppositories regularly and consistently, as directed.
If you think your Salofalk suppositories are too strong or too weak,
talk to your doctor.
If you use more Salofalk suppositories than you should
Contact a doctor if you are in doubt, so he or she can decide what
to do.
If you use too many suppositories on one occasion, just take your
next dose as prescribed. Do not use a smaller amount.

Salofalk suppositories contain the active substance mesalazine, an
anti-inflammatory agent used to treat inflammatory bowel disease.

You should only use Salofalk suppositories during pregnancy if your
doctor tells you to.

Salofalk suppositories are used for:
−  he treatment of mild and moderate episodes of an inflammatory
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disease in parts of the colon and the rectum (back passage)
known by doctors as ulcerative colitis or ulcerative proctitis.

You should also only use Salofalk suppositories during breastfeeding if your doctor tells you to, as this medicine may pass
into breast milk.

If you forget to use Salofalk suppositories
Do not take a larger than normal dose of Salofalk suppositories next
time, but continue treatment at the prescribed dosage.

Driving and using machines
There are no effects on the ability to drive and use machines.

If you stop using Salofalk suppositories
Do not stop taking this product until you have talked to your doctor.

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2.  EFORE YOU USE SALOFALK SUPPOSITORIES 500MG
Do not use Salofalk suppositories
–  you are or have been told you are allergic (hypersensitive)
If
to salicylic acid, to salicylates such as Aspirin® or to the other
ingredients of the suppositories (listed in section 6, Further
information).
− If you have a serious liver or kidney disease.

Important information about some of the ingredients
of Salofalk Suppositories 500mg
The other ingredients in Salofalk suppositories are not likely to
cause side effects (see 6. Further information).

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Salofalk suppositories can cause side effects,
although not everybody gets them.
All medicines can cause allergic reactions although serious
allergic reactions are very rare. If you get any of the following
symptoms after taking this medicine, you should contact your
doctor immediately:
– Allergic skin rash
– Fever
– Breathing difficulties
If you experience a marked reduction of your general health,
especially if accompanied by fever, and/or a sore throat and mouth,
stop using the suppositories and contact your doctor immediately.
These symptoms can, very rarely, be due to a fall in the number of
white cells in your blood (a condition called agranulocytosis) which
may make you more prone to developing a serious infection. A
blood test can confirm whether your symptoms are due to an effect
of this medicine on your blood.
The following side effects have also been reported by patients
using mesalazine:
Rare side effects (that affect less than 1 in 1,000 patients):
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−  bdominal pain, diarrhoea, wind (flatulence), nausea and
vomiting, constipation
– Headache, dizziness
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Chest pain, breathlessness or swollen limbs because of an effect
on your heart
Very Rare side effects (that affect less than 1 in 10,000 patients):
−  hanges in kidney function, sometimes with swollen limbs
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or flank pain
Severe abdominal pain because of acute inflammation of the
– 
pancreas
Fever, sore throat or malaise because of blood count changes
– 
– 
Shortness of breath, cough, wheezing, lung shadow on x-ray due
to allergic and/or inflammatory lung conditions
Severe diarrhoea and abdominal pain because of an allergic
– 
reaction to this medicine within the bowel
– Skin rash or inflammation
– Muscle and joint pain
– Jaundice or abdominal pain because of liver or bile flow disorders
– Hair loss and the development of baldness

– 
Numbness and tingling in the hands and feet (peripheral
neuropathy)
– Reversible decrease in semen production
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.
5. HOW TO STORE SALOFALK SUPPOSITORIES 500MG
Keep out of the reach and sight of children.
Do not use Salofalk suppositories after the expiry date which is
stated on the blister strip and on the carton. The expiry date refers
to the last day of that month.
Do not store above 25°C.
Store in the original container in order to protect contents from
light.
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 Salofalk suppositories contain
The active substance is mesalazine and one suppository contains
500mg mesalazine.
The other ingredients are
Hard fat, docusate sodium, cetyl alcohol.
What Salofalk suppositories look like and contents of the pack
Salofalk® suppositories are in white opaque PVC/PE strips of 5.
Available in packs of 10 or 30 suppositories.
Not all packs may be marketed.
Marketing Authorisation Holder
Dr. Falk Pharma UK Ltd
Bourne End Business Park, Cores End Road
Bourne End, Buckinghamshire, SL8 5AS

Manufacturer
Leinenweberstr. 5
79108 Freiburg
Germany

This leaflet was last approved in
March 2012

PL 10341/0009

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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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