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Active substance(s): MESALAZINE

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Salofalk 500mg Suppositorien Gebrauchsinformation (GI) für Großbritannien
Format: 300 x 185 mm
Druckfarben: (2/2) Schwarz + Pantone 644
Mat.-Nr.: Mock-up (Vifor AG)
Falk-Datumscode: GB/10.17
Leatuscode: 268
Font: 9pt / ZAB: 10,5pt


Package leaflet: Information for the user

Salofalk ® Suppositories 500mg
Read all of this leaflet carefully before you start using this
medicine because it contains important information for
– 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 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. See section 4.
What is in this leaflet:
1. What Salofalk suppositories are and what they are used for
2. What you need to know before you use Salofalk suppositories
3. How to use Salofalk suppositories
4. Possible side effects
5. How to store Salofalk suppositories
6. Contents of the pack and other information

1. What Salofalk suppositories 500mg are and
what they are used for
Salofalk suppositories contain the active substance mesalazine,
an anti-inflammatory agent used to treat inflammatory bowel
Salofalk suppositories are used for:
− the treatment of mild and moderate episodes of an
inflammatory disease in the rectum (back passage) known by
doctors as ulcerative colitis or ulcerative proctitis.

2. What you need to know before you use
Salofalk suppositories 500mg
Do not use Salofalk suppositories

– If you are allergic to salicylic acid, to salicylates such as aspirin
or to any of the other ingredients of this medicine (listed in
section 6).
− If you have a serious liver or kidney disease.

Warnings and precautions
Talk to your doctor or pharmacist before using this

− If you have a history of problems with your lungs, particularly
if you suffer from bronchial asthma.
− If you have a history of allergy to sulphasalazine, a substance
related to mesalazine.
− If you suffer with problems of your liver.
− If you suffer with problems of your kidney.
During treatment your doctor may want to keep you under
close medical supervision and you may need to have regular
blood and urine tests.

Other medicines and Salofalk suppositories 500mg

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any of the medicines mentioned below as
the effects of these medicines may change (interactions):
− Certain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood, e.g., warfarin)
– Azathioprine, 6-mercaptopurine or thioguanine (medicines
used to treat immune disorders).
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before using this medicine.
You should only use Salofalk suppositories during pregnancy if
your doctor tells you to.
You should also only use Salofalk suppositories during breastfeeding if your doctor tells you to, as this medicine may pass
into breast milk.

Driving and using machines

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

3. How to use Salofalk suppositories 500mg
Always use this medicine exactly as your doctor or pharmacist
has told you. 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.
Adults and elderly
The recommended dose is one or two suppositories two to
three times daily.
Use in 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
To obtain the maximum benefit from this medicine, you
should use Salofalk suppositories regularly and consistently, as
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 use
your next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk suppositories

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

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If you stop using Salofalk suppositories

Do not stop using this product until you have talked to your doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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):
− Abdominal pain, diarrhoea, wind (flatulence), nausea and
vomiting, constipation
– Headache, dizziness
– Chest pain, breathlessness or swollen limbs because of an
effect on your heart
– Increased sensitivity of your skin to sun and ultraviolet light
Very rare side effects (that affect less than 1 in 10,000 patients):
− Changes in kidney function, sometimes with swollen limbs
or flank pain

– Severe abdominal pain because of acute inflammation of the
– 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
– Reversible decrease in semen production
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via theYellow Card
Scheme Website:
By reporting side effects you can help provide more information
on the safety of this medicine.

6. Contents of the pack and other 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, SL8 5AS

Leinenweberstr. 5
79108 Freiburg

5. How to store Salofalk suppositories 500mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 30°C.
Store in the original container in order to protect contents from

This leaflet was last revised in
October 2017
PL 10341/0009

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the



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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.