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Active substance: MESALAZINE

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Salofalk 2g60ml Klysmen Gebrauchsinformation (GI) für Großbritannien
Format: 300 x 185 mm
Druckfarben: (2/2) Schwarz + Pantone 644
Mat.-Nr.: Mock-up (Vifor AG)
Falk-Datumscode: GB/04.15

Package leaflet: information for the user

Salofalk ® Enema 2g

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, ask your doctor or pharmacist.
−  his 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.
− f 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 enemas are and what they are used for
2. What you need to know before you use Salofalk enemas
3. How to use Salofalk enemas
4. Possible side effects
5. How to store Salofalk enemas
6. Contents of the pack and other information

1. What Salofalk Enemas 2g are and what they are used for
Salofalk enemas contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease.
Salofalk enemas are used for:
−  he treatment of mild episodes of an inflammatory disease in
parts of the colon and the rectum (back passage) known by
doctors as ulcerative colitis or ulcerative proctitis.

2.  hat you need to know before you use
Salofalk Enema 2g
Do not use Salofalk enemas

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

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Warnings and precautions
Talk to your doctor or pharmacist before using
Salofalk enema:

− f you have a history of problems with your lungs, particularly if
you suffer from bronchial asthma.
− f 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.
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.

Other medicines and Salofalk Enema 2g

Tell your doctor if you take or use any of the medicines mentioned
below as the effects of these medicines may change (interactions):
−  ertain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood, e.g., warfarin)
–  zathioprine, 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, including medicines obtained
without a prescription. It may still be alright for you to use Salofalk
enemas and your doctor will be able to decide what is suitable for

Pregnancy and breast-feeding

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 enemas during pregnancy if your
doctor tells you to.
You should also only use Salofalk enemas during breast-feeding 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.  ow to use Salofalk Enema 2g
Always use this medicine exactly as your doctor 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 enema once a day, at bedtime.
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 condition.
To obtain the maximum benefit from this medicine, you should use
Salofalk enemas regularly and consistently, as directed.
If you think your Salofalk enemas are too strong or too weak, talk to
your doctor.

If you use more Salofalk enemas 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 enemas on one occasion, just take your next
dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk enemas

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

If you stop using Salofalk enemas

Do not stop taking 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.

Salofalk Enema 2g contains sodium benzoate, which may be
mildly irritant to the skin, eyes and mucous membranes.

The other ingredients in Salofalk enemas are not likely to cause side
effects (see section 6).

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4. Possible side effects
Like all medicines, Salofalk enemas 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 enemas 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):
−  bdominal pain, diarrhoea, wind (flatulence), nausea and
vomiting, constipation
– Headache, dizziness
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 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 and bile flow disorders
– Hair loss and the development of baldness
Numbness and tingling in the hands and feet (peripheral
– Reversible decrease in semen production

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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 the national reporting system:
Yellow Card Scheme
By reporting side effects you can help provide more information on
the safety of this medicine.


Leinenweberstr. 5
79108 Freiburg
This leaflet was last revised in

5. How to store Salofalk Enema 2g
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the bottle 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 light.
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 to protect the environment.

6. Contents of the pack and other information
What Salofalk enemas contain

The active substance is mesalazine and one enema contains
2g mesalazine.
The other ingredients are
Carbomer, disodium edetate, potassium acetate (E261), potassium
metabisulphite (E224), purified water, sodium benzoate (E211),
xanthan gum (E415).

What Salofalk enemas look like and contents
of the pack

Salofalk enemas are in a low-density, concertina shaped, polythene
bottle with a low-density polythene application nozzle.
Salofalk enemas are available in packs of 7
Marketing Authorisation Holder
Dr. Falk Pharma UK Ltd
Bourne End Business Park, Cores End Road
Bourne End, Buckinghamshire, SL8 5AS

Mock-up GB/04.15

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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.