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SALOFALK ENEMA 2G

Active substance: MESALAZINE

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Salofalk 2g60ml Klysmen Gebrauchsinformation (GI) für Großbritannien
Format: 300 x 185 mm
Druckfarben: 2/2 (Schwarz + Pant. 644 C)
Mat.-Nr.: Mock-up (Vifor AG)
Falk-Datumscode: GB/07.13

PACKAGE LEAFLET: INFORMATION FOR THE USER

Salofalk ® Enema 2g
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
T
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
I
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Salofalk enemas are and what they are used for
2. Before you use Salofalk enemas
3. How to use Salofalk enemas
4. Possible side effects
5. How to store Salofalk enemas
6. Further information
1.  HAT SALOFALK ENEMAS 2G ARE AND WHAT THEY
W
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
t
parts of the colon and the rectum (back passage) known by
doctors as ulcerative colitis or ulcerative proctitis.

Take special care with Salofalk enemas
Before you start using this medicine you should tell
your doctor:

− f you have a history of problems with your lungs, particularly if
I
you suffer from bronchial asthma.
− f you have a history of allergy to sulphasalazine, a substance
I
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):
−  ertain agents that inhibit blood clotting (medicines for
C
thrombosis or to thin your blood, e.g., warfarin)
–  zathioprine, 6-mercaptopurine or thioguanine (medicines
A
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
enemas 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.
You should only use Salofalk enemas during pregnancy if your
doctor tells you to.

3. HOW TO USE SALOFALK ENEMAS 2G

Always take Salofalk enemas 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 enema once a day, at bedtime.
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 use Salofalk enemas

–  you are or have been told you are allergic (hypersensitive)
If
to salicylic acid, to salicylates such as Aspirin® or to the other
ingredient of the enemas (listed in section 6, Further information).
− If you have a serious liver or kidney disease.

Mockup_SAE2g60ml_GI_GB.indd 1

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

Driving and using machines
2.  EFORE YOU USE SALOFALK ENEMAS 2G
B

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

If you stop using Salofalk enemas

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

Important information about some of the ingredients
of Salofalk Enemas 2g

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.

This medicine 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 6. Further information).

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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
A
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
C
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 and 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

Mockup_SAE2g60ml_GI_GB.indd 2

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.

Manufacturer

Leinenweberstr. 5
79108 Freiburg
Germany

5. HOW TO STORE SALOFALK ENEMAS 2G
Keep out of the reach and sight of children.
Do not use Salofalk enemas 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.

This leaflet was last approved in
August 2013
PL 10341/0008

Do not store above 30°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 enemas contain

The active substance in Salofalk enemas 2g 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/07.13

01.08.13 09:32

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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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