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SALOFALK 500MG SUPPOSITORIES

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/05.15

268

Package leaflet: Information for the user

Salofalk Suppositories 500mg
®

Mesalazine
Read all of this leaflet carefully before you start using 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
T
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.
I
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.  hat Salofalk suppositories 500mg are and
W
what they are used for
Salofalk suppositories contain the active substance mesalazine, an
anti-inflammatory agent used to treat inflammatory bowel disease.
Salofalk suppositories are used for:
−  he treatment of mild and moderate episodes of an inflammatory
t
disease in parts of the colon and 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
–  you are allergic to salicylic acid, to salicylates such as aspirin or to
If
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 medicine:
− 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
I
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):
−  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).
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Dosage:
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 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 use your
next dose as prescribed. Do not use a smaller amount.

Pregnancy, breast-feeding and fertility
If your 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.

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.

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

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

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

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

4. Possible side effects

3.  ow to use Salofalk suppositories 500mg
H
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.

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
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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):
−  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
C
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
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: https://yellowcard.mhra.gov.uk
By reporting side effects you can help provide more information on
the safety of this medicine.

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 25°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 protect the environment.
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
Manufacturer
Leinenweberstr. 5
79108 Freiburg
Germany

This leaflet was last revised in
April 2015

PL 10341/0009
Mock-up GB/05.15
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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.

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