SALOFALK 1G SUPPOSITORIES

Active substance: MESALAZINE

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Salofalk 1g Suppositorien Gebrauchsinformation (GI) für Großbritannien-Irland
Format: 300 x 185 mm
Druckfarben: 2/2 (Schwarz + Pant. 644)
Mat.-Nr.: Mock-up (Vifor AG)
Falk-Datumscode: GB-IE/03.14

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Salofalk ® 1g Suppositories
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.
This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
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.

In this leaflet:
1. What Salofalk 1g Suppositories are and what they are used for
2. Before you use Salofalk 1g Suppositories
3. How to use Salofalk 1g Suppositories
4. Possible side effects
5. How to store Salofalk 1g Suppositories
6. Further information

1.  HAT SALOFALK 1g SUPPOSITORIES ARE AND
W
WHAT THEY ARE USED FOR

– 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):
− Certain agents that inhibit blood clotting (medicines for thrombosis
or to thin your blood, e.g., warfarin)
–  zathioprine, 6-mercaptopurine or thioguanine (medicines used to
A
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 all right for you to use Salofalk 1g 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.
You should only use Salofalk 1g Suppositories during pregnancy if your
doctor tells you to.
You should also only use Salofalk 1g Suppositories during breast-feeding if
your doctor tells you to, as this medicine may pass into breast milk.

Salofalk 1g Suppositories contain the active substance mesalazine, an
anti-inflammatory agent used to treat inflammatory bowel disease.

Driving and using machines

Salofalk 1g Suppositories are used for:
–  treatment of mild to moderate acute episodes of an inflammatory
the

disease limited to the rectum (back passage) known by doctors as
ulcerative colitis or ulcerative proctitis.

Important information about some of the ingredients of
Salofalk 1g Suppositories

2.  EFORE YOU USE SALOFALK 1g SUPPOSITORIES
B
Do not use Salofalk 1g Suppositories:





If you are or have been told you are allergic (hypersensitive) to salicylic
acid, to salicylates such as Aspirin® or to the other ingredient of Salofalk 1g
Suppositories (it is listed in section 6, Further information).
If you have a serious liver or kidney disease.

Take special care with Salofalk 1g Suppositories.
Before you start using this medicine you should tell your doctor:
− 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.

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

The other ingredient in Salofalk 1g Suppositories is not likely to cause side
effects (see 6. FURTHER INFORMATION).

3.  OW TO USE SALOFALK 1g SUPPOSITORIES
H
Always take Salofalk 1g 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 Salofalk 1g suppository 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
1g Suppositories regularly and consistently, as directed.
If you think your Salofalk 1g Suppositories are too strong or too weak, talk to
your doctor.

If you use more Salofalk 1g 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 much Salofalk 1g Suppositories on one occasion, just take
your next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk 1g Suppositories

Do not take a larger than normal dose of Salofalk 1g Suppositories next time,
but continue treatment at the prescribed dosage.

If you stop using Salofalk 1g Suppositories

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Salofalk 1g 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 these
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
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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 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.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorised in the Member States of
the EEA under the following names:

Austria, Bulgaria, Czech Republic, Cyprus, Denmark, Finland, Germany,
Great Britain, Greece, Hungary, Ireland, Latvia, Lithuania, The Netherlands,
Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Sweden
and Spain: Salofalk®.
Belgium and Luxembourg: Colitofalk®.

5. HOW TO STORE SALOFALK 1g SUPPOSITORIES
Keep out of the reach and sight of children.
Do not use Salofalk 1g Suppositories after the expiry date which is stated on
the strip for the Suppositories and on the carton. The expiry date refers to
the last day of that month.

This leaflet was last approved in 03/2014.
PL 08637/0018
PA 0573/4/4

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 1g Suppositories contain

The active substance in Salofalk 1g Suppositories is mesalazine, and one
suppository of Salofalk 1g Suppositories contains 1 g mesalazine.
The other ingredient is
hard fat.

What Salofalk 1g Suppositories look like and contents
of the pack

Salofalk 1g Suppositories are light beige coloured, torpedo-shaped
suppositories.
Salofalk 1g Suppositories are available in packs of 10,12, 15, 20, 30, 60,
90 suppositories.
Not all package sizes may be marketed.

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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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