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Active substance(s): 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/03.15


Package leaflet: information for the user

Salofalk ® 1g Suppositories

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 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 1g Suppositories are and what they are used for
2. What you need to know 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. Contents of the pack and other information

1.  hat Salofalk 1g Suppositories are and what they are used for
Salofalk 1g Suppositories contain the active substance mesalazine, an
anti-inflammatory agent used to treat inflammatory bowel disease.

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.

Duration of treatment
Your doctor will decide how long you need to continue the treatment with
this medicine. This will depend on your condition.

Other medicines and Salofalk 1g Suppositories

To obtain the maximum benefit from this medicine, you should use Salofalk
1g Suppositories regularly and consistently, as directed.

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
treat immune disorders).
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. 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.

If you stop using Salofalk 1g Suppositories

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.

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

Driving and using machines

Salofalk 1g Suppositories are not expected to affect your ability to drive or
operate machines.

3.  ow to use Salofalk 1g Suppositories

− 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
– If you suffer with problems of your liver.
– If you suffer with problems of your kidney.

If you forget to use Salofalk 1g Suppositories

You should only use Salofalk 1g Suppositories during pregnancy if your
doctor tells you to.

2.  hat you need to know before you use Salofalk 1g

Warnings and precautions
Talk to your doctor before using Salofalk 1g Suppositories

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 this medicine, use it as soon as you remember.
However, if it is almost time for your next dose, skip the dose you missed.
Then use the next dose at its usual time. Do not use a double dose to make
up for a forgotten dose

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.

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

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

If you use more Salofalk 1g Suppositories than you should

Pregnancy and breast-feeding

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

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

Do not use Salofalk 1g Suppositories:

If you think your Salofalk 1g Suppositories are too strong or too weak, talk to
your doctor.

The other ingredient in Salofalk 1g Suppositories is not likely to cause side
effects (see section 6. Contents of the pack and other information).

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.

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

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
using 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.

Adults and older people
The recommended dose is one Salofalk 1g suppository once a day, at bedtime.
Use in children
There is little experience and only limited documentation for an effect in

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The following side effects have also been reported by patients using
Rare side effects (may affect up to 1 in 1,000 patients):
− Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting,
– Headache, dizziness
Chest pain, breathlessness or swollen limbs because of an effect on
your heart
Very rare side effects (may affect up to 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
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:
Republic of Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website:; E-mail:
United Kingdom
Yellow Card Scheme
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 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
Salofalk 1g Suppositories are available in packs of 10,12, 15, 20, 30, 60,
90 suppositories.
Not all package sizes may be marketed.

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®.

This leaflet was last revised in 03/2015.

5. How to store Salofalk 1g Suppositories
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 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.

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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.