SALOFALK 1G SUPPOSITORIES

Active substance: MESALAZINE

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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

– 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):
−  zathioprine, 6-mercaptopurine or thioguanine (medicines used to
A
treat immune disorders).
−  ertain agents that inhibit blood clotting (medicines for thrombosis or
C
to thin your blood, e.g. warfarin)
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.

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.

You should only use Salofalk® 1g Suppositories during pregnancy if your
doctor tells you to.
1.  HAT SALOFALK® 1g SUPPOSITORIES ARE AND
W
WHAT THEY ARE USED FOR

Pregnancy and breastfeeding

If you stop using Salofalk® 1g Suppositories

You should also only use Salofalk 1g 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.

Ask your doctor or pharmacist for advice before taking any medicine.

®

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

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

Driving and using machines

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

4. POSSIBLE SIDE EFFECTS

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

Like all medicines, Salofalk® 1g Suppositories can cause side effects, although
not everybody gets them.

2.  EFORE YOU USE SALOFALK® 1g SUPPOSITORIES
B

Do not use Salofalk® 1g Suppositories:

–  you are or have been told you are hypersensitive (allergic) to salicylic
If
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.

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.

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
−  hest pain, breathlessness or swollen limbs because of an effect on your
C
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
C
− Severe abdominal pain because of acute inflammation of the pancreas
− Fever, sore throat or malaise, because of blood count changes
−  hortness of breath, cough, wheezing, lung shadow on x-ray due to
S
allergic and/or inflammatory lung conditions
−  evere diarrhoea and abdominal pain because of an allergic reaction to
S
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.
5. HOW TO STORE SALOFALK® 1g SUPPOSITORIES

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.

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 approved in 01/2012

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.
Do not store above 25 °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.


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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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