SALOFALK 500MG GASTRO-RESISTANT TABLETS

Active substance: MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Salofalk® 500mg
gastro-resistant tablets
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 500mg tablets are and
what they are used for
2. Before you take Salofalk 500mg tablets
3. How to take Salofalk 500mg tablets
4. Possible side effects
5. How to store Salofalk 500mg tablets
6. Further information
W
1.  HAT SALOFALK 500mg TABLETS ARE AND
WHAT THEY ARE USED FOR
Salofalk 500mg tablets contain the active substance
mesalazine, an anti-inflammatory agent used to treat
inflammatory bowel disease.
Salofalk 500mg tablets are used for:
– the treatment of acute episodes and prevention of further
episodes (recurrence) of an inflammatory disease of the
large intestine (colon), known by doctors as ulcerative
colitis.

Take special care with Salofalk 500mg tablets.
Before you start taking 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.
– 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.
In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileo-coecal area with removal of the
ileocoecal valve, it has been observed that Salofalk 500mg
tablets are excreted undissolved in the stool, due to an excessively rapid passage through the bowel. If you notice this
occurrence in your own case, please inform your doctor.

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 medicines that affect blood clotting (medicines
for thrombosis or to thin your blood, e.g., warfarin)
− Azathioprine, 6-mercaptopurine or thioguanine
(medicines 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 all right for
you to use Salofalk 500mg tablets 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 500mg tablets during pregnancy
if your doctor tells you to.

2.  EFORE YOU TAKE SALOFALK 500mg TABLETS
B

You should also only use Salofalk 500mg tablets during
breast-feeding if your doctor tells you to, as this the medicine may pass into breast milk.

Do not take Salofalk 500mg tablets:

Driving and using machines







If you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin® or to
any of the other ingredients of Salofalk 500mg tablets
(these are listed in section 6, Further information).
If you have a serious liver or kidney disease.

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

Important information about some of the
ingredients of Salofalk 500mg tablets

One Salofalk 500mg tablet contains 2.1 mmol (49 mg)
sodium. If you need to be on a controlled sodium salt diet,
you should take this into consideration.

3.  OW TO TAKE SALOFALK 500mg TABLETS
H
Always take Salofalk 500mg tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
Method of administration
Salofalk 500mg tablets are for oral use only.
Take the tablets in the morning, at midday and in the
evening, 1 hour before meals. They should be swallowed
whole, not chewed, and taken with plenty of fluid.
Dosage

If you think that the effect of Salofalk 500mg tablets is too
strong or too weak, talk to your doctor.

If you take more Salofalk 500mg tablets
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 500mg tablets on one
occasion, just take your next dose as prescribed. Do not
use a smaller amount.

If you forget to take Salofalk 500mg tablets

Do not take a larger than normal dose of Salofalk 500mg
tablets next time, but continue treatment at the prescribed
dosage.

Adults and the elderly
Ulcerative colitis
acute episode

prevention of
recurrence/ long-term
treatment

Mesalazine
(active
substance)

1.5 g

3.0 g

1.5 g

Salofalk 500mg
gastro-resistant
tablets

3x1
to
3x2

3x1

If you stop taking Salofalk 500mg tablets

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

Children
There is only limited documentation for an effect in children
(age 6-18 years).
Children 6 years of age and older
Please ask your doctor about the precise dosage of
Salofalk 500mg tablets for your child.
In acute episodes: to be determined individually, starting
with 30-50 mg mesalazine per kg body weight per day that
should be given in divided doses. The maximum dose is
75 mg mesalazine per kg body weight per day. The total
dose should not exceed the maximum adult dose.
To prevent a relapse: to be determined individually, starting
with15-30 mg mesalazine per kg body weight per day that
should be given in divided doses. The total dose should not
exceed the recommended adult dose.
It is generally recommended that half the adult dose should
be given to children up to a body weight of 40 kg; and the
normal adult dose to those above 40 kg.
Duration of treatment
How long you will use the medicine depends upon your
condition. Your doctor will decide how long you are to
continue the medication.
You should follow the treatment with Salofalk 500mg tablets
regularly and consistently both during the acute episode of
inflammation and also as long-term treatment, because this
is the only way to achieve the desired therapeutic effect.

Like all medicines, Salofalk 500mg tablets 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 tablets 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
− 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):
− 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 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
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 500mg TABLETS
Keep out of the reach and sight of children.
Do not use Salofalk 500mg tablets after the expiry date
which is stated on the carton and the blister. The expiry date
refers to the last day of that month.

What Salofalk 500mg tablets look like and
contents of the pack

Salofalk 500mg tablets are oval, light yellow to ochre,
gastro-resistant tablets, matt with smooth surface; they
are not scored.
Salofalk 500mg tablets are available in blister packs of
20, 45, 50, 90, 100 and 300 tablets.
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, Cyprus, Czech Republic, Estonia, Germany,
Great Britain, Greece, Hungary, Latvia, Lithuania, Malta, The
Netherlands, Poland, Portugal, Romania, Slovak Republic,
Slovenia and Spain: Salofalk®
Belgium and Luxembourg: Colitofalk®
Finland and Norway: Mesasal®
This leaflet was last approved in 01/2012

This medicinal product does not require any special storage
conditions.
6. FURTHER INFORMATION

What Salofalk 500mg tablets contain

The active substance in Salofalk 500mg tablets is mesalazine,
and one tablet of Salofalk 500mg tablets contains 500 mg
mesalazine.
The other ingredients are:
Calcium stearate; cellulose, microcrystalline; croscarmellose
sodium; basic butylated methylacrylate copolymer (=Eudragit
E); methacrylic acid-methyl methacrylate copolymer (1:1)
(=Eudragit L); glycine; silica, colloidal anhydrous; hypromellose; macrogol 6000; sodium carbonate, anhydrous;
povidone K25; talc; colouring agents: titanium dioxide
(E 171); iron oxide hydrate (E 172)



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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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