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Active substance: MESALAZINE

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Salofalk 250mg Tablets

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 250mg Tablets are and what they are used for
2. Before you take Salofalk 250mg Tablets
3. How to take Salofalk 250mg Tablets
4. Possible side effects
5. How to store Salofalk 250mg Tablets
6. Further information

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 250mg 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.

Taking 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)
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 alright for you to use Salofalk 250mg 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.
Salofalk 250mg tablets contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease.
Salofalk 250mg 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.

Do not take Salofalk 250mg tablets:

–  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 250mg tablets (these are listed in section 6, Further
– If you have a serious liver or kidney disease.

Take special care with Salofalk 250mg tablets.
Before you start taking this medicine you should tell your

− 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.

You should only use Salofalk 250mg tablets during pregnancy if your
doctor tells you to.
You should only use Salofalk 250mg tablets during breastfeeding if your
doctor tells you to as this medicine may pass into breast milk.

Adults and the elderly
Ulcerative colitis
Acute episode

Mesalazine (active substance)
Salofalk 250mg tablets

Prevention of

1.5g – 3.0g


3 x 2 to 3 x 4


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 Salofak 250mg Tablets
for your child. In acute episodes: to be determined individually, starting
with 30 – 50 mg mesalazine per kg body weight per day to be given in
divided doses. The maximum dose is 75mg 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 with 15-30 mg
mesalazine per kg body weight per day to 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 40kg and the normal adult dose to those above 40kg. The
daily dose may be divided into three portions, taken in the morning, at noon
and at night

Driving and using machines

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.

Important information about some of the ingredients of
Salofalk 250mg tablets.

You should follow the treatment with Salofalk 250mg 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.

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

Salofalk 250mg tablets contain 48mg of sodium per tablet. To be taken
into consideration by patients on a sodium controlled diet.
Always take Salofalk 250mg 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 250mg 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.

If you think that the effect of Salofalk 250mg tablets is too strong or too
weak, talk to your doctor.

If you take more Salofalk 250mg 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 250mg tablets on one occasion, just take
your next dose as prescribed. Do not use a smaller amount.

If you forget to take Salofalk 250mg tablets

Do not take a larger than normal dose of Salofalk 250mg tablets next
time, but continue treatment at the prescribed dosage.

If you stop taking Salofalk 250mg 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.



Like all medicines, Salofalk 250mg tablets can cause side effects,
although not everybody gets them.

What Salofalk 250mg tablets contain

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
Rare side effects (that affect less than 1 in 1,000 patients):
– Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting
– Headache, dizziness
−  hest 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 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.
Keep out of the reach and sight of children.
Do not use Salofalk 250mg tablets after the expiry date which is stated
on the carton and the blister pack. The expiry date refers to the last day of
that month.

This medicinal product does not require any special storage conditions.

The active substance is mesalazine, one tablet contains 250 mg mesalazine.
The other ingredients are:
Sodium carbonate, glycine, povidone, microcrystalline cellulose (E460),
colloidal anhydrous silica, calcium stearate, hydroxypropylmethylcellulose
(E464), methacrylic acid copolymner (Eudragit L), talc, titanium dioxide
(E171), iron oxide (E172), polyethylene glycol, polymethacrylate (Eudragit E).

What Salofalk® 250mg tablets look like and
contents of the pack

Salofalk 250mg tablets are round, yellow to ochre, gastro-resistant
tablets, matt with smooth surface; they are not scored.
Salofalk 250mg tablets are available in blister packs of 100 tablets.

Marketing Authorisation Holder
Dr Falk Pharma UK Ltd
Bourne End Business Park
Cores End Road
Bourne End

Manufactured by:
Dr Falk Pharma GmbH, 79041 Freiburg, Germany
This leaflet was last approved in

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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.