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SALOFALK 250MG TABLETS

Active substance(s): MESALAZINE

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Salofalk 250mg Tabletten Gebrauchsinformation (GI) für Großbritannien
Format: 300 x 200 mm
Druckfarben: (2/2) Schwarz + Pantone 644
Mat.-Nr.: Mock-up (Losan Pharma) Falk-Datumscode: GB/10.17
Grammatur: 50 g/m2
Laetuscode: 542
Machart: plano
Font: 9pt / ZAB: 10,5pt

Package leaflet: information for the user

Salofalk ® 250mg Tablets
Mesalazine

Read all of this leaflet carefully before you start taking 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.
– This 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.
– If 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 250mg Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information

1. What Salofalk 250mg Tablets are and
what they are used for
Salofalk 250mg Tablets contain the active substance
mesalazine, an anti-inflammatory 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.

2. What you need to know before you take
Salofalk 250mg Tablets
Do not take Salofalk 250mg Tablets

– If you are allergic to salicylic acid, to salicylates such as aspirin
or to any of the other ingredients of Salofalk 250mg Tablets
(listed in section 6).
– If you have a serious liver or kidney disease.

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Warnings and precautions
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 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.

Other medicines and Salofalk 250mg Tablets

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)
Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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

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 taking this medicine.
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.

Driving and using machines

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.

3. How to take Salofalk 250mg Tablets
Always take this medicine exactly as your doctor has told you.
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.
The recommended dose is:
Ulcerative colitis
Acute episode Prevention of
recurrence/
long-term
treatment
Mesalazine (active substance) 1.5g – 3.0g
1.5g
Salofalk 250mg Tablets
3 x 2 to 3 x 4
3x2
Use in children and adolescents: 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
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
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.

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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.
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 double 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 medicine,
ask your doctor or pharmacist.

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 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.

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The following side effects have also been reported by patients
using mesalazine:

This medicinal product does not require any special storage
conditions.

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
– Increased sensitivity of your skin to sun and ultraviolet light
(photosensitivity)

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 protect the
environment.

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
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:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

6. Contents of the pack and other information
What Salofalk 250mg Tablets contain

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, gastroresistant 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
Buckinghamshire
SL8 5AS, UK
Manufactured by:
Leinenweberstr. 5
79108 Freiburg
Germany

By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Salofalk 250mg Tablets
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 carton and the blister pack. The expiry date refers to the
last day of that month.

This leaflet was last revised in
10/2017

Mock-up

GB/10.17

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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