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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/04.15
Grammatur: 50 g/m2
Laetuscode: 542
Machart: plano

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.

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 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
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.

Driving and using machines

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

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.

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

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

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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.

– 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:

4. Possible side effects

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

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

By reporting side effects you can help provide more information on
the safety of this medicine.

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

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5. How to store Salofalk 250mg Tablets

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
Buckinghamshire
SL8 5AS, UK
Manufactured by:

Leinenweberstr. 5
79108 Freiburg
Germany
This leaflet was last revised in
04/2015

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 medicinal product does not require any special storage
conditions.
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.

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).
Mock-up GB/04.15

22.04.15 09:09

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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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