SALOFALK 250MG GASTRO-RESISTANT TABLETS

Active substance: MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SALOFALK® 250mg GASTRO-RESISTANT TABLETS
MESALAZINE 250mg GASTRO-RESISTANT TABLETS
(mesalazine)
This product is available as any of the above names but will be referred to as Salofalk 250mg tablets
throughout the following leaflet.
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
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. BEFORE YOU TAKE SALOFALK 250mg TABLETS
Do not take Salofalk 250mg tablets:
• 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 250mg tablets (these are listed in section 6, Further
information).
• 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 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.
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.
You should only use Salofalk 250mg tablets during pregnancy if your doctor tells you to.
You should only use Salofalk 250mg tablets during breast-feeding 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.
Important information about some of the ingredients of Salofalk 250mg tablets
Salofalk 250mg tablet contains 48 mg 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 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.
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 250mg tablets

3 x 2 to 3 x 4

3x2

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 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 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 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 40 kg and the normal adult dose to those above 40 kg. 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.
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 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Salofalk 250mg 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 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE SALOFALK 250mg TABLETS
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Salofalk 250mg tablets after the expiry date which is stated on the carton and the blister.
• If your medicine becomes discoloured, or shows any signs of deterioration, consult your pharmacist who
will tell you what to do.
• 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 250mg tablets contain
The active substance in Salofalk 250mg tablets is mesalazine.
Each tablet contains 250mg mesalazine.
The other ingredients are:
sodium carbonate anhydrous, glycine, povidone K25, microcrystalline cellulose, colloidal anhydrous silica,
calcium stearate, hypromellose, Eudragit L 100, macrogol 6000, talc, titanium dioxide (E 171), iron oxide
yellow (E172), 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 with no
markings.
Salofalk 250mg tablets are available in blister packs of 50 and 100 tablets.
PLPI 15814/1080

POM

Manufactured by: Dr Falk Pharma GmbH, Freiburg, Germany. Procured from within the EU and repackaged
by the Product Licence Holder: OPD Laboratories Ltd, 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 09.06.2014.
Ursofalk is a trade mark of Dr Falk Pharma GmbH, Germany.
To request a copy of this in Braille, large print or audio please call 01923 332 796.

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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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