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SALOFALK 500 MG GASTRO-RESISTANT TABLETS

Active substance(s): MESALAZINE

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T05568

Salofalk® 500 mg gastro-resistant tablets
(mesalazine)

Your medicine is called Salofalk 500 mg gastro-resistant tablets, but will be referred to as
Salofalk 500 mg tablets throughout the following:
Patient Information 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 500 mg tablets are and what they are used for
2. Before you take Salofalk 500 mg tablets
3. How to take Salofalk 500 mg tablets
4. Possible side effects
5. How to store Salofalk 500 mg tablets
6. Further information

1. What Salofalk 500 mg Tablets are and what they are used for
Salofalk 500 mg tablets contain the active substance mesalazine, an anti-inflammatory
agent used to treat inflammatory bowel disease.
Salofalk 500 mg 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 500mg Tablets
Do not take Salofalk 500mg 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 500 mg tablets
(these are listed in section 6, Further information).
• If you have a serious liver or kidney disease.
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
ileocoecal 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 500 mg tablets during pregnancy if your doctor tells you to.
You should also only use Salofalk 500 mg 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 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. How to take Salofalk 500 mg Tablets
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
Adults and the elderly
Ulcerative colitis
acute episode
Mesalazine
(active
sub-stance)
Salofalk
500 mg
gastroresistant
tablets

Prevention of recurrence/long-term treatment

1.5 g – 3.0 g

1.5 g

3x1
to
3x2

3x1

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.
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.

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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.
If you stop taking Salofalk 500mg tablets
Do not stop taking this product until you have talked to your doctor.

The other ingredients are:
sodium carbonate anhydrous, glycine, povidone K 25, microcrystalline cellulose, sodium
carboxymethylcellulose, colloidal anhydrous silica, calcium stearate, hypromellose,
macrogol 6000, eudragit L 100, talc, titanium dioxide (E 171), yellow iron oxide (E 172),
Eudragit E.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What Salofalk 500mg tablets look like and contents of the pack
Salofalk 500 mg tablets are oval, light yellow to ochre, gastro-resistant tablets, matt with
smooth surface, they are not scored.

4. Possible Side Effects

Salofalk 500 mg tablets are available in blister packs of 50 tablets.

Like all medicines, Salofalk 500mg tablets can cause side effects, although not everybody
gets them.

Manufacturer and Product Licence Holder

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.

This product is manufactured by DR. FALK PHARMA GmbH, Leineweberstrasse 5, 79 108
Freiburg, Germany. It is procured from within the EU by the Product Licence Holder:
Swinghope Limited, Brandon House, Marlowe Way, Croydon CR0 4XS UK.
Repackaged by Interport Limited, Brandon House, Marlowe Way, Croydon CR0 4XS UK.

POM
PL No: 10380/1581
Leaflet revision date: 21/05/2015
Salofalk® is registered trademark of Dr. Falk Pharma GmbH, Germany.

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
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 500 mg Tablets
• Keep out of the sight and reach of children.
• Do not store above 25ºC.
• Do not use Salofalk 500 mg 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.
• This medicinal product does not require any special storage conditions.
• 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 500 mg tablets contain
Each gastro-resistant tablet contains 500 mg mesalazine.

T05568

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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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