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SALOFALK 1.5G GASTRO-RESISTANT PROLONGED RELEASE GRANULES

Active substance: MESALAZINE

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Package leaflet: Information for the user

Salofalk ® 1.5g

gastro-resistant prolonged-release granules
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.
− f you have any further questions, ask your doctor or
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pharmacist.
−  his medicine has been prescribed for you only. Do not pass
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it on to others. It may harm them, even if their signs of
illness are the same as yours.
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− f 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 1.5g granules are and what they are used for
2.  hat you need to know before you take Salofalk 1.5g granules
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3. How to take Salofalk 1.5g granules
4. Possible side effects
5. How to store Salofalk 1.5g granules
6. Contents of the pack and other information
1.  hat Salofalk 1.5g granules are and what
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they are used for

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2.  hat you need to know before you take
Salofalk 1.5g granules
Do not take Salofalk granules
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− f you are allergic to mesalazine, salicylic acid, to salicylates
such as Aspirin or to any of the other ingredients of this
medicine (listed in section 6)
− If you have a serious liver or kidney disease
Warnings and precautions
Talk to your doctor before taking Salofalk 1.5g granules
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− f you have a history of problems with your lungs,
particularly if you suffer from bronchial asthma
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− f 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.
Other medicines and Salofalk granules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, in particular:
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−  zathioprine, 6-mercaptopurine or thioguanine
(medicines used to treat immune disorders)
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−  ertain agents that inhibit blood clotting (medicines
for thrombosis or to thin your blood, e.g. warfarin)
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−  actulose (medicine used to treat constipation) or other
preparations that can change the acidity of your stools

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 granules and your doctor will be able to decide
what is suitable for you.
Pregnancy and breastfeeding
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 granules during pregnancy if your
doctor tells you to.
You should also only use Salofalk granules during breastfeeding
if your doctor tells you to, as this medicine may pass into breast
milk.
Driving and using machines
Salofalk granules have no or negligible influence on the ability
to drive or use machines.
Salofalk 1.5g granules contain aspartame and sucrose
This medicine contains the sweetening agent aspartame.
Aspartame is a source of phenylalanine and may be harmful if
you suffer from phenylketonuria. One sachet of Salofalk 1.5g
granules contains the equivalent of 1.68 mg phenylalanine.
One sachet contains 0.06 mg sucrose. If you have been told
by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Salofalk 1.5g granules
Always take Salofalk granules exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.

Method of administration
Salofalk granules are for oral use only.
Salofalk granules should not be chewed. You should take
the Salofalk granules by placing the granules directly on the
tongue and then swallowing them with plenty of liquid
without chewing.
Dosage
Age and body weight

Single dose

Total daily
dose

Adults, elderly and children weighing more than 40kg
Treatment of acute
episodes

Up to 2 sachets
Salofalk 1.5g
granules

1 x 1-2 sachets

Prevention of further
episodes (for patients
at increased risk for
recurrence)

2 sachets
Salofalk 1.5g
granules

1 x 2 sachets

Adults and the elderly
Unless otherwise prescribed by your doctor, the normal dosage
for the treatment of acute episodes of ulcerative colitis is:
1-2 sachets of Salofalk 1.5g granules once daily preferably
in the morning (equivalent to 1.5-3 g mesalazine per day)
depending on the clinical requirements in the individual case.
To prevent a relapse of ulcerative colitis
The normal dosage to prevent further episodes of ulcerative
colitis is:
1 sachet of Salofalk 500mg granules three times daily
(equivalent to 1.5 g mesalazine per day).
If upon the decision of your doctor you are at increased risk
for recurrence, the dosage for prevention of further episodes
of ulcerative colitis is:

2 sachets of Salofalk 1.5g granules once daily preferably in the
morning (equivalent to 3 g mesalazine per day).
Use in 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
granules 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 once daily preferably in the morning or 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.
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.
Due to their high content in active substance, Salofalk 1.5g
granules are not suitable for children weighing less than 40 kg.
Please use Salofalk 500mg granules or 1000mg instead.

Package leaflet:
Information for the user

Duration of treatment
Your doctor will decide how long you need to continue the
treatment with this medicine. This will depend on your
condition. To obtain the maximum benefit from this medicine
you should use Salofalk granules regularly and consistently
both during the acute episode of inflammation and also as
long-term treatment, as directed.

Salofalk ® 1.5g

gastro-resistant
prolonged-release granules

If you think your Salofalk granules are too strong or too weak,
talk to your doctor.
If you take more Salofalk granules than you should
Contact a doctor if you are in doubt, so he or she can decide
what to do.



Salofalk granules contain the active substance mesalazine,
an anti-inflammatory agent used to treat inflammatory bowel
disease.

Salofalk 1.5g granules are used for:
−  he treatment of acute episodes and prevention of further
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episodes (recurrence) of an inflammatory disease of the large
intestine (colon), known by doctors as ulcerative colitis.

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If you use too much Salofalk granules on one occasion, just take
your next dose as prescribed. Do not use a smaller amount.
If you forget to take Salofalk granules
Do not take a double dose to make up for a forgotten dose.
If you stop taking Salofalk granules
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

Nicht
bedrucken!

Like all medicines, Salofalk granules 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 granules 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:
Rare side effects (may affect up to 1 in 1,000 patients):
−  bdominal pain, diarrhoea, wind (flatulence), nausea and
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vomiting
− Headache, dizziness
−  hest pain, breathlessness or swollen limbs because of an
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effect on your heart
Very rare side effects (may affect up to 1 in 10,000 patients):
−  hanges in kidney function, sometimes with swollen limbs
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or flank pain
−  evere abdominal pain because of acute inflammation of
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the pancreas
−  ever, sore throat or malaise because of blood count changes
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−  hortness of breath, cough, wheezing, lung shadow on
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x-ray due to allergic and/or inflammatory lung conditions
−  evere diarrhoea and abdominal pain because of an allergic
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reaction to this medicine within the bowel
− Skin rash or inflammation
− Muscle and joint pain
−  aundice or abdominal pain because of liver and bile flow
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disorders
− Hair loss and the development of baldness
−  umbness and tingling in the hands and feet (peripheral
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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:
Republic of Ireland:
Pharmacovigilance Section
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre

Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: hprapharmacovigilance@hpra.ie
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

silica, colloidal anhydrous; hypromellose; magnesium
stearate; methacrylic acid-methyl methacrylate copolymer (1:1)
(Eudragit L 100); methylcellulose; polyacrylate dispersion
40 % (Eudragit NE 40 D containing 2 % nonoxynol 100);
povidone K 25; simeticone; sorbic acid; talc; titanium dioxide
(E 171); triethyl citrate; vanilla custard flavour (containing
sucrose).

This leaflet was last revised in 06/2014

What Salofalk 1.5g granules look like and
contents of the pack
Salofalk 1.5g gastro-resistant prolonged-release granules are
rod-shaped or round, grey-white granules.
Each sachet contains 2.79g granules.

5. How to store Salofalk 1.5g granules

Salofalk 1.5g granules are available in packs of 20, 30, 35, 45,
50, 60, 70, 90, 100 and 150 sachets.

Keep this medicine out of the sight and reach of children.

Not all package sizes may be marketed.

Do not use Salofalk granules after the expiry date which is
stated on the carton and the sachet after Exp. The expiry date
refers to the last day of that month.

Marketing Authorisation Holder and Manufacturer

This medicine 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 to protect the
environment.
6. Contents of the pack and other information
What Salofalk 1.5g granules contain
The active substance is mesalazine and one sachet of
Salofalk 1.5g granules contains 1.5 g mesalazine.
The other ingredients are aspartame (E 951); carmellose
sodium; cellulose, microcrystalline; citric acid, anhydrous;

This medicinal product is authorised in the Member
States of the EEA under the following names:
Bulgaria, Czech Republic, Denmark, Finland, Germany,
Great Britain, Greece, Hungary, Ireland, Latvia,
The Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Sweden and Spain: Salofalk.
Belgium, Luxembourg: Colitofalk®.
Austria: Mesagran®.

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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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