SALOFALK 1000MG GASTRO-RESISTANT PROLONGED RELEASE GRANULES

Active substance: MESALAZINE

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Package leaflet: Information for the user

Salofalk ® 1000mg

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.
–  eep this leaflet. You may need to read it again.
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– 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
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pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
– f you get any side effects, talk to your doctor or pharmacist.
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This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1.  hat Salofalk 1000mg granules are and what they are used for
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2. What you need to know before you take Salofalk 1000mg
granules
3. How to take Salofalk 1000mg granules
4. Possible side effects
5. How to store Salofalk 1000mg granules
6. Contents of the pack and other information
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1.  hat Salofalk 1000mg granules are and what
they are used for

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2.  hat you need to know before you take
Salofalk 1000mg granules
Do not take Salofalk granules
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– f you are allergic to mesalazine, salicylic acid, 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 1000mg granules
− f you have a history of problems with your lungs,
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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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−  ertain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood e.g., warfarin)
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−  zathioprine, 6-mercaptopurine or thioguanine
(medicines used to treat immune disorders)

−  actulose (medicine used to treat constipation) or other
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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 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 granules during pregnancy if your
doctor tells you to.
You should also only use Salofalk granules during
breast-feeding 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 1000mg 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
1000mg granules contains the equivalent of 1.12mg
phenylalanine.
One sachet contains 0.04mg 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.  ow to take Salofalk 1000mg granules
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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
Single dose
Total daily dose
weight
Adults, elderly and children weighing more than 40kg
Up to 3 sachets
1 x 3 sachets
Treatment of
Salofalk 1000mg
or
acute episodes
granules
3 x 1 sachet
Prevention of
further episodes
3 sachets
(for patients at
Salofalk 1000mg
1 x 3 sachets
increased risk for
granules
recurrence)
Children 6 years of age and older
Treatment of
acute episodes
Prevention of
further episodes

30-50mg mesalazine/
kg body weight/day
once daily
or in divided doses
15-30mg mesalazine/
kg body weight/day
in divided doses

Adults and the elderly
Unless otherwise prescribed by your doctor, the normal
dosage for the treatment of acute episodes of ulcerative
colitis is:
Depending on the clinical requirements in the individual case,
3 sachets of Salofalk 1000mg granules (equivalent to 3g
mesalazine per day) once daily preferably in the morning or
1 sachet of Salofalk 1000mg granules three times daily (in
the morning, at midday, in the evening).
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 1.5g 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:
3 sachets of Salofalk 1000mg granules once daily preferably
in the morning (equivalent to 3g mesalazine per day).

Package leaflet:
Information for the user

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
30-50mg 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 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 15-30mg mesalazine per kg body weight per day that
should be given in divided doses. The total dose should not
exceed the recommended adult dose.

Salofalk ® 1000 mg

gastro-resistant
prolonged-release granules



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

Salofalk 1000mg 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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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.
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.
If you think that your Salofalk granules are too strong or too
weak, talk to your doctor.

Nicht
bedrucken!

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.
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.

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4. Possible side effects
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.
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

–  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
–  ever, sore throat or malaise because of blood count
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changes
–  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 as follows:
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.

5. How to store Salofalk SALOFALK 1000mg granules
Keep this medicine out of the sight and reach of children.
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.

Salofalk 1000mg granules are available in packs of 20, 50, 60,
100 and 150 sachets.
Not all package sizes may be marketed.
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 1000mg granules contain
The active substance is mesalazine and one sachet of Salofalk
1000mg granules contains 1000mg mesalazine.
The other ingredients are aspartame (E 951); carmellose
sodium; cellulose, microcrystalline; citric acid, anhydrous;
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 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®.
This leaflet was last revised in 06/2014
PL08637/0008
PA573/3/2

What Salofalk 1000mg granules look like and
contents of the pack
Salofalk 1000mg gastro-resistant prolonged-release granules
are rod-shaped or round, grey-white granules.
Each sachet contains 1.86g granules.
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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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