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SALOFALK 1G GASTRO-RESISTANT TABLETS

Active substance(s): MESALAZINE / MESALAZINE

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Package leaflet: Information for the user

Salofalk® 1g gastro-resistant 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Salofalk 1g tablets:
– 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, which is a
substance related to mesalazine.
– If you have liver problems.
– If you have kidney problems.
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 patients who have undergone certain types of bowel surgery,
Salofalk 1g tablets may be excreted undissolved in the stool. If you
notice this, please inform your doctor.

3. How to take Salofalk 1g tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Dosage
Take one Salofalk 1g tablet three times a day (morning, midday and
evening), or as instructed by your doctor.
Method of administration
Salofalk 1g tablets are for oral use only.
Take the tablets 1 hour before meals. They should be swallowed
whole, not chewed, and taken with plenty of fluid.
Use in children
There is only limited documentation for an effect in children (age
6-18 years).

Other medicines and Salofalk 1g tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This is because Salofalk 1g
tablets can affect the way some other medicines work. Also, some
other medicines can affect the way Salofalk 1g tablets work.

Children 6 years of age and older
Ask your doctor about the precise dosage of Salofalk 1g tablets for
your child. The dosage depends on how severe the condition is and
on your child’s body weight.

1. What Salofalk 1g tablets are and what they are used for

In particular, tell your doctor or pharmacist if you are taking:
– Azathioprine, 6-mercaptopurine or thioguanine (medicines
used to treat immune disorders)
– Certain medicines that prevent blood clotting (medicines for
thrombosis or to thin your blood, e.g. warfarin)

The dose should 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.

Salofalk 1g tablets contain the active substance mesalazine, an antiinflammatory agent used to treat inflammatory bowel disease.

You may still be able to use Salofalk 1g tablets and your doctor will
decide what is suitable for you.

Salofalk 1g tablets are used for the treatment of acute episodes
of mild to moderate forms of an inflammatory disease of the large
intestine (colon), called ulcerative colitis.

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.

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.

2. What you need to know before you take Salofalk 1g tablets

You should only use Salofalk 1g tablets during pregnancy if
instructed by your doctor.

What is in this leaflet
1. What Salofalk 1g tablets are and what they are used for
2. What you need to know before you take Salofalk 1g tablets
3. How to take Salofalk 1g tablets
4. Possible side effects
5. How to store Salofalk 1g tablets
6. Contents of the pack and other information

Do not take Salofalk 1g tablets:
– If 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.

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You should only use Salofalk 1g tablets during breast-feeding if
instructed by your doctor, as this medicine may pass into breast
milk.
Driving and using machines
Salofalk 1g tablets have no influence on your ability to drive and use
machines.

Due to the size of Salofalk 1g tablets and the dosage
recommendations, preparations of lower strengths should be
used in children (e.g. Salofalk 500 mg gastro-resistant tablets or
Salofalk 500 mg gastro-resistant prolonged-release granules).
Duration of treatment
The length of treatment will depend upon your condition. Your
doctor will decide how long you are to continue the medication.
You should take Salofalk 1g tablets regularly and consistently during
the acute episode of inflammation so the desired therapeutic effect
can be achieved.
If you think that the effect of Salofalk 1g tablets is too strong or too
weak, talk to your doctor.

If you take more Salofalk 1g tablets than you should
Contact your doctor if you are in doubt as they can decide what to do.
If you take too many Salofalk 1g tablets on one occasion, take your
next dose as prescribed. Do not use a smaller amount.
If you forget to take Salofalk 1g tablets
If you miss a dose, continue your treatment at the prescribed
dosage. Do not take a double dose to make up for the forgotten
one.
If you stop taking Salofalk 1g tablets
Do not stop taking this product before having spoken to your doctor.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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, stop taking it and contact
your doctor immediately:
– Allergic skin rash
– Fever
– Breathing difficulties.
If you experience a marked worsening of your general health,
especially if accompanied by fever and/or a sore throat and
mouth, stop using Salofalk 1g tablets and contact a 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
medicines containing mesalazine, the active substance in Salofalk
1g tablets:
Rare side effects (may affect up to 1 in 1,000 people):
– Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting
– Headache, dizziness
– Chest pain, breathlessness or swollen limbs because of an effect
on your heart

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Very rare side effects (may affect up to 1 in 10,000 people):
– 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, due to 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the 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.

6. Contents of the pack and other information
What Salofalk 1g tablets contain
The active substance is mesalazine. Each Salofalk 1g tablet contains
1 g of mesalazine.
The other ingredients are:
Microcrystalline cellulose, povidone K 25, croscarmellose sodium,
methacrylic acid methyl methacrylate copolymer (1:1) (Eudragit
L 100), methacrylic acid methyl methacrylate copolymer (1:2)
(Eudragit S 100), calcium stearate [herbal origin], talc, Macrogol
6000, hypromellose, colloidal anhydrous silica, iron oxide yellow
(E172), titanium dioxide (E171).
What Salofalk 1g tablets look like and contents of the pack
Salofalk 1g tablets are yellow to ochre yellow, oblong, biconvex,
rounded edges gastro-resistant tablets with a smooth surface.
Salofalk 1g tablets are available in packs of 20, 50, 60, 90, 100 and
150 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

5. How to store Salofalk 1g tablets
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 blister and the carton. 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 household waste. Ask your
pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

This medicinal product is authorised in the Member States
of the EEA under the following names:
Germany, Greece, Hungary, Spain and United Kingdom: Salofalk®
This leaflet was last revised in May 2017.
Marketing Authorisation No.: PL08637/0027

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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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