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.

-    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.

What is in this leaflet:

1.    What Salofalk 1.5g granules are and what they are used for

2.    What you need to know before you take Salofalk 1.5g granules

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

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

Salofalk 1.5g granules 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.

Do not take Salofalk granules

-    If 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

-    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.

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:

-    Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders)

-    Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood, e.g. warfarin)

-    Lactulose (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.

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.

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.

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 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.

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.

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):

-    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 (may affect up to 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 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.

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.

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.

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;

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).

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.

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

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

DR. FALK PHARMA GmbH

Leinenweberstr. 5 79108 Freiburg Germany

Tel.: +49 (0)761/1514-0 Fax: +49 (0)761/1514-321 E-Mail: zentrale@drfalkpharma.de

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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