If you stop using Salofalk rectal foam

Do not stop using this product until you have talked to your doctor.

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

Like all medicines, Salofalk rectal foam 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 using 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 this foam 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:

Common side effects (that affect less than 1 in 10 patients):

•    Abdominal discomfort.

Uncommon side effects (that affect less than 1 in 100 patients):

•    Anal discomfort, anal irritation and painful urgent need to empty the bowels.

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

•    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

•    Fever, sore throat or malaise because of blood count changes

•    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 national reporting system:

Ireland

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

IRL- Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.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 rectal foam after the expiry date which is stated on the carton and the spray can. The expiry date refers to the last day of that month.

The contents of the container must be used within 12 weeks after first opening.

Do not store above 30°C.

Do not refrigerate or freeze.

The container is pressurised and contains 3.75% by weight of flammable propellant. Protect from sunlight and temperatures over 50°C. Do not force open, pierce or bum empty containers, even after use. Do not spray near a flame or incandescent material.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

Salofalk Rektalschaum Gl fur GroBbritannien-lriand (GB-IE/09.13)

Open size: 371 x 140 mm    Printing Colour: Black (1/1)    Material number: EX13645 (ASM)

Folded size: 53 x 140 mm    Folding: zigzag-folding    Type font/ine space: 8pt/9,5pt

These measures will help protect the environment.

What Salofalk rectal foam contains

The active substance of Salofalk rectal foam is mesalazine and each spray actuation contains 1 g of mesalazine.

The other ingredients are sodium metabisulphite (E 223), disodium edetate, cetostearyl alcohol, polysorbate 60, propylene glycol and propane, n-butane, isobutane as propellants.

What Salofalk rectal foam looks like and contents of the pack

Salofalk rectal foam is a white-greyish to slightly reddish-violet and creamy firm foam.

Salofalk rectal foam is available in packs containing 1 spray can and 14 applicators and as a bundle pack. A bundle pack consists of 4 packs containing 1 spray can and 14 applicators each.

Each spray can of Salofalk rectal foam contains 80 grams of foam, which is sufficient for 14 spray actuations (equivalent to 7 doses).

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

Salofalk rectal foam is authorised in the Member States of the EEA under the following name:

Austria, Denmark, Finland, Germany, Great Britain, Greece, Ireland, Luxembourg, The Netherlands, Norway, Portugal, Spain and Sweden: Salofalk.

This leaflet was last revised in 11/2013

Salofalk® 1g/Actuation Rectal Foam

mesalazine

Read all of this leaflet carefully before you start using 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.

Salofalk rectal foam contains the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk rectal foam is used for the treatment of:

• Inflammation of the large intestine (colon) and rectum (back passage) known by doctors as ulcerative colitis.

Do not use Salofalk rectal foam

•    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 rectal foam (listed in section 6).

•    If you have a serious liver or kidney disease.

Warnings and precautions

Before you start using 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.

Other medicines and Salofalk rectal foam

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

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

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk rectal foam and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, 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 rectal foam during pregnancy if your doctor tells you to.

You should also only use Salofalk rectal foam 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.

Salofalk rectal foam contains sulphite, propylene glycol and cetostearyl alcohol

This medicine contains sulphite, which may, very rarely, cause allergic reactions that may be experienced in the form of breathing problems.

This medicine contains propylene glycol, which can cause certain blood changes and may cause slight to mild skin irritation.

This medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Always use Salofalk rectal foam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration:

This medicine may only be used rectally, so it has to be inserted through the anus. It is not intended to be taken by mouth. Do not swallow.

Dosage:

Dose for adults

The usual dose is 2 spray actuations once a day at bedtime. If you have difficulty retaining this amount of foam, it may also be administered in two separate doses: one at bedtime and the other during the night or early in the morning (after excreting the first dose).

Emptying your bowels before using Salofalk rectal foam produces the best results.

Use in children

Salofalk rectal foam should not be used in children because there is little experience and only limited documentation for an effect in children.

Preparing to use the foam:

Store and use Salofalk rectal foam at room temperature (between 20 and not more than 30°C; see also section 5).

Push the applicator firmly onto the spout of the spray can.

Shake the spray can for about 20 seconds to mix the contents.

Before first use, remove the safety lock (plastic flap) from under the pump dome.

Twist the dome on the top of the spray can until the semi-circular gap underneath is in line with the nozzle. The spray can is now

Place your index finger on the top of pump dome and turn the can upside down. Please note that the spray can will only work properly when held with the pump dome pointing down.

Insert the applicator into your rectum as \| far as possible. The best way to do this is to place one foot on a chair or stool. To administer a dose of Salofalk rectal foam, push down fully the pump dome once and slowly release it. For the second spray, push the dome again and release slowly. Wait 10-15 seconds before withdrawing the applicator as the foam still expands a little and would otherwise drop out of the applicator.

After administering the foam, remove the applicator and dispose of it as house-hold

•    Please wash your hands and try not to empty your bowels until the next morning.

•    If you go to hospital or see another doctor, tell them you are using this medicine.

You should use Salofalk rectal foam regularly and consistently to achieve the desired effect.

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.

Mild acute episodes of inflammatory bowel disease (ulcerative colitis) generally subside after 4-6 weeks.

If long-term treatment is required, your doctor will prescribe you an oral form of mesalazine, e.g.

Salofalk granules.

If you think that the effect of Salofalk rectal foam is too strong or too weak, talk to your doctor.

If you use more Salofalk rectal foam 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 rectal foam on one occasion, just take your next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk rectal foam

Do not take a larger than normal dose of Salofalk rectal foam next time, but continue treatment at the prescribed dosage.