Salofalk 1g Suppositorien Gebrauchsinformation (GI) fur Gro^britannien-iriand Format: 300 x 185 mm    Druckfarben: 2/2 (Schwarz + Pant. 644)

Mat.-Nr.: Mock-up (Vifor AG)    Falk-Datumscode: GB-IE/03.15

Salofalk® 1g Suppositories

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.

What is in this leaflet:

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

2.    What you need to know before you use Salofalk 1g Suppositories

3.    How to use Salofalk 1g Suppositories

4.    Possible side effects

5.    How to store Salofalk 1g Suppositories

6.    Contents of the pack and other information

Salofalk 1g Suppositories contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk 1g Suppositories are used for:

- the treatment of mild to moderate acute episodes of an inflammatory disease limited to the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis.

Do not use Salofalk 1g Suppositories:

-    If you are allergic to salicylic acid, to salicylates such as acetylsalicylic acid (aspirin) or to the other ingredient of this medicine (listed in section 6).

-    If you have a serious liver or kidney disease.

Warnings and precautions

Talk to your doctor before using Salofalk 1g Suppositories

-    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 1g Suppositories

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, have recently taken or might take any other medicines. It may still be all right for you to use Salofalk 1g Suppositories 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 using this medicine.

You should only use Salofalk 1g Suppositories during pregnancy if your doctor tells you to.

You should also only use Salofalk 1g Suppositories during breast-feeding if your doctor tells you to, as this medicine may pass into breast milk.

Driving and using machines

Salofalk 1g Suppositories are not expected to affect your ability to drive or operate machines.

Important information about some of the ingredients of Salofalk 1g Suppositories

The other ingredient in Salofalk 1g Suppositories is not likely to cause side

effects (see section 6. Contents of the pack and other information).

Always use this medicine 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. Do NOT take by mouth.

Dosage:

Adults and older people

The recommended dose is one Salofalk 1g suppository once a day, at bedtime. Use in children

There is little experience and only limited documentation for an effect in children.

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 1g Suppositories regularly and consistently, as directed.

If you think your Salofalk 1g Suppositories are too strong or too weak, talk to your doctor.

If you use more Salofalk 1g Suppositories 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 1g Suppositories on one occasion, just take

your next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk 1g Suppositories

If you forget to use this medicine, use it as soon as you remember.

However, if it is almost time for your next dose, skip the dose you missed. Then use the next dose at its usual time. Do not use a double dose to make up for a forgotten dose

If you stop using Salofalk 1g Suppositories

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, 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 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 these suppositories 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, constipation

-    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 or 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:

Republic of Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@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.

What Salofalk 1g Suppositories contain

The active substance in Salofalk 1g Suppositories is mesalazine and one suppository of Salofalk 1g Suppositories contains 1 g mesalazine.

The other ingredient is

hard fat.

What Salofalk 1g Suppositories look like and contents of the pack

Salofalk 1g Suppositories are light beige coloured, torpedo-shaped suppositories.

Salofalk 1g Suppositories are available in packs of 10,12, 15, 20, 30, 60, 90 suppositories.

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:

Austria, Bulgaria, Czech Republic, Cyprus, Denmark, Finland, Germany, Great Britain, Greece, Hungary, Ireland, Latvia, Lithuania, The Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Sweden and Spain: Salofalk®.

Belgium and Luxembourg: Colitofalk®.

This leaflet was last revised in 03/2015.

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 strip and on the carton. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Store in the original container in order to protect contents from light.

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.    M_ock_-up    GB_-IE/03.15

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