iMedi.co.uk

Salofalk Enema 2g

Salofalk 2g60ml Klysmen Gebrauchsinformation (GI) fur GroRbritannien Format: 300 x 185 mm    Druckfarben: (2/2) Schwarz + Pantone 644

Mat.-Nr.: Mock-up (Vifor AG)    Falk-Datumscode: GB/04.15


Package leaflet: information for the user


1. What Salofalk Enemas 2g are and what they are used for


3. How to use Salofalk Enema 2g


Salofalk® Enema 2g

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 enemas are and what they are used for

2.    What you need to know before you use Salofalk enemas

3.    How to use Salofalk enemas

4.    Possible side effects

5.    How to store Salofalk enemas

6.    Contents of the pack and other information

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

Salofalk enemas are used for:

- the treatment of mild episodes of an inflammatory disease in parts of the colon and the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis.

2. What you need to know before you use Salofalk Enema 2g

Do not use Salofalk enemas

-    If you are allergic to mesalazine, salicylic acid, salicylates such as aspirin or 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 or pharmacist before using

Salofalk enema:

-    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 Enema 2g

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, including medicines obtained without a prescription. It may still be alright for you to use Salofalk enemas 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 enemas during pregnancy if your doctor tells you to.

You should also only use Salofalk enemas 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 Enema 2g contains sodium benzoate, which may be mildly irritant to the skin, eyes and mucous membranes.

The other ingredients in Salofalk enemas are not likely to cause side effects (see section 6).

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 elderly

The recommended dose is one enema 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 enemas regularly and consistently, as directed.

If you think your Salofalk enemas are too strong or too weak, talk to your doctor.

If you use more Salofalk enemas than you should

Contact a doctor if you are in doubt, so he or she can decide what to do.

If you use too many enemas on one occasion, just take your next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk enemas

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

If you stop using Salofalk enemas

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.


4. Possible side effects


Like all medicines, Salofalk enemas 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 the enemas 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 (that affect less than 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 (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

-    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 via the national reporting system:

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.


Manufacturer

DR. FALK PHARMA GmbH


Leinenweberstr. 5 79108 Freiburg Germany


This leaflet was last revised in

04/2015


5. How to store Salofalk Enema 2g


Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle 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.


6. Contents of the pack and other information


What Salofalk enemas contain

The active substance is mesalazine and one enema contains 2g mesalazine.

The other ingredients are

Carbomer, disodium edetate, potassium acetate (E261), potassium metabisulphite (E224), purified water, sodium benzoate (E211), xanthan gum (E415).

What Salofalk enemas look like and contents of the pack

Salofalk enemas are in a low-density, concertina shaped, polythene bottle with a low-density polythene application nozzle.

Salofalk enemas are available in packs of 7


Marketing Authorisation Holder

Dr. Falk Pharma UK Ltd

Bourne End Business Park, Cores End Road

Bourne End, Buckinghamshire, SL8 5AS


Mock-up


GB/04.15


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