Friday, September 23, 2016

Salofalk Suppositories 500mg





SALOFALK SUPPOSITORIES 500mg


MESALAZINE





Please read this leaflet carefully before you start to take your medicine.
It does not contain complete information about your treatment but if you have any questions or are not sure about anything ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all your treatment. You may want to read it again.


If you are helping someone else to take this medicine, please read this leaflet before you give the first dose.


The name of this medicine is Salofalk Suppositories 500mg. The active ingredient is mesalazine and each suppository contains 500mg of this ingredient. The suppositories also contain hard fat, docusate sodium (total sodium content 0.1mg) and cetyl alcohol.


Each box of Salofalk Suppositories 500mg contains either 10 or 30 suppositories.


Mesalazine is used to treat diseases in the lower bowel.




Product Licence Holder:



Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks
SL8 5AS

UK



Manufactured by:



Dr. Falk Pharma GmbH

D-79041 Freiburg

Germany



Salofalk Suppositories 500mg may be used to treat the following:


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


Before using Salofalk Suppositories 500mg


  • If you are pregnant, think you might be pregnant, trying to become pregnant or breastfeeding, you should tell your doctor.


If the answer to any of the following questions is yes, tell your doctor or pharmacist.


  • Do you suffer from kidney or liver disease?

  • Do you have or have you ever had a stomach or duodenal ulcer?

  • Do you tend to bleed easily or have you ever been told that there is a problem with the clotting of your blood?

  • Are you or have you ever been told you are allergic to aspirin or other salicylates?

  • Are you taking any medicines for thrombosis or to thin your blood?

  • Are you taking any medicines for the treatment of gout, heart problems, psoriasis, arthritis, leukaemia, tuberculosis or diabetes?

  • Are you taking any anti-inflammatory agents, pain relief drugs or any other medicines which your doctor does not know about?



Using Salofalk Suppositories 500mg


It is important to take your medicine as directed by your doctor. The usual dose is one to two suppositories, two to three times daily although the dispensing label will tell you how many to use and how often. If it does not or you are unsure ask your doctor or pharmacist.


  • This medicine should not be swallowed.

  • Empty your bowels if necessary and wash your hands. Remove a suppository from the plastic strip. Lie down on your left side with the left leg outstretched and the right leg bent. Gently insert the suppository – pointed end first, into the rectum and then try to remain lying on your left side for one hour as this will aid the action of the suppositories.

  • Wash your hands again.

  • If you forget to take your medicine continue with the next dose as instructed on the label.

  • If you go into hospital or visit a dentist or another doctor tell them you are taking this medicine.



After using Salofalk Suppositories 500mg



Like all medicines, Salofalk Suppositories 500mg may occasionally cause side-effects in some people. Normally these effects are mild and rare but if you experience any of the following effects severely, stop using the suppositories and tell your doctor as soon as possible.


  • Fever, sore throat, bleeding, bruising and anaemia.

  • Skin rash, inflammation, blistering and peeling skin (sometimes severe).

  • Chest tightness or shortage of breath.

  • Headache, nausea or diarrhoea or hair loss.

  • Numbness or tingling in the hands or feet.

  • Swelling of ankles, feet or lower leg.

  • Very rarely, liver problems and jaundice, and pancreatitis might occur.

  • If you become dehydrated (lose too much water) which can occur with severe or prolonged vomiting and/or diarrhoea, high fever or excess sweating, contact your doctor or pharmacist for advice. Adequate fluid replacement is important in preventing kidney problems.


If you experience any other undesirable effects then tell your doctor or pharmacist, particularly if they are severe or persistent.




Storing Salofalk Suppositories 500mg


  • Store the suppositories at room temperature (15 – 25ÂșC) in their original packaging but keep them in a place where they cannot be reached by children, your medicine could harm them.

  • Check the expiry date on the packaging and do not use the suppositories if this date has been passed.

  • If your doctor decides to stop treatment, return any left over suppositories to the pharmacist. Only keep them if the doctor tells you to.

  • If the suppositories look to be deteriorating in any way, do not use but return them to the pharmacist.

  • Protect from light.


Date leaflet prepared: March 2010


PL 10341/0009


This leaflet provides a summary of the information available on your medicine. This information applies only to Salofalk Suppositories 500mg. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.




REMEMBER: This medicine is yours. Never give it to others.




It may not be suitable for them even if their symptoms are the same as yours.




Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks
SL8 5AS

UK


Mock-up GB/02.10





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