Salofalk 1g Rectal Foam
Mesalazine
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Salofalk rectal foam is and what it is used for
- 2. Before you use Salofalk rectal foam
- 3. How to use Salofalk rectal foam
- 4. Possible side effects
- 5. How to store Salofalk rectal foam
- 6. Further information
What Salofalk Rectal Foam Is And What It Is Used For
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.
Before You Use Salofalk Rectal Foam
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 (these are listed in section 6, Further information).
- If you have a serious liver and/or kidney disease.
- If you have a stomach or duodenal ulcer.
- If you have a tendency to bleed easily or you have ever been told that there is a problem with the clotting of your blood.
Take special care with Salofalk rectal foam.
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, where you will have regular blood and urine tests.
Using other medicines
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)
Glucocorticoids (certain steroid-like anti-inflammatory agents, such as prednisolone)
Sulphonyl ureas (substances used to control your blood sugar, such as glibenclamide)
Methotrexate (an agent used to treat leukaemia or immune disorders)
Probenecid/sulphinpyrazone (agents used to treat gout)
Spironolactone/frusemide (agents used to treat heart problems)
Rifampicin (substance used against tuberculosis)
Medicines containing azathioprine or 6-mercaptopurine (used to treat immune disorders.
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 rectal foam and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should only use Salofalk rectal foam during pregnancy if your doctor tells you to.
Salofalk rectal foam should not be used during breast-feeding as the drug and its metabolite may pass into breast milk.
Driving and using machines
There are no effects on the ability to drive and use machines.
Important information about some of the ingredients of Salofalk rectal foam
This medicine contains sulphite which may very rarely cause allergic reactions, which 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).
How To Use Salofalk Rectal Foam
Always use Salofalk rectal foam exactly as your doctor has told you. You should 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.
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:
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 ready for use.
Using the foam:
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 household waste in the plastic bag provided. Use a new applicator for another administration.
- 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.
If you stop using Salofalk rectal foam
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.
Possible Side Effects
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 taking this medicine, you should contact your doctor immediately:
Allergic skin rash
Fever
Breathing difficulties.
If you experience the following serious side effects, stop taking the medicine and contact your doctor immediately:
If you experience a serious reduction of your general health condition with fever, and/or sore throat and mouth, please report to your doctor immediately. The symptoms might derive from a reduction in the number of white blood cells in your blood (agranulocytosis). This may increase your chances of suffering from a serious infection.
A blood test will be taken to check possible reduction of white blood cells. It is important to inform your doctor about your medicine.
The following side effects have also been reported:
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, nausea and vomiting
- Headache, dizziness.
Very Rare side effects (that affect less than 1 in 10,000 patients):
- Changes in kidney function, sometimes with swollen limbs or flank pain because of renal disorders
- Chest pain, breathlessness or swollen limbs because of heart disorders
- Severe abdominal pain because of acute inflammation of the pancreas
- Severe breathlessness because of allergic inflammation of the lung
- Severe diarrhoea and abdominal pain because of allergic inflammation of the intestine
- 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
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Salofalk Rectal Foam
Keep out of the reach and sight 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 25°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 burn empty containers, even after use. Do not spray near a flame or incandescent material.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
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 (E223), 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).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tel +49 (0) 761 / 1514-0
Fax+49(0) 761 / 1514-321
zentrale@drfalkpharma.de
Salofalk rectal foam is approved in the following EU countries under the trademark Salofalk: Austria, Denmark, Finland, Germany, Great Britain, Greece, Ireland, Luxembourg, The Netherlands, Norway, Portugal, Spain and Sweden.
This leaflet was last approved in MM/YYYY
May 2010
Marketing authorisation number:
PL 08637/003
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