Salofalk Granules
(Mesalamine)

What Salofalk Granules is and what it is used for

Salofalk rectal foam contains the active substance mesalazine, an antiinflammatory 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.

How to take Salofalk Granules

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: Using the foam: Store and use Salofalk rectal foam between 20 and 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 ready for use. 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. 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.
• 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 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.

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 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
• Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)

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 United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Fax: +353 1 6762517 Website: www.imb.ie e-mail: [email protected] By reporting side effects, you can help provide more information n on the safety of this medicine.

How to Store Salofalk Granules

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 burn 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. These measures will help protect the environment.