Salofalk

Salofalk tablets, granules, suppositories, enema and rectal foam all contain the active ingredient mesalazine, which is a type of medicine that is used to reduce inflammation in the intestines.

Salofalk is used to reduce inflammation in the intestines and can also be taken continuously to help prevent inflammation. Salofalk contains the active ingredient mesalazine, which is an aminosalicylate.

Salofalk is prescribed to reduce chronic inflammation in the intestines. It is used to treat the following conditions:

Ulcerative colitis:
This is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed. This results in ulceration and bleeding in the intestine and causes symptoms including abdominal pain, fatigue, rectal pain and diarrhoea that is mixed with blood and mucus. Most people with ulcerative colitis go through periods when the symptoms are active, which is known as a flare, and periods when the symptoms disappear, which is known as remission. Ulcerative colitis usually starts at the rectum and eventually spreads to the large intestine. If only the rectum is affected, the disease is referred to as ulcerative proctitis.

Crohn’s disease:
This is an inflammatory bowel disease which not only causes the large intestine and rectum to become inflamed but also the small intestine. The main symptoms of Crohn’s disease are stomach pain, diarrhoea, fever and loss of appetite. Fistulas on the inside wall of the intestine and blockage or obstruction in the intestinal tract are common complications. Inflammation from Crohn’s disease can spread through the intestinal wall and affect other organs, while many patients with Crohn’s disease also suffer from joint problems. Patients commonly have periods where the disease is more active, alternating with periods where it is inactive (remission).

Salofalk reduces the inflammation in the intestines, which in turn reduces the symptoms. Salofalk can be used for the short- term treatment of symptoms and can also be taken on a continuous basis to control the inflammation in the intestines, help prevent attacks and reduce their severity.

Salofalk comes in various forms. The general recommended dose is:

• Salofalk tablets:
  These should be taken directly after a meal and swallowed whole without chewing. If you are taking more than one dose, it is important to space the doses evenly throughout the day.
• Salofalk Granu Stix granules:
  These should be placed onto the tongue and washed down with plenty of liquid. The contents of the sachets should not be chewed because the Salofalk granules have a functional coating on the particles, which ensures gastro-resistance.
• Salofalk enema:
  This is only used to treat symptoms affecting the lower bowel and rectum. Administer the enema before going to bed according to the instructions on the package leaflet. For maximum efficacy, hold in the enema all night if possible.
• Salofalk suppositories:
  These are only used to treat symptoms affecting the lower bowel and rectum. Administer into the back passage (rectum) just before going to bed at night.
• Salofalk rectal foam:
  This is for rectal use only. Administer into the back passage (rectum) according to the instructions on the package leaflet. The foam should be administered in one dose, at bedtime. If you have difficulty in holding this amount of foam, it can also be administered in divided doses: one at bedtime and the other during the night or early in the morning.

The best results are obtained when the intestine is evacuated prior to administration of Salofalk, reducing the urge to defecate.

For more information on how to use Salofalk, see the package leaflet.

Salofalk is available in various forms and strengths. The exact dosage can sometimes differ from patient to patient, so it is essential to follow the instructions of the prescribing doctor. The general recommended dose in adults is:

Salofalk tablets:

• Ulcerative colitis: in the acute phase, 2 to 4.5 grams a day, divided into three to four doses. The maximum maintenance dose in the remission phase is 500 mg, three times a day;
• Crohn’s disease: in the acute phase, 4.5 grams a day, divided into four doses. The maximum maintenance dose in the remission phase is 2 grams a day, divided into three doses.

Salofalk Granu-Stix:

• In the acute phase, 1.5 to 3 grams a day (preferably in the morning) or 500 mg – 1000 mg three times daily;
• The maintenance dose in the remission phase is 500 mg three times daily, or 3 grams once daily (preferably in the morning).

Salofalk enema:

• In the acute phase, one dose of 2 g / 30 g twice daily, or 4 g / 60 g given as single nightly dose;
• The maintenance dose in the remission phase is 2 g / 30 g once daily or 2 g / 60 g given as single nightly dose, or one dose of 4g / 60 g every other day;
• Ulcerative proctitis: the recommended maintenance dose in the remission phase is 2 g /30 g given as single nightly dose.

Salofalk suppositories:

• In the acute phase, one 500 mg suppository three times a day, or one 1 g suppository once daily before bedtime;
• The maintenance dose in the remission phase is one 250 mg suppository three times a day.

Salofalk rectal foam:

• One dose, administered at bedtime (if necessary divided into two doses: one at bedtime and the other during the night or early in the morning).

Salofalk tablets and granules:
See the package leaflet for the proper dosage for use in children. Salofalk suppositories, enema and rectal foam are not recommended for children.

Salofalk can cause side effects, although of course not everyone will suffer from them. Some of the side effects that are known to be associated with this medicine are headaches, gastrointestinal symptoms., skin rashes, itching and tiredness, and anal or rectal irritation with the suppositories, rectal foam and enema. Side effects should be reported to a doctor or pharmacist, particularly if you experience severe side effects. For a complete list of possible side effects, see the package leaflet.

Salofalk is not suitable for everyone and should not be used if you are allergic to the active ingredient mesalazine, salicylates (e.g. aspirin) or any other ingredient in this medicine, or if you have severely decreased liver or kidney function. If you have a lung condition (e.g. asthma), a slightly compromised liver or kidney function, or are you allergic to a related medicine called sulfasalazine, you should use Salofalk with caution. Talk to your doctor before you start taking this medicine.

Salofalk not be used by pregnant women without consulting a doctor first. Salofalk passes into breast milk in small amounts. It is therefore advisable not to take this medicine if you are breastfeeding unless your doctor tells you to do so.

For more information on contraindications and warnings, see the package leaflet.

Some medicines interact with each other. Salofalk is known to interact with:

• Azathioprine, 6-mercaptopurine and thioguanine (used for immune-related disorders);
• Certain medicines that decrease blood clotting, such as warfarin;
• Lactulose or other medicines that change the acidity of stools.

Check with your doctor or pharmacist if you are taking any of these medicines. You can find more information on this topic in the package leaflet.

This medicine is only available at pharmacies. Salofalk tablets, granules, suppositories, enema and rectal foam cannot be bought over the counter.

Salofalk is a prescription-only medicine and as such, you need a prescription to order it.

College ter Beoordeling van Geneesmiddelen (Dutch Drug Evaluation Committee). (2019a, 1 September). Salofalk 2 g/30 g, klysma (Salofalk 2 g/30 g, enema) | Geneesmiddeleninformatiebank. Consulted on 28 April 2020 on https://www.geneesmiddeleninformatiebank.nl/ords/f? p=111:3::SEARCH:NO::P0_DOMAIN,P0_LANG,P3_RVG1:H,NL,15393

College ter Beoordeling van Geneesmiddelen. (2019b, 1 September). Salofalk 250, maagsapresistente tabletten 250 mg (Salofalk 250, enteric-coated, 250 mg tablets) | Geneesmiddeleninformatiebank. Consulted on 28 April 2020 on https://www.geneesmiddeleninformatiebank.nl/ords/f? p=111:3::SEARCH:NO::P0_DOMAIN,P0_LANG,P3_RVG1:H,NL,11086

College ter Beoordeling van Geneesmiddelen. (2019c, 1 September). Salofalk 1000 mg Granu-Stix, maagsapresistent granulaat met verlengde afgifte (Salofalk 1000 mg Granu-Stix, enteric-coated delayed release granules) | Geneesmiddeleninformatiebank. Consulted on 28 April 2020 on https://www.geneesmiddeleninformatiebank.nl/ords/f? p=111:3::SEARCH:NO::P0_DOMAIN,P0_LANG,P3_RVG1:H,NL,28131

College ter Beoordeling van Geneesmiddelen. (2019d, 1 September). Salofalk Schuim, 1 g/dosis schuim voor rectaal gebruik (Salofalk Rectal Foam, 1g/dose for rectal use) | Geneesmiddeleninformatiebank. Consulted on 28 April 2020 on https://www.geneesmiddeleninformatiebank.nl/ords/f? p=111:3::SEARCH:NO::P0_DOMAIN,P0_LANG,P3_RVG1:H,NL,28179

College ter Beoordeling van Geneesmiddelen. (2019e, 1 September). Salofalk zetpil 250, zetpillen 250 mg (Salofalk suppository 250, suppositories 250 mg) | Geneesmiddeleninformatiebank. Consulted on 28 April 2020 on https://www.geneesmiddeleninformatiebank.nl/ords/f? p=111:3::SEARCH:NO::P0_DOMAIN,P0_LANG,P3_RVG1:H,NL,10115

Crohn en Colitis Ulcerosa Vereniging Nederland (CCUVN) (Crohn’s & Ulcerative Colitis Association). (n.d.). Inflammatory bowel diseases (IBD): Crohn en colitis ulcerosa (Crohn’s disease and ulcerative colitis). Consulted on 28 April 2020 on https://www.crohn-colitis.nl/ibd/

KNMP (Royal Dutch Pharmaceutical Society). (2019, 3 December). Mesalazine – Apotheek.nl. Consulted on 28 April 2020 on https://www.apotheek.nl/medicijnen/mesalazine#!

Zorginstituut Nederland (Dutch National Health Care Institute). (n.d.). Mesalazine – FarmacotherapeutischKompas. Consulted on 28 April 2020 on https://www.farmacotherapeutischkompas.nl/bladeren/preparaatteksten/m/mesalazine