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Salofalk

Salofalk

​​Salofalk is used to reduce inflammation in the intestines. It can also be taken continuously to help prevent inflammation. Salofalk contains the active ingredient mesalazine, which is a type of medicine called an aminosalicylate.  ​ 

​​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.​ 

What is ​Salofalk​? 

​​Salofalk is used to reduce inflammation in the intestines. It can also be taken continuously to help prevent inflammation. Salofalk contains the active ingredient mesalazine, which is a type of medicine called an aminosalicylate.  ​ 

When is ​Salofalk​ used? 

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

  • ​​Ulcerative colitis. Ulcerative colitis 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 that include 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 propagates to the large intestine. If only the rectum is affected, the disease is referred to as ulcerative proctitis.​ 
  • ​​Crohn’s disease. Crohn’s disease is an inflammatory bowel disease which not only causes the large intestine and rectum, but also the small intestine to become inflamed. 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 of Crohn’s disease. Inflammation from Crohn’s disease can spread through the intestinal wall and affect other organs. 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 the disease 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 intestine and help prevent attacks and reduce their severity.​ 

How is ​Salofalk​ used? 

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

  • ​​Salofalk tablets: Salofalk tablets should be taken directly after a meal. They should be swallowed whole without chewing. If you are taking more than one dose, it’s important to space the doses evenly throughout the day.​ 
  • ​​Salofalk Granu Stix granules: Salofalk granules should be placed onto the tongue and washed down with plenty of liquid. The contents of the sachets of Salofalk granules should not be chewed because the granules have a functional coating on the particles, which ensures gastro-resistance.​ 
  • ​​Salofalk enema: Salofalk enema 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: Salofalk suppositories 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: Salofalk rectal foam 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, the foam 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. This will reduce the urge to defecate. 

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

What doses are available? 

​​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 per day, divided in three to four doses. The maximum maintenance dose in the remission phase is 500mg, three times a day.​ 
  • Crohn’s disease: in the acute phase, 4.5 grams per day, divided in four doses. The maximum maintenance dose in the remission phase is 2 grams a day, divided in three doses. 
  • ​​Salofalk Granu-Stix: in the acute phase, 1.5 to 3 grams per day (preferably in the morning) or 500 to 1000mg three times daily. The maintenance dose in the remission phase is 500mg three times daily, or 3 grams once daily (preferably in the morning).​ 
  • ​​Salofalk enema: in the acute phase, one dose of 2g/30g twice daily, or 4g/60g given as single nightly dose. The maintenance dose in the remission phase is 2g/30g once daily or 2g/60g given as single nightly dose, or one dose of 4g/60g every other day or once every two days. ​Ulcerative proctitis: the recommended maintenance dose in the remission phase is 2g/30g given as single nightly dose. 
  • Salofalk suppositories: in the acute phase, one 500mg suppository three times a day, or one 1-gram suppository once daily before bedtime. The maintenance dose in the remission phase is one 250mg suppository three times a day. 
  • Salofalk rectal foam: One dose, administered at bedtime (if necessary divided in 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. 

What are the side effects of ​Salofalk​? 

​​Salofalk can cause side effects, although not everyone gets them. The following are some of the side effects that are known to be associated with this medicine:​ 

  • ​​Headache.​ 
  • ​​Gastrointestinal symptoms.​ 
  • ​​Skin rash.​ 
  • Itching. 
  • Tiredness. 
  • Anal or rectal irritation with the suppositories, rectal foam and enema. 

Side effects should be reported to a doctor or pharmacist. Consult a doctor if you experience severe side effects. For a complete list of possible side effects, see the package leaflet. 

When not to use Salofalk? 

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. 
  • You have severely decreased liver or kidney function. 

Do 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? Then Salofalk should be used 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. 

Can Salofalk be used in combination with other medicines? 

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. 

Where can I buy Salofalk? 

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

Can I buy Salofalk without a prescription? 

Salofalk is a prescription medicine. This means you need a prescription to order it. 

Sources 

College ter Beoordeling van Geneesmiddelen (Dutch Drug Evaluation Committee). (2019a, 1 September). Salofalk 2 g/30 g, klysma (Salofalk 2 g/30g, 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, 250mg 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 250mg) | 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