Salofalk

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Salofalk on Prescriptsy

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Salofalk is a brand of mesalazine (5-aminosalicylic acid, 5-ASA), an anti-inflammatory medicine used for the treatment and maintenance of remission in ulcerative colitis and for the management of Crohn's disease affecting the ileum and colon.

Salofalk is available in several formulations including gastro-resistant tablets, prolonged-release granules, suppositories, and rectal foam, allowing treatment to be tailored to the location and extent of disease.

It is a prescription-only medicine (POM) manufactured by Dr Falk Pharma.

This page provides a comprehensive clinical guide to Salofalk, covering how mesalazine works, dosage, side effects, important safety warnings including the need for renal monitoring, and how to obtain a prescription in the United Kingdom.

Important safety information about Salofalk

• Renal function must be checked before starting mesalazine, at 3 months, and at least annually during treatment. More frequent monitoring is recommended for elderly patients and those with pre-existing kidney disease.
• Blood counts and liver function should also be monitored before and during treatment.
• Mesalazine brands are not interchangeable. Do not switch from Salofalk to another brand without medical advice.
• Seek urgent medical attention if you develop severe abdominal pain (possible pancreatitis), unexplained bruising or bleeding, persistent fever, or chest pain.
• Continue mesalazine during pregnancy unless specifically advised otherwise by your IBD team. Stopping treatment risks disease flare, which carries greater risk to mother and baby.

Understanding ulcerative colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes inflammation and ulceration of the mucosal lining of the large intestine (colon) and rectum.

It follows a relapsing-remitting course, with periods of active disease (flares) alternating with periods of remission.

Symptoms during active disease include bloody diarrhoea, urgency, tenesmus (a constant feeling of needing to empty the bowel), abdominal cramping, and fatigue.

The extent of colonic involvement is classified as proctitis (rectum only), left-sided colitis (up to the splenic flexure), or extensive colitis (beyond the splenic flexure).

Approximately 240,000 people in the United Kingdom live with ulcerative colitis.

The cause of UC is not fully understood but involves a dysregulated immune response to commensal gut bacteria in genetically susceptible individuals.

Environmental factors including diet, stress, smoking cessation (paradoxically, smoking appears protective against UC), and antibiotic use may influence disease onset and course.

UC is diagnosed by a combination of clinical assessment, laboratory tests (including faecal calprotectin), endoscopy with mucosal biopsy, and imaging.

How mesalazine works

Mesalazine exerts its therapeutic effect locally on the inflamed intestinal mucosa.

It is the active moiety of the older prodrug sulfasalazine but without the sulphapyridine carrier, which was responsible for many of sulfasalazine's side effects.

The anti-inflammatory mechanisms of mesalazine are complex and not completely elucidated but include inhibition of cyclooxygenase (COX) and 5-lipoxygenase (5-LOX) pathways, reducing the synthesis of pro-inflammatory prostaglandins, thromboxanes, and leukotrienes.

Mesalazine also acts as a potent free radical scavenger, neutralising reactive oxygen species that damage the colonic mucosa during inflammation.

It may modulate the NF-kappaB signalling pathway, a central regulator of inflammatory gene transcription, and inhibit the production of pro-inflammatory cytokines including tumour necrosis factor alpha (TNF-alpha) and interleukin-1 beta (IL-1-beta).

Mesalazine also activates peroxisome proliferator-activated receptor gamma (PPAR-gamma), a nuclear receptor that is highly expressed in colonic epithelial cells and has anti-inflammatory and anti-proliferative effects.

This mechanism may also contribute to the chemopreventive effect of long-term mesalazine use, as observational studies have suggested that mesalazine may reduce the risk of colorectal cancer in patients with UC, although this remains an area of active research.

Salofalk formulations and drug delivery

A critical aspect of mesalazine therapy is that the drug must be delivered to the site of inflammation in the gut.

Different mesalazine brands achieve this through different delivery mechanisms, which is why brands are not interchangeable.

Salofalk gastro-resistant tablets use a Eudragit-L coating that dissolves at pH 6.0 or above, releasing mesalazine in the terminal ileum and colon.

Salofalk granules use ethylcellulose-coated mesalazine pellets that provide prolonged release throughout the small intestine and colon.

These different release profiles mean that switching between Salofalk and other mesalazine brands (such as Asacol, which uses a Eudragit-S coating dissolving at pH 7.0, or Pentasa, which uses ethylcellulose microspheres with continuous release from the duodenum) may alter the amount of drug reaching the inflamed mucosa and potentially affect disease control.

Topical (rectal) formulations of Salofalk include suppositories and rectal foam.

These deliver mesalazine directly to the rectum and distal colon and are the treatment of choice for proctitis and left-sided colitis.

NICE and BSG guidelines recommend topical mesalazine as first-line treatment for mild to moderate proctitis and left-sided UC, either alone or in combination with oral mesalazine.

Combination therapy (oral plus topical) is more effective than either route alone for inducing remission in left-sided and extensive disease.

Clinical evidence for mesalazine in ulcerative colitis

Mesalazine is the treatment of choice for inducing and maintaining remission in mild to moderate ulcerative colitis.

NICE guideline NG130 (ulcerative colitis: management) recommends mesalazine as first-line treatment for inducing remission in mild to moderate active UC and for maintaining remission.

The British Society of Gastroenterology (BSG) guideline on the management of inflammatory bowel disease in adults (2019) similarly recommends mesalazine as the cornerstone of UC management.

Systematic reviews and meta-analyses have consistently shown that oral mesalazine is significantly more effective than placebo for both induction and maintenance of remission in UC.

For induction of remission, doses of 2 g to 4 g daily are recommended, with higher doses (4 g daily) providing greater efficacy for moderate disease.

For maintenance of remission, doses of 1.5 g to 2 g daily are effective, with once-daily dosing shown to be as effective as divided dosing and associated with better adherence.

The PODIUM trial (Pentasa Once Daily In Ulcerative colitis for Maintenance of remission) and subsequent studies confirmed the non-inferiority of once-daily mesalazine dosing for maintenance therapy.

Topical mesalazine (suppositories or enemas) is more effective than oral mesalazine alone for distal disease and is recommended as first-line monotherapy for proctitis. For left-sided and extensive disease, combining oral and topical mesalazine improves remission rates compared with either alone.

Mesalazine in Crohn's disease

The role of mesalazine in Crohn's disease is more limited and controversial.

It may be considered for mild ileal or ileocolonic Crohn's disease, though current evidence suggests modest benefit at best.

The NICE guideline on Crohn's disease management and BSG guidelines acknowledge that mesalazine is less effective in Crohn's disease than in UC.

Conventional immunomodulators (azathioprine, mercaptopurine, methotrexate) and biological therapies (anti-TNF agents, vedolizumab, ustekinumab) are the mainstay of treatment for moderate to severe Crohn's disease.

Mesalazine may have a role in maintaining surgically induced remission after ileal or ileocolonic resection, though evidence is mixed.

Dosage and administration

For active ulcerative colitis (mild to moderate): oral Salofalk 1.5 g to 3 g daily (up to 4 g daily for moderate disease under specialist guidance).

For maintenance of remission: 1.5 g to 2 g daily. Once-daily dosing is acceptable for maintenance.

For distal disease: Salofalk suppositories 0.5 g to 1 g two to three times daily (acute) or once daily (maintenance); Salofalk rectal foam one application (1 g) once or twice daily.

Combination oral and topical therapy is recommended for left-sided and extensive disease. Salofalk tablets should be swallowed whole with water without chewing or crushing.

Side effects of Salofalk

Common side effects

Headache, nausea, abdominal pain, diarrhoea, and flatulence are the most frequently reported side effects. These are usually mild and often settle with continued use.

Uncommon but important side effects

Skin rash, urticaria, and photosensitivity may occur. Use sunscreen and avoid excessive sun exposure. Worsening of colitis symptoms may paradoxically occur and should be reported to your gastroenterologist.

Rare but serious side effects

Nephrotoxicity (interstitial nephritis, renal impairment): renal function monitoring is mandatory before and during treatment. Blood dyscrasias (leucopenia, neutropenia, thrombocytopenia, aplastic anaemia): blood counts should be monitored.

Acute pancreatitis may occur, usually within the first few weeks of treatment. Hepatotoxicity: liver function tests should be monitored. Myocarditis and pericarditis are very rare hypersensitivity reactions.

Seek immediate medical attention for chest pain, severe abdominal pain, unexplained bruising, or persistent fever.

When to seek urgent help

Call 999 if you experience severe chest pain, difficulty breathing, or signs of a severe allergic reaction.

Contact your GP, call NHS 111, or attend A and E for severe abdominal pain, signs of bleeding (blood in stools not related to your colitis, unexplained bruising), persistent high fever, or worsening colitis symptoms.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Renal monitoring is the most important safety requirement. Check renal function (serum creatinine, eGFR) before starting, at 3 months, and annually.

More frequent monitoring is advised for elderly patients and those with pre-existing renal disease. Blood counts and liver function should also be monitored.

Mesalazine brands are not interchangeable due to different release mechanisms. Mesalazine may interact with azathioprine and mercaptopurine by inhibiting TPMT, increasing the risk of myelosuppression.

Avoid concomitant NSAIDs where possible (increased nephrotoxicity risk).

Pregnancy: mesalazine is considered low risk and should be continued to maintain remission. Active IBD carries greater risk than the medicine. Breastfeeding: generally compatible; monitor infant for diarrhoea. Children: used under specialist supervision with weight-adjusted dosing.

How to get Salofalk in the UK

Salofalk is available on NHS prescription from your GP, gastroenterologist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Patients with inflammatory bowel disease may be eligible for a medical exemption certificate if they have a permanent stoma or a continuing physical disability that prevents them from leaving the house without help, though IBD alone does not qualify for automatic exemption.

A prescription prepayment certificate may be more economical for patients requiring multiple items.

Sources

• Salofalk 500 mg gastro-resistant tablets, Summary of Product Characteristics (EMC)
• Mesalazine, British National Formulary (BNF)
• Ulcerative colitis: management, NICE NG130
• BSG consensus guidelines on IBD management
• Mesalazine, NHS
• MHRA Yellow Card Scheme