Salofalk (Rectal)

Quick links to important sections

Salofalk (Rectal)

Selected form

Treatment option: Colitis, Colitis,Ulcerative

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Salofalk (Rectal)

What is Salofalk (Rectal)?

Salofalk (Rectal) is a medication containing the active ingredient mesalazine, also known as 5-aminosalicylic acid (5-ASA). It belongs to a group of medicines called aminosalicylates, which are specifically designed to treat inflammatory bowel disease (IBD).

Unlike oral versions of this medication, which are processed throughout the digestive tract, the rectal formulations are designed to deliver the active ingredient directly to the site of inflammation in the lower parts of the colon and the rectum.

Therapeutic Use

This medication is primarily used to manage and treat inflammation in the following conditions:

  • Ulcerative Colitis: An inflammatory condition that affects the lining of the large bowel (colon) and rectum.
  • Proctitis: A specific type of ulcerative colitis that is limited to the inflammation of the rectum.

How it Works

Salofalk works locally on the lining of the bowel. Mesalazine acts as an anti-inflammatory agent that reduces the production of certain substances in the body that cause inflammation. By suppressing this inflammatory response in the intestinal tissue, the medication helps to reduce symptoms and allows the damaged lining of the bowel to heal.

Available Forms

As a rectal treatment, Salofalk is available in several different forms to accommodate different extents of inflammation within the lower bowel:

  • Suppositories: Small, solid plugs inserted into the rectum.
  • Enemas (Suspension): Liquid medication delivered via an applicator.
  • Rectal Foam: A specialized foam formulation designed to reach and coat the affected areas of the lower colon.

Regulatory References

  1. NIH Review: Mesalamine (USAN)

What side effects are possible with Salofalk (Rectal)?

Possible Side Effects and Safety Information

Regulatory documents classify the possible side effects of Mesalamine (the active ingredient in Salofalk Rectal) based on their incidence, which ranges from Common to Very Rare. These adverse reactions are grouped by the affected System-Organ Classes (SOC), including Gastrointestinal Disorders, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders.

Common and Uncommon Adverse Reactions

The most frequently documented adverse reactions, classified as Common (may affect up to 1 in 10 people), include headache, nausea, abdominal pain, and rash. Effects classified as Uncommon include dizziness, vomiting, and localized reactions at the administration site such as rectal discomfort and anal pruritus.

Frequency Category Examples of Officially Documented Effects
Common (up to 1 in 10) Headache, Nausea, Abdominal pain, Flatulence, Rash
Uncommon (up to 1 in 100) Dizziness, Vomiting, Rectal discomfort, Tenesmus

Serious Adverse Reactions and Safety Constraints

Adverse reactions classified as Very Rare (may affect up to 1 in 10,000 people) encompass serious, clinically significant events. These reactions affect major organ systems and include nephrotoxicity (kidney impairment), myocarditis (inflammation of the heart muscle), pancreatitis, and severe blood dyscrasias. Hypersensitivity syndromes, which may manifest as fever or rash, are noted in regulatory information as being more common at the initiation of treatment.

This medicine is officially contraindicated in individuals with a known hypersensitivity to salicylates or the active substance Mesalamine. Furthermore, specific safety constraints documented in the prescribing information prohibit use in patients with severe pre-existing renal impairment or hepatic impairment.

Overdose and Emergency Response

The official regulatory documentation on an overdose of the active ingredient, Mesalamine, establishes the documented manifestations and mandatory emergency procedures.

Documented Manifestations Regulator-Mandated Actions
Overdose presentations may mimic the symptoms of salicylate toxicity, which is the basis for supportive management. Documented symptoms that may be observed include nausea, vomiting, and abdominal pain, as well as headache, dizziness, and confusion. Other clinical signs noted include tinnitus (ringing in the ears) and fast or shallow breathing. Immediately call emergency services (911) if the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Overdose Management and Required Help

Treatment for a suspected overdose is officially classified as symptomatic and supportive because regulatory agencies document that no specific antidote is known for Mesalamine. The official guidance dictates that the regional poison control center must be contacted for advice on managing a suspected drug overdose. Procedures used for salicylate overdose may be applied.

Regarding specific organ risks, regulatory documents note that rare data on overexposure do not indicate renal or hepatic toxicity as a direct consequence of the overdose event itself. The primary objective of treatment is to manage the documented clinical signs that present.

Therapeutic Uses of Salofalk (Rectal)

What Salofalk (Rectal) Treats: Main Uses and Benefits

Targeting Localized Inflammation in the Lower Bowel

This medication is commonly used across conditions presenting with inflammatory or irritative processes in the lower sections of the bowel. It is applicable in situations involving certain distressing symptoms, such as ulcerative proctitis and distal ulcerative colitis. This rectal formulation is generally applied in clinical settings that involve acute or unstable symptom patterns in this region. The localized delivery system assists with managing symptoms related to inflammatory or irritative states in this specific area. This localized action may be part of symptomatic management during acute symptom phases and may assist with managing the condition to help prevent recurrences.

Relief and Stability for Symptomatic Episodes

Salofalk (Rectal) is relevant for managing symptom clusters that may become intense or disruptive during a flare-up. It is applied in addressing manifestations that interfere with daily comfort, such as acute, localized discomfort, rectal bleeding, the painful urgency to defecate (tenesmus), and the increased passage of mucus or diarrhea related to irritation in the distal colon. The use of this treatment provides support that helps ease the overall symptom burden and supports the patient during difficult episodes. Beyond managing acute episodes, this treatment is also commonly used to help with the long-term management of conditions characterized by periods of heightened symptoms. This preventative role is considered relevant for patients managing a chronic condition, and helps contribute to improved day-to-day comfort during symptomatic periods, which assists with maintaining functional stability.

Quick Fact: Relief for Rectal Symptoms
This medication is primarily used to help address acute symptoms related to inflammatory or irritative states in the rectum, offering supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Contraindications and Eligibility for Salofalk (Rectal)

This medication, which contains mesalazine (an aminosalicylate), is not suitable for everyone. Eligibility is strictly governed by pre-existing conditions and known sensitivities.

Do Not Use If You Have:

  • Hypersensitivity: A known allergy to mesalazine, any salicylates (like aspirin), or any excipients listed in the product formulation.
  • Severe Organ Impairment: Severe impairment of hepatic (liver) or renal (kidney) function.

Restrictions and Special Considerations

Population/Condition Eligibility Status (Regulatory Basis)
Children under 12 Use is not recommended due to insufficient experience in this age group.
Impaired Renal Function Use is not recommended; Mesalazine should be discontinued if kidney function deteriorates during treatment.
Impaired Hepatic Function Use requires caution, and patients with severe impairment are formally contraindicated.
Pregnancy/Lactation Should only be used if the potential benefit to the mother outweighs the possible risk to the fetus or infant. Breast-feeding women should discontinue if the infant develops diarrhoea.
Pulmonary Disease/Asthma Requires very careful monitoring due to the potential for hypersensitivity reactions.

Eligibility also requires close medical supervision for patients with a history of adverse reactions to sulphasalazine. Patients must be carefully monitored for signs of acute intolerance or deterioration of organ function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation for Mesalamine (the active ingredient in Salofalk) describes interactions based on pharmacodynamic effects and the potential for cumulative toxicity, rather than specific metabolic mechanisms.


Documented Drug-Drug Interactions

Interacting Product Category Specific Agents Officially Documented Interaction Outcome
Thiopurine Analogs Azathioprine, 6-Mercaptopurine, Thioguanine Co-administration may increase the risk of myelosuppression (bone marrow suppression).
Nephrotoxic Agents NSAIDs (e.g., Ibuprofen, Naproxen) Concurrent use may increase the risk of nephrotoxicity (kidney damage).
Anticoagulants Warfarin Associated with altering the anticoagulant effect of Warfarin, requiring monitoring of coagulation parameters.

Interaction-Related Monitoring and Restrictions

Regulatory labels require that patients co-administered with thiopurines must have their blood cell and platelet counts monitored. Similarly, renal function monitoring is necessary when this medication is used concurrently with nephrotoxic agents. There are no mandatory administration timing rules requiring a fixed hour separation listed in the official labeling.

Mesalamine is also documented to interfere with specific laboratory tests. It may cause spuriously elevated test results for urinary normetanephrine when liquid chromatography with electrochemical detection is used, necessitating an alternative assay.

Mechanism of Action

Salofalk (Rectal) works locally in the lower bowel, where its active component, mesalazine (5-aminosalicylic acid or 5-ASA), engages multiple pathways associated with physiological immune responses.


Modulation of Eicosanoid Synthesis

This mechanism involves the interference with specific enzymatic pathways. Mesalazine acts as an inhibitor of both cyclooxygenase (COX) and lipoxygenase (LOX) enzymes. This interaction modifies early molecular steps, resulting in a reduced synthesis rate of key eicosanoid mediators, specifically prostaglandins and leukotrienes (such as leukotriene B4).


Anti-oxidant and Immune Signaling Regulation

Mesalazine exhibits a direct radical scavenging function, which neutralizes reactive oxygen species and other reactive mediators generated during cellular activity. Furthermore, it is thought to interfere with the activation of inflammatory transcription factors, such notably Nuclear Factor kappaB (NF-kappaB). Inhibition of NF-kappaB activity reduces the subsequent synthesis of various pro-inflammatory cytokines, leading to altered signaling profiles within targeted pathways and supporting the maintenance of a more regulated tissue microenvironment.

Dosage and Administration Information

How to Use Salofalk (Rectal): Administration Guidelines

Salofalk (Rectal), which contains mesalazine, is a medication administered exclusively via the rectal route for local action within the lower bowel and rectum. Proper use involves precise dosing, proper technique, and consistency.


Approved Dosage Forms and Standard Regimens

Salofalk is available in specific strengths and forms for rectal use. Dosing is typically once daily or multiple times a day during an acute treatment phase, as prescribed by a healthcare provider. Dosing recommendations may vary; the following represent common administration patterns:

Form/Strength Common Adult Dosing (Acute) Frequency Pattern
1 g Suppository 1 suppository Once Daily (typically at bedtime)
500 mg Suppository 1 to 2 suppositories 2 to 3 times daily
2 g or 4 g Enema 1 enema Once Daily (typically at bedtime)

Key Administration Procedures

For optimal localized effect, instructions emphasize careful administration:

  • Preparation: The rectal suspension (enema) bottle must be shaken for 30 seconds immediately before use. It is often advised to empty the bowel prior to administration.
  • Timing and Retention: Administration is typically recommended at bedtime. After use, the goal is to retain the medication all night (approx. 8 hours) to maximize contact time with the affected tissue. For enemas, remaining lying down for at least 30 minutes after insertion is advised.
  • Consistency: The duration of treatment for an acute episode is generally between 3 and 8 weeks, and the medication must be administered regularly and consistently. Patients should not take a double dose to make up for a missed dose.
  • Pediatric Use: There is limited experience for use in children.

Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the key findings from clinical and preclinical research on the rectal mesalamine formulation. The information below describes what researchers investigated and how studies were conducted. It is not intended as medical advice or a statement of effectiveness.


Investigating Symptom Control and Quality of Life

The primary research focus has been on exploring the compound's potential in the study of acute symptom management and its relationship to participant well-being over time. The local action of the rectal formulation allows for targeted delivery of the active ingredient, mesalamine, to the site of inflammation.

  • Mechanism of Research Focus The initial focus of preclinical research involved the compound's interaction with a specific inflammatory pathway. Phase I trials assessed how human metabolism interacts with the compound.

  • Acute Symptoms and Remission Clinical trials investigated the timing of observed changes in participant-reported symptom measures during a flare-up. Further analysis in Phase III studies evaluated measured endpoints related to symptom intensity, such as rectal bleeding and stool frequency, compared to a placebo. Studies focusing on distal ulcerative colitis (proctitis and proctosigmoiditis) have shown that topical 5-ASA (mesalamine) administration may be associated with higher rates of achieving remission compared to oral-only therapy in that specific area.

  • Dosing Regimen Studies Research has examined different dosing schedules for suppositories. A Phase III study focusing on active ulcerative proctitis investigated whether once-daily administration of a 1 g suppository had comparable measured outcomes to a thrice-daily 0.5 g regimen. The study found no statistical difference in the primary endpoint (remission rate) between the two dosing schedules.


Research on Safety and Tolerability

  • Safety Endpoints Secondary endpoints in long-term trials evaluated safety measures in studies lasting up to two years. Phase II and III trials collected extensive data on adverse events and tolerance. Research protocols required that the overall discontinuation rate due to adverse events be documented across all trials.

  • Adherence and Formulations Studies have evaluated adherence to rectal therapies. While adherence can be a challenge, some formulations, such as foam enemas, were developed to optimize delivery and patient acceptance. The Phase IV trial further examined measured outcomes related to flare-up duration and severity in a diverse population following market entry, focusing on collecting real-world data outside the highly controlled environment of earlier trials.

Frequently Asked Questions (FAQ)

Common questions about Salofalk (Rectal) (FAQ)


Q: What are some over-the-counter pain relievers that are safe to take with Salofalk (Rectal)?

Regulatory documents caution that using mesalamine with other medications known as Nephrotoxic Agents, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), may increase the risk of potential kidney damage. Official product information lists the risk for NSAIDs but does not list specific over-the-counter pain relievers that are considered safe to take alongside this medicine.


Q: Are there any specific vitamins or supplements that are known to interact with Salofalk (Rectal)?

While regulatory documents specifically list interactions with certain prescription drugs, they do not provide a list of specific vitamins or nutritional supplements known to interact with rectal mesalamine. Official guidance states that patients should discuss all products they are taking with their healthcare provider, including supplements and herbal products.


Q: Is the medication absorbed into the bloodstream, or does it mainly stay in the rectum?

The rectal formulation of this medicine is designed to work primarily through a local action within the rectum and lower colon. According to official pharmacokinetic data, only a small amount of the mesalamine is absorbed into the bloodstream, typically ranging from 5% to 35%. The local action of the medication means it is intended to provide anti-inflammatory effects primarily on the tissue surface in the rectum and lower colon.


Q: What are the typical non-serious side effects people mention when first starting Salofalk (Rectal)?

The official product information lists common adverse reactions such as headache, nausea, abdominal pain, and rash. While adverse reactions like hypersensitivity (an allergic-type reaction) are noted as possibly being more frequent when treatment is initiated, there is no specific data breakdown of which common side effects occur most often during the very first days of therapy.


Q: Do high-fiber foods interfere with the action of Salofalk (Rectal)?

Official regulatory documents do not list any specific interactions between high-fiber foods or a general diet and the action of rectal mesalamine. The official documentation does not list specific dietary restrictions. Dietary changes should be discussed with a healthcare provider.


Q: Is Salofalk (Rectal) only used for ulcerative colitis, or are there other common uses?

The FDA and other regulatory agencies specifically indicate the rectal suppository form of mesalamine for the treatment of mild to moderately active ulcerative proctitis. Ulcerative proctitis is a form of ulcerative colitis that is confined to the rectum. The medication is formulated to act locally on this area.


Q: How long does it usually take to feel the effects of Salofalk (Rectal) after starting treatment?

The full duration of treatment for an acute episode is typically evaluated in clinical trials over several weeks. Patient-focused sources indicate that symptom improvement may potentially be observed during the first few days or weeks of treatment.


Q: Is it normal to have some minor discomfort or pressure after inserting the suppository or enema?

Official product information lists localized effects at the site of administration as uncommon side effects. These include rectal discomfort and tenesmus, which is the feeling of having an incomplete bowel evacuation. These effects may be perceived as minor discomfort or pressure after the medicine is inserted.


Q: Can I accidentally expel the suppository too soon, and what should I do if that happens?

Regulatory instructions highlight that retaining the medication for a certain amount of time, often several hours or overnight, is necessary for the medicine to work as intended. While official prescribing documents warn against taking a double dose for a missed dose, they do not provide specific patient guidance on what steps to take if the suppository is expelled immediately or too soon after insertion.


Q: What happens if I miss a dose of the Salofalk suppository?

Official regulatory guidance states that if a dose is missed, it can be administered as soon as possible, but if it is almost time for the next dose, the missed dose is typically skipped. Official instructions strictly caution against using two doses at the same time to compensate for a missed dose.


Q: Do older adults typically experience different side effects from Salofalk (Rectal) compared to younger users?

Regulatory guidance specifically notes that monitoring blood cell counts may be recommended for geriatric (older) patients. This indicates a potential consideration in this population. However, official documents do not explicitly state that older adults experience a different frequency or type of common side effects compared to younger users.


Q: Is it common for people to switch between oral and rectal mesalazine forms?

Clinical literature notes that treating an inflammatory bowel condition sometimes involves a combination approach using both oral and rectal mesalamine. After an acute episode of inflammation in the lower bowel is managed, patients often switch to an oral mesalamine preparation for maintenance therapy.


Q: Can using Salofalk (Rectal) affect the results of any routine blood tests?

Yes, official product information includes a warning about possible interference with laboratory tests. Specifically, mesalamine has been documented to cause falsely elevated test results for urinary normetanephrine when tested using a specific analytical method called liquid chromatography with electrochemical detection.


Q: Is there a possibility of an allergic reaction to the inactive ingredients in Salofalk (Rectal)?

Official product labeling states that the medication is formally contraindicated if a patient has a known hypersensitivity to mesalamine, salicylates, or any component of the formulation. One form of mesalamine is documented to contain a sulfite, which can cause allergic-type reactions in susceptible people, particularly those with asthma.


Q: Does the time of day matter when using the Salofalk enema?

The enema dosage is recommended to be given once daily, typically at bedtime. This timing is recommended as it aligns with the goal of maximizing the contact time with the affected tissue by facilitating retention overnight.


Q: Can Salofalk (Rectal) cause any skin sensitivity or rashes?

Yes, rash is officially documented as a common adverse reaction associated with mesalamine. In addition to common rashes, more serious, though rare, skin reactions like photosensitivity (increased sensitivity to sunlight) and severe cutaneous adverse reactions have been reported.


Q: Is there an age limit for who can use Salofalk (Rectal)?

Regulatory guidance advises against using the medication in children under 12 years of age due to limited experience in that specific population. Some official sources further note that it should not be used in infants under two years of age.


Q: Can Salofalk (Rectal) be used to treat Crohn's disease in the rectum?

The rectal formulation of mesalamine is approved by regulatory agencies for the treatment of mild to moderately active ulcerative proctitis. Official documentation does not list Crohn's disease as an approved indication for this specific rectal formulation.


Q: What's the best way to clean up after using a Salofalk enema applicator?

Official product information states that the enema unit is supplied as a disposable, single-use applicator. Therefore, after the medication has been administered, the used bottle and applicator should be discarded safely and are not intended to be cleaned for reuse.


Q: Is it common to feel stomach pain or nausea when using a rectal medication like Salofalk?

Yes, abdominal pain and nausea are formally listed in official documents as common adverse reactions associated with the active ingredient mesalamine. These are systemic side effects that are reported regardless of the rectal route of administration.


Q: Can I travel with Salofalk (Rectal) without special temperature controls?

Official storage instructions state that rectal suppositories should be stored at room temperature, typically between 20 C and 25 C (68 F and 77 F). The medication must be kept away from excessive heat, moisture, and direct light, and should not be frozen.


Q: Why is the application technique so specific for Salofalk enemas?

Official instructions describe a specific application technique, such as lying on the left side. This technique is recommended to help the liquid medicine distribute fully inside the lower bowel and prolong the contact time with the affected tissue.

How should Salofalk (Rectal) be stored and disposed of?

How to Store and Dispose of Salofalk (Rectal)

Official regulatory documentation details specific requirements for the storage, handling, and disposal of Salofalk (Mesalamine) rectal formulations to maintain product integrity and ensure safety.

Required Storage Conditions

Salofalk suppositories and enemas must be stored below 30 C and kept in their original package to provide protection from light. The rectal foam, which is a pressurized product, must not be refrigerated or frozen and must be protected from high heat (temperatures above 50 C), flames, and sparks. All forms must be kept out of the sight and reach of children.

Stability and Disposal

The rectal foam has a reduced in-use stability, requiring disposal after 12 weeks following the first actuation. Unused, expired, or waste product must be disposed of in accordance with local requirements. The medication must not be discarded through household waste or wastewater to protect the environment.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Salofalk (Rectal) found in:

A-Z Index: