Intestifalk

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Intestifalk

Quick Facts

Property Description
Active ingredient Budesonide
Form Gastro-resistant capsules, Rectal foam
Pharmacological class Glucocorticoid; Corticosteroid
General purpose Anti-inflammatory treatment for chronic intestinal diseases
Origin Synthetic steroid

What is Intestifalk?

What Type of Medicine is Intestifalk?

Intestifalk is a prescribed pharmaceutical product that contains the active ingredient Budesonide, which is a synthetic steroid. The compound is classified as a glucocorticoid or corticosteroid, a class of medicines clinically recognized for their potent anti-inflammatory agent properties. This classification establishes the drug's fundamental function in modulating inflammation.

Composition and Targeted Delivery Forms

The composition of Intestifalk is a single-ingredient formulation of Budesonide, distinguished by its specialized delivery system. It is available in two dosage forms: gastro-resistant capsules for oral administration and a metered-dose rectal foam. These preparations are engineered for targeted release of the active compound directly to the inflamed intestinal lining, ensuring drug exposure is maximized at the site of inflammation.

General Purpose: Addressing Chronic Intestinal Inflammation

The core purpose of Intestifalk is to help reduce the active signs of chronic inflammatory diseases of the intestine. The drug is defined as a locally acting steroid because Budesonide undergoes rapid and extensive first-pass hepatic metabolism. This process ensures that the majority of the absorbed drug is deactivated by the liver, which leads to low systemic bioavailability. This strategic design concentrates the powerful anti-inflammatory effect directly on the diseased tissue, mitigating the risk of widespread steroid-related effects.

Regulatory References

  1. NIH MedlinePlus, Budesonide Information

What side effects are possible with Intestifalk?

The safety profile of Intestifalk, which contains the glucocorticoid Budesonide, is officially defined by the potential for systemic corticosteroid effects, despite the drug’s intended localized action and high first-pass metabolism. The official regulatory documents classify adverse reactions across several System Organ Classes.

Adverse Reaction Scope

Classification Representative Adverse Reactions
Common (up to 1 in 10 people) Hypercorticism (e.g., moon face, weight gain), Headache, Increased risk of infection, Dyspepsia, Abdominal pain, Osteoporosis, Muscle and joint pain, Mood changes (e.g., depression, euphoria).
Rare (up to 1 in 1,000 people) Glaucoma, Cataract, Pancreatitis, Osteonecrosis (bone damage), Aggression.

Serious adverse reactions documented in official labeling include Hypercorticism and Adrenal Axis Suppression. The drug is associated with immunosuppression, meaning the risk of infection is increased, and the signs of serious infections may be masked.

Regulatory Safety Limitations

  • Severe Hepatic Impairment: The medicine is formally contraindicated in individuals with severe liver disease (Child-Pugh Class C) due to the risk of substantially increased systemic exposure of Budesonide.
  • Dose and Duration: The potential for systemic glucocorticosteroid effects, such as Hypercorticism, is explicitly noted as more likely with high doses and prolonged periods of use.
  • Pediatrics: Official safety data for children and adolescents documents the potential for Growth retardation as a rare systemic effect.

Connection to the Overall Safety Profile

The official safety information structures the risk profile around the inherent nature of the glucocorticoid class, primarily defining risks related to the potential for systemic HPA axis suppression and infection. The frequency classification formally communicates the likelihood of common adverse reactions versus rare, clinically significant events like Glaucoma or Osteonecrosis, while the contraindication in severe liver disease defines a specific population constraint.

Overdose and Emergency Response

Intestifalk (budesonide) is a locally acting corticosteroid, and due to its high first-pass metabolism, acute overdose is generally unlikely to lead to life-threatening toxicity. However, taking the medication at very high doses or for a prolonged period beyond the recommended course can significantly increase the systemic concentration of budesonide, leading to potential corticosteroid-related side effects.

Potential Overdose Symptoms

Symptoms of an acute or chronic overdose may resemble the known side effects of high-dose corticosteroids. These can include Cushing's syndrome features such as 'moon face,' easy bruising, weight gain in the torso, and an increased risk of infection. Over time, high exposure can also lead to symptoms of adrenal suppression, including weakness, fatigue, loss of appetite, and nausea.

When to Seek Immediate Help

Contact emergency medical services or a poison control center immediately if you suspect an overdose. Do not wait for symptoms to appear. While severe acute reactions are rare, seek urgent medical attention if you experience signs of a serious adverse reaction, such as:

Symptom Category Signs Requiring Immediate Medical Attention
Infection Fever, chills, severe sore throat, or a wound that will not heal
Adrenal Issues Severe vomiting, feeling faint or very dizzy, extreme muscle weakness
Psychological Severe mood changes (e.g., profound depression, aggression, or hallucinations)

Treatment for overdose is generally supportive and based on the symptoms presented.

Therapeutic Uses of Intestifalk

Quick Facts: Therapeutic Domain

  • Intestifalk is intended to induce remission in people with mild to moderate active Crohn's disease involving the ileum and/or ascending colon.
  • The compound may also be used for the management of active microscopic colitis (lymphocytic colitis and collagenous colitis).

What Intestifalk Treats: Main Uses and Benefits

Intestifalk (budesonide) is a medication that plays a role in the management of specific chronic inflammatory conditions within the gastrointestinal tract. Its primary purpose is to help achieve remission in adult patients experiencing mild to moderate active Crohn’s disease where the inflammation is located in the ileum (the final part of the small intestine) and/or the ascending colon (the beginning of the large intestine). It offers a therapeutic approach to help address the symptoms associated with this type of inflammatory bowel disease.

Furthermore, the medication is utilized in the care of individuals diagnosed with microscopic colitis, which encompasses both collagenous colitis and lymphocytic colitis. In these contexts, the compound is intended to induce and maintain remission, contributing to the overall stability of the condition. Treatment decisions should always be made with a healthcare provider, who can offer personalized guidance on the medication’s role in the treatment plan.

Eligibility and Restrictions for Use

Official Eligibility for Intestifalk (Budesonide)

The use of Intestifalk is strictly governed by population eligibility rules defined in regulatory documents. Eligibility and non-eligibility are determined by specific age, weight, and clinical status criteria.

Population Status Regulatory Classification
Contraindicated Patients with known hypersensitivity to the active substance or excipients; those with severe hepatic impairment (Child-Pugh Class C).
Conditional Use Patients with moderate hepatic impairment (Child-Pugh Class B) require close monitoring. Caution is mandated for co-morbidities such as hypertension, diabetes mellitus, glaucoma, or active infections.

Age and Weight Restrictions: The medicine is approved for adults for both Crohn's disease and microscopic colitis. For the pediatric population, eligibility is limited: Intestifalk is approved only for children 8 years of age or older who weigh more than 25 kg. Use is not recommended below this specific age and weight threshold.

Pregnancy and Lactation: Use during pregnancy is generally avoided unless the expected maternal benefits clearly outweigh the potential risks to the fetus. The active substance is known to be excreted in breast milk.

What should I know about interactions with other medicines?

The official regulatory profile for Intestifalk (budesonide) is structured around documented pharmacokinetic and absorption interference patterns. The primary metabolic pathway involves the Cytochrome P450 3A4 (CYP3A4) enzyme.

Documented Pharmacokinetic Interactions

  • Strong CYP3A4 Inhibitors: Co-administration with inhibitors such as Ketoconazole or Ritonavir significantly increases systemic exposure to budesonide; official documentation records an up to eight-fold increase in exposure with Ketoconazole. Conversely, CYP3A4 inducers are documented to lower budesonide plasma levels.
  • Gastrointestinal Absorption Interference: Bile acid binding resins (e.g., Cholestyramine) interfere with intestinal absorption, resulting in decreased budesonide plasma concentrations. This interaction necessitates a formal timing separation rule: budesonide must be administered at least one hour before or four to six hours after the resin dose.

Restrictions and Population Notes

  • The consumption of Grapefruit or Grapefruit Juice must be avoided during therapy, as it inhibits gut-wall CYP3A4 and is documented to approximately double the systemic exposure of oral budesonide.
  • Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) due to the risk of substantially increased systemic availability.
  • Additive effects on electrolyte levels may occur with medicines that also lower serum potassium, such as certain diuretics.

Mechanism of Action

Modulation of Gene Expression via the Glucocorticoid Receptor

The drug acts as an agonist (activator) at the intracellular Glucocorticoid Receptor ( GRalpha) found within immune cells in the intestinal lining. This interaction initiates a genomic cascade where the activated receptor complex enters the nucleus to directly reprogram cellular activity. This process primarily functions through transrepression, inhibiting the pro-inflammatory transcription factors NF-kappa B and AP-1.


Suppression of Pro-Inflammatory Signaling

By blocking these transcription factors, the drug profoundly reduces the cell's ability to synthesize and release the chemical signals that amplify inflammation, such as cytokines ( TNF-alpha, IL-1beta) and inflammatory lipids like prostaglandins. This suppression results in a physiological effect that limits the influx and activation of immune cells and lowers capillary leakage, which in turn decreases localized tissue swelling (edema).


Localized Action and Delayed Physiological Effect

The mechanism is dependent on the specialized formulation, which concentrates high drug levels directly onto the affected mucosal tissue. The mechanism is highly localized, concentrating the anti-inflammatory action onto the affected mucosal tissue. Since this anti-inflammatory effect requires changes in gene transcription and new protein synthesis, it is a genomic action that manifests with a characteristic delay, meaning the full physiological quieting of the inflammation develops over hours to days.

Dosage and Administration Information

Administration Scope

Field Instruction
Route of Administration: Rectal (inserted through the anus).
Dosing Schedule: One spray application, corresponding to 2 mg budesonide.
Frequency and Timing: Once daily, applied either in the morning or in the evening.
Use-Context Constraint: For best results, it should be administered after emptying the intestine.

Preparation and Administration Procedural Steps

Intestifalk rectal foam is for rectal application only and must not be taken by mouth. The official application process requires specific steps to ensure the correct dose is delivered and retained:

  1. Preparation: The aerosol canister must be shaken for approximately 15 seconds to mix the contents. For the first use, remove the plastic safety lock from the dosing head.
  2. Assembly: Connect a new, single-use applicator firmly to the discharge tube.
  3. Positioning the Can: Hold the aerosol canister completely upside down with the dosing head facing down and as vertically as possible, as the can only works properly in this position.
  4. Insertion: Insert the applicator gently and as far as possible into the rectum. The patient may stand with one foot raised on a chair or lie on their side with the upper leg bent.
  5. Dose Release: Fully push down the pump dome once, and then release it very slowly. The foam is actuated from the can as the pump dome is released.
  6. Retention: Keep the applicator in position for 10 to 15 seconds before withdrawing it. This ensures the full dose is administered.
  7. Post-Application: The applicator must be removed from the canister and discarded after use. The patient should aim not to empty their bowels again until the next morning if the dose is applied at bedtime.

Population-Specific Rules and Restrictions

  • Adults (over 18 years): The standard dose is 1 spray application once daily.
  • Children and Adolescents (under 18 years): Use in this age group is not recommended due to insufficient experience with the medicine.
  • Duration: The duration of treatment is determined by the physician; an acute course is typically limited to 6 to 8 weeks.
  • Dietary Restriction: Grapefruit juice should not be consumed during the treatment period as it may alter the medicine's effects.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Intestifalk

This overview describes the types of clinical research and studies that have been conducted on Intestifalk, focusing on what was examined and what limitations exist in the current evidence. It does not provide medical advice or specific instructions on how to use the medicine.


Evidence for Use in Mild to Moderate Crohn’s Disease

Studies have focused on the medicine in adult patients with Crohn's disease, specifically when the inflammation is limited to the ileum and/or the ascending colon. The research typically includes Randomized Controlled Trials (RCTs), some of which evaluated the medicine against an inactive substance (placebo) or against other studied steroids. These studies were used in research exploring how symptoms change over time during periods of increased symptom activity.

The main outcomes measured in these short-term studies included whether clinical remission was observed, which is defined by a pre-specified change in disease activity scores. Research examined the changes measured during the study period in comparison to the control groups.

What remains uncertain is the medicine’s role outside of this specific part of the intestine, as studies examining inflammation in other areas are limited. Furthermore, while the research provides insight into short-term changes, evidence is limited regarding the medicine's role in the long-term maintenance of remission in this condition.


Evidence for Use in Microscopic Colitis

The evidence base for microscopic colitis (a condition marked by functional limitations and fluctuating symptoms) includes extensive Randomized Controlled Trials (RCTs) and systematic reviews. Studies explored both the initial observation of outcomes related to symptom activity and the subsequent goal of sustaining stability (maintenance of remission).

These studies monitored outcomes related to physical discomfort and changes in the frequency and type of stools. Studies also monitored changes in the actual colon tissue (histological remission) via biopsies. Studies report how symptoms evolved in the observed populations, and findings indicate patterns related to the observation of short-term remission in both the collagenous colitis and lymphocytic colitis subtypes.

However, the existing research suggests that evidence quality varies across the two subtypes, particularly concerning long-term use. Data related to the maintenance of remission is less extensive for the lymphocytic colitis subtype than for the collagenous colitis subtype.

Key Studies & References

  1. Decentralised Procedure RMS Day 210 Assessment Report OVERVIEW Budenofalk 9 mg gastro-resistant granules (EMA/MHRA/CBG)

Frequently Asked Questions (FAQ)

Common questions about Intestifalk (FAQ)


Q: Is Intestifalk used for Crohn's disease or ulcerative colitis, or both?

A: According to official product information, the rectal foam form of Intestifalk (budesonide) is used to help induce remission in patients with mild to moderate active ulcerative colitis. Specifically, this is for inflammation that is localized in the rectum and the lower part of the large intestine (sigmoid colon). Research has examined its use in specific types of Crohn’s disease.


Q: What is the most common side effect people report when starting Intestifalk?

A: Official documentation classifies known side effects by how often they occur in studies, but it does not usually identify a single most common reaction for the general patient population. Side effects categorized as common include headache, indigestion (dyspepsia), and abdominal pain. It is described that these common effects may happen in up to 1 in 10 people.


Q: Can Intestifalk be used long-term?

A: The standard treatment course for active disease is typically limited to 8 weeks. In some cases, continued use for maintenance has been studied, but official information describes treatment duration generally not exceeding 3 months. Research evidence suggests that continued use beyond this period may not provide substantial additional clinical benefit.


Q: Are there different versions or strengths of Intestifalk available?

A: Intestifalk is available in different formulations to target different areas of the intestine. The product information describes the rectal foam, which is typically 2 mg, and gastro-resistant oral capsules, which are often 3 mg or 9 mg depending on the product prescribed. The final selection of the form and strength is documented to be based on the specific condition being addressed.


Q: Do older adults (seniors) need to take a different dose of Intestifalk?

A: Regulatory documentation generally provides a standard dose for all adults over 18, including seniors, and no specific dose change is typically noted for older adults alone. However, official information cautions that patients with existing liver (hepatic) or kidney (renal) impairment require monitoring, and close monitoring is noted as necessary in official documents.


Q: How often do people typically need to take Intestifalk each day?

A: The required frequency of administration is outlined in the official instructions for use for the specific form prescribed. Both the rectal foam and oral capsules are designed for targeted delivery to the inflamed tissue.


Q: Is Intestifalk available as an enema or only as oral capsules?

A: Intestifalk is available as oral capsules and a rectal foam. While both the foam and a liquid enema are administered into the rectum, the rectal foam is a different type of formulation that uses an applicator to deliver the dose. This allows the drug to coat the local area of inflammation.


Q: How long does Intestifalk typically take to start working?

A: Because the drug works by changing gene expression in the immune cells, its full anti-inflammatory effect has a characteristic delay. The physiological quieting of inflammation develops over hours to days. Clinical studies often measure the effectiveness of the treatment after a period of several weeks, such as the completion of an 8-week course.


Q: Can Intestifalk cure inflammatory bowel disease (IBD)?

A: Intestifalk is prescribed to help reduce active signs of chronic intestinal diseases and to induce remission, which means reducing symptoms and inflammation. Regulatory documents do not typically describe this class of medicine as a cure for chronic inflammatory conditions.


Q: What is the purpose of the coating on the Intestifalk tablets/capsules?

A: The oral capsules have a specialized gastro-resistant coating. This coating is essential because it prevents the medicine from dissolving in the stomach acid. The purpose is to ensure the drug travels further down the digestive tract and is released in a targeted manner into the affected areas of the small or large intestine.


Q: What happens if I forget to take a dose of Intestifalk?

A: Official product information describes that if a dose is forgotten, the instruction is generally to continue with the next scheduled dose. Regulatory documents specify that a double dose is not indicated to compensate for the missed one.


Q: Does Intestifalk interact with common over-the-counter pain relievers?

A: Official information indicates that the use of corticosteroids like Intestifalk along with certain non-prescription pain relievers, specifically NSAIDs (like ibuprofen), may increase the risk of irritation or ulceration in the digestive tract. Official information indicates that this combination is noted as requiring close monitoring.


Q: Does Intestifalk interact with birth control pills?

A: Yes, official product information describes a potential interaction with estrogen-containing oral contraceptives. Regulatory documents state that these types of birth control pills may increase the blood levels of budesonide, which could raise the potential for systemic steroid-related side effects.


Q: What are the known potential interactions with prescription blood thinners?

A: According to regulatory reviews, corticosteroids may potentially influence the effect of prescription blood thinners (anticoagulants). In some cases, this interaction may lead to either a decrease in the blood thinner's effect or an increased risk of bleeding due to effects on vascular health.


Q: Can Intestifalk make you feel tired or fatigued?

A: Regulatory documents list fatigue and unusual weakness or tiredness among the reported side effects of the active ingredient, budesonide. These are considered potential effects that have been documented in clinical use reports.


Q: Why does Intestifalk need to be swallowed whole?

A: The oral capsules must be swallowed whole and not chewed, crushed, or opened. This is critical to keep the protective, gastro-resistant coating intact. Breaking the capsule would cause the medicine to be released too early in the stomach, preventing its targeted delivery to the inflamed part of the intestine.


Q: Does taking Intestifalk affect future ability to get pregnant?

A: Official documentation provides information about the drug's use during active pregnancy or breastfeeding. However, specific long-term data on the drug's effect on future fertility or the ability to conceive is often limited or not provided in patient-facing regulatory materials.


Q: Are there any specific blood tests required while taking Intestifalk?

A: Regulatory guidelines recommend that patients be monitored for signs of adrenal suppression. This monitoring is typically done via clinical assessment, but blood tests are documented as an option to evaluate adrenal gland function in certain situations.


Q: Is Intestifalk safe for people with known kidney problems?

A: Official documents do not typically provide specific dosage recommendations for individuals with kidney (renal) problems. This means that specific safety data or dosage guidelines for this population may be limited, and close monitoring is noted as necessary in official documents.


Q: What happens when you stop taking Intestifalk?

A: Official instructions describe the need for the dose to be reduced gradually over time rather than stopping abruptly. This gradual reduction is noted as a measure to avoid potential symptoms related to steroid withdrawal.


Q: Can Intestifalk be taken with acid reflux medicine?

A: Official product information notes that taking the oral capsules with certain acid reflux medications, such as some antacids or PPIs, requires close monitoring. These medicines work by reducing the acidity in the stomach, which could potentially cause the protective coating on the capsule to dissolve prematurely, affecting its function.


Q: Do official documents mention any research on Intestifalk for non-IBD conditions?

A: Official documentation for Intestifalk lists its approved uses, such as specific types of Crohn's disease and microscopic colitis. While research on the active ingredient, budesonide, for certain other conditions exists in medical literature, those uses are not part of the specific official indication for this brand.


Q: Is Intestifalk gluten-free or lactose-free?

A: According to official product excipient lists, the oral capsule formulation of Intestifalk contains lactose and sucrose as inactive ingredients. The full list of inactive ingredients for both formulations is detailed in the official product information.


Q: Does Intestifalk have a risk of withdrawal effects?

A: Yes, because the active ingredient is a glucocorticoid, there is a known risk of steroid withdrawal effects. Symptoms can include generalized weakness, fatigue, and muscle pain. Official product information addresses this risk and describes the process of gradual dose reduction.


Q: Does Intestifalk need to be taken with food or on an empty stomach?

A: Official administration guidelines for the oral capsules specify a particular relationship between the dose and meal times. This timing is designed to ensure proper function of the targeted release mechanism in the intestine.


How should Intestifalk be stored and disposed of?

How to Store and Dispose of Intestifalk

Storage Conditions

Formulation Temperature Requirement Protection Requirements
Capsules Store below 30 C. Keep in original packaging, protected from moisture.
Rectal Foam Store below 25 C. Do not refrigerate or freeze. Protect from direct sunlight, flames, and temperatures above 50 C.

The medicine must be kept out of the sight and reach of children. Prohibited storage locations include the bathroom or areas near a sink.

Stability and Disposal

The rectal foam must be used within four weeks after the container is first opened. The product must not be used after the expiry date printed on the packaging. Unused or expired Intestifalk must not be thrown away via wastewater or household waste. Disposal must be carried out in accordance with local regulatory requirements for unused medicinal products.

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

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