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Djutan® (Tablets, Capsules) Instructions for Use

ATC Code

A03AA04 (Mebeverine)

Active Substance

Mebeverine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

A myotropic-acting spasmolytic that has a direct effect on the smooth muscle of the gastrointestinal tract without affecting normal intestinal peristalsis.

The exact mechanism of action is unknown, but multiple mechanisms, such as reducing ion channel permeability, blocking norepinephrine reuptake, local anesthetic action, and altering water absorption, may cause the local effect of mebeverine on the gastrointestinal tract.

Through these mechanisms, Mebeverine exhibits a spasmolytic effect, normalizing intestinal peristalsis and not causing persistent relaxation of the smooth muscle cells of the gastrointestinal tract (“hypotonia”).

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed, undergoes presystemic hydrolysis, and is not detected in plasma.

It is metabolized in the liver to veratric acid and mebeverine alcohol.

It is excreted mainly by the kidneys in the form of metabolites, in small amounts – with bile (completely – within 24 hours).

Indications

Symptomatic treatment of pain, spasms, dysfunction, and discomfort in the intestinal area associated with irritable bowel syndrome (symptoms may include abdominal pain, cramps, feeling of bloating and flatulence, change in stool frequency (diarrhea, constipation, or alternating diarrhea and constipation), change in stool consistency).

ICD codes

ICD-10 code Indication
K58 Irritable bowel syndrome
R10.4 Other and unspecified abdominal pain (colic)
R14 Flatulence and related conditions (including abdominal bloating, belching)
ICD-11 code Indication
DD91.0Z Irritable bowel syndrome, unspecified
DD93.1 Infantile colic
MD81.4 Other and unspecified abdominal pain
ME08 Flatulence and related conditions

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally with a glass of water.

Take the dose 20 minutes before meals.

The standard adult dosage is one tablet or capsule (135 mg)three times daily.

Swallow the tablet or capsule whole; do not chew or crush.

Once symptoms are controlled, reduce the dosage to one tablet or capsule twice daily for maintenance therapy.

Adjust the dose, frequency, and duration of treatment individually based on clinical response and symptom severity.

Do not exceed the maximum daily dose of 405 mg (three tablets or capsules).

If symptom relief is not achieved after two weeks of continuous therapy, re-evaluate the diagnosis and treatment plan.

Discontinue use if symptoms resolve.

This medication is intended for short-term symptomatic management.

Adverse Reactions

Skin and subcutaneous tissue disorders: urticaria (allergic rash), angioedema (a serious allergic reaction that may include: difficulty breathing, swelling of the face, neck, lips, tongue, throat), facial edema, exanthema (skin rash).

Immune system disorders: hypersensitivity reactions (anaphylactic reactions – serious allergic reactions that may include difficulty breathing, rapid pulse, sharp decrease in blood pressure (weakness and dizziness), increased sweating).

Contraindications

Hypersensitivity to mebeverine; age under 18 years; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Mebeverine is contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

If the patient is over 50 years old and if the symptoms of the disease have occurred for the first time, the patient should consult a doctor before starting the use of mebeverine.

Special Precautions

The patient should consult a doctor before starting the use of mebeverine in the following cases: if the symptoms of the disease have occurred for the first time; with unintentional and unexplained weight loss; with anemia; with rectal bleeding or blood in the stool; with fever; in case of a family history of colon cancer, celiac disease, or inflammatory bowel disease; if the patient is over 50 years old and if the symptoms of the disease have occurred for the first time; in case of recent antibiotic use.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle Rx Icon Djutan® Prolonged-release capsules 200 mg: 10, 15, 20, 30, 40, 45, 50, 60, 75, or 90 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release capsules hard gelatin, size No. 0, with a white body and cap; the contents of the capsules are spherical pellets of white or almost white color.

1 caps.
Mebeverine hydrochloride* 200 mg

* 1 caps. contains: mebeverine hydrochloride, pellets 70% – 286 mg.

Excipients: microcrystalline cellulose, mannitol, sucrose (sugar), sodium lauryl sulfate, povidone K30 (polyvinylpyrrolidone).

Shell composition: ethylcellulose, hypromellose, cetyl alcohol.

Capsule composition (body and cap) titanium dioxide, gelatin.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (5) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle OTC Icon Djutan® Film-coated tablets, 135 mg: 10, 15, 20, 30, 40, 45, 50, 60, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.

1 tab.
Mebeverine hydrochloride 135 mg

Excipients: mannitol, microcrystalline cellulose type 102, sodium carboxymethyl starch (sodium starch glycolate), povidone K30, talc, magnesium stearate.

Shell composition Opadry II 85F18422 white (polyvinyl alcohol, titanium dioxide, macrogol, talc)

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (5) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (6) – cardboard packs.

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