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Mebeverine (Tablets, Capsules) Instructions for Use

ATC Code

A03AA04 (Mebeverine)

Active Substance

Mebeverine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; synthetic anticholinergic agents, esters with a tertiary amino group

Pharmacological Action

A myotropic-acting antispasmodic 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 an antispasmodic effect, normalizing intestinal peristalsis and not causing persistent relaxation of gastrointestinal smooth muscle cells (“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 Mebeverine orally.

For adults, the standard dosage is one 135 mg tablet or capsule three times daily, preferably taken 20 minutes before meals.

Swallow the tablet or capsule whole with a glass of water; do not chew or crush.

Once symptoms are controlled, consider reducing the dosage to a maintenance regimen of one tablet or capsule twice daily.

The maximum daily dose is 405 mg (three tablets or capsules).

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

Do not use Mebeverine for more than two to three weeks without consulting a physician for re-evaluation.

Discontinue treatment if symptoms persist or worsen despite therapy.

This medication is not intended for the acute relief of sudden spasms but for the ongoing management of chronic symptoms.

Do not exceed the recommended dose.

Adverse Reactions

From the skin and subcutaneous tissues: 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).

From the immune system: 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 the patient’s family has been diagnosed with 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

Rx Only

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

Biocom, JSC (Russia)

Dosage Form

Bottle Rx Icon Mebeverine Extended-release capsules 200 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 60, 63, or 90 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules hard gelatin No. 1, white in color, the contents of the capsules are spherical pellets of white or almost white color.

1 caps.
Mebeverine hydrochloride 200 mg

Excipients: sugar spheres [sucrose – 62.5 – 91.5%, corn starch – 8.5 – 37.5%] – 25.875 mg, povidone K30 – 4.125 mg, hypromellose – 0.4 mg, ethylcellulose – 9.25 mg, macrogol 6000 – 1.775 mg, magnesium stearate – 8.575 mg.

Hard gelatin capsules:
Body gelatin – up to 100%, titanium dioxide (E171) – 2%; cap gelatin – up to 100%, titanium dioxide (E171) – 2%.

7 pcs. – blisters – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.
7 pcs. – blisters (3) – cardboard packs.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (5) – cardboard packs.
7 pcs. – blisters (6) – cardboard packs.
7 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Bottle OTC Icon Mebeverine Film-coated tablets, 135 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; slight surface roughness is acceptable; on the cross-section, the tablet core is white or almost white.

1 tab.
Mebeverine hydrochloride 135 mg

Excipients: lactose monohydrate, microcrystalline cellulose 112, maltodextrin, hyprolose (hydroxypropylcellulose), sodium starch glycolate, magnesium stearate, talc.

Coating composition Opadry 03F180012 white (hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol (polyethylene glycol)).

10 pcs. – PVC/aluminum foil blisters (1) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (2) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (3) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (4) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (5) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (6) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (7) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (8) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (9) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (10) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (11) – cardboard packs.
10 pcs. – PVC/aluminum foil blisters (12) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Mebeverine Extended-release capsules 200 mg: 10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 100, 105, 120, 135, or 150 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules hard gelatin No. 1, white in color, the contents of the capsules are spherical pellets of white or almost white color.

1 caps.
Mebeverine hydrochloride 200 mg

Excipients: microcrystalline cellulose, mannitol, sucrose, sodium lauryl sulfate, povidone K30.

Pellet coating composition: ethylcellulose, hypromellose phthalate HP55, cetyl alcohol.
Gelatin capsule composition: titanium dioxide, gelatin.

10 pcs. – contour cell blisters – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
15 pcs. – contour cell blisters (1) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (5) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (7) – cardboard packs.
15 pcs. – contour cell blisters (8) – cardboard packs.
15 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
70 pcs. – jars – cardboard packs.
80 pcs. – jars – cardboard packs.
90 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Or

Velpharm-M, LLC (Russia)

Dosage Form

Bottle Rx Icon Mebeverine Velpharm Extended-release capsules 200 mg

Dosage Form, Packaging, and Composition

Extended-release capsules

1 caps.
Mebeverine 200 mg

10 pcs. – jars – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell blisters (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell blisters (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell blisters (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell blisters (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell blisters (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – contour cell blisters (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – contour cell blisters (9 pcs.) – cardboard packs (90 pcs.) – By prescription
100 pcs. – jars – cardboard packs (100 pcs.) – By prescription
15 pcs. – contour cell blisters – cardboard packs (15 pcs.) – By prescription
15 pcs. – contour cell blisters (10 pcs.) – cardboard packs (150 pcs.) – By prescription
15 pcs. – contour cell blisters (2 pcs.) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell blisters (3 pcs.) – cardboard packs (45 pcs.) – By prescription
15 pcs. – contour cell blisters (4 pcs.) – cardboard packs (60 pcs.) – By prescription
15 pcs. – contour cell blisters (5 pcs.) – cardboard packs (75 pcs.) – By prescription
15 pcs. – contour cell blisters (6 pcs.) – cardboard packs (90 pcs.) – By prescription
15 pcs. – contour cell blisters (7 pcs.) – cardboard packs (105 pcs.) – By prescription
15 pcs. – contour cell blisters (8 pcs.) – cardboard packs (120 pcs.) – By prescription
15 pcs. – contour cell blisters (9 pcs.) – cardboard packs (135 pcs.) – By prescription
20 pcs. – jars – cardboard packs (20 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
40 pcs. – jars – cardboard packs (40 pcs.) – By prescription
50 pcs. – jars – cardboard packs (50 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
70 pcs. – jars – cardboard packs (70 pcs.) – By prescription
80 pcs. – jars – cardboard packs (80 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription

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