Veremed (Capsules) Instructions for Use

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Oxford Laboratories, Pvt. Ltd. (India)

ATC Code

A03AA04 (Mebeverine)

Active Substance

Mebeverine (Rec.INN registered by WHO)

Dosage Form

Veremed

Extended-release capsules 200 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules hard gelatin, size 0, capsule body transparent, capsule cap opaque, red in color; capsule contents – pellets white or almost white in color.

Excipients: sugar spheres (nonpareil) – 90 mg, colloidal silicon dioxide – 1 mg, talc – 28 mg, titanium dioxide – 6.1 mg, hypromellose – 5 mg, cetyl alcohol – 6.1 mg, ethylcellulose – 17.3 mg.

Pellet coating: sugar spheres (nonpareil) – 66 mg, ethylcellulose – 3.5 mg, talc – 0.6 mg, titanium dioxide – 0.7 mg, cetyl alcohol – 0.7 mg.
Hard gelatin capsule: gelatin – 79.116 mg, sodium methylparaben – 0.48 mg, sodium propylparaben – 0.096 mg, sodium benzoate – 0.096 mg, sodium lauryl sulfate – 0.192 mg, Ponceau 4R supra dye – 1.67 mg, Azorubine (Carmoisine supra) dye – 0.0192 mg, purified water – 14.4 mg.

10 pcs. – Al/Al blisters (3) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

A myotropic action spasmolytic, it has a direct effect on the smooth muscles 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 the 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

Dosage Regimen

Take Veremed capsules orally, swallowed whole with a sufficient amount of water. Do not chew or crush the capsules.

The standard adult dosage is one 200 mg capsule twice daily, preferably taken in the morning and evening.

Take the capsules approximately 20 minutes before meals.

Initiate treatment for the relief of acute symptoms. Continue use as long as symptomatic control is required.

The maximum daily dose is 400 mg (two capsules). Do not exceed this dose.

The duration of therapy is determined by the prescribing physician based on the clinical situation and patient response.

If symptoms persist despite treatment, re-evaluate the diagnosis.

This medication is not intended for use in children and adolescents under 18 years of age.

Adverse Reactions

Skin and subcutaneous tissue disorders urticaria (allergic rash), angioedema (serious allergic reaction which 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 which 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 a family member of the patient 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 30°C (86°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.