Talinda^® Retard (Capsules) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

ATC Code

A03AA04 (Mebeverine)

Active Substance

Mebeverine (Rec.INN registered by WHO)

Dosage Form

Talinda® Retard

Extended-release capsules 200 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules white in color, hard gelatin size No. 1, capsule contents – white or almost white spherical pellets.

Excipients : microcrystalline cellulose – 7.426 mg, mannitol – 18.855 mg, sucrose (sugar) – 34.283 mg, sodium lauryl sulfate – 1.713 mg, povidone K30 – 5.713 mg, ethylcellulose – 8.57 mg, hypromellose phthalate (HP 55) – 8.57 mg, cetyl alcohol – 0.57 mg.

Hard gelatin capsules – titanium dioxide – 2%, gelatin – up to 100 %

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Spasmolytic agent

Pharmacological Action

A myotropic antispasmodic that 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 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

Administer Talinda^® Retard capsules orally with a sufficient amount of water.

Swallow the capsules whole; do not chew or crush the pellets.

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

Take the capsules approximately 20 minutes before meals.

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

Continue treatment as long as symptomatic control is required; periodically reassess the need for ongoing therapy.

Do not exceed the recommended daily dose of 400 mg (two capsules).

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose; in that case, continue with the regular schedule and do not double the dose.

Discontinue use if symptoms persist or worsen despite treatment.

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 (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 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.