Product image of Modolex (Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride) supplied by GNH India

Modolex

Active Ingredient:
Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride
Origin:
EU

Modolex (Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride)

Calcium Dobesilate Monohydrate, the active ingredient in Modolex, is a vasoprotective agent presented as a rectal formulation for local administration. It is combined with Lidocaine Hydrochloride, a local anesthetic, to address hemorrhoidal disease, anal fissures, and other microvascular disorders by reducing capillary permeability and providing analgesia.

GNH India supplies Modolex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality, regulatory compliance and reliable logistics for global distribution.

Manufacturer / TM Owner

Lek Pharmaceuticals D.D. Ljubljana

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Indications & Clinical Uses

Modolex combines a vasoprotective agent with a local anesthetic to treat conditions involving impaired microcirculation and pain in the anorectal region.

  • Hemorrhoids: reduces swelling and bleeding while providing local pain relief.
  • Anal fissure: improves microvascular blood flow and eases discomfort during defecation.
  • Microvascular disorders: enhances capillary stability and mitigates associated pain.

How It Works

  • Calcium Dobesilate Monohydrate decreases capillary permeability and enhances microcirculatory flow by stabilising endothelial cells and inhibiting inflammatory mediators. Lidocaine Hydrochloride blocks voltage‑gated sodium channels on peripheral nerves, preventing depolarisation and producing a reversible local anaesthetic effect at the site of application.

Side Effects

Adverse reactions may occur following rectal administration of Modolex.

Common Side Effects

  • Mild rectal irritation or burning sensation.
  • Transient pruritus around the application site.
  • Light‑headedness or mild headache.
  • Nausea without vomiting.
  • Temporary increase in bowel movements.

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis) with swelling, rash or difficulty breathing.
  • Persistent or worsening rectal bleeding.
  • Ulceration or necrosis of the rectal mucosa.
  • Systemic lidocaine toxicity presenting as dizziness, tinnitus or cardiac arrhythmia.
  • Vasovagal syncope triggered by the rectal procedure.

Precautions & Warnings

Before using Modolex, consider the following safety measures.

  • Pregnancy: safety not established; avoid unless the potential benefit outweighs the risk.
  • Breastfeeding: unknown excretion; use with caution.
  • Concomitant anticoagulants: monitor for increased bleeding.
  • Active rectal infection or severe inflammation: contraindicated until resolved.
  • Known hypersensitivity to calcium dobesilate, lidocaine or any excipients: discontinue immediately.
  • Store at ambient temperature: keep in the original packaging, protect from moisture and light.

Avoid Interactions

Modolex may interact with other medicines; monitor accordingly.

Major Interactions (Avoid)

  • Systemic local anesthetics: risk of cumulative lidocaine toxicity.
  • Anticoagulants (e.g., warfarin, DOACs): heightened bleeding tendency.
  • Other vasoprotective agents: additive effects on capillary permeability.

Moderate Interactions (Monitor Closely)

  • NSAIDs: may increase gastrointestinal irritation.
  • Antihistamines: can potentiate local anesthetic effect.
  • Alcohol: may exacerbate dizziness or sedation.

Frequently Asked Questions

Modolex is indicated for the symptomatic management of hemorrhoids, anal fissures and other microvascular disorders of the anorectal region. It works by improving microcirculation and providing local analgesia, helping to reduce swelling, bleeding and pain associated with these conditions.

Calcium Dobesilate reduces capillary permeability and stabilises the endothelial lining of small blood vessels, which improves microcirculatory flow and limits oedema. This vasoprotective action helps to lessen the swelling and bleeding that occur in hemorrhoidal and fissure disease.

The dosage of Modolex is determined by the prescribing healthcare professional based on the severity of the condition, patient age and overall health. The prescriber will specify the amount, frequency and duration of rectal application appropriate for each individual case.

Safety data for Modolex in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the possible risk to the fetus or infant, and this decision must be made by a qualified healthcare provider.

To request Modolex, submit an enquiry on the product page at gnhindia.com, indicating the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with plain topical steroids or simple analgesics, Modolex combines a vasoprotective agent (calcium dobesilate) with a local anesthetic (lidocaine), offering both microcirculatory improvement and immediate pain relief. This dual mechanism can be advantageous in cases where swelling and pain are prominent.

Modolex should be stored at ambient temperature, below 25 °C, in its original container. Keep the product away from moisture and direct sunlight to maintain stability and potency throughout its shelf life.

Modolex is supplied as a rectal formulation. The prescribed amount is applied directly to the affected area using the provided applicator or as directed by the healthcare professional, ensuring gentle insertion and even distribution over the lesion.

The most serious adverse events include severe allergic reactions (anaphylaxis), persistent rectal bleeding, ulceration of the mucosa and systemic lidocaine toxicity, which can present with neurological or cardiac symptoms. Immediate medical attention is required if any of these occur.

Modolex should be avoided in patients with known hypersensitivity to calcium dobesilate, lidocaine or any formulation excipients, as well as in individuals with active rectal infections, severe inflammation, or those taking anticoagulant therapy without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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