GNH USA

Europe — EMA

Modolex (Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride)

GNH USA supplies Modolex (Calcium Dobesilate, Lidocaine), a vasoprotective and analgesic for hemorrhoids, anal fissure, microvascular disorders.

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What is 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 USA 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.

What is Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride used for?

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.

What are the side effects of Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride?

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.

What precautions apply to Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride?

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.

What does Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride interact with?

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

What conditions is Modolex used to treat?+
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.
How does Calcium Dobesilate work in Modolex?+
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.
What is the usual dose of Modolex?+
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.
Is Modolex safe to use during pregnancy or breastfeeding?+
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.
How do I order Modolex from GNH USA?+
To request Modolex, submit an enquiry on the product page at gnh-usa.com, indicating the required quantity. GNH USA 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.
How does Modolex compare with other hemorrhoid treatments?+
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.
What are the storage requirements for Modolex?+
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.
How is Modolex administered?+
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.
What are the most serious risks associated with Modolex?+
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.
Who should not use Modolex?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Calcium Dobesilate Monohydrate, Lidocaine Hydrochloride
Route
Rectal Use
Manufacturer
Lek Pharmaceuticals D.D. Ljubljana
Origin
EU

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