Product Description
Procto-Glyvenol Rectal Cream is a medicinal product intended for the local treatment of external and internal hemorrhoids.
Ingredients
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Active substances: tribenoside 50 mg, lidocaine hydrochloride 20 mg
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Excipients: Arlacel 60, cetomacrogol 1000, cetyl alcohol, isopropyl palmitate, liquid paraffin, methylparaben, propylparaben, sorbitol (solution), stearic acid, purified water
Dosage and Administration
Procto-Glyvenol rectal cream should be applied in the morning and evening until acute symptoms subside. Thereafter, the dose can be reduced to once daily.
For the treatment of internal hemorrhoids, the cream should be applied using the supplied applicator, which screws onto the tube and is fitted with a protective cap. Remove the cap before application and replace it afterward.
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Do not exceed the recommended dose.
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Avoid contact with eyes.
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Wash hands thoroughly after each application.
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Do not administer orally.
Pharmacological Action
Procto-Glyvenol cream contains tribenoside, which exerts anti-inflammatory, anti-edematous, analgesic, and anti-pruritic effects, and protects vascular endothelium from damage. Lidocaine provides rapid pain relief. The product acts locally and has minimal systemic effect.
Indications
Local treatment of external and internal hemorrhoids.
Contraindications
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Hypersensitivity to tribenoside, lidocaine hydrochloride, any other amide-type local anesthetic, or any other ingredients of the preparation.
Adverse Reactions
Common adverse effects (≥1/10,000, <1/1,000):
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Urticaria, local pruritus, local rash, local pain
Very rare adverse effects (≤1/10,000):
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Anaphylactic reaction
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Cardiovascular disturbances
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Bronchospasm
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Angioedema
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Facial edema
Warnings and Precautions
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Use with caution in patients with severe liver impairment.
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Consult a physician before use in patients with liver dysfunction.
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Maintain anal hygiene, perform appropriate physical exercises, and follow a diet to ensure soft stool consistency.
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Avoid contact with eyes.
Interactions with Other Drugs
Inform your doctor or pharmacist of all medicines currently or recently taken, as well as any planned medications.
Pregnancy and Lactation
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Do not use during the first trimester of pregnancy.
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May be used from the fourth month of pregnancy and during breastfeeding, provided recommended doses are not exceeded.
Use in Children and Adolescents
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Not recommended for children due to lack of safety data in this age group.
Effects on Ability to Drive and Use Machines
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Procto-Glyvenol rectal cream has no or negligible effect on the ability to drive and operate machinery.