Proctophytol Antihaemorrhoidas species (Herbal mixture) Instructions for Use

ATC Code

A06AB57 (Cascara in combination with other drugs)

Clinical-Pharmacological Group

Laxative phytopreparation with anti-inflammatory and antispasmodic action

Pharmacotherapeutic Group

Antihemorrhoidal agent of plant origin

Pharmacological Action

A combined agent of plant origin.

It has a laxative, astringent, antispasmodic, anti-inflammatory, and hemostatic action.

Indications

• Regulation of stool in patients with hemorrhoids.
• Atonic constipation.

Use for the symptomatic management of constipation associated with hemorrhoidal disease to facilitate defecation and reduce straining.

ICD codes

Dosage Regimen

Prepare and take orally as an infusion. Administer 1/2 to 1 glass of the prepared infusion once daily, at night.

The duration of therapy is not fixed and must be individually determined based on the patient’s clinical response, the nature and severity of the condition, and the context of any concomitant treatments being administered.

Adverse Reactions

Monitor for allergic reactions, including skin rash, pruritus, or urticaria, which may occur in susceptible individuals.

With prolonged or excessive use, anticipate and monitor for potential adverse effects such as worsening constipation, thirst, weight loss, headache, cardialgia (chest pain), and hypokalemia due to chronic loss of potassium.

Contraindications

• Peptic ulcer disease of the stomach or duodenum in the acute phase.
• Suspected or confirmed “acute abdomen” symptom complex.
• Any form of intestinal obstruction or strangulated hernia.
• Pregnancy and the entire period of lactation (breastfeeding).
• Children under 12 years of age.
• Known hypersensitivity or allergy to any of the plant components in the mixture.

Use in Pregnancy and Lactation

This combination is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children under 12 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

The prepared decoction can be stored in a cool place for no more than 48 hours.

Drug Interactions

Observe caution with concomitant administration of other medications. Components such as senna may reduce the gastrointestinal absorption of concurrently administered tetracycline antibiotics, potentially decreasing their systemic exposure and efficacy.

Administer with caution with other medications that affect electrolyte balance, such as diuretics or corticosteroids, due to the risk of hypokalemia.

Overdose

Symptoms of overdose are primarily an exacerbation of adverse reactions, including severe abdominal pain, cramping, profuse diarrhea, dehydration, and significant electrolyte disturbances, most notably hypokalemia.

Institute supportive measures focused on fluid and electrolyte replacement. Discontinue use immediately. There is no specific antidote; treatment should be symptomatic.

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

Over-the-Counter

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.