Octosedan 50 mg/g - rectal ointment 25 g

Product Description

Rectal ointment for itching and hemorrhoids.

Indications

Octosedan is a rectal ointment for the short-term symptomatic treatment of itching and pain in the anal region caused by hemorrhoidal disorders.

Composition

Active ingredients

1 gram of ointment contains 50 mg of lidocaine. Excipient with known effect: cetyl alcohol.

Excipients

Cetyl alcohol, macrogol, purified water.

Directions for use and Dosage

In the initial phase, apply the ointment 2-3 times a day; subsequently, apply it twice a day.
The amount to be applied depends on the size of the skin and mucosal area to be treated.
Do not exceed the maximum dose of 2.5 g of ointment (125 mg of lidocaine) per single application, which corresponds to 5 fingertip units.
A fingertip unit is the amount squeezed from the tube onto the surface of the first phalanx of the index finger.
The duration of treatment depends on the type and severity of the disorder; the ointment should not be used for more than 7 days without clinical evaluation.
Paediatric population: There is no specific indication for the use of Octosedan in the pediatric population.
Method of administration: Apply the ointment morning and evening, preferably after bowel movements, to the skin and mucosal areas to be treated and rub in gently with a finger.
An applicator with lateral openings is included in the package.

Warnings

The product must be used at the lowest effective dose, reducing the dose appropriately in relation to the characteristics of the subject to be treated.
In particular, it must be used with extreme caution in patients with severely damaged mucous membranes and inflammation in the area to be treated, as in such situations excessive absorption of the active ingredient could occur.
Caution must also be exercised in case of sepsis in the area intended for application and in diabetic patients.
Important information on some excipients: Octosedan contains cetyl alcohol.
It may cause allergic reactions. cause localized skin reactions (e.g. contact dermatitis).

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Undesirable effects

Adverse reactions are listed according to their frequency according to the MedDRA system organ class.
Frequency categories are defined as follows: very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100), rare (> 1/10,000, < 1/1,000), very rare (< 1/10,000; including isolated reports), not known (frequency cannot be estimated from the available data).
Gastrointestinal disorders: Common: diarrhoea.
/>Systemic disorders and conditions related to the administration site Very common: local hypersensitivity reactions (for example, itching and burning at the application site); Uncommon: discomfort and erythema at the application site.
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

There are no data on the passage of lidocaine administered rectally into the placenta and breast milk.
There are no clinical data available on the risk during pregnancy and breastfeeding.
The administration of Octosedan during pregnancy and breastfeeding should be considered only if the expected benefit for the mother outweighs the risk for the fetus or child.

Storage

Do not store above 30°C.

Format

Tube 25 g.