BUDENOFALK RECTAL FOAM 2MG/DOSE [SIN14115P]

Product Info

BUDENOFALK RECTAL FOAM 2MG/DOSE

[SIN14115P]

4.1 Therapeutic indications

For the acute treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.

4.2 Posology and method of administration

Posology:

Adults:
One actuation of 2 mg budesonide daily.

Children and adolescents:
Budenofalk Rectal Foam should not be taken by children and adolescents due to insufficient experience in this age group.

Method of administration:

For rectal use
This medicine may only be used rectally, so it has to be inserted through the anus. It is not intended to be taken by mouth. Do not swallow.

Budenofalk Rectal Foam may be used in the morning or evening.

The best results are obtained if you use Budenofalk Rectal Foam after you have defecated.

The applicator (insertion aid) is in a special rail. Please hold the rail firmly and pull the applicator out sharply.

Preparing to use the foam:

Ensure that Budenofalk Rectal Foam is at room temperature before use. Push the applicator firmly onto the nozzle of the spray can. Mix contents by shaking the spray can vigorously for 10 to 15 seconds.

Before first use, remove the safety tab under the pump dome.

Twist the pump dome on top of the canister until the semi-circular notch underneath it is in line with the nozzle. The spray can is now ready for use.

Using the foam:

Place your forefinger on the top of the pump dome and turn the spray can upside down. Note that the spray can will only work properly when held with the pump dome pointing down as vertically as possible.

Place one foot on a chair or stool or lie on your side, with your lower leg stretched out and your upper leg bent at an angle. Insert the applicator into the rectum as far as possible. To apply a dose of Budenofalk Rectal Foam, push the pump dome down fully once and hold it in this position for about 2 seconds. Then release it very slowly. The foam is now released into the rectum. Wait 10–15 seconds before withdrawing the applicator from the rectum, as the foam still expands a little and would otherwise drop out of the applicator unused.

After applying the foam, remove the applicator and dispose of it as domestic waste, using the plastic bag provided. Use a new applicator for each application. In order to prevent the inadvertent loss of foam from the spray can between applications, turn the pump dome around so that the semi-circular notch faces the direction opposite to the nozzle.

Duration of treatment
The attending physician determines the duration of use. An acute episode generally subsides after 6 to 8 weeks. Budenofalk rectal foam should not be used after this period of time.

4.3 Contraindications

Budenofalk Rectal Foam must not be used in:

• hypersensitivity to budesonide or any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• hepatic cirrhosis.