Budenofalk 4 mg suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Budesonide

Available from:

Dr. Falk Pharma GmbH

ATC code:

A07EA06

INN (International Name):

Budesonide

Pharmaceutical form:

Suppository

Therapeutic area:

budesonide

Authorization status:

Not marketed

Authorization date:

2023-02-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUDENOFALK 4 MG SUPPOSITORIES
budesonide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Budenofalk 4 mg suppositories are and what they are used for
2.
What you need to know before you use Budenofalk 4 mg suppositories
3.
How to use Budenofalk 4 mg suppositories
4.
Possible side effects
5.
How to store Budenofalk 4 mg suppositories
6.
Contents of the pack and other information
1.
WHAT BUDENOFALK 4 MG SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Budenofalk 4 mg suppositories contain the active substance budesonide,
a type of locally acting
steroid used to treat inflammatory bowel disease.
Budenofalk 4 mg suppositories are used in adult patients for the
treatment of acute episodes of
inflammatory disease of the rectum (ulcerative proctitis).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUDENOFALK 4
MG SUPPOSITORIES
DO NOT USE BUDENOFALK 4
MG SUPPOSITORIES
-
if you are allergic to budesonide or any of the other ingredients of
this medicine (listed in section
6).
-
if you have a severe liver disease (liver cirrhosis)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Budenofalk 4 mg
suppositories if you have
-
tuberculosis
-
high blood pressure
-
diabetes, or if diabetes has been diagnosed in your family
-
brittle bones (osteoporosis)
-
ulcers in the stomach or first part of the small intestine (peptic
ulcer)
-
increased pressure in your eye (glaucoma) or eye problems such as
clouding of the lens (cataracts)
or if glaucoma has been diagnos

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2024
CRN00DZZH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budenofalk 4 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 4 mg of budesonide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White, torpedo-formed suppositories (approximately 2 cm length) with a
smooth surface.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of mild to moderate acute ulcerative colitis
limited to the rectum (ulcerative proctitis) in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dose is 4 mg budesonide as one
4‑mg-suppository.
_ _
Method of administration
For rectal administration only.
Budenofalk 4 mg suppositories should be administered at bedtime. If
possible, the bowel should be emptied prior to
administration of Budenofalk 4 mg suppositories in order to obtain the
best results.
Duration of treatment
The duration of treatment is determined by the physician. An acute
episode generally subsides after 6 to 8 weeks. Budenofalk 4
mg suppositories should not be used after this period of time.
Special populations
_ _
_Renal impairment_
There are currently no data available for patients with renal
impairment. Because budesonide is excreted via the kidneys only to
a minor extent, patients with mild to moderate impairment may be
treated with the same doses as patients without renal
impairment.
Even though the pharmacokinetics of budesonide are not expected to be
altered in patients with renal impairment, in the
absence of further data, caution should be exercised in the
administration of the product to patients with severe renal
impairment.
_Hepatic impairment_
Budenofalk 4 mg suppositories have not been studied in patients with
hepatic impairment, therefore caution should be
exercised in the administration of the product in these patients (see
also sections 4.3, 4.4 and 5.2).
_Elderly (>65 years)_
Health Products Regu