Kirnom XL 400 micrograms Prolonged-Release Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tamsulosin hydrochloride

Available from:

Wockhardt UK Limited

ATC code:

G04CA; G04CA02

INN (International Name):

Tamsulosin hydrochloride

Dosage:

400 microgram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; tamsulosin

Authorization status:

Marketed

Authorization date:

2010-09-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
KIRNOM XL 400 MICROGRAMS
PROLONGED-RELEASE HARD CAPSULES
TAMSULOSIN HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, please ask your doctor or nurse.
- 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.
The name of your medicine is Kirnom XL 400 micrograms
Prolonged-Release Hard
Capsules. In the rest of this leaflet it is called Kirnom XL Capsules.
WHAT IS IN THIS LEAFLET:
1. What Kirnom XL Capsules are and what they are used for
2. What you need to know before you take Kirnom XL Capsules
3. How to take Kirnom XL Capsules
4. Possible side effects
5. How to store Kirnom XL Capsules
6. Contents of the pack and other information
1. WHAT KIRNOM XL CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance in Kirnom XL Capsules is tamsulosin (as
hydrochloride), which belongs
to a group of medicines called alpha- blockers (alpha- adrenoreceptor
antagonists). It acts by
relaxing the muscles in the prostate and urethra (the tube that
carries urine to the outside), and
lets urine pass more readily through the urethra and aids urination.
In the prostate gland, bladder and urethra there are specialised cells
containing alpha1A-
receptors that cause the muscles in the urethra to tighten. Kirnom XL
is an alpha1A-
adrenoceptor blocker, which reduces the action of these specialised
cells and relaxes the
muscles making it easier to pass water.
Kirnom XL Capsules is used to treat the symptoms associated with
benign prostatic
hyperplasia (BPH) which is enlargement of the prostate gland. These
symptoms include
difficulty in starting to pass water, frequent trips to the to

Summary of Product characteristics

Health Products Regulatory Authority
30 October 2019
CRN009FDZ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kirnom XL 400 micrograms Prolonged-Release Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains tamsulosin hydrochloride 400 microgram,
equivalent to 367 microgram tamsulosin.
For full list of the excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Kirnom XL Capsules consist of a light green opaque cap and light
yellowopaque body containing white to off white pellets,
imprinted with
on the cap with black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lower urinary tract symptoms (LUTS)associated with benign prostatic
hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
One Capsule daily, to be taken after the same meal each day.
The capsule should be swallowed whole and should not be crunched or
chewed as this will interfere with the modified release
of the active ingredient.
Paediatric Population
The safety and efficacy of tamsulosin in children <18 years have not
been established. Currently available data are described in
section 5.1.
4.3 CONTRAINDICATIONS
Hypersensitivity to tamsulosin hydrochloride or to any other component
of the product (see section 6.1); a history of
orthostatic hypotension; severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other alpha
1
blockers, a reduction in blood pressure can occur in individual cases
during treatment with Kirnom XL, as a
result of which, rarely, syncope can occur. At the first signs of
orthostatic hypotension (dizziness, weakness) the patient should
sit or lie down until the symptoms have disappeared.
Before therapy with Kirnom XL is initiated the patient should be
examined in order to exclude the presence of other conditions
which can cause the same symptoms as benign prostatic hyperplasia.
Digital rectal examination and when necessary
determination of prostate specific antigen (PSA) should be performed
befor