OMNIC 0.4

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

TAMSULOSIN HYDROCHLORIDE

MAH:

CTS LTD

ATC_code:

 G04CA

pharmaceutical_form:

MODIFIED RELEASE CAPSULES HARD

composition:

TAMSULOSIN HYDROCHLORIDE 0.4 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

therapeutic_indication:

Treatment of functional symptoms of benign prostatic hyperplasia (BPH).

authorization_date:

2023-08-31

PIL

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
OMNIC 0.4
MODIFIED-RELEASE CAPSULES
The active ingredient and its quantity per dosage unit:
Tamsulosin Hydrochloride 0.4 mg/cap
For a list of the inactive and allergenic ingredients in the
preparation - see Section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others.
It may harm them even if it seems to you that their ailment is
similar.
The medicine is not intended for children or adolescents under the age
of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of functional symptoms
caused by benign
prostatic hyperplasia (BPH).
THERAPEUTIC GROUP: Selective alpha
1A,1D
-adrenoreceptor antagonist.
2. BEFORE USING THE MEDICINE:
X XX DO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to tamsulosin or to any of the other
ingredients
contained in the medicine. Hypersensitivity may present as sudden
local
swelling of the soft tissues of the body (e.g., the throat or tongue),
difficulty
breathing and/or itching and rash (angioedema).
•
you suffer from severe liver failure.
•
you suffer from dizziness or faint due to decreased blood pressure
when
changing posture (transitioning to a sitting or standing position).
!
! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
•
Periodic medical examinations are necessary to monitor the progression
of
the condition you are being treated for.
•
In rare instances, this medicine can cause fainting. At the first
signs of
dizziness or weakness, the patient should sit or lie down until the
signs pass.
•
BEFORE TREATMENT WITH OMNIC 0.4, INFORM THE DOCTOR IF:
o
you suffer or have suffered in the past from severe kidney problems.
o
you are about to under

SPC

1
SUMMARY OF PRODUCT CHARACTERISTIC
1. NAME OF THE MEDICINAL PRODUCT
Omnic 0.4 mg, modified release capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains as active ingredient tamsulosin hydrochloride
0.4 mg.
Excipient(s): For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Modified release capsule, hard
Orange/olive-green coded 0.4 and logo and 701
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Treatment of functional symptoms of benign prostatic hyperplasia
(BPH).
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
Oral use
One capsule daily, to be taken after breakfast or the first meal of
the day.
The capsule should be swallowed whole with a drink of water (about
150ml).
The capsule must be swallowed whole and must not be crunched or
chewed, as this
interferes with the modified release of the active ingredient.
No dose adjustment is warranted in renal impairment. No dose
adjustment is warranted in
patients with mild to moderate hepatic insufficiency (see also 4.3
Contraindications).
Pediatrics population
There is no relevant indication for use of Omnic in children.
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 of the
excipients.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
_4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
As with other α
1
-adrenoceptors antagonists, a reduction in blood pressure can occur in
individual cases during treatment with Omnic 0.4, 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 Omnic 0.4 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, w