Carteolol hydrochloride Thea 20 mg/ml eye drops, solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Carteolol Hydrochloride

Saadav alates:

Laboratoires Thea

ATC kood:

S01ED05

INN (Rahvusvaheline Nimetus):

Carteolol Hydrochloride

Annus:

20 milligram(s)/millilitre

Ravimvorm:

Eye drops, solution

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

carteolol

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2018-11-30

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARTEOLOL HYDROCHLORIDE THEA 20 MG/ML, EYE DROPS, SOLUTION
carteolol hydrochloride
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, pharmacist 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Carteolol hydrochloride Thea is and what it is used for
2.
What you need to know before you use Carteolol hydrochloride Thea
3.
How to use Carteolol hydrochloride Thea
4.
Possible side effects
5.
How to store Carteolol hydrochloride Thea
6.
Contents of the pack and other information
1.
WHAT CARTEOLOL HYDROCHLORIDE THEA IS AND WHAT IT IS USED FOR
Carteolol hydrochloride Thea contains the active substance carteolol
hydrochloride a beta-blocker
administered in the eye.
It is used for the treatment of certain types of eye disease involving
intraocular hypertension
(glaucoma and ocular hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CARTEOLOL HYDROCHLORIDE THEA
DO NOT USE CARTEOLOL HYDROCHLORIDE THEA
-
if you are allergic to carteolol hydrochloride, beta-blockers or any
of the other ingredients of
this medicine (listed in section 6).
-
if you have now or have had in past respiratory problems such as
asthma, severe chronic
obstructive bronchitis (severe lung disease which may cause
wheeziness, difficulty in breathing
and/or long-standing cough).
-
if you have a slow heart beat, heart failure or disorders of heart
rhythm (irregular heart beats).
WARNINGS AND PRECAUTIONS
This medicine is a preservative-free eye drops, solution. Do not allow
the tip of the bottle to touch the
eye or areas around the eye. It ma

Toote omadused

Health Products Regulatory Authority
30 November 2018
CRN008LHX
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carteolol hydrochloride Thea 20 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops solution contains 20 milligrams of carteolol
hydrochloride. One vial of
5 ml eye drops solution contains 100 mg of carteolol hydrochloride.
One drop contains approximately 0.58 milligram of carteolol
hydrochloride.
Excipients with known effect: 1 ml eye drops solution contains 0.51 mg
of
phosphates (disodium phosphate dodecahydrate, sodium dihydrogen
phosphate
dihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
It is a clear, colourless to slightly brown-yellow solution.
pH: 6.0 – 7.0
Osmolality: 270-340 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ocular hypertension and primary open-angle glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One drop, twice daily.
The medical prescription should be complemented by an IOP check,
especially at the
start of treatment.
If
appropriate,
therapy
with
parasympathomimetic
agents,
prostaglandin-like
carbonic anhydrase inhibitors or alpha agonists may be associated.
Health Products Regulatory Authority
30 November 2018
CRN008LHX
Page 2 of 13
_Replacement _
_of _
_other _
_anti-glaucoma _
_agents _
_for _
_topical _
_use _
_with _
_Carteolol _
_hydrochloride Thea_
Discontinue treatment after a full day of therapy and initiate
treatment with Carteolol
hydrochloride Thea by instilling one drop twice daily.
_Paediatric population_
The safety and efficacy of Carteolol hydrochloride Thea in children
aged 0 to 18 years
have
not
been
established,
therefore,
the
use
of
these
eye
drops
is
not
recommended for this patient group.
_ _
Method of administration
Ocular use.
Contact lenses should be removed before instillation of the eye drops
and may be
reinserted after 15 minutes.
If more than one topical ophthalmic medicine is being used, the
medicinal p