TILOPTIC 0.5 %

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

TIMOLOL AS MALEATE

제공처:

RAFA LABORATORIES LTD

ATC 코드:

S01ED01

약제 형태:

EYE DROPS, SOLUTION

구성:

TIMOLOL AS MALEATE 5 MG/ML

관리 경로:

OCULAR

처방전 유형:

Required

Manufactured by:

LABORATORIES MERCK,SHARP & DOHME-CHIBRET (MIRABEL), FRANCE

치료 그룹:

TIMOLOL

치료 영역:

TIMOLOL

치료 징후:

For the reduction of elevated intraocular pressure may be used in patients with chronic open-angle glaucoma, aphakic glaucoma, some patients with secondary glaucoma and patients with ocular hypertension

승인 날짜:

2013-12-31

환자 정보 전단

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
This medicine can be sold under doctor's prescription only
TILOPTIC
® 0.5%
OPHTHALMIC SOLUTION
The ophthalmic solution contains: Timolol (as maleate)
5 mg/ml
For a list of inactive ingredients see section 6.1 "What TILOPTIC
contains". See also section 2.6
“IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF TILOPTIC”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about TILOPTIC. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their medical condition seems similar to yours.
•
This medicine is not intended for use in children and infants.
1. WHAT TILOPTIC IS AND WHAT IT IS USED FOR?
Timolol lowers the intraocular pressure. TILOPTIC is used to treat
glaucoma and to reduce elevated
intraocular pressure.
THERAPEUTIC GROUP: beta blockers.
BEFORE YOU USE TILOPTIC
2.
2.1 DO NOT USE TILOPTIC IF:
-
you are hypersensitive (allergic) to timolol, beta-blockers or any of
the other ingredients of TILOPTIC
(for a list of inactive ingredients, see section 6.1).
-
you are suffering or have suffered in the past from respiratory
problems such as asthma, severe
chronic obstructive bronchitis (severe lung disease which may cause
wheeziness, difficulty in
breathing and/or long-standing cough)
-
you have heart problems
-
slow heartbeat
-
disorders of heart rhythm (irregular heartbeats)
-
heart failure
-
“cardiogenic shock” – a serious heart condition caused by very
low blood pressure, which may result
in the following symptoms: dizziness and lightheadedness, fast pulse
rate, white skin, sweating,
restlessness, loss of consciousness.
If you are not sure whether you should use TILOPTIC talk to your
doctor or pharmacist
.
2.2 SPECIAL WARNINGS CONCERNING USE OF TILOPTIC
BEFORE STARTING TREATMENT WITH TILOPTIC, TELL YOUR DOCTOR IF you are
suff

제품 특성 요약

1
1.
NAME OF THE MEDICINAL PRODUCT
TILOPTIC® 0.5 %
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
‘Tiloptic’ 0.5% w/v Eye Drops Solution contains timolol maleate
equivalent to 0.5%
w/v solution of timolol.
Excipients with known effect:
Benzalkonium chloride 0.10mg/ml
Disodium phosphate dodecahydrate 30.42mg/ml
Sodium dihydrogen phosphate dihydrate 6.10mg/ml
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops solution.
Clear, colourless to light yellow, sterile eye drops, solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the reduction of elevated intraocular pressure may be used in
patients with chronic
open angle glaucoma, aphakic glaucoma, some patients with secondary
glaucoma and
patients with ocular hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Recommended therapy is one drop in the affected eye twice a day.
If
needed,
‘Tiloptic’
may
be
used
with
other
agent(s)
for
lowering
intra-ocular
pressure. The use of two topical beta-adrenergic blocking agents is
not recommended
(see 4.4 ‘Special warnings and precautions for use’).
Intra-ocular pressure should be reassessed approximately four weeks
after starting
treatment because response to ‘Tiloptic’ may take a few weeks to
stabilise.
Provided that the intra-ocular pressure is maintained at satisfactory
levels, many
patients can then be placed on once-a-day therapy.
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic
absorption is reduced. This may result in a decrease in systemic side
effects and an
increase in local activity.
_Transfer from other agents _
2
When another topical beta-blocking agent is being used, discontinue
its use after a full
day of therapy and start treatment the next day with one drop of
‘Tiloptic’ in each
affected eye twice a day.
When transferring a patient from a single anti-glaucoma agent other
than a topical
beta-blocking agent, continue the agent and add one drop of
‘Tiloptic’ in each affected
eye twice a day. On the following day, d