Timofluid 1 mg/g eye gel in single-dose container

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Timolol Maleate

Dostopno od:

Laboratoires Thea

Koda artikla:

S01ED; S01ED01

INN (mednarodno ime):

Timolol Maleate

Odmerek:

1 milligram(s)/gram

Farmacevtska oblika:

Eye gel in single-dose container

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Beta blocking agents1); timolol

Status dovoljenje:

Marketed

Datum dovoljenje:

2010-05-14

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIMOFLUID 1 MG/G, EYE GEL IN SINGLE-DOSE CONTAINER
TIMOLOL
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 of the 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 TIMOFLUID is and what it is used for
2.
What you need to know before you use TIMOFLUID
3.
How to use TIMOFLUID
4.
Possible side effects
5.
How to store TIMOFLUID
6.
Contents of the pack and other information
1.
WHAT TIMOFLUID IS AND WHAT IT IS USED FOR
This medicine is a beta-blocker administered to the eye.
It is used for the treatment of certain types of eye disease involving
high pressure in the eye (glaucoma and
ocular hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TIMOFLUID
DO NOT USE TIMOFLUID
-
if you are allergic to timolol maleate, beta-blockers or any of the
other ingredients of this medicine
(listed in section 6),
-
if you have now or have had in the 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),
-
in case of untreated pheochromocytoma (high blood pressure caused by
high levels of a hormone due to
a tumour near the kidney),
-
in case of corneal dystrophies (alteration of the surface of the eye).
TAKE SPECIAL CARE WITH TIMOFLUID
If you use TIMOFLUID, you will have to have regular checks of
intraocular pressure and cornea.
Before you use this medicine, tell your doctor if y

Lastnosti izdelka

Health Products Regulatory Authority
20 December 2019
CRN009F9M
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timofluid 1 mg/g eye gel in single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 1 mg of timolol as timolol maleate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye gel in single-dose container.
Opalescent, colourless to slightly yellow gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of the elevated intraocular pressure in patients with:
- ocular hypertension,
- chronic open angle glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ocular use.
ADULTS
The recommended dosage regimen is 1 drop of Timofluid 1 mg/g in the
affected eye (or eyes), once a day, in the morning.
ELDERLY:
There has been wide experience with the use of timolol eye drops in
elderly patients. The dosage recommendations given
above reflect the clinical data derived from this experience.
CHILDREN AND ADOLESCENTS
There is no experience in children and adolescents. This eye gel is
therefore not recommended in such patients.
If the ophthalmologist considers it necessary, Timofluid 1 mg/g may be
combined with one or more other anti-glaucoma
treatments (local and/or systemic route of administration).
However, the combination of two beta-blocker eye drops is not
recommended (see section 4.4.).
The other eye drops should be administered at least 15 minutes before
Timofluid 1 mg/g. The eye gel should be the last
medication instilled.
Nonetheless, response to Timofluid 1 mg/g may take several weeks to
stabilise intraocular pressure, therefore the monitoring
of the treatment should include intraocular pressure assessment after
a treatment period of approximately four weeks.
METHOD OF ADMINISTRATION
Timolol eye gel should be instilled into the conjunctival sac.
A single-dose contains enough gel to treat both eyes.
For single use only.
_Patients should be instructed: _
- to avoid contact between the dropper tip and the eye or eyelids,
- to u