VIZIOBLOK 2.5 Mg/Ml Eye Drops Solution

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

TIMOLOL MALEATE

Sẵn có từ:

PharmaSwiss Ceska republika s.r.o.

Mã ATC:

S01ED01

INN (Tên quốc tế):

TIMOLOL MALEATE

Liều dùng:

2.5 Mg/Ml

Dạng dược phẩm:

Eye Drops Solution

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Beta blocking agents

Tình trạng ủy quyền:

Transfer Pending

Ngày ủy quyền:

2016-09-16

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER 

[INVENTED NAME] 2.5 MG/ML EYE DROPS, SOLUTION 
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 or pharmacist.  
- 
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 or nurse. This includes any 
possible side effects not listed in this leaflet. See section 4.  

WHAT IS IN THIS LEAFLET 
1. What [Invented name] is and what it is used for  
2. What you need to know before you use [Invented name] 
3. How to use [Invented name] 
4. Possible side effects  
5. How to store [Invented name] 
6. Contents of the pack and other information 

1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR 

[Invented name] contains a substance called timolol which
belongs to a group of medicines 
called beta-blockers. Timolol lowers the pressure in
your eye(s). It is used to treat chronic 
open-angle and secondary glaucoma, when the pressure in the eye
is raised, in adults.  
[PRODUCT NAME] eye drops solution is a sterile solution
that does not contain a 
preservative. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE [INVENTED NAME] 

DO NOT USE [INVENTED NAME] IF:  

  you are allergic to timolol, beta-blockers
or any of the other ingredients of this medicine 
(listed in section 6); 

  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);  

  you have a slow heart

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vizioblok 2.5 mg/ml Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Vizioblok 2.5 mg/ml solution contains 3.417 mg of timolol
maleate (equivalent to 2.5 mg of timolol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, eye drops
pH: 6.5-7.5
Osmolality: 270-330 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Visioblok Eye Drops Solution is a beta-adrenoreceptor blocking agent
used topically in the reduction of elevated intra-
ocular pressure in various conditions.
Visioblok is indicated in adult patients with ocular hypertension;
adult patients with chronic open-angle glaucoma
including aphakic patients; some adult patients with secondary
glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
_Posology:_
Recommended therapy is one drop of 2.5 mg/ml solution in the affected
eye, once or twice (morning and evening) a
day.
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.
If clinical response is not adequate, dosage may be changed to one
drop of 5 mg/ml solution in each affected eye, once
or twice (morning and evening) a day. If needed, Visioblok 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).
Intra-ocular pressure should be reassessed approximately four weeks
after starting treatment because response to
Visioblok 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 of Visioblok.
_Transfer from other agents_
When another topical beta-blocking agent is being used, discontinue
its use after a full day of therapy and start
treatment with Visioblok the next day with one drop of 2.5 mg/ml
Visio