Bitifrin 0.3 mg/ml + 5 mg/ml eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bimatoprost; Timolol Maleate

Available from:

Farmaprojects S.A.

ATC code:

S01ED51

INN (International Name):

Bimatoprost; Timolol Maleate

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

timolol, combinations

Authorization status:

Not marketed

Authorization date:

2022-09-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BITIFRIN 0.3 MG/ML + 5 MG/ML, EYE DROPS, SOLUTION
bimatoprost/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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bitifrin is and what it is used for
2.
What you need to know before you use Bitifrin
3.
How to use Bitifrin
4.
Possible side effects
5.
How to store Bitifrin
6.
Contents of the pack and other information
1.
WHAT BITIFRIN IS AND WHAT IT IS USED FOR
Bitifrin contains two different active substances (bimatoprost and
timolol) that both reduce pressure in
the eye. Bimatoprost belongs to a group of medicines called
prostamides, a prostaglandin analogue.
Timolol belongs to a group of medicines called beta-blockers.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly being
drained out of the eye and new liquid is made to replace this. If the
liquid cannot drain out quickly
enough, the pressure inside the eye builds up and could eventually
damage your sight (an illness called
glaucoma). Bitifrin works by reducing the production of liquid and
also increasing the amount of
liquid that is drained. This reduces the pressure inside the eye.
Bitifrin eye drops are used to treat high pressure in the eye in
adults, including the elderly. This high
pressure can lead to glaucoma. Your doctor will prescribe you Bitifrin
when other eye drops
containing beta-blockers or prostaglandin analogues have not worked
sufficiently on their own.
This medicine does not contain a preservative.
2.
WHAT YOU NEED TO KNOW BEFORE

Summary of Product characteristics

Health Products Regulatory Authority
02 September 2022
CRN00CD4N
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bitifrin 0.3 mg/ml + 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol
(as 6.83 mg of timolol maleate).
Each 5 ml bottle contains 3 ml of solution.
Each 11 ml bottle contains 9 ml of solution
Excipient with known effect:
Each ml of solution contains about 0.95 mg phosphates.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Transparent, colourless, solution
pH: 6.8 to 7.6
osmolality: 270 to 320 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular hypertension who are
insufficiently responsive to topical beta-blockers or prostaglandin
analogues.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage in adults (including older people)_
The recommended dose is one drop of Bitifrin in the affected eye(s)
once daily, administered either in the morning or in the
evening. It should be administered at the same time each day.
Existing literature data for bimatoprost/timolol suggest that evening
dosing may be more effective in IOP lowering than
morning dosing. However, consideration should be given to the
likelihood of compliance when considering either morning or
evening dosing (see section 5.1).
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not exceed one drop in the
affected eye(s) daily.
_ _
_Renal and hepatic impairment_
Bitifrin has not been studied in patients with hepatic or renal
impairment. Therefore caution should be used in treating such
patients.
_ _
_Paediatric population _
The safety and efficacy of Bitifrin in children aged less than 18
years has not been established. No data are available.
Method of administration
For ocular use only.
Health Products Regulatory Authori