DUOTRAV

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

TIMOLOL AS MALEATE; TRAVOPROST

Disponible des:

NOVARTIS ISRAEL LTD

Codi ATC:

S01ED51

formulario farmacéutico:

OPHTHALMIC SOLUTION

Composición:

TRAVOPROST 40 MCG/ML; TIMOLOL AS MALEATE 5 MG/ML

Vía de administración:

OCULAR

tipo de receta:

Required

Fabricat per:

ALCON COUVREUR, BELGIUM

Grupo terapéutico:

TIMOLOL, COMBINATIONS

Área terapéutica:

TIMOLOL, COMBINATIONS

indicaciones terapéuticas:

Decrease of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

Data d'autorització:

2015-09-30

Informació per a l'usuari

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DUOTRAV
®
EYE DROPS (SOLUTION)
COMPOSITION:
Active ingredients:
Travoprost 40 mcg/mL
Timolol as maleate 5 mg/mL
For the list of inactive ingredients in the preparation see section
6 - “Further Information” and section 2 – “Important
information
regarding some of the ingredients of the medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
Keep this leaflet; you may need to read it again.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even if it
seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
To reduce intraocular pressure in cases of open-angle glaucoma
or intraocular hypertension that are insufficiently responsive to
topical beta blockers or prostaglandin analogs.
THERAPEUTIC GROUP:
Travoprost – prostaglandin analog, which works by increasing the
outflow of aqueous fluid from the eye, thereby lowering ocular
pressure.
Timolol (as maleate) – beta blocker, which works by reducing the
production of fluid within the eye.
The two substances work together to reduce pressure within the
eye.
2. BEFORE USING THE MEDICINE
X DO NOT USE THIS MEDICINE IF:
∙ You are sensitive (allergic) to travoprost, prostaglandins,
timolol, beta blockers or to any of the other ingredients of the
medicine (as detailed in section 6).
∙ You are breastfeeding.
∙ You are suffering, or have suffered in the past, from breathing
problems, such as asthma or severe chronic bronchitis (a severe
lung disease that may cause wheezing, breathing difficulties
and/or persistent cough) or other breathing problems.
∙ You suffer from severe hay fever.
∙ You have a slow heart rate, heart failure or arrhythmia (irregular

Fitxa tècnica

DUO API DEC20 V
3
EU SmPC Oct2020
1.
NAME OF THE MEDICINAL PRODUCT
DuoTrav
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 40 micrograms of travoprost and 5 mg of
timolol (as timolol maleate).
Excipient(s) with known effect:
Each ml of solution contains polyquaternium-1 (POLYQUAD) 10 microgram,
propylene glycol 7.5 mg,
polyoxyethylene hydrogenated castor oil 40 1.0 mg (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic solution (eye drops).
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Decrease of intraocular pressure (IOP) in patients with open-angle
glaucoma or ocular hypertension who are
insufficiently responsive to topical beta-blockers or prostaglandin
analogues (see section- 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults, including the elderly
The dose is one drop of DuoTrav in the conjunctival sac of the
affected eye(s) once daily, in the morning or
evening. It should be administered at the same time each day.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not exceed
one drop in the affected eye(s) daily.
SPECIAL POPULATIONS
Hepatic and renal impairment
No studies have been conducted with DuoTrav or with timolol 5 mg/ml
eye drops in patients with hepatic
or renal impairment.
Travoprost has been studied in patients with mild to severe hepatic
impairment and in patients with mild to
severe renal impairment (creatinine clearance as low as 14 mL/min). No
dose adjustment was necessary in
these patients.
Patients with hepatic or renal impairment are unlikely to require dose
adjustment with DuoTrav (see section
5.2).
Paediatric population
The safety and efficacy of DuoTrav in children and adolescents below
the age of 18 years have not been
established. No data are available.
Method of administration For
DUO API DEC20 V
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EU SmPC Oct2020
ocular use.
The patient should remove the protective overwrap immediately prior to
initial use. T