DuoTrav

Informazzjoni prinċipali

  • Isem kummerċjali:
  • DuoTrav
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • DuoTrav
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Ophthalmologicals,
  • Żona terapewtika:
  • Glaucoma, Open-Angle, Ocular Hypertension
  • Indikazzjonijiet terapewtiċi:
  • Decrease 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.,
  • Sommarju tal-prodott:
  • Revision: 16

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/000665
  • Data ta 'l-awtorizzazzjoni:
  • 22-04-2006
  • Kodiċi EMEA:
  • EMEA/H/C/000665
  • L-aħħar aġġornament:
  • 26-03-2019

Rapport ta 'Valutazzjoni Pubblika

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Telephone

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Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

EMA/502114/2010

EMEA/H/C/000665

EPAR summary for the public

DuoTrav

travoprost / timolol

This document is a summary of the European public assessment report (EPAR) for DuoTrav. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for DuoTrav.

What is DuoTrav?

DuoTrav is a clear eye drop solution. It contains two active substances: travoprost (40 micrograms per

millilitre) and timolol (5 mg/ml).

What is DuoTrav used for?

DuoTrav is used to reduce the pressure inside the eye. It is used in adults with ‘open angle glaucoma’

or ‘ocular hypertension’ who do not respond sufficiently to eye drops containing beta-blockers or

prostaglandin analogues (other medicines used for these conditions).

Ocular hypertension is when the pressure in the eye is higher than normal. In open angle glaucoma

the high pressure is caused by fluid being unable to drain out of the eye.

DuoTrav can only be obtained with a prescription.

How is DuoTrav used?

The dose of DuoTrav is one drop in the affected eye(s) once a day, in the morning or evening, at the

same time every day. If more than one type of eye drop is being used, each one should be given at

least five minutes apart.

How does DuoTrav work?

When the pressure inside the eye rises, it causes damage to the retina (the light sensitive membrane

at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can

result in serious vision loss and even blindness. By lowering the pressure, DuoTrav reduces the risk of

damaging these structures.

DuoTrav contains two active substances, travoprost and timolol, which lower the pressure in the eye in

different ways. Travoprost is a prostaglandin analogue (a man-made copy of the natural substance

prostaglandin) that works by increasing the drainage of fluid out of the eye. Travoprost on its own has

been authorised in the European Union as Travatan since 2001. Timolol is a beta-blocker that works by

reducing the production of fluid within the eye. Timolol has been used to treat glaucoma since the

1970’s. The combination of the two active substances has an additive effect, reducing the pressure

inside the eye more than either medicine alone.

How has DuoTrav been studied?

DuoTrav has been studied in five main studies involving a total of 1,482 patients (aged 18 to 91) with

open-angle glaucoma or ocular hypertension. The studies lasted between six weeks and 12 months.

One study compared DuoTrav taken in the morning with DuoTrav taken in the evening. Three studies

compared DuoTrav with travoprost and timolol either given on their own, or together but as separate

eye drops. The fifth was a 12-month study that compared DuoTrav with eye drops containing a

combination of latanoprost (another prostaglandin analogue) and timolol.

In all of the studies, the main measure of effectiveness was the change in pressure inside the eye

measured in ‘millimetres of mercury’ (mmHg). In a patient with glaucoma, the eye pressure is usually

higher than 21 mmHg.

What benefit has DuoTrav shown during the studies?

DuoTrav reduced the pressure inside the eye by about a third in all of the studies (the average

reduction was about 8-10 mmHg).

DuoTrav taken in the evening was as effective as DuoTrav taken in the morning. DuoTrav was more

effective at reducing the pressure inside the eye than timolol on its own, or travoprost on its own. It

was as effective as the two medicines given as separate eye drops, and as effective as eye drops

containing both latanoprost and timolol.

What is the risk associated with DuoTrav?

The most common side effects with DuoTrav (seen in more than 1 patient in 10) are ocular hyperaemia

(increased blood supply to the eye, leading to redness) and eye irritation. For the full list of all side

effects reported with DuoTrav, see the package leaflet.

DuoTrav should not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and

other beta-blockers), or any of the other ingredients. DuoTrav must not be used in people with asthma

or severe lung disease, or in people with some heart conditions. It must also not be used in people

with severe allergic rhinitis (inflammation of the nasal passages caused by an allergy) and corneal

dystrophies (disorders that cause clouding of the cornea, the transparent layer in front of the eye).

DuoTrav contains benzalkonium chloride which is known to discolour soft contact lenses. Therefore,

care should be taken by people who wear soft contact lenses. DuoTrav may cause the iris of the eye to

change colour (darken) and the eyelashes to thicken, darken or lengthen.

DuoTrav

EMA/502114/2010

Page 2/3

DuoTrav

EMA/502114/2010

Page 3/3

Why has DuoTrav been approved?

The CHMP decided that DuoTrav’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Other information about DuoTrav:

The European Commission granted a marketing authorisation valid throughout the European Union, for

DuoTrav to Alcon Laboratories (UK) Limited on 24 April 2006. The marketing authorisation is valid for

an unlimited period.

The full EPAR for DuoTrav is available here

. For more information about treatment with DuoTrav, read

the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2010.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Package leaflet: Information for the user

DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution

travoprost/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

What DuoTrav is and what it is used for

What you need to know before you use DuoTrav

How to use DuoTrav

Possible side effects

How to store DuoTrav

Contents of the pack and other information

1.

What DuoTrav is and what it is used for

DuoTrav eye drop solution is a combination of two active substances (travoprost and timolol).

Travoprost is a prostaglandin analogue which works by increasing the outflow of aqueous fluid from

the eye, which lowers its pressure. Timolol is a beta blocker which works by reducing the production

of fluid within the eye. The two substances work together to reduce pressure within the eye.

DuoTrav eye drops are used to treat high pressure in the eye in adults, including the elderly. This

pressure can lead to an illness called glaucoma.

2.

What you need to know before you use DuoTrav

Do not use DuoTrav

if you are allergic to travoprost, prostaglandins, timolol, 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), or other types of breathing problems.

if you have severe hay fever.

if you have a slow heartbeat, heart failure or a disorder of heart rhythm (irregular heartbeat).

if the surface of your eye is cloudy.

Ask your doctor for advice if any of these applies to you.

Warning and precautions

Talk to your doctor before using DuoTrav if you have now or have had in the past

coronary heart disease (symptoms can include chest pain or tightness, breathlessness or

choking), heart failure, low blood pressure.

disturbances of heart rate such as slow heartbeat.

breathing problems, asthma or chronic obstructive pulmonary disease.

poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome).

diabetes (as timolol may mask signs and symptoms of low blood sugar).

overactivity of the thyroid gland (as timolol may mask signs and symptoms of thyroid disease).

myasthenia gravis (chronic neuromuscular weakness).

cataract surgery.

eye inflammation.

If you need to have any type of surgery, tell your doctor that you are using DuoTrav as timolol may

change the effects of some medicines used during anaesthesia.

If you get any severe allergic reaction (skin rash, redness and itching of the eye) while using

DuoTrav, whatever the cause, adrenaline treatment may not be as effective. It is therefore important to

tell the doctor that you are using DuoTrav when you are to receive any other treatment.

DuoTrav may change the colour of your iris (the coloured part of your eye). This change may be

permanent.

DuoTrav may increase the length, thickness, colour and/or number of your eyelashes and may cause

unusual hair growth on your eyelids.

Travoprost may be absorbed through the skin and therefore should not be used by women who are

pregnant or are attempting to become pregnant. If any of the medicine comes into contact with the skin

then it should be washed off straight away.

Children

DuoTrav is not to be used by children and adolescents under 18 years of age.

Other medicines and DuoTrav

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

DuoTrav can affect or be affected by other medicines you are using, including other eye drops for the

treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to lower blood

pressure, heart medicines including quinidine (used to treat heart conditions and some types of

malaria), medicines to treat diabetes or the antidepressants fluoxetine or paroxetine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before taking this medicine.

Do not use DuoTrav if you are pregnant unless your doctor considers it necessary. If you could get

pregnant you must use adequate contraception whilst you use the medicine.

Do not use DuoTrav if you are breast-feeding. DuoTrav may get into your milk.

Driving and using machines

You may find that your vision is blurred for a time just after you use DuoTrav. Do not drive or use

machines until this has worn off.

DuoTrav contains hydrogenated castor oil and propylene glycol which may cause skin reactions

and irritation.

3.

How to use DuoTrav

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

The recommended dose is one drop in the affected eye or eyes once a day in the morning or in the

evening. Use at the same time each day.

Only use DuoTrav in both eyes if your doctor told you to do so.

Only use DuoTrav as eye drops.

Immediately before using a bottle for the first time, tear open the overwrap (picture 1), remove

the bottle and write the date of opening on the label in the space provided.

Make sure you have a mirror available.

Wash your hands.

Twist off the bottle cap.

Hold the bottle, pointing down, between your thumb and fingers.

Tilt your head back. Pull your lower eyelid down with a clean finger until there is a “pocket”

between the eyelid and your eye. The drop will go in here (picture 2).

Bring the bottle dropper close to the eye. Use the mirror if it helps.

Do not touch your eye or eyelid, the surrounding areas or other surfaces with the dropper. It

could infect the drops.

Gently squeeze the bottle to release one drop of DuoTrav at a time (picture 3). If a drop misses

your eye, try again.

After using DuoTrav, press your finger into the corner of your eye by your nose for 2 minutes

(picture 4). This helps to stop DuoTrav getting into the rest of the body.

If you have to use DuoTrav in both eyes, repeat the above steps for your other eye.

Close the bottle cap firmly immediately after use.

Only use one bottle at a time. Do not open the overwrap until you need to use the bottle.

Use DuoTrav for as long as your doctor has told you to.

If you use more DuoTrav than you should

If you use more DuoTrav than you should, rinse it all out with warm water. Do not put in any more

drops until it is time for your next regular dose.

If you forget to use DuoTrav

If you forget to use DuoTrav, continue with the next dose as planned. Do not use a double dose to

make up for the forgotten dose. The dose should not exceed one drop daily in the affected eye(s).

If you stop using DuoTrav

If you stop using DuoTrav without speaking to your doctor the pressure in your eye will not be

controlled, which could lead to loss of sight.

If you are using other eye drops in addition to DuoTrav, leave at least 5 minutes between applying

DuoTrav and the other drops.

If you wear soft contact lenses do not use the drops with your lenses in. After using the drops wait

15 minutes before putting your lenses back in.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

You can usually carry on using the drops, unless the effects are serious. If you are worried, talk to a

doctor or pharmacist. Do not stop using DuoTrav without speaking to your doctor.

Very common side effects (may affect more than 1 in 10 people)

Effects in the eye

Eye redness.

Common side effects (may affect up to 1 in 10 people)

Effects in the eye

Eye surface inflammation with surface damage, eye pain, blurred vision, abnormal vision, dry eye,

itchy eye, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging).

Uncommon side effects (may affect up to 1 in 100 people)

Effects in the eye

Inflammation of the eye surface, inflammation of the eyelid, swollen conjunctiva, increased growth of

eyelashes, iris inflammation, eye inflammation, sensitivity to light, reduced vision, tired eyes, eye

allergy, eye swelling, increased tear production, eyelid redness, eyelid colour change, skin darkening

(around the eye).

General side effects

Allergic reaction to active substance, dizziness, headache, increased or decreased blood pressure,

shortness of breath, excessive hair growth, drip at back of throat, skin inflammation and itching,

decreased heart rate.

Rare side effects (may affect up to 1 in 1,000 people)

Effects in the eye

Thinning of the eye surface, inflammation of the eyelid glands, broken blood vessel in the eye, eyelid

crusting, abnormally positioned eyelashes, abnormal growth of lashes.

General side effects

Nervousness, irregular heart rate, loss of hair, voice disorders, difficulty breathing, cough, throat

irritation, hives, abnormal liver blood tests, skin discolouration, thirst, tiredness, discomfort inside of

nose, coloured urine, pain in hands and feet.

Not known (frequency cannot be estimated from the available data)

Effects in the eye

Droopy eyelid (making the eye stay half closed), sunken eyes (eyes appear more inset), changes in the

colour of the iris (coloured part of the eye).

General side effects

Rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or

tingling sensation, palpitations, swelling in the lower limbs, bad taste.

Additionally:

DuoTrav is a combination of two active substances, travoprost and timolol. Like other medicines

administered to the eyes, travoprost and timolol (a beta blocker) are absorbed into the blood. This may

cause side effects similar to those seen when beta-blocking medicines that are administered by mouth

or by injection. The incidence of side effects after administration to the eyes is lower than after

administration by mouth or by injection.

The side effects listed below include reactions seen with the class of beta blockers used for treating

eye conditions or reactions seen with travoprost alone:

Effects in the eye

Inflammation of the eyelid, inflammation in the cornea, detachment of the layer below the retina that

contains blood vessels following filtration surgery which may cause visual disturbances, decreased

corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye

discharge,

swelling around the eye, eyelid itching, outward turning of eyelid with redness, irritation

and excessive tears, blurred vision (sign of clouding of the eye lens), swelling of a section of the eye

(uvea), eczema of the eyelids, halo vision, decreased eye sensation, pigmentation inside the eye,

dilatated pupils, change in eyelash colour, change in the texture of the eyelashes, abnormal field of

vision.

General side effects

Ear and labyrinth disorders: dizziness with spinning sensation, ringing in the ears.

Heart and circulation: slow heart rate, palpitations, oedema (fluid build-up), changes in heartbeat

rhythm or speed, congestive heart failure (heart disease with shortness of breath and swelling of the

feet and legs due to fluid build-up), a type of heart rhythm disorder, heart attack, low blood pressure,

Raynaud’s phenomenon, cold hands and feet, reduced blood supply to the brain.

Respiratory: constriction of the airways in the lungs (predominantly in patients with pre-existing

disease), runny or stuffy nose, sneezing (due to allergy), difficulty breathing, nose bleed, nasal

dryness.

Nervous system and general disorders: difficulty sleeping (insomnia), nightmares, memory loss, loss

of strength and energy, anxiety (excessive emotional distress).

Gastrointestinal: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,

vomiting and constipation.

Allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath the

skin that can occur in areas such as the face and limbs and can obstruct the airway. which may cause

difficulty swallowing or breathing, localised and generalised rash, itchiness, severe sudden

life-threatening allergic reaction.

Skin: skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis,

peeling skin, abnormal hair texture, inflammation of the skin with itchy rash and redness, hair colour

change, loss of eyelashes, itching, abnormal hair growth, skin redness.

Muscular: increases in signs and symptoms of myasthenia gravis (muscle disorder), unusual

sensations like pins and needles, muscle weakness/tiredness, muscle pain not caused by exercise, joint

pain.

Renal and urinary disorders: difficulty and pain when passing urine, involuntary leakage of urine,

Reproduction: sexual dysfunction, decreased libido.

Metabolism: low blood sugar levels, increase in prostate cancer marker.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store DuoTrav

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.

The expiry date refers to the last day of that month.

Do not store above 30°C.

You must throw away the bottle 4 weeks after you first opened it to prevent the risk of infections.

Each time you start a new bottle write down the date you open it in the spaces on the bottle label and

carton.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What DuoTrav contains

-

The active substances are travoprost and timolol. Each mL of solution contains 40 micrograms

of travoprost and 5 mg of timolol (as timolol maleate).

-

The other ingredients are Polyquaternium-1, mannitol (E421), propylene glycol (E1520),

polyoxyethylene hydrogenated castor oil 40, boric acid, sodium chloride, sodium hydroxide or

hydrochloric acid (to adjust pH), purified water.

Tiny amounts of sodium hydroxide or hydrochloric acid are added to keep acidity levels (pH

levels) normal.

What DuoTrav looks like and contents of the pack

DuoTrav is a liquid (a clear, colourless solution) supplied in a 2.5 mL plastic bottle with a screw cap.

Each bottle is packed in an overwrap.

Packs of 1, 3 or 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

S.A. Alcon-Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium

Alcon Cusí, S.A.

Camil Fabra 58

08320 El Masnou

Spain

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

SIA “Novartis Baltics” Lietuvos filialas

Tel: +370 5 269 16 50

България

Novartis Bulgaria EOOD

Тел.: +359 2 489 98 28

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Ελλάδα

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Novartis Slovakia s.r.o.

Tel: + 421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA “Novartis Baltics”

Tel: +371 67 887 070

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu