Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - duotrav

Document Subject

Generated Narrative: MedicinalProductDefinition mpa8470e7b18972c2dec141fc0fb92e8c0

identifier: http://ema.europa.eu/identifier/EU/1/06/338/001-6

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a8470e7b18972c2dec141fc0fb92e8c0

identifier: http://ema.europa.eu/identifier/EU/1/06/338/001-6

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - duotrav

Attesters

What is in this leaflet

1. What DuoTrav is and what it is used for
2. What you need to know before you use DuoTrav
3. How to use DuoTrav
4. Possible side effects
5. How to store DuoTrav
6. Contents of the pack and other information

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.

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. DuoTrav may also cause hallucinations, dizziness, nervousness or fatigue in some patients.

Do not drive or use machines until any such symptoms has worn off.

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

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.

1 2 3 4

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.

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, hallucinations, 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.

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.

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 Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

S.A. Alcon-Couvreur N.V. Rijksweg B-2870 Puurs Belgium

Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Siegfried El Masnou, S.A. Camil Fabra El Masnou 08320 Barcelona Spain

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc.
Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: + 421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This 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