40 micrograms / ml + 5 mg / ml eye drops 
Solution

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What DuoTrav is and what it is used for 
2. What you need to know before using DuoTrav 
3. How to use DuoTrav 
4. Possible side effects 
5. How to store DuoTrav 
6. Contents of the packaging and other information 

1. What DuoTrav is and what it is used for

DuoTrav eye drops, the solution is a combination of two active substances (travoprost and timolol ). Travoprost is a prostaglandin analog, which works by increasing the outflow of fluid in the eye, which lowers the pressure in the eye. Timolol is a beta-blocker, which works by reducing the production of fluid in the eye. The two substances work together to reduce eye pressure.

DuoTrav is used to treat high pressure in the eye in adults, including the elderly. Too high pressure can lead to a disease called glaucoma.

2. What you need to know before using 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 currently have or have ever had breathing problems such as asthma, severe chronic obstructive bronchitis (severe lung disease that may cause wheezing, difficulty breathing, and/or persistent cough), or other types of breathing problems
  • if you have severe hay fever
  • if you have a slow heart rate, heart failure, or a condition that affects your heart rhythm (irregular heartbeat)
  • if the surface of your eye is cloudy

Ask your doctor for advice if any of these affect you.

Warnings and cautions

Talk to your doctor before using DuoTrav if you currently have or have ever had:

  • coronary heart disease (symptoms may include pain or tightness in the chest, shortness of breath, or suffocation), heart failure, low blood pressure.
  • heart rate disorders such as slow heartbeat.
  • respiratory problems, asthma, or chronic obstructive pulmonary disease.
  • disease with impaired blood circulation (eg Raynaud’s disease or Raynaud’s syndrome).
  • diabetes (because timolol can mask the signs and symptoms of low blood sugar).
  • overactive thyroid gland (because timolol can mask signs and symptoms).
  • myasthenia gravis ( chronic neuromuscular weakness).
  • operated on cataracts.
  • eye inflammation.

If you are going to have any kind of surgery, tell your doctor that you are using DuoTrav as timolol may alter the effects of certain medicines used during anesthesia.

If you get a severe allergic reaction (skin rash, redness, or itching of the eye) when using DuoTrav, for whatever reason, it is possible that adrenaline treatment will not help as usual. When you receive any other treatment, tell your doctor that you are being treated with DuoTrav.

DuoTrav can change the color of the iris (the colored part of your eye). This change may be permanent.

DuoTrav can increase the length, thickness, color, and/or a number of your eyelashes and can cause unusual hair growth on your eyelids.

Travoprost can be absorbed through the skin and should therefore not be used by women who are pregnant or trying to conceive. If the medicine comes in contact with the skin, wash it off immediately.

Children

DuoTrav is not intended for use 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 that you use, including other eye drops for the treatment of glaucoma. Tell your doctor if you use or plan to use medicines for high blood pressure, heart medicines such as quinidine (used to treat heart conditions and certain types of malaria ), medicines for diabetes, or the antidepressants fluoxetine or paroxetine.

Pregnancy, breastfeeding, 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 using this medicine.

Do not use DuoTrav if you are pregnant unless your doctor considers it necessary. If you are likely to become pregnant, you must use effective contraception when using this medicine.

Do not use DuoTrav if you are breast-feeding. DuoTrav can go into breast milk.

Driving and using machines

You may find that your vision becomes foggy immediately after taking DuoTrav. DuoTrav may also cause hallucinations, dizziness, nervousness, or fatigue in some patients.

Do not drive or use any tools or machines until these symptoms have disappeared.

DuoTrav contains macrogol glycerol hydroxy stearate (hydrogenated castor oil) and propylene glycol,

which can cause skin reactions and skin irritation.

3. How to use DuoTrav

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is

a drop in the affected eye or eyes, once daily in the morning or evening. Take DuoTrav at the same time each day.

Use DuoTrav in both eyes only if your doctor has prescribed it.

DuoTrav should only be used as eye drops.

Administration
  • Immediately before using a bottle for the first time, open the protective bag (Fig. 1) and remove the bottle and note the date when you opened the bottle in the space on the label.
  • Make sure you have a mirror available.
  • Wash your hands.
  • Unscrew the bottle cap.
  • Hold the bottle upside down between your thumb and fingers.
  • Tilt your head back. Pull down the lower eyelid with a clean finger so that a “pocket” is formed between the eyelid and the eye. The drop should end up here (picture 2).
  • Hold the drip tip close to the eye. Use the mirror if it helps.
  • Do not touch the eye or eyelid, surrounding areas, or other surfaces with the drip tip. It can contaminate the drops.
  • Gently press on the bottle to release one drop of DuoTrav at a time (Figure 3). If a drop misses the eye, try again.
  • After taking DuoTrav, press with your finger in the corner of your eye next to your nose for 2 minutes (picture 4). This prevents DuoTrav from entering the rest of the body.
  • If you are going to use DuoTrav in both eyes, repeat the above steps for your other eye.
  • Screw on the lid firmly immediately after use.
  • Use only one bottle at a time. Do not open the protective bag until you need to use the bottle.

Use DuoTrav for as long as your doctor tells you to.

If you use more DuoTrav than you should 

If you have used too much DuoTrav, rinse everything out with warm water. Do not take 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 take a double dose to make up for a forgotten dose. Dose one should not exceed one drop in each affected eye per day.

If you stop using DuoTrav

If you stop using DuoTrav without talking to your doctor, the pressure in your eye can not be controlled and this can lead to vision loss.

If you are using other eye drops in addition to DuoTrav, wait at least 5 minutes between taking DuoTrav and the other drops.

If you wear soft contact lenses, do not use the drops with the contact lenses left in your eyes. Wait for 15 minutes after dripping the eye drops, before putting the lenses back in the eyes.

If you have any further questions on the use of this product, 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 continue to use the drops unless the side effects are severe. If you are concerned, talk to a doctor or pharmacist. Do not stop using DuoTrav without talking to your doctor.

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

Effects in the eyes

Blushing.

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

Effects in the eyes

Inflammation of the surface of the eye with surface damage, eye pain, blurred vision, abnormal vision, dry eyes, itchy eyes, eye discomfort, signs and symptoms of eye irritation (eg burning, pain).

Less common side effects are (may affect up to 1 in 100)

Effects in the eyes

Inflammation of the eye surface, inflammation of the eyelid, swollen conjunctiva, increased growth of the eyelashes, iris inflammation, eye inflammation, photosensitivity, impaired vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, change in eyelid color, darker skin (round skin).

General effects

Allergic reaction to active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, increased hair growth, drip at the back of the throat, inflammation of the skin and itching, slower heartbeat.

Rare side effects are (may affect up to 1 in 1000)

Effects in the eyes

Thinning of the surface of the eye, inflammation of the eyelid glands, ruptured blood vessels in the eye, crust formation on the eyelids, abnormally placed eyelashes, abnormally increased growth of the eyelashes.

General effects

Nervousness, irregular heartbeat, hair loss, voice problems, difficulty breathing, cough, throat irritation, hives, abnormal liver values, skin discoloration, thirst, fatigue, discomfort inside the nose, colored urine, pain in hands, and feet.

Has been reported (occurs in an unknown number of users)

Effects in the eyes

Drooping eyelids (keeps the eye half-closed), sunken eyes, changed the color of the iris(colored part of the eye).

General effects

Rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling sensation, palpitations, swelling in the lower legs, bad taste in the mouth.

Also:

DuoTrav is a combination of two active substances, travoprost and timolol. Like other medicines that are administered (given) to the eyes, travoprost and timolol (a beta-blocker ) are absorbed into the bloodstream. This can have similar side effects as those observed when beta-blockers are administered orally or by injection. The incidence of side effects after administration to the eyes is lower than after administration by mouth or by injection.

The following side effects have not been reported with DuoTrav but include reactions seen in the beta-blocker class when used to treat eye conditions or reactions seen with travoprost alone:

Eye effects

Inflammation of the eyelid, inflammation of the cornea, loosening of the layer under the retina that contains blood vessels after filtration surgery, which can cause visual disturbances, decreased sensitivity of the cornea, erosion of the cornea (damage to the anterior layer of the eyeball), double vision, runny eye, swelling around the eye, itching of the eyelids, the eyelid is turned outwards with redness irritation and increased tearing, blurred vision (signs of cloudiness of the eye lens), swelling of a part of the eye (uvea), eczema of the eyelids, halo effect (light rings around a point of light), decreased sensation in the eye, pigmentation inside the eye, enlarged (dilated) pupils, discoloration eyelashes, the altered texture of the eyelashes, abnormal field of vision.

General effects

Ears and balance organs: dizziness along with a feeling of tingling, ringing in the ears.

Heart and blood circulation: slow heartbeat, palpitations, edema (fluid retention), change in heart rate or rate, chronic heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid retention), a type of palpitations, low blood pressure, myocardial infarction phenomena, cold hands, and feet, decreased blood supply to the brain.

Respiratory tract: contraction of the airways in the lungs (especially in patients with pre-existing disease), runny nose or nasal congestion, sneezing (due to allergies ), difficulty breathing, nosebleeds, dryness of the nose.

Nervous system and general symptoms: difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional distress).

Gastrointestinal disorders: taste changes, nausea, stomach upset, diarrhea, dry mouth, abdominal pain, vomiting, and constipation.

Allergy: increased allergic symptoms, generalized allergic reactions, including swelling under the skin that may occur in places such as. face and arms and legs and may obstruct the airways which may cause difficulty in swallowing or breathing, limited and generalized rash, itching, severe, sudden life-threatening allergic reaction.

Skin: rash with white silvery-colored appearance (psoriasis-like rash) or worsening of psoriasis, scaly skin, abnormal hair quality, inflammation of the skin with itchy rash and redness, altered hair color, loss of eyelash scars, itching, abnormal hair growth, skin redness.

Muscles increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as tingling in the skin. Muscle weakness/muscle fatigue, muscle pain not caused by exercise, joint pain.

Kidneys and urinary tract: difficulty and pain when urinating, involuntary urine leakage.

Reproductive organs: Decreased sexual ability, decreased sexual desire.

Metabolism: low blood sugar, elevated prostate-specific antigen.

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 and the carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C

You must discard the bottle 4 weeks after opening it, to prevent the risk of infection, and take a new bottle. Each time you start a new bottle, write down the date you opened it on the designated space on the bottle and carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are travoprost and timolol. One ml solution contains 40 micrograms of travoprost and 5 mg timolol (as timolol maleate).
  • The other ingredients are polyquaternium-1, mannitol (E421), propylene glycol (E1520), macrogol glycerol hydroxy stearate (hydrogenated castor oil), boric acid, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust the pH ), and purified water. Small amounts of sodium hydroxide or hydrochloric acid are added to keep the acidity ( pH ) normal.

What the medicine looks like and the contents of the pack

DuoTrav is a liquid (a clear, colorless solution) supplied in a 2.5 ml plastic bottle with a screw cap. Each bottle is packed in a protective bag.

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

SA Alcon-Couvreur NV

Rijksweg 14

B-2870 Puurs

Belgium

Alcon Cusí, SA

Camil Fabra 58

08320 El Masnou

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Lithuanian branchTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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