Travoprost + Timolol Medical Vallei

Leaflet accompanying the packaging: information for the user

Travoprost + Timolol Medical Valley, 40 micrograms/mL + 5 mg/mL, eye drops, solution

Travoprost + Timolol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Travoprost + Timolol Medical Valley and what is it used for
• 2. Important information before using Travoprost + Timolol Medical Valley
• 3. How to use Travoprost + Timolol Medical Valley
• 4. Possible side effects
• 5. How to store Travoprost + Timolol Medical Valley
• 6. Contents of the pack and other information

1. What is Travoprost + Timolol Medical Valley and what is it used for

Travoprost + Timolol Medical Valley eye drop solution is a combination of two active substances (travoprost and timolol). Travoprost is a prostaglandin analogue that works by increasing the outflow of aqueous fluid from the eye, which lowers its pressure. Timolol is a beta-adrenergic blocker that works by reducing the production of fluid inside the eye. Both substances work together to lower the pressure inside the eye.
Travoprost + Timolol Medical Valley eye drops are used to treat high pressure in the eye in adults, including the elderly. This pressure can lead to the development of a disease called glaucoma.

2. Important information before using Travoprost + Timolol Medical Valley

When not to use Travoprost + Timolol Medical Valley

• if the patient is allergic to travoprost, prostaglandins, timolol, beta-adrenergic receptor blockers or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has had respiratory problems, such as asthma, severe, chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing and/or chronic cough) or other types of respiratory problems;
• if the patient has severe hay fever;
• if the patient has slow heart rate, heart failure or irregular heartbeat (irregular heart rhythm);
• if the patient's eye surface is cloudy.

If any of the above conditions apply to the patient, they should consult a doctor.

Warnings and precautions

Before starting to use Travoprost + Timolol Medical Valley, the patient should discuss with their doctor if they have or have had any of the following conditions:

• coronary heart disease (symptoms may include chest pain or feeling of pressure in the chest, difficulty breathing, shortness of breath), heart failure, low blood pressure;
• irregular heart rhythm, such as slow heart rate;
• breathing difficulties, asthma or chronic obstructive pulmonary disease;
• diseases with impaired blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes (as timolol may mask the symptoms of low blood sugar levels);
• hyperthyroidism (as timolol may mask the objective and subjective symptoms of thyroid disease);
• myasthenia gravis (a chronic neuromuscular disease);
• cataract surgery;
• eye inflammation.

If the patient is to undergo any surgical procedure, they should inform their doctor about the use of Travoprost + Timolol Medical Valley, as timolol may affect the action of certain anesthetics.
If the patient experiences any severe allergic reaction (skin rash, redness and itching of the eye) while using Travoprost + Timolol Medical Valley, because adrenaline treatment may not be effective enough. It is therefore important to tell the doctor about the use of Travoprost + Timolol Medical Valley if the patient is to receive any other treatment.
Travoprost + Timolol Medical Valley may change the color of the iris (the colored part of the eye); this change may be permanent.
Travoprost + Timolol Medical Valley may increase the length, thickness, color and/or number of eyelashes and may cause abnormal hair growth on the eyelids.
Travoprost may be absorbed through the skin and therefore should not be used by pregnant or breastfeeding women. If any amount of the medicine gets on the skin, it should be washed off immediately.

Children and adolescents

Travoprost + Timolol Medical Valley is not intended for use in children and adolescents under 18 years of age.

Travoprost + Timolol Medical Valley and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Travoprost + Timolol Medical Valley may affect the action of other medicines taken at the same time or other medicines may affect the action of Travoprost + Timolol Medical Valley; this also applies to other eye drops used to treat glaucoma. The patient should inform their doctor about the use of medicines that lower blood pressure, heart medicines (including quinidine, used to treat heart conditions and certain types of malaria), anti-diabetic medicines or antidepressants, such as fluoxetine or paroxetine.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
Travoprost + Timolol Medical Valley should not be used in pregnant women unless the doctor considers it necessary. If the patient may become pregnant, they should use appropriate contraceptive methods during treatment with Travoprost + Timolol Medical Valley.
Travoprost + Timolol Medical Valley should not be used during breastfeeding.
Travoprost + Timolol Medical Valley may pass into breast milk.

Driving and using machines

For some time after using Travoprost + Timolol Medical Valley, vision may be blurred. Travoprost + Timolol Medical Valley may also cause hallucinations, dizziness, nervousness and/or fatigue.
The patient should not drive or operate machinery until these symptoms have resolved.

Travoprost + Timolol Medical Valley contains benzalkonium chloride and macrogolglycerol hydroxystearate 40

The medicine contains 150 mg of benzalkonium chloride in each mL of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before using the eye drops and wait at least 15 minutes before putting them back in.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders affecting the cornea (the transparent layer on the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging or pain in the eye after using the medicine, they should contact their doctor.
This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Travoprost + Timolol Medical Valley

This medicine should always be used exactly as the doctor has instructed. If the patient is unsure, they should consult their doctor or pharmacist.

Recommended dose

One drop into the conjunctival sac of the affected eye(s) once daily, in the morning or evening. The medicine should be used at the same time every day.
Travoprost + Timolol Medical Valley can be used in both eyes only if the doctor has recommended it.
Travoprost + Timolol Medical Valley should only be used as eye drops.

1	Immediately before the first use of the bottle, tear open the sachet (Figure 1), remove the bottle and record the opening date in the space provided on the label. Make sure a mirror is available. Wash your hands. Remove the bottle cap.

2	Tilt the head back. With a clean finger, pull the lower eyelid down to create a "pocket" between the eye and the eyelid. The drop should fall into this pocket (Figure 2). Bring the dropper tip close to the eye. To make it easier, you can look into a mirror.
3	Do not touch the dropper tip to the eye or eyelid, or to other surfaces. Touching may lead to infection of the drops. Gently squeeze the bottom of the bottle to release a single drop of medicine at the right time (Figure 3). If the drop does not get into the eye, try again.
4	After using Travoprost + Timolol Medical Valley, press the finger into the corner of the eye near the nose for 2 minutes (Figure 4). This will help prevent the medicine from entering the entire body. If the patient needs to use Travoprost + Timolol Medical Valley in both eyes, they should repeat the above steps for the second eye. Immediately after use, replace the bottle cap. Only use one bottle at a time. Do not open the sachet until the next bottle is needed.

Using more Travoprost + Timolol Medical Valley than recommended

If more Travoprost + Timolol Medical Valley is used than recommended, the eye should be flushed with warm water. Do not use more medicine until the next normal dose is due.

Missing a dose of Travoprost + Timolol Medical Valley

If a dose of Travoprost + Timolol Medical Valley is missed, the patient should continue with the normal dosage schedule. They should not use a double dose to make up for the missed dose. The dose of medicine for the affected eye(s) should not exceed one drop per day.

Stopping the use of Travoprost + Timolol Medical Valley

If the use of Travoprost + Timolol Medical Valley is stopped without consulting a doctor, the pressure in the eye will not be controlled, which may lead to loss of vision.
If the patient is using other eye drops with Travoprost + Timolol Medical Valley, they should leave at least a 5-minute interval between using Travoprost + Timolol Medical Valley and other eye drops.
If the patient wears soft contact lenses, they should not use the drops while wearing the lenses. After using the drops, they should wait 15 minutes before putting the lenses back in.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In general, it is possible to continue using the drops unless the side effects are severe.
If the patient is concerned, they should contact their doctor or pharmacist. The patient should not stop using Travoprost + Timolol Medical Valley without consulting their doctor.
Very common side effects(may affect more than 1 in 10 people):
Eye symptoms: eye redness.
Common side effects(may affect up to 1 in 10 people):
Eye symptoms: inflammation of the surface of the eye with damage to the surface of the eye, eye pain, blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, subjective and objective symptoms of eye irritation (e.g. burning, stinging).
Uncommon side effects(may affect up to 1 in 100 people):
Eye symptoms: inflammation of the surface of the eye, eyelid inflammation, swelling of the conjunctiva, increased growth of eyelashes, inflammation of the iris, eye inflammation, sensitivity to light, limited vision, eye fatigue, eye allergy, eye swelling, increased tear production, eyelid redness, changes in eyelid color, darkening of the skin (around the eye).
General symptoms: allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, runny nose or feeling of nasal congestion, abnormal dreams.
Rare side effects(may affect up to 1 in 1000 people):
Eye symptoms: thinning of the surface of the eye, inflammation of the meibomian glands, rupture of blood vessels in the eye, scales on the edges of the eyelids, abnormal position of the eyelashes, abnormal growth of the eyelashes.
General symptoms: nervousness, irregular heart rhythm, loss of hair, voice disorders, breathing difficulties, cough, throat irritation, hives, abnormal liver function test results, skin discoloration, increased thirst, fatigue, discomfort in the nose, urine discoloration, pain in the hands and feet.
Unknown frequency(cannot be estimated from the available data):
Eye symptoms: drooping eyelids (giving the impression of half-closed eyes), sunken eyes (eyes appear to be more deeply set), changes in iris color (color of the colored part of the eye).
General symptoms: rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, feeling of numbness or tingling, palpitations, swelling of the lower limbs, unpleasant taste, hallucinations.

• Ear and labyrinth disorders:dizziness with a feeling of spinning, ringing in the ears.
• Heart and blood vessel disorders:slow heart rate, palpitations, swelling (fluid retention), changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of the ankles and feet due to fluid accumulation), a certain type of heart rhythm disorder, heart attack, low blood pressure, Raynaud's syndrome, cold hands and feet, decreased blood flow to the brain.
• Respiratory disorders:bronchial spasm in the lungs (mainly in patients with pre-existing disease), runny nose or feeling of nasal congestion, sneezing (caused by allergy), breathing difficulties, nosebleeds, dryness of the nasal mucosa.
• Nervous system and general disorders:difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional distress).
• Gastrointestinal disorders:taste disturbances, nausea, indigestion, diarrhea, dry mouth, stomach pain, vomiting and constipation.
• Allergic reactions:exacerbation of allergic symptoms, generalized allergic reactions, including skin swelling on areas such as the face and limbs, which can cause respiratory tract obstruction and difficulty swallowing and breathing, localized or generalized rash, itching, severe and sudden life-threatening allergic reactions.
• Skin and subcutaneous tissue disorders:rash with a white-silver color (resembling psoriasis) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with itchy rash and redness, hair color changes, loss of eyelashes, itching, abnormal hair growth, redness of the skin.
• Musculoskeletal and connective tissue disorders:worsening of objective and subjective symptoms of myasthenia gravis (a chronic neuromuscular disease), abnormal sensations, such as tingling and numbness, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.
• Renal and urinary disorders:difficult and painful urination, urinary incontinence.
• Reproductive system and breast disorders:sexual function disorders, decreased libido.
• Metabolic and nutritional disorders:low blood sugar levels, increased prostate cancer marker values.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Travoprost + Timolol Medical Valley

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet and bottle after "Expiry date (EXP)". The expiry date refers to the last day of the month.
No special precautions for storage temperature are required before opening.
Store the bottle in the sachet to protect it from light.
No special precautions are required for storing the medicine after first opening.
In order to prevent the risk of infection, the bottle should be discarded after 28 days of first opening. Each time a new bottle is started, the patient should write the opening date on the spaces provided on the bottle label and carton.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Travoprost + Timolol Medical Valley contains

• The active substances of the medicine 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 benzalkonium chloride, solution, macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (to adjust pH) and purified water.

What Travoprost + Timolol Medical Valley looks like and contents of the pack

Travoprost + Timolol Medical Valley is a clear, colorless aqueous solution, practically free from particles, supplied in a 5 mL bottle made of polypropylene, with a colorless dropper made of LDPE and a white, opaque cap made of HDPE/LDPE or HDPE, with a tamper-evident seal. Each bottle is placed in a sachet. Each bottle contains 2.5 mL of solution. The outer packaging is a cardboard box.
The following pack sizes are available:
Cardboard box containing 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer

Pharmathen SA
6 Dervenakion Str
15351 Pallini
Greece
BALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd.
7200 Razgrad
Bulgaria
JADRAN - GALENSKI LABORATORIJ d.d.
Svilno 20
51000 Rijeka
Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Travoprost/Timolol Medical Valley 40 mikrogram/ml + 5 mg/ml øjendråber, opløsning
Iceland:
Travoprost/Timolol Medical Valley 40 míkrógrömm/ml + 5 mg/ml augndropar, lausn
Norway: Travoprost/Timolol Medical Valley 40 mikrogram/ml + 5 mg/ml øyedråper, oppløsning
Poland:
Travoprost + Timolol Medical Valley
Sweden:
Travoprost/Timolol Medical Valley 40 mikrogram/ml + 5 mg/ml ögondroppar, lösning
Date of last revision of the leaflet:07.10.2022