Travoprost + timolol medical valley

Package leaflet: Information for the user

Travoprost + Timolol Medical Valley, 40 micrograms/mL + 5 mg/mL, eye drops, solution
Travoprostum + Timololum
Please read all of this leaflet carefully before 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Travoprost + Timolol Medical Valley is and what it is used for
2. What you need to know 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 Travoprost + Timolol Medical Valley is and what it is 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, thereby lowering intraocular pressure. Timolol is a beta-blocker that works by reducing the production of fluid inside the eye. Both substances act together to lower the pressure inside the eye.
Travoprost + Timolol Medical Valley eye drops are used to treat elevated intraocular pressure in adults, including elderly patients. This pressure may lead to a condition 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-blocking agents, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has previously had respiratory disorders such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, difficulty breathing, and/or prolonged coughing), or other types of breathing disorders;
• if the patient has severe hay fever;
• if the patient has a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat);
• if the surface of the patient's eye is clouded.

If any of the conditions listed above apply to the patient, consult a doctor.
Warnings and precautions
Before starting treatment with Travoprost + Timolol Medical Valley, discuss with a doctor if any of the following medical conditions are currently present or have occurred in the past:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, shortness of breath), heart failure, low blood pressure;
• heart rhythm disorders, such as slow heartbeat;
• breathing difficulties, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
• diabetes (because timolol may mask symptoms of low blood sugar);
• hyperthyroidism (because timolol may mask subjective and objective symptoms of thyroid disease);
• myasthenia gravis (chronic neuromuscular weakness);
• cataract surgery;
• eye inflammation.

If the patient is to undergo any surgical procedure, inform the doctor about the use of Travoprost + Timolol Medical Valley, as timolol may affect the action of certain anesthetic medicines.
If the patient experiences any severe allergic reaction (skin rash, eye redness and itching) while using Travoprost + Timolol Medical Valley, treatment with adrenaline may not be sufficiently effective. It is therefore important to inform the doctor about the use of Travoprost + Timolol Medical Valley if the patient requires any other treatment.
Travoprost + Timolol Medical Valley may change the colour of the iris (the coloured part of the eye); this change may be permanent.
Travoprost + Timolol Medical Valley may increase the length, thickness, colour, and/or number of eyelashes and may cause unusual hair growth on the eyelids.
Travoprost may be absorbed through the skin and therefore should not be used by pregnant women or women planning to become pregnant. If any amount of the medicine comes into contact with the skin, wash it 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Travoprost + Timolol Medical Valley may alter the effect of other medicines taken simultaneously, or these medicines may alter the effect of Travoprost + Timolol Medical Valley; this includes other eye drops used in the treatment of glaucoma. Inform the doctor if the patient is taking or intends to take medicines that lower blood pressure, medicines used to treat heart conditions (including quinidine, used in the treatment of heart conditions and certain forms of malaria), antidiabetic medicines, or antidepressants such as fluoxetine or paroxetine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Do not use Travoprost + Timolol Medical Valley during pregnancy unless considered essential by the doctor. If the patient could become pregnant, she should use appropriate contraceptive methods during treatment with this medicine.
Do not use Travoprost + Timolol Medical Valley if the patient is breastfeeding.
Travoprost + Timolol Medical Valley may pass into breast milk.
Driving and operating machinery
Vision may be blurred for a short time after instilling Travoprost + Timolol Medical Valley. Travoprost + Timolol Medical Valley may also cause hallucinations, dizziness, nervousness, and/or fatigue.
Do not drive or operate machinery until these symptoms have subsided.
Travoprost + Timolol Medical Valley contains benzalkonium chloride and macrogol glycerol 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 may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, contact a doctor.
This medicine contains macrogol glycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Travoprost + Timolol Medical Valley

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
One drop into the conjunctival sac of the affected eye or eyes, once daily, in the morning or evening. The medicine should be used every day at the same time.
Travoprost + Timolol Medical Valley may be used in both eyes only if recommended by your doctor.
Travoprost + Timolol Medical Valley should only be used as eye drops.

1	Immediately before first use of the bottle, tear open the sachet (Figure 1), remove the bottle and write the date of opening in the space provided on the label. Ensure a mirror is available. Wash hands. Unscrew the bottle cap.
2	Hold the inverted bottle between thumb and fingers. Tip the head backwards. With a clean finger, gently pull down the lower eyelid to form a "pocket" between the eyeball and the eyelid. The drop should be instilled into this pocket (Figure 2). Bring the dropper tip of the bottle close to the eye. A mirror may be used to assist.
3	Do not let the dropper tip touch the eye, eyelid, surrounding areas or any other surface. Touching may lead to contamination of the eye drops. Gently squeeze the bottom of the bottle to release a single drop at the appropriate moment (Figure 3). If the drop misses the eye, repeat the instillation procedure.
4	After instilling Travoprost + Timolol Medical Valley, press a finger against the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent Travoprost + Timolol Medical Valley from being absorbed into the rest of the body. If Travoprost + Timolol Medical Valley needs to be used in both eyes, repeat the procedure described above for the second eye. Immediately after use, replace the cap on the bottle. Only one bottle should be in use at any one time. Do not open the sachet until the next bottle is needed.

Use of a higher than recommended dose of Travoprost + Timolol Medical Valley
If more Travoprost + Timolol Medical Valley has been used than the recommended dose, rinse the eyes with warm water. Do not administer further drops until the next scheduled dose.

Missed dose of Travoprost + Timolol Medical Valley
If a dose of Travoprost + Timolol Medical Valley has been missed, continue treatment according to the normal dosing schedule. Do not use a double dose to make up for the missed dose. The dose administered to the affected eye(s) should not exceed one drop per day.

Discontinuation of Travoprost + Timolol Medical Valley
If treatment with Travoprost + Timolol Medical Valley is discontinued without medical advice, intraocular pressure may not be controlled, which could lead to vision loss.

When using other eye drops concurrently with Travoprost + Timolol Medical Valley, an interval of at least 5 minutes should be maintained between instillation of Travoprost + Timolol Medical Valley and the other eye drops.

If the patient wears soft contact lenses, the medication should not be administered while the lenses are in place. After instilling the drops, wait 15 minutes before reinserting the contact lenses.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You can usually continue using the drops unless the adverse reactions are severe.
If you have any concerns, contact your doctor or pharmacist. Do not stop using
Travoprost + Timolol Medical Valley without consulting your doctor.
Very common adverse reactions (may affect more than 1 in 10 people):
Eye-related symptoms: eye redness.
Common adverse reactions (may affect up to 1 in 10 people):
Eye-related symptoms: inflammation of the eye surface with damage to the eye surface, eye pain,
blurred vision, abnormal vision, dry eye, eye itching, eye discomfort,
subjective and objective symptoms of eye irritation (e.g. burning, stinging).
Uncommon adverse reactions (may affect up to 1 in 100 people):
Eye-related symptoms: inflammation of the eye surface, blepharitis (inflammation of the eyelids), conjunctival swelling, increased eyelash growth, iritis (inflammation of the iris), eye inflammation, light sensitivity, limited vision, eye fatigue, eye allergy, eye swelling, increased tear production, eyelid redness, changes in eyelid colour, skin darkening (around the eye).
General symptoms: allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, postnasal drip, skin inflammation and itching, slowed heart rate.
Rare adverse reactions (may affect up to 1 in 1000 people):
Eye-related symptoms: thinning of the eye surface, inflammation of the meibomian glands, rupture of blood vessels in the eye, crusts on the eyelid margins, misdirected eyelashes, abnormal eyelash growth.
General symptoms: nervousness, irregular heartbeat, hair loss, voice disorders, breathing difficulties, cough, sore throat, urticaria, abnormal blood test results regarding liver function, skin discoloration, excessive thirst, fatigue, nasal discomfort, discoloured urine, pain in hands and feet.
Unknown frequency (cannot be estimated from the available data):
Eye-related symptoms: eyelid drooping (giving the appearance of half-closed eyes), enophthalmos (sunken eyes, eyes appearing deeper set), changes in iris colour (the coloured part of the eye).
General symptoms: rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, tingling or numbness sensation, palpitations, swelling of the lower limbs, unpleasant taste, hallucinations.
Additional information:
Travoprost + Timolol Medical Valley is a combination of two active substances, travoprost and timolol. Travoprost and timolol (a beta-blocker), like other ophthalmic medicines, are absorbed into the bloodstream. This may lead to adverse reactions similar to those observed when beta-blockers are administered orally or by injection.
The frequency of adverse reactions after ophthalmic administration is lower than after oral or injectable administration.
The adverse reactions listed below include those observed with the entire class of ophthalmic beta-blockers or those observed with travoprost alone:
Eye-related symptoms: blepharitis, keratitis (corneal inflammation), choroidal detachment after filtration surgery (a layer beneath the retina containing blood vessels detaches, possibly causing vision disturbances), decreased corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eyes, eyelid itching, eyelid eversion with redness, eye irritation and excessive tearing, blurred vision (signs of lens clouding), swelling of ocular tissue (vascular membrane), eyelid rash, halo vision, reduced eye sensitivity, pigmentation inside the eye, pupil dilation, eyelash colour change, eyelash texture change, abnormal visual field.
General adverse reactions:

• Ear and labyrinth disorders: dizziness with spinning sensation, tinnitus (ringing in the ears).
• Heart and circulatory system: slowed heartbeat, palpitations, edema (fluid retention), changes in heart rhythm or rate, congestive heart failure (heart disease causing shortness of breath and swelling of ankles and legs due to fluid accumulation), certain types of cardiac arrhythmias, heart attack, low blood pressure, Raynaud's syndrome, coldness in hands and feet, reduced blood flow to the brain.
• Respiratory system: bronchoconstriction in the lungs (mainly in patients with pre-existing respiratory disease), nasal discharge or nasal congestion, sneezing (due to allergy), breathing difficulties, nosebleeds, dryness of the nasal mucosa.
• Nervous system and general disorders: difficulty falling asleep (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional unease).
• Gastrointestinal tract: taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting, constipation.
• Allergic reactions: worsening of allergic symptoms, generalized allergic reactions including skin swelling in areas such as the face and limbs, potentially causing airway obstruction and difficulty swallowing and breathing, localized or generalized rash, itching, severe and sudden life-threatening allergic reactions.
• Skin: silver-white rash (resembling psoriasis) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with itchy rash and redness, hair colour change, eyelash loss, itching, abnormal hair growth, skin redness.
• Musculoskeletal system: worsening of subjective and objective symptoms of myasthenia gravis (a muscle disease), unusual sensations such as chills and tingling, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.
• Kidney and urinary disorders: difficulty and pain during urination, urinary incontinence.
• Reproductive system: sexual dysfunction, decreased libido.
• Metabolism: low blood sugar levels, increased prostate-specific antigen (PSA) levels.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Travoprost + Timolol Medical Valley

Keep this medicine out of the 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 stated month.
Before opening, no special storage temperature requirements apply.
Store the bottle in the sachet to protect it from light.
No special storage instructions apply after first opening.
To prevent the risk of contamination, discard the bottle 28 days after first opening.
Each time a new bottle is opened, write the date of opening in the spaces provided on the bottle label and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Travoprost + Timolol Medical Valley contains

• The active substances in this 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 (for pH adjustment), and purified water.

What Travoprost + Timolol Medical Valley looks like and contents of the pack
Travoprost + Timolol Medical Valley is a clear, colourless aqueous solution, practically free from particles, supplied in a 5 mL bottle made of polypropylene, with a colourless 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. Outer packaging: cardboard box.
Pack sizes available:
Cardboard box containing 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturers
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 authorised in the European Economic Area member states under the following names:
Denmark: Travoprost/Timolol Medical Valley 40 microgram/ml + 5 mg/ml eye drops, solution
Iceland: Travoprost/Timolol Medical Valley 40 microgram/ml + 5 mg/ml eye drops, solution
Norway: Travoprost/Timolol Medical Valley 40 microgram/ml + 5 mg/ml eye drops, solution
Poland: Travoprost + Timolol Medical Valley
Sweden: Travoprost/Timolol Medical Valley 40 microgram/ml + 5 mg/ml eye drops, solution