Traotim

Package leaflet: Information for the user

TRAOTIM 0.3 mg/ml + 5 mg/ml eye drops, solution

Bimatoprost/timolol
Equivalent medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What TRAOTIM is and what it is used for

TRAOTIM contains two different active substances (bimatoprost and timolol); both reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, which are prostaglandin analogues. Timololo belongs to a group of medicines called beta-blockers.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is drained too slowly, the pressure inside the eye increases and, over time, may damage vision (a condition called glaucoma). TRAOTIM works by reducing the production of fluid and also by increasing the amount of fluid that is drained. In this way, it reduces the pressure inside the eye.
TRAOTIM eye drops are used to treat elevated eye pressure in adults, including elderly patients. This increased pressure may lead to glaucoma. Your doctor will prescribe TRAOTIM if other eye drops containing beta-blockers or prostaglandin analogues have not been effective.

2. What you should know before using TRAOTIM

Do not use TRAOTIM eye drops, solution

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if you have or have previously had respiratory problems such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause shortness of breath, difficulty breathing, and/or persistent cough)
• if you have heart problems, such as slow heart rate, heart block, or heart failure

Warnings and precautions
Before using this medicine, tell your doctor if you have or have had:

• heart disorders due to coronary problems (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure
• heart rhythm disorders such as slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• conditions caused by poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disease
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• liver or kidney problems
• eye surface disorders
• separation of one of the layers inside the eyeball after surgery to reduce intraocular pressure
• known risk factors for macular edema (swelling of the retina inside the eye leading to worsening vision), for example cataract surgery

Before undergoing surgical anesthesia, inform your doctor that you are using TRAOTIM, as timolol may alter the effects of certain medicines used during anesthesia.
TRAOTIM may cause darkening and lengthening of the eyelashes; it may also darken the skin around the eyelid. Over time, the color of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated. TRAOTIM may cause hair growth if it comes into contact with the skin surface.
Children and adolescents
TRAOTIM must not be used in children and adolescents under 18 years of age.
Other medicines and TRAOTIM
TRAOTIM may affect or be affected by other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are using or intend to use medicines to lower blood pressure, medicines for heart conditions, medicines for diabetes treatment, quinidine (used to treat heart diseases and some types of malaria), or medicines for depression known as fluoxetine and paroxetine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use TRAOTIM during pregnancy unless specifically instructed by your doctor.
Do not use TRAOTIM if you are breastfeeding. Timolol may be excreted in breast milk. Consult your doctor before taking any medicines while breastfeeding.
Driving and using machines
In some patients, TRAOTIM may cause blurred vision. Do not drive or operate machinery until symptoms resolve.
TRAOTIM contains benzalkonium chloride
This medicine contains 0.15 mg of benzalkonium chloride in 3 ml, equivalent to 0.05 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience unusual eye sensations, burning, or pain after using this medicine, speak with your doctor.
TRAOTIM contains disodium phosphate heptahydrate
This medicine contains 2.85 mg of phosphate buffer in 3 ml of solution, equivalent to 0.95 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use TRAOTIM

Use TRAOTIM exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one drop daily in the morning or evening in each eye requiring treatment.
Take the dose at the same time each day.

Instructions for use

Do not use the bottle if the tamper-evident seal on the cap is not intact before first use.

1. Wash your hands. Tilt your head backwards and look upwards (fig. 1).
2. Gently pull down the lower eyelid to create a small pocket (fig. 2).
3. Invert the bottle and apply gentle pressure to release one drop of eye drops into each eye to be treated (fig. 3).
4. Release the lower eyelid and close your eye (fig. 4).
5. While keeping the eye closed, press a finger against the corner of the closed eye (where the eye meets the nose) and hold for 2 minutes. This will help prevent TRAOTIM from entering the rest of the body (fig. 5).

If the drop does not enter the eye, repeat the procedure.
To avoid contamination, the tip of the bottle must not touch the eye or any other surface. After using the bottle, close it tightly by screwing the cap back on.
If you are using TRAOTIM together with other eye medications, wait at least 5 minutes between applying TRAOTIM and the other medication. Ocular ointments or gels should be used last.

If you use more TRAOTIM than you should
If you have instilled more TRAOTIM than recommended, it is unlikely to cause serious problems. Take your next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use TRAOTIM
If you forget to use TRAOTIM, as soon as you remember, apply one single drop and then return to your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using TRAOTIM
For TRAOTIM to work properly, it must be used every day.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, TRAOTIM can cause side effects, although not everyone experiences them.
You may continue using the eye drops normally unless the side effects are severe. If you are concerned, consult your doctor or pharmacist.
Do not stop using TRAOTIM without speaking to your doctor first.

The following side effects may occur with TRAOTIM (multi-dose and/or single-dose):

Very common side effects
May affect more than 1 in 10 people
Eye-related:
redness.

Common side effects
May affect up to 1 in 10 people
Eye-related:
burning, itching, stinging sensation, conjunctival irritation (irritation of the transparent membrane of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye, small ulcers on the surface of the eye with or without inflammation, blurred vision, redness and itching of the eyelids, growth of hair around the eyes, darkening of the eyelids, darkening of the skin colour around the eyes, headache, eyelash lengthening, eye irritation, watery eyes, swollen eyelids, reduced vision.

Other body parts:

• runny nose, headache.

Uncommon side effects
May affect up to 1 in 100 people
Eye-related:
abnormal sensation in the eye, iris inflammation, conjunctival swelling (swelling of the transparent membrane of the eye), painful eyelids, tired eyes, inward-growing eyelashes, darkening of the iris colour, sunken eyes, drooping eyelid, eyelid retraction (eyelid pulling away from the eye surface leading to incomplete eyelid closure), tightness of the eyelid skin, darkening of eyelashes.

Other body parts:
shortness of breath.

Side effects with unknown frequency
Eye-related:
cystoid macular edema (swelling of the retina inside the eye causing worsening of vision), eye swelling, blurred vision, eye discomfort.

Other body parts:
breathing difficulties/wheezing, allergic reaction symptoms (swelling, eye redness, skin rash), taste disturbances, dizziness, slow heart rate, high blood pressure, sleep disorders, nightmares, asthma, hair loss, skin colour changes around the eye, fatigue.

Additional side effects have been observed in patients using eye drops containing timolol or bimatoprost and may therefore also occur with TRAOTIM.

Like other topical ophthalmic medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with intravenous and/or oral beta-blockers. The likelihood of side effects after eye drop administration is lower than with oral or injectable medicines. The listed side effects include reactions known to occur with the class of beta-blockers used to treat eye diseases:

• Severe allergic reactions with swelling and breathing difficulties, which could potentially be life-threatening
• Low blood sugar levels
• Depression; memory loss; hallucinations
• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
• Reduced sensitivity of the eye surface; double vision; drooping eyelid; separation of one of the layers inside the eyeball after glaucoma surgery; inflammation of the eye surface; retrobulbar haemorrhage (bleeding of the retina); intraocular inflammation; frequent blinking
• Heart failure; irregular or stopped heartbeat; slow or fast heartbeats; fluid accumulation, mainly water, in the body; chest pain
• Low blood pressure; swollen or cold hands, feet, and extremities due to blood vessel constriction
• Cough; worsening of asthma; worsening of chronic obstructive pulmonary disease (COPD)
• Diarrhoea; stomach ache; nausea and vomiting; indigestion; dry mouth
• Red, scaly skin patches; skin rash
• Muscle pain
• Reduced sexual desire; sexual dysfunction
• Weakness
• Increased levels of certain liver function blood tests

Other side effects reported with eye drops containing phosphates
This medicine contains 2.85 mg of phosphates in 3 ml of solution, equivalent to 0.95 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRAOTIM

Keep this medicine out of the sight and reach of children.
Do not use TRAOTIM after the expiry date stated on the label of the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening, the solution may become contaminated, which could cause eye infections. For this reason, even if you have not used all the solution, you must discard the bottle 4 weeks after first opening.
To help you remember, write the date of opening in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TRAOTIM contains

• The active substances are: bimatoprost 0.3 mg/ml and timolol 5 mg/ml, equivalent to 6.83 mg/ml of timolol maleate.
• The other components are: benzalkonium chloride (a preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections.

Description of the appearance of TRAOTIM and contents of the pack
TRAOTIM is a colourless eye drop solution in a plastic bottle.
Each pack contains 1 LDPE bottle with screw cap. Each bottle contains 3 ml of solution, sufficient for 4 weeks of treatment.

Marketing Authorisation Holder
Genetic S.p.A. Via G. Della Monica, 26 – 84084 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)

Package leaflet: information for the user

TRAOTIM 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container

Bimatoprost/timolol
Generic medicine
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What TRAOTIM is and what it is used for
2. What you need to know before using TRAOTIM
3. How to use TRAOTIM
4. Possible side effects
5. How to store TRAOTIM
6. Package contents and other information

1. What TRAOTIM is and what it is used for

TRAOTIM contains two different active substances (bimatoprost and timolol); both reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, which are analogues of prostaglandin. Timolol belongs to a group of medicines called beta-blockers.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is constantly drained from the eye, while new fluid is produced to replace what is drained. If the drainage of fluid occurs too slowly, the pressure inside the eye increases and, over time, may damage vision (a condition called glaucoma).
TRAOTIM works by reducing the production of fluid and also by increasing the amount of fluid that is drained. In this way, it reduces the pressure inside the eye.
The TRAOTIM eye drops are used to treat elevated eye pressure in adults, including the elderly. This elevated pressure may lead to glaucoma. Your doctor will prescribe TRAOTIM if other eye drops containing beta-blockers or prostaglandin analogues have not been effective.
This medicine does not contain preservatives.

2. What you need to know before using TRAOTIM

Do not use TRAOTIM eye drops, solution

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if you have or have previously had respiratory problems such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause breathlessness, difficulty breathing, and/or persistent cough)
• if you have heart problems, such as slow heart rate, heart block, or heart failure.

Warnings and precautions
Before using this medicine, tell your doctor if you have or have had:

• heart disorders due to coronary problems (symptoms may include chest pain or tightness, shortness of breath, or suffocation)
• heart failure, low blood pressure
• disorders of heart rhythm such as slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• conditions due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disease
• diabetes, as timolol may mask signs and symptoms of low blood sugar levels
• severe allergic reactions
• liver or kidney problems
• problems affecting the surface of the eye
• separation of one of the layers inside the eyeball following surgery to reduce intraocular pressure
• known risk factors for macular edema (swelling of the retina inside the eye leading to worsening of vision), for example cataract surgery

Before surgical anaesthesia, inform your doctor that you are using TRAOTIM, as timolol may alter the effects of certain medicines used during anaesthesia.
TRAOTIM may cause darkening and lengthening of the eyelashes; it may also darken the skin around the eye. Over time, the colour of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated.
TRAOTIM may cause growth of hair if it comes into contact with the skin surface.

Children and adolescents
TRAOTIM must not be used in children and adolescents under 18 years of age.

Other medicines and TRAOTIM
TRAOTIM may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are using or intend to use medicines to lower blood pressure, medicines for the heart, medicines for the treatment of diabetes, quinidine (used to treat heart conditions and certain types of malaria), or medicines for depression known as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use TRAOTIM during pregnancy unless specifically instructed by your doctor.
Do not use TRAOTIM if you are breastfeeding. Timolol may be excreted in breast milk. Consult your doctor before taking any medicines while breastfeeding.

Driving and using machines
In some patients, TRAOTIM may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.

TRAOTIM contains disodium phosphate heptahydrate
This medicine contains 0.38 mg of phosphates in 0.4 ml of solution, equivalent to 0.95 mg/ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use TRAOTIM

Use TRAOTIM exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The usual dose is one drop daily in the morning or evening in each eye requiring treatment.
Take the dose at the same time each day.

Instructions for use

Wash your hands before use. Ensure the single-dose container is intact before use. The solution
should be used immediately after opening. To avoid contamination, the open end of the
single-dose container must not touch the eye or come into contact with any other surfaces.

1. Tear off one single-dose container from the strip ( fig. 1 ).
2. Hold the single-dose container upright (with the cap facing upwards) and twist the cap ( fig. 2 ).
3. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and gently squeeze to release one drop of eye drops into each eye to be treated ( fig. 3 ).
4. With the eye closed, press a finger against the inner corner of the closed eye (where the eye meets the nose) and hold for 2 minutes. This will help prevent TRAOTIM from entering the rest of the body ( fig. 4 ).
5. Discard the single-dose container after use, even if some solution remains inside.

If the drop does not enter the eye, repeat the procedure. Wipe away any excess eye drops running down the cheek.
If you wear contact lenses, remove them before using this medicine. After instilling the eye drops, wait at least 15 minutes before reinserting your contact lenses.
If you use TRAOTIM together with other eye medicines, leave at least 5 minutes between applying TRAOTIM and the other medicine. Ocular ointments or gels should be used last.
If you use more TRAOTIM than you should
If you have instilled more TRAOTIM than you should, it is unlikely to cause serious problems.
Take your next dose at the usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use TRAOTIM
If you forget to use TRAOTIM, as soon as you remember, apply one single drop and then continue with your regular dosing schedule. Do not use a double dose to make up for the forgotten dose.
If you stop using TRAOTIM
For TRAOTIM to work properly, it must be used every day.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, TRAOTIM may cause side effects, although not everybody gets them.
You may continue using the eye drops normally unless the side effects are severe. If you are concerned, consult
your doctor or pharmacist. Do not stop using TRAOTIM without talking to your doctor.
The following side effects may occur with TRAOTIM (single-dose and/or multi-dose):

Very common side effects
May affect more than 1 in 10 people
Eye-related
Redness

Common side effects
May affect up to 1 in 10 people
Eye-related
Burning, itching, stinging sensation, conjunctival irritation (irritation of the transparent membrane of the eye),
light sensitivity, eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye, small ulcers on the eye surface,
with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, growth of hair around the eyes,
darkening of the eyelids, darkening of the skin colour around the eyes, eyelash lengthening, eye irritation, watery eyes,
swollen eyelids, reduced vision.

Other parts of the body
Runny nose, headache.

Uncommon side effects
May affect up to 1 in 100 people
Eye-related
Abnormal sensation in the eye, iris inflammation, conjunctival swelling (swelling of the transparent membrane of the eye),
painful eyelids, tired eyes, ingrown eyelashes, darkening of the iris colour, sunken eyes, drooping eyelid, eyelid retraction
(movement away from the eye surface leading to incomplete eyelid closure), eyelid skin tightness, darkening of eyelashes.

Other parts of the body
Shortness of breath

Side effects with unknown frequency
Eye-related:
Cystoid macular edema (swelling of the retina inside the eye causing worsening of vision), eye swelling, blurred vision,
ocular discomfort.

Other parts of the body:
Breathing difficulties/wheezing, symptoms of allergic reaction (swelling, eye redness, skin rash), taste disturbances,
dizziness, slowed heart rate, elevated blood pressure, sleep disturbances, nightmares, asthma, hair loss, skin colour changes
around the eye, fatigue.

Additional side effects have been observed in patients treated with eye drops containing timolol or bimatoprost and may
therefore also occur with TRAOTIM.
Like other topical ophthalmic medicines, timolol is absorbed and passes into the bloodstream. This may cause side effects
similar to those observed with beta-blockers administered intravenously and/or orally.
The likelihood of side effects after administration of eye drops is lower than that following oral or injectable medicines.

The listed side effects include reactions known within the class of beta-blockers used for the treatment of eye diseases:

• Severe allergic reactions with swelling and breathing difficulties, which could potentially be life-threatening

• Low blood sugar levels

• Depression; memory loss; hallucinations

• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation

• Reduced sensitivity of the eye surface; double vision; drooping eyelid; separation of one of the layers inside the eyeball after eye pressure-lowering surgery; inflammation of the eye surface; retrobulbar haemorrhage (bleeding of the retina), intraocular inflammation, frequent blinking

• Heart failure; irregular or stopped heartbeat; slow or fast heartbeats; fluid accumulation, mainly water, in the body; chest pain

• Low blood pressure; swollen or cold hands, feet, and extremities due to constriction of blood vessels

• Cough; worsening of asthma; worsening of chronic obstructive pulmonary disease (COPD)

• Diarrhoea; stomach ache; nausea and vomiting; indigestion; dry mouth

• Red, scaly skin patches; skin rash

• Muscle pain

• Reduced sexual desire; sexual dysfunction

• Weakness

• Increased levels in certain blood tests indicating liver function

Other side effects reported with eye drops containing phosphates
This medicine contains 2.85 mg of phosphates in 3 ml of solution, equivalent to 0.95 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause
opaque corneal deposits due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also
report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRAOTIM

Keep TRAOTIM out of the sight and reach of children.
Do not use TRAOTIM after the expiry date stated on the single-dose container and on the outer carton. The expiry date refers to the last day of that month.
This medicinal product is for single use only and does not contain preservatives. Do not store any unused solution.
This medicine does not require any special storage temperature.
Keep the single-dose containers in the pouch to protect the medicine from light and moisture. After first opening the aluminium pouch, use within 7 days; any remaining containers must be discarded after this period.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TRAOTIM contains

• The active substances are: bimatoprost 0.3 mg/ml and timolol 5 mg/ml, corresponding to 6.83 mg/ml of timolol maleate.
• The other components are: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections.

Description of the appearance of TRAOTIM and contents of the pack
TRAOTIM is a colourless solution supplied in single-dose containers, each containing 0.4 ml of solution.
The pack contains 30 single-dose containers of 0.4 ml.
Marketing Authorisation Holder
Genetic S.p.A. Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)