Lomitrav: detailed information

Patient Information Leaflet: Information for the User

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

Bimatoprost/timolol
Equivalent 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What LOMITRAV is and what it is used for
What you need to know before using LOMITRAV
How to use LOMITRAV
Possible side effects
How to store LOMITRAV
Contents of the pack and other information

1. What LOMITRAV is and what it is used for

LOMITRAV contains two different active substances (bimatoprost and timolol); both reduce the pressure inside the eye. Bimatoprost belongs to a group of medicines called prostamides, analogues of prostaglandins. 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, and new fluid is produced to replace the drained fluid. If the drainage of fluid occurs too slowly, the pressure inside the eye increases and, over time, this may damage vision (a condition called glaucoma). LOMITRAV 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.
LOMITRAV eye drops are used to treat elevated eye pressure in adults, including the elderly. This increased pressure may lead to glaucoma. Your doctor will prescribe LOMITRAV if other eye drops containing beta-blockers or prostaglandin analogues have not been effective.

2. What you need to know before using LOMITRAV

Do not use LOMITRAV 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 LOMITRAV, as timolol may alter the effects of certain medicines used during anesthesia.
LOMITRAV 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 being treated. LOMITRAV may cause hair growth if it comes into contact with the skin surface.

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

Other medicines and LOMITRAV
LOMITRAV may affect or be affected by other medicines you are taking, including other eye drops used to treat 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, heart medications, diabetes treatments, quinidine (used to treat heart conditions and certain types of malaria), or antidepressants known as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use LOMITRAV during pregnancy unless specifically instructed by your doctor.
Do not use LOMITRAV 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, LOMITRAV may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.

LOMITRAV 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 transparent outer layer of the eye). If you experience unusual eye sensations, burning, or pain after using this medicine, speak with your doctor.

LOMITRAV 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 LOMITRAV

Use LOMITRAV exactly as directed 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.

Wash your hands. Tilt your head back and look upwards (fig. 1).
Gently pull down the lower eyelid to form a small pocket (fig. 2).
Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated (fig. 3).
Release the lower eyelid and close the eye (fig. 4).
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 LOMITRAV 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 come into contact with any other surfaces. After using the bottle, close it tightly by screwing the cap back on.
If you are using LOMITRAV together with other eye medications, wait at least 5 minutes between applying LOMITRAV and the other medication. Ointments or ocular gels should be used last.

If you use more LOMITRAV than you should
If you have instilled more LOMITRAV than you should have, 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 LOMITRAV
If you forget to use LOMITRAV, as soon as you remember, apply one drop only and then continue with your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using LOMITRAV
For LOMITRAV 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, LOMITRAV may cause side effects, although not everybody experiences them.
You may continue using the eye drops as usual, unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using LOMITRAV without first discussing it with your doctor.

The following side effects may occur with LOMITRAV (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 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, increased hair growth around the eyes, darkening of the eyelids, darkening of the skin around the eyes, headache, eyelash elongation, 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 in the retina inside the eye causing worsening of vision), eye swelling, blurred vision, eye discomfort.

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

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

Like other topical ophthalmic medicines, timololo is absorbed and passes into the bloodstream. This may cause side effects similar to those seen with intravenously or orally administered beta-blockers. The likelihood of side effects after administration of eye drops is lower than with oral or injectable medications. 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 eye pressure-lowering surgery; eye surface inflammation; retrobulbar haemorrhage (bleeding of the retina); intraocular inflammation; frequent blinking
Heart failure; irregular or stopped heartbeat; slow or rapid 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 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 corneal deposits due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 help provide more information on the safety of this medicine.

5. How to store LOMITRAV

Keep this medicine out of the sight and reach of children.
Do not use LOMITRAV after the expiry date stated on the bottle label after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once opened, 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 LOMITRAV 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: benzalkonium chloride (a preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections.

Description of the appearance of LOMITRAV and contents of the pack
LOMITRAV is a colourless ophthalmic solution in a plastic bottle.
Each pack contains 1 bottle made of LDPE with a 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

LOMITRAV 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 others, even if they have the same symptoms as you, because it could 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:

What LOMITRAV is and what it is used for
What you need to know before using LOMITRAV
How to use LOMITRAV
Possible side effects
How to store LOMITRAV
Contents of the pack and other information

1. What LOMITRAV is and what it is used for

LOMITRAV 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 replaced by newly produced fluid. If the drainage of fluid occurs too slowly, the pressure inside the eye increases and, over time, this may damage vision (a condition called glaucoma).
LOMITRAV works by reducing the production of fluid and also increasing the amount of fluid that is drained. In this way, it reduces the pressure inside the eye.
LOMITRAV eye drops are used to treat elevated eye pressure in adults, including the elderly. This increased pressure may lead to glaucoma. Your doctor will prescribe LOMITRAV if other eye drops containing beta-blockers or prostaglandin analogues have not been effective.
This medicine does not contain preservatives.

2. What you should know before using LOMITRAV

Do not use LOMITRAV 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, 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 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 timol0l may mask signs and symptoms of low blood sugar levels
severe allergic reactions
liver or kidney problems
eye surface disorders
detachment 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 vision), for example cataract surgery

Before surgical anesthesia, inform your doctor that you are using LOMITRAV, as timolol may alter the effects of certain medicines used during anesthesia.
LOMITRAV may cause darkening and lengthening of the eyelashes; it may also darken the skin around the eye. 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.
LOMITRAV may cause hair growth if it comes into contact with the skin surface.

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

Other medicines and LOMITRAV
LOMITRAV 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 to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use LOMITRAV during pregnancy unless specifically instructed by your doctor.
Do not use LOMITRAV 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, LOMITRAV may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.

LOMITRAV 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 LOMITRAV

Use LOMITRAV exactly as directed 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 every 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.

Tear off one single-dose container from the strip ( fig. 1 ).
Hold the single-dose container upright (with the cap facing upwards) and twist the cap ( fig. 2 ).
Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and squeeze to release 1 drop of eye drops into each eye to be treated ( fig. 3 ).
With 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 LOMITRAV from entering the rest of the body (fig. 4).
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 using the eye drops, wait at least 15 minutes before reinserting your contact lenses.
If you use LOMITRAV together with other eye medicines, leave at least 5 minutes between applying LOMITRAV and the other medicine. Ocular ointments or gels should be used last.
If you use more LOMITRAV than you should
If you have instilled more LOMITRAV than you should, it is unlikely to cause serious problems. Use the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use LOMITRAV
If you forget to use LOMITRAV, 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 a forgotten dose.
If you stop using LOMITRAV
For LOMITRAV 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, LOMITRAV 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 about any side effects, consult your doctor or pharmacist. Do not stop using LOMITRAV without talking to your doctor first.

The following side effects may occur with LOMITRAV (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 surface of the eye with or without inflammation, blurred vision, redness and itching of the eyelids, growth of hairs around the eyes, darkening of the eyelids, darkening of the skin around the eyes, eyelash elongation, 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, ingrown 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, symptoms of allergic reaction (swelling, eye redness, skin rash), taste disturbances, dizziness, slowing of heart rate, elevated blood pressure, sleep disturbances, nightmares, asthma, hair loss, changes in skin colour 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 LOMITRAV.

Like other ophthalmic medicines for topical use, 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 administration of eye drops is lower than with medicines taken orally or by injection.

The listed side effects include reactions known within 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 intraocular pressure-lowering surgery; inflammation of the eye surface; retrobulbar haemorrhage (bleeding of the retina); intraocular inflammation; frequent blinking
Heart failure; irregularities or arrest of heartbeat; slow or rapid 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 of 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 cloudy spots on the cornea due to calcium deposits 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 LOMITRAV

Keep LOMITRAV out of the sight and reach of children.
Do not use LOMITRAV 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 medicine 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 should be discarded after this period.
Do not dispose of medicines 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 LOMITRAV 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: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections.

Description of the appearance of LOMITRAV and contents of the pack
LOMITRAV is a clear 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 Authorization 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)