Bitimax
ItalyTable of Contents
- Package leaflet: information for the user
- Bitimax 0.3 mg/ml + 5 mg/ml eye drops, solution
- 1. What Bitimax is and what it is used for
- 2. What you need to know before using Bitimax
- 3. How to use Bitimax
- 4. Possible side effects
- 5. How to store Bitimax
- 6. Package contents and other information
- PACKAGE LEAFLET
- Package leaflet: Information for the user
- Bitimax 0.3 mg/ml + 5 mg/ml eye drops, solution in single-dose container
- 1. What Bitimax monodose is and what it is used for
- 2. What you need to know before using Bitimax monodose
- 3. How to use Bitimax monodose
- 4. Possible side effects
- 5. How to store Bitimax monodose
- 6. Package contents and other information
PACKAGE LEAFLET
Package leaflet: information for the user
Bitimax 0.3 mg/ml + 5 mg/ml eye drops, solution
bimatoprost/timolol
Equivalent medicine
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Bitimax is and what it is used for
- What you need to know before using Bitimax
- How to use Bitimax
- Possible side effects
- How to store Bitimax
- Contents of the pack and other information
1. What Bitimax is and what it is used for
Bitimax 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. 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 it. If the fluid drains too slowly, the pressure inside the eye increases and, over time, this may damage vision (a condition called glaucoma).
Bitimax works by reducing the production of fluid and also increasing the amount of fluid that is drained away. In this way, it reduces the pressure inside the eye.
The Bitimax eye drops are used to treat high eye pressure in adults, including the elderly. This elevated pressure may lead to glaucoma. Your doctor will prescribe Bitimax if other eye drops containing beta-blockers or prostaglandin analogues have not worked effectively.
2. What you need to know before using Bitimax
Do not use Bitimax
- if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6);
- if you currently have or have previously had respiratory problems such as asthma and/or severe chronic obstructive pulmonary disease (a lung condition that may cause shortness of breath, difficulty breathing, and/or persistent cough) or other types of breathing problems;
- if you have heart problems, such as slow heart rate, heart block, or heart failure.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bitimax.
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 lung 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;
- severe allergic reactions;
- liver or kidney problems;
- eye surface problems;
- separation of one of the layers within 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 anesthesia, inform your doctor that you are using Bitimax, as timolol may alter the effects of certain medicines used during anesthesia.
Bitimax 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. Bitimax may cause hair growth if it comes into contact with the skin surface.
For athletes: using this medicine without a therapeutic indication constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Bitimax must not be used in children and adolescents under 18 years of age.
Other medicines and Bitimax
Bitimax 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 plan to use medicines to lower blood pressure, medicines for the heart, medicines to treat diabetes, quinidine (used to treat heart conditions and certain types of malaria), or medicines used to treat depression known as fluoxetine and paroxetine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use Bitimax during pregnancy unless specifically instructed by your doctor.
Do not use Bitimax 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, Bitimax may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.
Bitimax contains benzalkonium chloride
Bitimax contains a preservative called benzalkonium chloride.
This medicine contains 0.05 mg of benzalkonium chloride per ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your 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 outermost layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.
Bitimax contains phosphates
This medicine contains 0.95 mg of phosphates per 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 buildup during treatment.
3. How to use Bitimax
Use this medicine 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
Do not use the bottle if the tamper-evident seal on the cap is not intact before first use.
5.
- Wash your hands. Tilt your head backward and look upward.
- Gently pull down the lower eyelid to form a small pocket.
- Invert the bottle and apply gentle pressure to release one drop of eye drops into each eye to be treated.
- Release the lower eyelid and close your eye.
- Keeping 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 helps prevent Bitimax from entering the rest of the body.
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 properly by screwing the cap back on tightly.
If you use Bitimax together with other eye medicines, wait at least 5
minutes between applying Bitimax and the other medicine. Ointments or ocular gels should
be used last.
If you use more Bitimax than you should
If you have instilled more Bitimax than recommended, it is unlikely to cause serious consequences.
Take the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use Bitimax
If you forget to use Bitimax, 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 missed dose.
If you stop using Bitimax
For Bitimax to work properly, it must be used every day.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
You may continue to use the eye drops normally unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Bitimax without first talking to your doctor.
The following side effects may occur with Bitimax (multi-dose and/or single-dose):
Very common side effects
May affect more than 1 in 10 people
In the eye
Redness.
Common side effects
May affect up to 1 in 10 people
In the eye
Burning, itching, stinging sensation, conjunctival irritation (irritation of the transparent membrane of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, foreign body sensation in the eye, small ulcers on the surface of the eye, with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, increased hair growth around the eyes, darkening of the eyelids, darkening of the skin around the eyes, eyelash elongation, eye irritation, watery eyes, swollen eyelids, reduced vision.
In other parts of the body
Runny nose, headache.
Uncommon side effects
May affect up to 1 in 100 people
In the eye
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.
In other parts of the body
Shortness of breath.
Side effects with unknown frequency
Frequency cannot be estimated from the available data
In the eye
Cystoid macular edema (swelling in the retina inside the eye causing worsening of vision), eye swelling, blurred vision, ocular discomfort.
In other parts of the body
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, change in skin colour around the eye, fatigue.
Additional side effects have been observed in patients treated with eye drops containing timolol or bimatoprost, and therefore may also occur with Bitimax. Like other topical ophthalmic medicines, timolol is absorbed and passes 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 oral or injectable medicines. The listed side effects include reactions observed with bimatoprost and timololo 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 following eye surgery to reduce intraocular pressure; inflammation of the eye surface; retroocular haemorrhage (retinal bleeding); intraocular inflammation; frequent blinking
- Heart failure; irregular or stopped heartbeat; slow or rapid heartbeat; 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)
- Diarrhea; 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 0.95 mg of phosphates per ml of solution. 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 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 https://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 Bitimax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 solutions 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 28 days after
first opening.
Do not store above 25°C after first opening of the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Bitimax contains
- The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml, corresponding to 6.8 mg/ml of timolol maleate.
- The excipients are: benzalkonium chloride (a preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, sodium hydroxide (to adjust pH), purified water.
Description of the appearance of Bitimax and contents of the package
Bitimax is an eye drop solution, colourless or slightly yellow, clear, contained in a plastic bottle.
Each package contains one 3 ml bottle made of transparent low-density polyethylene with a transparent polyethylene dropper and a white polypropylene cap.
Each bottle is approximately half full and contains 3 ml of solution, sufficient for 28 days.
Marketing Authorization Holder and Manufacturer
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)
PACKAGE LEAFLET
Package leaflet: Information for the user
Bitimax 0.3 mg/ml + 5 mg/ml eye drops, solution in single-dose container
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, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as 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 Bitimax single-dose is and what it is used for
- What you need to know before using Bitimax single-dose
- How to use Bitimax single-dose
- Possible side effects
- How to store Bitimax single-dose
- Package contents and other information
1. What Bitimax monodose is and what it is used for
Bitimax monodose 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. 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 continuously drained from the eye, and 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, this may damage vision (a condition known as glaucoma).
Bitimax monodose 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 eye drop Bitimax monodose is used to treat elevated eye pressure in adults, including elderly patients. This increased pressure may lead to glaucoma. Your doctor will prescribe Bitimax monodose if other eye drops containing beta-blockers or prostaglandin analogues have not been effective.
2. What you need to know before using Bitimax monodose
Do not use Bitimax monodose
- 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 and/or severe chronic obstructive pulmonary disease (a lung condition that may cause shortness of breath, difficulty breathing, and/or persistent cough), or other types of breathing disorders;
- if you have heart problems, such as slow heart rate, heart block, or heart failure.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Bitimax monodose.
Before using this medicine, inform 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 lung 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;
- severe allergic reactions;
- liver or kidney problems;
- eye surface disorders;
- separation of one of the layers within 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 anesthesia, inform your doctor that you are using Bitimax monodose, as timolol may alter the effects of certain medicines used during anesthesia.
Bitimax monodose 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. Bitimax monodose may cause hair growth if it comes into contact with the skin surface.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Bitimax monodose must not be used in children and adolescents under 18 years of age.
Other medicines and Bitimax monodose
Bitimax monodose 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 plan to use medicines to lower blood pressure, medicines for the heart, medicines for diabetes treatment, 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 might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Do not use Bitimax monodose during pregnancy unless specifically instructed by your doctor.
Do not use Bitimax monodose 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, Bitimax monodose may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.
Bitimax monodose contains phosphates
This medicine contains 0.95 mg of phosphates in 1 ml of solution.
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 buildup during treatment.
3. How to use Bitimax monodose
Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual dose is one drop 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 must 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.
- Detach one single-dose container from the strip.
- Hold the single-dose container vertically (with the cap facing upwards) and twist the cap.
- Gently pull down the lower eyelid to form a pocket. Invert the single-dose container and gently squeeze to release 1 drop of eye drops into each eye to be treated.
- 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 Bitimax monodose from being absorbed into the rest of the body.
- 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 the medicine. After applying the eye drops, wait
at least 15 minutes before reinserting your contact lenses.
If you use Bitimax monodose together with other eye medicines, leave at least 5 minutes between the
application of Bitimax monodose and the other medicine. Ocular ointments or gels should be used last.
If you use more Bitimax monodose than you should
If you have instilled more Bitimax monodose than intended, it is unlikely to cause serious
consequences. Take the next dose at the usual time. If you are concerned, consult your
doctor or pharmacist.
If you forget to use Bitimax monodose
If you forget to use Bitimax monodose, as soon as you remember, apply one single drop and then
resume your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop using Bitimax monodose
To work properly, Bitimax monodose 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, this medicine can cause side effects, although not everyone will experience 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 Bitimax single-dose without discussing it with your doctor.
The following side effects may occur with Bitimax (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, 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 body parts:
Runny nose, headache.
Uncommon side effects
May affect up to 1 in 100 people
Eye-related:
Abnormal sensation in the eye, inflammation of the iris, swelling of the conjunctiva (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
Frequency cannot be estimated from the available data
Eye-related:
Cystoid macular oedema (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, high blood pressure, sleep disorders, 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, so they may also occur with Bitimax. Like other topical ophthalmic medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with intravenously and/or orally administered beta-blockers. The likelihood of side effects after administration of eye drops is lower than with oral or injected medicines. The listed side effects include reactions observed with bimatoprost and timololo 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; eye surface inflammation; 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 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 deposits during treatment.
Reporting of side effects
If you experience any side effect, 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 https://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 Bitimax monodose
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. 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 and store the pouch back in the carton to protect the medicine from light and moisture. All single-dose containers must be kept inside the pouch and discarded 10 days after the first opening of the pouch.
Do not store above 25°C after opening the aluminium pouch.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Bitimax monodose contains
- The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml, corresponding to 6.8 mg/ml of timolol maleate.
- The excipients are: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, sodium hydroxide (to adjust pH), purified water.
Description of the appearance of Bitimax monodose and contents of the pack
Bitimax monodose is a colourless or slightly yellow, clear eye drop solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.
Packaging consists of 3 aluminium pouches, each containing 10 single-dose containers, for a total of 30 single-dose containers.
Marketing Authorisation Holder and Manufacturer
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)