Ganfort

Package leaflet: Information for the patient

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

bimatoprost/timolol
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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What GANFORT is and what it is used for

GANFORT 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 known as 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 fluid is drained too slowly, the pressure inside the eye increases and, over time, this may damage vision (a condition called glaucoma).
GANFORT works by reducing the production of fluid and also by increasing the amount of fluid that is drained away. In this way, it reduces the pressure inside the eye.
GANFORT eye drops are used to treat high pressure in the eyes in adults, including elderly patients. This elevated pressure may lead to glaucoma. Your doctor will prescribe GANFORT if other eye drops containing beta-blockers or prostaglandin analogues have not worked effectively.

2. What you need to know before using GANFORT

Do not use GANFORT

• 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 breathing 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 respiratory disorders
• 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 or low blood pressure
• heart rhythm disorders such as slow heartbeat
• breathing 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 levels
• severe allergic reactions
• liver or kidney problems
• eye surface disorders
• separation of one of the layers within 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 anesthesia, inform your doctor that you are using GANFORT, as timolol may alter the effects of certain medicines used during anesthesia.
GANFORT may cause darkening and lengthening of the eyelashes; it may also darken the skin around the eyelid. 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. GANFORT may cause hair growth if it comes into contact with the skin surface.
Children and adolescents
GANFORT must not be used in children and adolescents under 18 years of age.
Other medicines and GANFORT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
GANFORT may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. 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 GANFORT during pregnancy unless specifically instructed by your doctor.
Do not use GANFORT 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, GANFORT may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.
GANFORT contains benzalkonium chloride
GANFORT contains a preservative called benzalkonium chloride.
This medicine contains 0.15 mg of benzalkonium chloride in 3 ml of solution, equivalent to 0.05 mg/ml.
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, particularly if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience an abnormal sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use GANFORT

Use GANFORT 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 every day.
Instructions for use
Do not use the bottle if the tamper-evident seal on the cap is broken before first use.

5.

1. Wash your hands. Tilt your head backward and look upward.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and close the eye.
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 helps prevent GANFORT from entering the rest of the body.

If the drop did 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 GANFORT together with other eye medications, wait at least 5 minutes between applying GANFORT and the other medication. Ocular ointments or gels should be used last.
If you use more GANFORT than you should
If you have instilled more GANFORT than recommended, it is unlikely to cause serious problems. Take the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use GANFORT
If you forget to use GANFORT, 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 forgotten dose.
If you stop using GANFORT
To work properly, GANFORT 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, GANFORT may cause side effects, although not everybody gets them.
You may continue to use the eye drops as usual unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using GANFORT without first talking to your doctor.

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

Very common: may affect more than 1 in 10 people
In the eye
Redness.

Common: 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, 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, 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: 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, inward-growing eyelashes, darkening of the iris colour, sunken eyes, drooping eyelid, eyelid retraction (eyelid pulling away from the eye surface causing incomplete eyelid closure), tightness of the eyelid skin, darkening of eyelashes.

In other parts of the body
Shortness of breath.

Not known: frequency cannot be estimated from the available data
In the eye
Cystoid macular oedema (swelling of the retina inside the eye leading to worsening of vision), eye swelling, blurred vision, eye discomfort.

In other parts of the body
Breathing difficulties/wheezing, symptoms of allergic reaction (swelling, redness of the eye and skin rash), taste disturbances, dizziness, slowing of heart rate, high 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 may therefore also occur with GANFORT. 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 administration of eye drops is lower than with oral or injectable medicines. The listed side effects include reactions observed with bimatoprost and timolol 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; inflammation of the eye surface; retinal haemorrhage; inflammation inside the eye; frequent blinking
• Heart failure; irregular heartbeat or cardiac arrest; slow or fast heartbeat; 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 a lung disease called 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 opaque corneal spots due to calcium accumulation during treatment.

Reporting of side effects
If you get 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GANFORT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the carton after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Once opened, the solution may become contaminated, which could lead to 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 first opening in the space provided on the box.
Do not dispose of any medicine 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 GANFORT contains

• The active substances are: bimatoprost 0.3 mg/ml and timolol 5 mg/ml, equivalent to 6.8 mg/ml of timolol maleate.
• The other ingredients are: benzalkonium chloride (a preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may have been added to adjust the solution to the correct pH (acidity) (see section 2).

Description of the appearance of GANFORT and contents of the pack
GANFORT is a colourless or slightly yellow, clear eye drop solution in a plastic bottle.
Each pack contains 1 or 3 plastic bottles with screw caps. Each bottle is approximately half full and contains 3 ml of solution, sufficient for 4 weeks. Not all pack sizes may be marketed.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: +370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел: +359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel.: +420 233 098 111 Tel: +36 1 455 8600

Danmark Malta
AbbVie A/S Vivian Corporation Ltd.
Tlf: +45 72 30 20 28 Tel: +356 27780331

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel.: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel.: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel.: +372 6231011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 913840910 Tel.: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel.: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: +385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Sími: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu/ .
To listen to or request a copy of this package leaflet in an alternative format, such as enlarged text, please contact the local representative of the Marketing Authorisation Holder.

Patient information leaflet

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

bimatoprost/timolol
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 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What GANFORT monodose is and what it is used for

GANFORT 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 the drained fluid. If the drainage of fluid occurs too slowly, the pressure inside the eye increases and, over time, may damage vision (a condition called glaucoma).
GANFORT monodose 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.
The eye drop GANFORT monodose is used to treat elevated eye pressure in adults, including the elderly. This increased pressure may lead to glaucoma. Your doctor will prescribe GANFORT monodose 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 GANFORT single-dose

Do not use GANFORT

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this single-dose 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 disease that may cause shortness of breath, difficulty breathing, and/or persistent cough), or other types of respiratory disorders
• 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, or low blood pressure
• heart rate disorders such as slow heartbeat
• respiratory disorders, 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 timol0l 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 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 anesthesia, inform your doctor that you are using GANFORT single-dose, as timolol may alter the effects of certain medicines used during anesthesia.
GANFORT single-dose 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. GANFORT single-dose may cause hair growth if it comes into contact with the skin surface.
Children and adolescents
GANFORT single-dose must not be used in children and adolescents under 18 years of age.
Other medicines and GANFORT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
GANFORT single-dose may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. 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 GANFORT single-dose during pregnancy unless specifically instructed by your doctor.
Do not use GANFORT single-dose 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, GANFORT single-dose may cause blurred vision. Do not drive or operate machinery until symptoms have resolved.

3. How to use GANFORT single-dose

Use GANFORT single-dose 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

Wash your hands before use. Check that 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 one single-dose container from the strip.
2. Hold the single-dose container upright (with the cap facing upwards) and twist the cap to remove it.
3. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and gently squeeze to release 1 drop of eye drops into each eye to be treated.
4. With the eye closed, press a finger against the corner of the closed eye (where the eye meets the nose) and hold pressure for 2 minutes. This will help prevent GANFORT single-dose from entering the rest of the body.
5. Discard the single-dose container after use, even if there is some solution remaining 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 GANFORT single-dose together with other eye medicines, leave at least 5 minutes between applying GANFORT single-dose and the other medicine. Ocular ointments or gels should be used last.
If you use more GANFORT than you should
If you have instilled more GANFORT single-dose than you should have, it is unlikely to cause serious problems. Take the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.
If you forget to use GANFORT
If you forget to use GANFORT single-dose, as soon as you remember, apply one 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 GANFORT
For GANFORT single-dose 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, GANFORT single-dose may cause side effects, although not everybody gets 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 GANFORT single-dose without talking to your doctor.

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

Very common: may affect more than 1 in 10 people
Eye
redness.

Common: may affect up to 1 in 10 people
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, 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, eyelash elongation, eye irritation, watery eyes, swollen eyelids, reduced vision.

Other parts of the body
runny nose, headache.

Uncommon: may affect up to 1 in 100 people
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, causing incomplete eyelid closure), eyelid skin tightness, darkening of eyelashes.

Other parts of the body
shortness of breath.

Not known: frequency cannot be estimated from the available data
Eye
cystoid macular oedema (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, redness of the eye and skin rash), taste disturbances, dizziness, slowing of 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 GANFORT. Like other topical ophthalmic medicines, timolol is absorbed and passes 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 medicines taken by mouth or by injection. The listed side effects include reactions observed with bimatoprost and timolol 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; 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 a lung disease called 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 a severe injury to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque corneal spots due to calcium deposits 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 through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GANFORT single-dose

Keep this single-dose medicine out of the sight and reach of children.
Do not use this single-dose medicine after the expiry date stated on the single-dose container after EXP and on the box 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 their pouch and store the pouch back in the box to protect the medicine from light and moisture. Once removed from the pouch, use the single-dose container within 7 days. All single-dose containers must be stored inside the pouch and discarded after 10 days from the first opening of the pouch.
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 GANFORT single-dose contains

• The active substances are: bimatoprost 0.3 mg/ml and timolol 5 mg/ml, equivalent to 6.8 mg/ml of timolol maleate.
• The other ingredients are: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may have been added to adjust the solution to the correct pH (acidity).

Description of the appearance of GANFORT single-dose and contents of the pack
GANFORT single-dose is a colourless or slightly yellow solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.
Pack containing 1 aluminium pouch with 5 single-dose containers.
Packs containing 3 or 9 aluminium pouches, each pouch containing 10 single-dose containers, for a total of 30 or 90 single-dose containers, respectively.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road,
Westport,
Co. Mayo,
Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: + 370 5 205 3023

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел:+359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel.: +420 233 098 111 Tel:+36 1 455 8600

Danmark Malta
AbbVie A/S Vivian Corporation Ltd.
Tlf: +45 72 30 20 28 Tel: +356 27780331

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel.: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel.: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel. +372 6231011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 913840910 Tel.: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel.: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: + 385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Sími: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ .
To listen to or request a copy of this summary of product characteristics in an alternative format, such as enlarged text, please contact the local representative of the Marketing Authorisation Holder.