ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
GANFORT 300 micrograms/ml + 5 mg/ml eye drops, solution
2.
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).
Contains benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1.
3.
Eye drops, solution.
Colourless to slightly yellow solution.
4.
Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Recommended dosage in adults (including the elderly)
The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered in
the morning.
If one dose is missed, treatment should continue with the next dose as planned. The dose should not
exceed one drop in the affected eye(s) daily.
If more than one topical ophthalmic product is to be used, the different products should be instilled at
least 5 minutes apart.
Use in renal and hepatic impairment
GANFORT has not been studied in patients with hepatic or renal impairment. Therefore caution
should be used in treating such patients.
Use in children and adolescents
GANFORT has only been studied in adults and therefore its use is not recommended in children or
adolescents.
Hypersensitivity to the active substances or to any of the excipients.
Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe
chronic obstructive pulmonary disease.
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure,
cardiogenic shock.
2
Like other topically applied ophthalmic agents, GANFORT may be absorbed systemically. No
enhancement of the systemic absorption of the individual active substances has been observed.
Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary
adverse reactions as seen with systemic beta-blockers may occur.
Cardiac failure should be adequately controlled before beginning GANFORT therapy. Patients with a
history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse
rates checked. Cardiac and respiratory reactions, including death due to bronchospasm in patients with
asthma, and, rarely, death in association with cardiac failures have been reported following
administration of timolol maleate.
Beta-blockers may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina,
severe peripheral and central circulatory disorders and hypotension.
Beta-adrenergic blocking agents should be administered with caution in patients subject to
spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) as
beta-blockers may mask the signs and symptoms of acute hypoglycemia.
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction
to a variety of allergens may be unresponsive to the usual dose of adrenaline used to treat anaphylactic
reactions.
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate
aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver
function over 24 months. There are no known adverse reactions of ocular timolol on liver function.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth,
darkening of the eyelid skin and increased iris pigmentation since these have been observed during
treatment with bimatoprost and GANFORT. Some of these changes may be permanent, and may lead
to differences in appearance between the eyes if only one eye is treated. After discontinuation of
GANFORT, pigmentation of iris may be permanent. After 12 months treatment with GANFORT, the
incidence of iris pigmentation was 0.2%. After 12 months treatment with bimatoprost eye drops
alone, the incidence was 1.5% and did not increase following 3 years treatment.
Cystoid macular oedema has been reported with GANFORT. Therefore, GANFORT should be used
with caution in patients with known risk factors for macular oedema (e.g. aphakic patients,
pseudophakic patients with a torn posterior lens capsule).
The preservative in GANFORT, benzalkonium chloride, may cause eye irritation. Contact lenses must
be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium
chloride is known to discolour soft contact lenses. Contact with soft contact lenses must be avoided.
Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative
keratopathy. Therefore monitoring is required with frequent or prolonged use of GANFORT in dry
eye patients or where the cornea is compromised.
GANFORT has not been studied in patients with inflammatory ocular conditions, neovascular,
inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
3
No interaction studies have been performed.
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when eye
drops containing timolol are administered concomitantly with oral calcium channel blockers,
guanethidine, or beta-blocking agents, anti-arrhythmics, digitalis glycosides or parasympathomimetics.
Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask
the signs and symptoms of hypoglycaemia (see section 4.4).
The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking
beta-blockers.
Pregnancy
There are no adequate data from the use of GANFORT in pregnant women.
Bimatoprost
No adequate clinical data in exposed pregnancies are available. Animal studies have shown
reproductive toxicity at high maternotoxic doses (see section 5.3).
Timolol
Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine
growth retardation when beta-blockers are administered by the oral route. In addition, signs and
symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia)
have been observed in the neonate when beta-blockers have been administered until delivery. If
GANFORT is administered until delivery, the neonate should be carefully monitored during the first
days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly
higher than would be used in clinical practice (see section 5.3).
Consequently, GANFORT should not be used during pregnancy unless clearly necessary.
Lactation
Timolol is excreted in breast milk. It is not known if bimatoprost is excreted in human breast milk but
it is excreted in the milk of the lactating rat. GANFORT should not be used by breast-feeding women.
GANFORT has negligible
influence on the ability to drive and use machines. As with any ocular
treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears
before driving or using machinery.
No adverse drug reactions (ADRs) specific for GANFORT have been observed in clinical studies.
The ADRs have been limited to those earlier reported for bimatoprost and timolol.
The majority of ADRs were ocular, mild in severity and none were serious. Based on 12-month
clinical data, the most commonly reported ADR was conjunctival hyperaemia (mostly trace to mild
and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to
discontinuation in 1.5% of patients.
The following ADRs were reported during clinical trials with GANFORT (within each frequency
grouping, undesirable effects are presented in order of decreasing seriousness):
4
Nervous system disorders
Uncommon (≥1/1000 to <1/100): headache
Eye disorders
Very common (≥1/10): conjunctival hyperaemia, growth of eyelashes.
Common (≥1/100 to <1/10): superficial punctuate keratitis, corneal erosion, burning sensation, eye
pruritus, stinging sensation in the eye, foreign body sensation, eye dryness, eyelid erythema, eye pain,
photophobia, eye discharge, visual disturbance, eyelid pruritus.
Uncommon (≥1/1000 to <1/100): iritis, eye irritation, conjunctival oedema, blepharitis, epiphora,
eyelid oedema, eyelid pain, visual acuity worsened, asthenopia, trichiasis.
Not known: cystoid macular oedema.
Respiratory, thoracic and mediastinal disorders
Uncommon (≥1/1000 to <1/100): rhinitis
Skin and subcutaneous tissue disorders
Common (≥1/100 to <1/10): blepharal pigmentation
Uncommon (≥1/1000 to <1/100): hirsutism
Additional adverse events that have been seen with one of the components and may potentially occur
also with GANFORT:
Bimatoprost
Infections and infestations:
infection (primarily colds and upper respiratory symptoms).
Nervous system disorders:
dizziness
Eye disorders:
allergic conjunctivitis, cataract, eyelash darkening, increased iris pigmentation,
blepharospasm, eyelid retraction, retinal haemorrhage, uveitis.
Vascular disorders:
hypertension.
General disorders and administration site condition:
asthenia, peripheral oedema.
Investigations:
liver function tests (LFT) abnormal.
Timolol
Psychiatric disorders:
insomnia, nightmares, decreased libido
Nervous system disorders:
dizziness, memory loss, increase in signs and symptoms of myasthenia
gravis, paresthaesia, cerebral ischaemia
Eye disorders:
decreased corneal sensitivity, diplopia, ptosis, choroidal detachment (following
filtration surgery), refractive changes (due to withdrawal of miotic therapy in some cases), keratitis.
Ear and labyrinth disorders:
tinnitus.
Cardiac disorders
: heart block, cardiac arrest, arrhythmia, syncope, bradycardia, cardiac failure,
congestive heart failure.
Vascular disorders:
hypotension, cerebrovascular accident, claudication, Raynaud’s phenomenon,
cold hands and feet, palpitation.
Respiratory, thoracic and mediastinal disorders:
bronchospasm (predominantly in patients with pre-
existing bronchospastic disease) dyspnoea, cough.
Gastrointestinal disorders:
nausea, diarrhoea, dyspepsia, dry mouth.
Skin and subcutaneous tissue disorders:
alopecia, psoriasiform rash or exacerbation of psoriasis.
Musculoskeletal and connective tissue disorders:
systemic lupus erythematosus.
Renal and urinary disorders:
Peyronie’s disease.
General disorders and administration site conditions:
oedema, chest pain, fatigue.
No case of overdose has been reported, and is unlikely to occur after ocular administration.
Bimatoprost
If GANFORT is accidentally ingested, the following information may be useful: in two-week oral rat
and mouse studies, doses of bimatoprost up to 100 mg/kg/day did not produce any toxicity. This dose
5
expressed as mg/m
2
is at least 70-times higher than the accidental dose of one bottle of GANFORT in
a 10 kg child.
Timolol
Symptoms of systemic timolol overdose are: bradycardia, hypotension, bronchospasm, headache,
dizziness, shortness of breath, and cardiac arrest. A study of patients showed that timolol did not
dialyse readily.
If overdose occurs treatment should be symptomatic and supportive.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmological – beta-blocking agents – timolol, combinations, ATC
code: S01ED 51
Mechanism of action:
GANFORT consists of two active substances: bimatoprost and timolol maleate. These two
components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and
the combined effect results in additional IOP reduction compared to either compound administered
alone. GANFORT has a rapid onset of action.
Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to
prostaglandin F
2α
(PGF
2α
) that does not act through any known prostaglandin receptors. Bimatoprost
selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The
prostamide receptor, however, has not yet been structurally identified. The mechanism of action by
which bimatoprost reduces intraocular pressure in man is by increasing aqueous humour outflow
through the trabecular meshwork and enhancing uveoscleral outflow.
Timolol is a beta
1
and beta
2
non-selective adrenergic receptor blocking agent that does not have
significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic
(membrane-stabilising) activity. Timolol lowers IOP by reducing aqueous humour formation. The
precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP
synthesis caused by endogenous beta-adrenergic stimulation is probable.
Clinical effects:
The IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of
bimatoprost (once daily) and timolol (twice daily).
There are no studies with evening dosing of GANFORT.
Morning dosing of GANFORT is therefore
recommended to ensure maximal IOP-lowering effect at the time of the physiological IOP rise.
However, if necessary for patient compliance, an evening dosing may be considered. Once-daily
dosing of timolol 0.5% has a rapid onset of maximal effect, corresponding with the time of this rise,
and maintains clinically meaningful IOP-lowering over the 24-hour period. Bimatoprost studies show
comparable IOP control regardless of morning or evening dosing.
5.2 Pharmacokinetic properties
GANFORT:
Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the
monotherapy treatments to GANFORT treatment in healthy subjects. Systemic absorption of the
individual components was minimal and not affected by co-administration in a single formulation.
6
In two 12-month studies where systemic absorption was measured, no accumulation was observed
with either of the individual components.
Bimatoprost:
Bimatoprost penetrates the human cornea and sclera well
in vitro
. After ocular administration, the
systemic exposure of bimatoprost is very low with no accumulation over time. After once daily ocular
administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations
peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025
ng/ml) within 1.5 hours after dosing. Mean C
max
and AUC
0-24hrs
values were similar on days 7 and 14
at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady drug
concentration was reached during the first week of ocular dosing.
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in
humans at steady-state was 0.67 1/kg. In human blood, bimatoprost resides mainly in the plasma. The
plasma protein binding of bimatoprost is approximately 88%.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation
following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation
to form a diverse variety of metabolites.
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered
to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The
elimination half-life, determined after intravenous administration, was approximately 45 minutes; the
total blood clearance was 1.5 1/hr/kg.
Characteristics in elderly patients:
After twice daily dosing, the mean AUC
0-24hrs
value of 0.0634 ng•hr/ml bimatoprost in the elderly
(subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml in young healthy adults.
However, this finding is not clinically relevant as systemic exposure for both elderly and young
subjects remained very low from ocular dosing. There was no accumulation of bimatoprost in the
blood over time and the safety profile was similar in elderly and young patients.
Timolol:
After ocular administration of a 0.5% eye drops solution in humans undergoing cataract surgery, peak
timolol concentration was 898 ng/ml in the aqueous humour at one hour post-dose. Part of the dose is
absorbed systemically where it is extensively metabolised in the liver. The half-life of timolol in
plasma is about 4 to 6 hours. Timolol is partially metabolised by the liver with timolol and its
metabolites excreted by the kidney. Timolol is not extensively bound to plasma.
5.3 Preclinical safety data
GANFORT:
Repeated dose ocular toxicity studies on GANFORT showed no special hazard for humans. The
ocular and systemic safety profile of the individual components is well established.
Bimatoprost:
Non-clinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, genotoxicity, carcinogenic potential. Studies in rodents produced species-specific
abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular
administration.
Monkeys administered ocular bimatoprost concentrations of ≥0.03% daily for 1 year had an increase
in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper
and/or lower sulcus and widening of the palpebral fissure. The increased iris pigmentation appears to
be caused by increased stimulation of melanin production in melanocytes and not by an increase in
7
melanocyte number. No functional or microscopic changes related to the periocular effects have been
observed, and the mechanism of action for the periocular changes is unknown.
Timolol:
Non-clinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
6.
6.1 List of excipients
Benzalkonium chloride
Sodium chloride
Sodium phosphate dibasic heptahydrate
Citric acid monohydrate
Hydrochloric acid or sodium hydroxide (to adjust pH)
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
From a microbiological point of view, the in-use storage times and conditions are the responsibility of
the user and would normally not be longer than 28 days at 25°C.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
White opaque low-density polyethylene bottles with polystyrene screw cap. Each bottle has a fill
volume of 3 ml.
The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml. Not all pack sizes
may be marketed.
6.6 Special precautions for disposal
No special requirements.
7.
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
8
8.
EU/1/06/340/001-002
9.
19 May 2006
9
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
10
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR SINGLE BOTTLE
1.
GANFORT 300 micrograms/ml + 5 mg/ml eye drops, solution
bimatoprost/timolol
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)
3.
LIST OF EXCIPIENTS
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid
monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
4.
Eye drops, solution, 3 ml
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Ocular use. Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Remove contact lenses before use.
8.
EXPIRY DATE
EXP:
Discard four weeks after first opening.
Opened:
9.
SPECIAL STORAGE CONDITIONS
14
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
EU/1/06/340/001
13. BATCH NUMBER
Batch:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
GANFORT
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON CONTAINING THREE BOTTLES
1.
GANFORT 300 micrograms/ml + 5 mg/ml eye drops, solution
bimatoprost/timolol
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)
3.
LIST OF EXCIPIENTS
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid
monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
4.
Eye drops, solution, 3 x 3 ml
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Ocular use. Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Remove contact lenses before use.
8.
EXPIRY DATE
EXP:
Discard four weeks after first opening.
Opened (1):
Opened (2):
Opened (3):
9.
SPECIAL STORAGE CONDITIONS
16
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
EU/1/06/340/002
13. BATCH NUMBER
Batch:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
GANFORT
17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
BOTTLE
1.
GANFORT 300 micrograms/ml + 5 mg/ml eye drops, solution
bimatoprost/timolol
Ocular Use
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use.
3.
EXPIRY DATE
EXP:
4.
BATCH NUMBER
Batch:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
3 ml
6.
OTHER
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
GANFORT 300 micrograms/ml + 5 mg/ml
eye drops, solution
bimatoprost and timolol maleate
Read all of this leaflet carefully before you start using this medicine.
-
If you have any further questions, please ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
:
1.
What GANFORT is and what it is used for
2.
Before you use GANFORT
4.
Possible side effects
5
How to store GANFORT
6.
Further information
1.
WHAT GANFORT IS AND WHAT IT IS USED FOR
GANFORT is an eye drop that is used to control glaucoma. It contains two different active substances
(bimatoprost and timolol) that both reduce high pressure in the eye. Bimatoprost belongs to a group of
medicines called prostamides. Timolol belongs to a group of medicines called beta-blockers.
GANFORT is prescribed to reduce high pressure in the eye.
Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being
drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly
enough, the pressure inside the eye builds up and could eventually damage your sight. GANFORT
works by reducing the production of liquid and also increasing the amount of liquid that is drained.
This reduces the pressure inside the eye.
2.
BEFORE YOU USE GANFORT
Do not use GANFORT:
-
if you are allergic (hypersensitive) to bimatoprost, timolol or any of the other ingredients of
GANFORT
-
if you have any breathing illnesses such as asthma or a history of asthma, or severe chronic
obstructive lung disease
-
if you have heart problems such as heart weakness or heart beat disorders
Take special care with GANFORT:
Before you use this medicine, tell your doctor
-
if you have now or have had in the past
•
heart, blood pressure or breathing problems
•
overactivity of the thyroid
•
diabetes or low blood sugar levels (hypoglycaemia)
•
severe allergic reactions
•
liver or kidney problems
•
known risk factors for macular oedema (swelling of the retina within the eye
leading to worsening vision), for example, cataract surgery
20
-
Keep this leaflet. You may need to read it again.
3.
How to use GANFORT
GANFORT may cause your eyelashes to darken and grow, and cause the skin around the eyelid to
darken too. The colour of your iris may also go darker over time. These changes may be permanent.
The change may be more noticeable if you are only treating one eye.
GANFORT should not be used in people under 18 unless your doctor still recommends it.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
If you use GANFORT with another eye medicine, leave at least 5 minutes between putting in
GANFORT and the other medicine. Use any eye ointment or eye gel last.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are
pregnant or planning to become pregnant. GANFORT should not be used during pregnancy unless
your doctor still recommends it.
GANFORT should not be used if you are breast-feeding.
Driving and using machines
GANFORT may cause blurred vision in some patients. Do not drive or use machinery until the
symptoms have cleared.
Important information about some of the ingredients of GANFORT
Do not use the drops while your contact lenses are in your eyes. Wait at least 15 minutes after using
the eye drops before putting your lenses back in your eyes. A preservative in GANFORT
(benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.
3.
HOW TO USE GANFORT
Always use GANFORT exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is one drop in the morning in each eye that needs
treatment. However, your doctor may recommend you apply the drop in the evening instead.
Instructions for use
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds.
If a drop misses your eye, try again.
To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Put the cap
back on and close the bottle straight after you have used it.
21
If you use more GANFORT than you should
If you use more GANFORT than you should, it is unlikely to cause you any serious harm. Put your
next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.
If you forget to use GANFORT
If you forget to use GANFORT, use a single drop as soon as you remember, and then go back to your
regular routine. Do not use a double dose to make up for a forgotten dose.
If you stop using GANFORT
GANFORT should be used every day to work properly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, GANFORT can cause side effects, although not everybody gets them. The chance
of having a side effect is described by the following categories:
Very common
May occur in more than one person in every 10 people
Common
Occurs in up to nine people in every 100 people
Uncommon
Occurs in up to nine people in every 1000 people
Not known
Cannot be estimated from the available data
The following eye side effects may be seen with GANFORT:
Very common: eye redness, longer eyelashes
Common:
burning, itching, stinging, sensitivity to light, eye pain, sticky eyes, dry eyes, a
feeling of something in the eye, small breaks in the surface of the eye with or
without inflammation, difficulty in seeing clearly, redness and itching of the
eyelids, darkening of the eyelids
Uncommon:
watery eyes, swollen or painful eyelids, tired eyes, in-growing eyelashes, headache,
runny nose, hair growing around the eye
Not known:
cystoid macular oedema (swelling of the retina within the eye leading to worsening
vision)
The following side effects have been seen with bimatoprost or timolol and so may possibly be seen
with GANFORT: Allergic reaction in the eye, cataract, darkening of the eyelashes, darkening of the
iris colour, dizziness, high blood pressure, an increase in blood test results that show how your liver is
working, cold, effects on the heart beat, heart failure, increased heart rate, low blood pressure, skin
rash, cough, dry mouth, hair loss, nightmares, reduced sexual urge, memory loss, tiredness, ringing in
the ears and a worsening of myasthenia gravis (increased muscle weakness).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
22
5.
HOW TO STORE GANFORT
Keep out of the reach and sight of children.
Do not use GANFORT after the expiry date which is stated on the bottle label and the carton after
EXP:. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you
must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you
remember, write down the date that you opened it in the space on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What GANFORT contains
•
The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol
maleate 6.8 mg/ml.
•
The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium
phosphate dibasic heptahydrate, citric acid monohydrate and purified water. Small amounts of
hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH
level.
What GANFORT looks like and contents of the pack
GANFORT is a colourless, clear eye drop solution in a plastic bottle. Each pack contains either 1 or 3
plastic bottles each with a screw-cap. Each bottle is about half full and contains 3 millilitres of
solution. This is enough for 4 weeks’ usage. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
België/Belgique/Belgien
Allergan n.v.
Terhulpsesteenweg 6D
B-1560 Hoeilaart
Tél/Tel: +32 (0)2 351 2424
E-mail: uk_medinfo@allergan.com
Luxembourg/Luxemburg
Allergan n.v.
Terhulpsesteenweg 6D
B-1560 Hoeilaart
Belgique/Belgien
Tél/Tel: +32 (0)2 351 2424
E-mail:
uk_medinfo@allergan.com
България
Eвофарма АГ
Представителство ул. Персенк 73, ап. 27, ет. 8
1164 София
Magyarország
Vicis Pharma Kft.
Kapás utca 11-15., Buda Business Center
H-1027 Budapest
23
Tel.: +36 1 457 9921
E-mail:
uk_medinfo@allergan.com
Česká republika
NEOMED s.r.o.
Sodomkova 1474/6, Praha 10
CZ-102 00
Tel: +420 274 008 411
E-mail: uk_medinfo@allergan.com
Malta
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
United Kingdom/Renju Unit
Tel: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
Danmark
Allergan Norden AB
Johanneslundsvägen 3-5
S-194 81 Upplands Väsby
Sverige
Tlf: + 46 (0)8 594 100 00
E-mail: uk_medinfo@allergan.com
Nederland
Allergan n.v.
Terhulpsesteenweg 6D
B-1560 Hoeilaart
België
Tel: + 32 (0)2 351 24 24
E-mail: uk_medinfo@allergan.com
Deutschland
Pharm-Allergan GmbH
Pforzheimer Straße 160
D-76275 Ettlingen
Tel: + 49 (0)7243 501 0
E-mail: uk_medinfo@allergan.com
Norge
Allergan Norden AB
Johanneslundsvägen 3-5
S-194 81 Upplands Väsby
Sverige
Tlf: + 46 (0)8 594 100 00
E-mail: uk_medinfo@allergan.com
Eesti
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
Ühendkuningriik
Tel: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
Österreich
Pharm-Allergan GmbH
Pforzheimer Straße 160
D-76275 Ettlingen
Deutschland
Tel: + 49 (0)7243 501 0
E-mail: uk_medinfo@allergan.com
Ελλάδα
Nexus Medicals S.A.
Λεωφ. Μαρκοπούλου - Σουνίου
Θέση Βγέντζι
GR-190 03 Μαρκόπουλο Μεσογαίας - Αττική
Tηλ: +30 22990.41350
E-mail: uk_medinfo@allergan.com
Polska
Ewopharma AG Sp z o.o.
ul.Świętokrzyska 36/16
PL-00 116 Warszawa
Tel.: +48 22 620 11 71
E-mail: uk_medinfo@allergan.com
24
España
Allergan S.A.U
Edificio la Encina
Plaza de la Encina, 10-11
E-28760 Tres Cantos
Madrid
Tel: + 34 91 807 6130
E-mail: uk_medinfo@allergan.com
Portugal
Profarin Lda.
Rua da Quinta dos Grilos, 30
P-2790-476 Carnaxide
Tel: + 351 21 425 3242
E-mail: uk_medinfo@allergan.com
France
Allergan France S.A.S
Bâtiment A
4, place de la Défense
F-92400 Courbevoie
Tél: + 33 (0)1 49 07 83 00
E-mail: uk_medinfo@allergan.com
România
Ewopharma AG România
B-dul Primăverii, nr. 19-21,
Bucureşti 011372-RO
Tel.: +40 21 260 13 44
E-mail: uk_medinfo@allergan.com
Ireland
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
United Kingdom
Tel: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
Slovenija
Ewopharma d.o.o.
Cesta 24. junija 23
SI-1231 Ljubljana – Črnuče
Tel: + 386 (0) 590 848 40
E-mail: uk_medinfo@allergan.com
Ísland
Vistor hf.
Hörgatún 2
IS-212 Garðabær
Sími: + 354 535 7000
Netfang: uk_medinfo@allergan.com
Slovenská republika
NEOMED,s.r.o., pobočka Bratislava
Šťastná 11
SK-821 05 Bratislava
Tel: +421 2 434 150 12
E-mail: uk_medinfo@allergan.com
Italia
Allergan S.p.A
Via S.Quasimodo 134/138
I-00144 Roma
Tel: + 39 06 509 561
E-mail: uk_medinfo@allergan.com
Suomi/Finland
Allergan Norden AB
Johanneslundsvägen 3-5
S-194 81 Upplands Väsby
Ruotsi/Sverige
Puh/Tel: + 46 (0)8 594 100 00
E-mail: uk_medinfo@allergan.com
Κύπρος
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
Ηνωμένο Βασίλειο
Τηλ: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
Sverige
Allergan Norden AB
Johanneslundsvägen 3-5
S-194 81 Upplands Väsby
Tel: +46 (0)8 594 100 00
E-mail: uk_medinfo@allergan.com
25
Latvija
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
Lielbritānija
Tel: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
United Kingdom
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
Tel: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
Lietuva
Allergan Ltd
1
st
Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
Jungtinė Karalystė
Tel: + 44 (0) 1628 494026
E-mail: uk_medinfo@allergan.com
This leaflet was last approved in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
site:
http://www.emea.europa.eu/
.
26
Source: European Medicines Agency
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