ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
AZOPT 10 mg/ml eye drops, suspension
2.
Each ml of suspension contains 10 mg brinzolamide.
Excipients:
Each ml of suspension contains 0.15 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3.
Eye drops, suspension.
White to off-white suspension.
4.
4.1
AZOPT is indicated to decrease elevated intraocular pressure in:
• ocular hypertension
• open-angle glaucoma
as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers
are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues (see also
section 5.1).
4.2
Posology
When used as monotherapy or adjunctive therapy, the dose is one drop of AZOPT in the conjunctival sac
of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a
day.
When substituting another ophthalmic antiglaucoma agent with AZOPT, discontinue the other agent and
start the following day with AZOPT.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered
at least 5 minutes apart.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not
exceed one drop in the affected eye(s) three times daily.
Method of administration
For ocular use.
2
Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended. This may reduce the
systemic absorption of medicinal products administered via the ocular route and result in a decrease in
systemic side effects.
Instruct the patient to shake the bottle well before use. To prevent contamination of the dropper tip and
suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the
dropper tip of the bottle. Instruct patients to keep the bottle tightly closed when not in use.
Elderly population
No dose adjustment in elderly patients is necessary.
Paediatric population
The efficacy and safety of AZOPT in patients below the age of 18 have not been established and its use is
not recommended in these patients. However, there is limited experience in children. The safety and
efficacy of AZOPT have been studied in a small number of paediatric patients less than 6 years of age (see
also section 4.4, 4.8 and 5.1).
Hepatic and renal impairment
AZOPT has not been studied in patients with hepatic impairment and is therefore not recommended in
such patients.
AZOPT has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min)
or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted
predominantly by the kidney, AZOPT is therefore contra-indicated in such patients (see also section 4.3).
4.3
Contra-indications
•
Hypersensitivity to the active substance or any of the excipients.
•
Known hypersensitivity to sulphonamides (see also section 4.4).
•
Hyperchloraemic acidosis.
4.4
Systemic effects
AZOPT is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is
absorbed systemically. The same types of adverse reactions that are attributable to sulphonamides may
occur with topical administration. If signs of serious reactions or hypersensitivity occur, discontinue the
use of this preparation.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. Brinzolamide has not
been studied in pre-term infants (less than 36 weeks gestational age) or those less than 1 week of age.
Patients with significant renal tubular immaturity or abnormalities should only receive brinzolamide after
careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.
Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness
and/or physical coordination in elderly patients. AZOPT is absorbed systemically and therefore this may
occur with topical administration.
3
•
Severe renal impairment.
Concomitant therapy
There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition
in patients receiving an oral carbonic anhydrase inhibitor and AZOPT. The concomitant administration of
AZOPT and oral carbonic anhydrase inhibitors has not been studied and is not recommended (see also
section 4.5).
AZOPT was primarily evaluated in concomitant administration with timolol during adjunctive glaucoma
therapy. Additionally the IOP-reducing effect of AZOPT as adjunctive therapy to the prostaglandin
analogue travoprost has been studied. No long term data are available on the use of AZOPT as adjunctive
therapy to travoprost(see also section 5.1).
There is limited experience with AZOPT in the treatment of patients with pseudoexfoliative glaucoma or
pigmentary glaucoma. Caution should be used in treating these patients and close monitoring of
intraocular pressure (IOP) is recommended. AZOPT has not been studied in patients with narrow-angle
glaucoma and its use is not recommended in these patients.
The possible role of brinzolamide on corneal endothelial function has not been investigated in patients
with compromised corneas (particularly in patients with low endothelial cell count). Specifically, patients
wearing contact lenses have not been studied and careful monitoring of these patients when using
brinzolamide is recommended, since carbonic anhydrase inhibitors may affect corneal hydration and
wearing contact lenses might increase the risk for the cornea. Likewise, in other cases of compromised
corneas such as patients with diabetes mellitus, careful monitoring is recommended.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been
reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since AZOPT contains
benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or
in conditions where the cornea is compromised.
AZOPT has not been studied in patients wearing contact lenses. AZOPT contains benzalkonium
chloridewhich may cause eye irritation and is known to discolour soft contact lenses. Contact with soft
contact lenses is to be avoided. Patients must be instructed to remove contact lenses prior to the
application of AZOPT and wait 15 minutes after instillation of the dose before reinsertion.
Potential rebound effects following cessation of treatment with AZOPT have not been studied; the
IOP-lowering effect is expected to last for 5-7 days.
4.5
Specific interaction studies with other medicinal products have not been performed with AZOPT. In
clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic
preparations without evidence of adverse interactions. Association between AZOPT and miotics or
adrenergic agonists has not been evaluated during adjunctive glaucoma therapy.
AZOPT is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors. The potential for
interactions must be considered in patients receiving AZOPT.
The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main),
CYP2A6, CYP2C8 and CYP2C9. It is expected that inhibitors of CYP3A4 such as ketoconazole,
itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by
CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly. However, accumulation of
brinzolamide is unlikely as renal elimination is the major route. Brinzolamide is not an inhibitor of
cytochrome P-450 isozymes.
4
4.6
Pregnancy
There are no or limited amount of data from the use of brinzolamide in pregnant women. Studies in
animals have shown reproductive toxicity (see also section 5.3). AZOPT is not recommended during
pregnancy and in women of childbearing potential not using contraception.
Lactation
It is not known whether brinzolamide/metabolites are excreted in human milk. Animal studies have
shown the excretion of brinzolamide in breast milk. Brinzolamide should only be used during
breast-feeding when the benefit of breast-feeding for the child and the benefit of therapy for the woman
outweigh the possible risks.
4.7
Temporary blurred vision or other visual disturbances, may affect the ability to drive or use machines (see
also section 4.8). If blurred vision occurs at instillation, the patient must wait until the vision clears before
driving or using machines.
Oral carbonic anhydrase inhibitors may impair the ability of elderly patients to perform tasks requiring
mental alertness and/or physical coordination (see also section 4.4).
4.8
In clinical studies involving over 1800 patients treated with AZOPT as monotherapy or adjunctive therapy
to timolol maleate 5 mg/ml, the most frequently reported treatment-related adverse reactions were:
dysgeusia (5.8%) (bitter or unusual taste, see description below) and temporary blurred vision (5.8%)
upon instillation, lasting from a few seconds to a few minutes (see also section 4.7).
The following adverse reactions were assessed to be treatment-related and are classified according to the
following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon
(≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be
estimated from the available data). Within each frequency grouping, adverse reactions are presented in
order of decreasing seriousness. The adverse reactions were obtained from clinical trials and
postmarketing spontaneous reports.
System Organ Classification
MedDRA Preferred Term
Infections and infestations
Uncommon
: nasopharyngitis, pharyngitis, sinusitis
Not Known
: rhinitis
Blood and lymphatic system disorders
Uncommon
: red blood cell count decreased, blood chloride increased
Immune system disorders
Not Known
: hypersensitivity
Psychiatric disorders
Uncommon
: apathy, depression, depressed mood, libido decreased,
nightmare, insomnia, nervousness
Nervous system disorders
Common
: dysgeusia, headache
Uncommon
: somnolence, motor dysfunction, amnesia, memory
impairment, dizziness, paraesthesia
Not Known
: tremor, hypoaesthesia, ageusia
5
Eye disorders
Common
: blepharitis, blurred vision, eye irritation, eye pain, dry eye,
eye discharge, eye pruritus, foreign body sensation in eyes, ocular
hyperaemia
Uncommon
: corneal erosion, keratitis, punctate keratitis, keratopathy,
deposit eye, corneal staining, corneal epithelium defect, corneal
epithelium disorder, intraocular pressure increased, optic nerve cup/disc
ratio increased, corneal oedema, conjunctivitis, eye swwelling,
meibomianitis, diplopia, glare, photophobia, photopsia, visual acuity
reduced, allergic conjunctivitis, pterygium, scleral pigmentation,
asthenopia, ocular discomfort, abnormal sensation in eye,
keratoconjunctivitis sicca, hypoaesthesia eye, subconjunctival cyst,
conjunctival hyperaemia, eyelids pruritus, eyelid margin crusting,
eyelid oedema, lacrimation increased
Not Known
: corneal disorder, visual disturbance, eye allergy,
madarosis, eyelid disorder, erythema of eyelid
Ear and labyrinth disorders
Uncommon
: tinnitus
Not Known
: vertigo
Cardiac disorders
Uncommon
: cardio-respiratory distress, angina pectoris, bradycardia,
palpitations heart rate irregular
Not Known
: arrhythmia, tachycardia, hypertension, blood pressure
increased, heart rate increased
Respiratory, thoracic and mediastinal
disorders
Uncommon
: dyspnoea, bronchial hyperactivity, cough, epistaxis,
pharyngolaryngeal pain, throat irritation, nasal congestion, upper
respiratory tract congestion, postnasal drip, rhinorrhoea, sneezing, nasal
dryness
Not Known
: asthma
Gastrointestinal disorders
Common
: dry mouth
Uncommon
: oesophagitis, diarrhoea, nausea, vomiting, dyspepsia,
upper abdominal pain, abdominal discomfort, stomach discomfort,
flatulence, frequent bowel movements, gastrointestinal disorder,
hypoaesthesia oral, paraesthesia oral
Hepatobiliary disorders
Not Known
: liver function test abnormal
Skin and subcutaneous tissue disorders
Uncommon
: urticaria, rash, rash maculo-papular, pruritus generalized,
alopecia, skin tightness
Not Known
: dermatitis, erythema
Musculoskeletal and connective tissue
disorders
Uncommon
: back pain, muscle spasms, myalgia
Not Known
: arthralgia, pain in extremity
Uncommon
: renal pain
Not Known
: pollakiuria
Reproductive system and breast disorders
Uncommon
: erectile dysfunction
General disorders and administration site
conditions
Uncommon
: pain, chest discomfort, asthenia, fatigue, feeling abnormal,
feeling jittery, irritability
Not Known
: chest pain, peripheral oedema, malaise, medication residue
Injury, poisoning and procedural
complications
Uncommon
: foreign body in eye
In small short-term clinical trials, approximately 12.5% of paediatric patients were observed to experience
adverse reactions, the majority of which were local, non-serious ocular reactionssuch as conjunctival
hyperaemia, eye irritation, eye discharge, and lacrimation increased (see also section 5.1).
Dysgeusia (bitter or unusual taste in the mouth following instillation) was the most frequently reported
systemic adverse reaction associated with the use of AZOPT during clinical studies. It is likely caused by
passage of the eye drops in the nasopharynx via the nasolacrimal canal. Nasolacrimal occlusion or gently
closing the eyelid after instillation may help reduce the incidence of this effect (see also section 4.2).
6
Renal and urinary disorders
AZOPT is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption. Gastrointestinal,
nervous system, haematological, renal and metabolic effects are generally associated with systemic
carbonic anhydrase inhibitors. The same type of adverse reactions that are attributable to oral carbonic
anhydrase inhibitors may occur with topical administration.
No unexpected adverse reactions have been observed with AZOPT when used as adjunctive therapy to
travoprost. The adverse reactions seen with the adjunctive therapy have been observed with each active
substance alone.
4.9
No case of overdose has been reported.
Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state,
and possible nervous system effects may occur. Serum electrolyte levels (particularly potassium) and
blood pH levels must be monitored.
5.
5.1
Pharmacodynamic properties
Pharmacotherapeutic Group:Antiglaucoma preparations and miotics, carbonic anhydrase inhibitors, ATC
code: S01EC04
Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. Carbonic
anhydrase catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration
of carbonic acid.
Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion,
presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid
transport. The result is a reduction in intraocular pressure (IOP) which is a major risk factor in the
pathogenesis of optic nerve damage and glaucomatous visual field loss. Brinzolamide, an inhibitor of
carbonic anhydrase II (CA-II), the predominant iso-enzyme in the eye, with an
in vitro
IC
50
of 3.2 nM and
a K
i
of 0.13 nM against CA-II.
The IOP-reducing effect of AZOPT as adjunctive therapy to the prostaglandin analogue travoprost was
studied. Following a 4 week run-in with travoprost, patients with an IOP ≥19 mmHg were randomized to
receive added treatment with brinzolamide or timolol. An additional decrease in mean diurnal IOP of
3.2 to 3.4 mmHg for the brinzolamide group and 3.2 to 4.2 mmHg for the timolol group were observed.
There was an overall higher incidence of non-serious ocular adverse reactions, mainly related to signs of
local irritation, in the brinzolamide/travoprost groups. The events were mild and did not affect the overall
discontinuation rates in the studies (see also section 4.8).
A clinical trial was conducted with AZOPT in 32 paediatric patients less than 6 years of age, diagnosed
with glaucoma or ocular hypertension. Some patients were naive to IOP therapy whilst others were on
other IOP-lowering medicinal product(s). Those who had been on previous IOP medicinal product(s) were
not required to discontinue their IOP medicinal product(s) until initiation of monotherapy with AZOPT.
7
Among patients who were naive to IOP therapy (10 patients), the efficacy of AZOPT was similar to that
seen previously in adults, with mean IOP reductions from baseline ranging up to 5 mmHg. Among
patients who were on topical IOP-lowering medicinal product(s) (22 patients), mean IOP increased
slightly from baseline in the AZOPT group.
5.2
Pharmacokinetic properties
Following topical ocular administration, brinzolamide is absorbed into the systemic circulation. Due to its
high affinity for CA-II, brinzolamide distributes extensively into the red blood cells (RBCs) and exhibits a
long half-life in whole blood (mean of approximately 24 weeks). In humans, the metabolite
N-desethylbrinzolamide is formed, which also binds to CA and accumulates in RBCs. This metabolite
binds mainly to CA-I in the presence of brinzolamide. In plasma, both brinzolamide and
N-desethylbrinzolamide concentrations are low and generally below assay quantitation limits
(<7.5 ng/ml).
Binding to plasma proteins is not extensive (about 60%). Brinzolamide is eliminated primarily by renal
excretion (approximately 60%). About 20% of the dose has been accounted for in urine as metabolite.
Brinzolamide and N-desethylbrinzolamide are the predominant components in the urine along with trace
levels (<1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
In an oral pharmacokinetic study, healthy volunteers received 1 mg capsules of brinzolamide twice daily
for up to 32 weeks and RBC CA activity was measured to assess the degree of systemic CA inhibition.
Brinzolamide saturation of RBC CA-II was achieved within 4 weeks (RBC concentrations of
approximately 20 µM). N-Desethylbrinzolamide accumulated in RBCs to steady state within 20-28 weeks
reaching concentrations ranging from 6-30 µM. The inhibition of total RBC CA activity at steady state
was approximately 70-75%.
Subjects with moderate renal impairment (creatinine clearance of 30-60 ml/minute) were administered
1 mg of brinzolamide twice daily orally for up to 54 weeks. Brinzolamide RBC concentration ranged from
about 20 to 40 µM by week 4 of treatment. At steady-state, brinzolamide and its metabolite RBC
concentrations ranged from 22.0 to 46.1 and 17.1 to 88.6 µM, respectively.
N-desethylbrinzolamide RBC concentrations increased and total RBC CA activity decreased with
decreasing creatinine clearance but brinzolamide RBC concentrations and CA-II activity remained
unchanged. In subjects with the highest degree of renal impairment inhibition of total CA activity was
greater although it was inferior to 90% at steady-state.
In a topical ocular study, at steady-state, brinzolamide RBC concentrations were similar to those found in
the oral study, but levels of N-desethylbrinzolamide were lower. Carbonic anhydrase activity was
approximately 40-70% of predose levels.
5.3
Preclinical safety data
Non-clinical data reveal no special hazard for humans with brinzolamide based on conventional studies of
safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
8
Developmental toxicity studies in rabbits with oral doses of brinzolamide of up to 6 mg/kg/day (125 times
the recommended human ophthalmic dose) revealed no effect on foetal development despite significant
maternal toxicity. Similar studies in rats resulted in slightly reduced ossification of skull and sternebrae of
foetuses of dams receiving brinzolamide at doses of 18 mg/kg/day (375 times the recommended human
ophthalmic dose), but not 6 mg/kg/day. These findings occurred at doses that caused metabolic acidosis
with decreased body weight gain in dams and decreased foetal weights. Dose-related decreases in foetal
weights were observed in pups of dams receiving brinzolamide orally ranging from a slight decrease
(about 5-6%) at 2 mg/kg/day to nearly 14% at 18 mg/kg/day. During lactation, the no adverse effect level
in the offspring was 5 mg/kg/day.
6.
6.1
List of excipients
Benzalkonium chloride,
mannitol (E421),
carbomer 974P,
tyloxapol,
edetate disodium,
sodium chloride,
hydrochloric acid/sodium hydroxide (to adjust pH)
purified water.
6.2
Incompatibilities
Not applicable.
6.3
Shelf-life
2 years.
4 weeks after first opening.
6.4
Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5
Nature and contents of container
5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer).
The following pack sizes are available: outer cartons containing 1 x 5 ml, 3 x 5 ml and 1 x 10 ml bottles.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal
No special requirements.
9
7.
Alcon Laboratories (UK) Ltd.
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom.
8.
EU/1/00/129/001-3
9.
Date of first authorisation: 9 March 2000
Date of last renewal: 9 March 2005
10.
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu
10
ANNEX II
A
MANUFACTURING AUTHORISATION HOLDERS
RESPONSIBLE FOR BATCH RELEASE
B
CONDITIONS OF THE MARKETING AUTHORISATION
11
A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
S.A. Alcon-Couvreur N.V.,
Rijksweg 14,
B-2870 Puurs,
Belgium.
or
Alcon Cusí, S.A.,
Camil Fabra 58,
08320 El Masnou,
Barcelona,
Spain.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer
responsible for the release of the concerned batch.
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
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 presented in
Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is
on the market.
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the
Pharmacovigilance Plan, as agreed in version 01 of the Risk Management Plan (RMP) presented in
Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the
CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any
updated RMP should be submitted at the same time as the following Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted
12
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
•
At the request of the EMEA
13
ANNEX III
LABELLING AND PACKAGE LEAFLET
14
A. LABELLING
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR SINGLE BOTTLE, 5 ml, 10 ml + CARTON FOR 3 x 5 ml BOTTLES
1.
AZOPT 10 mg/ml eye drops, suspension
Brinzolamide
2.
STATEMENT OF ACTIVE SUBSTANCE
Each ml of suspension contains 10 mg of brinzolamide
3.
LIST OF EXCIPIENTS
Contains benzalkonium chloride, mannitol (E421), carbomer 974P, tyloxapol, edetate disodium, sodium
chloride, hydrochloric acid/sodium hydroxide (to adjust pH) and purified water. See the package leaflet
for further information.
4.
Eye drops, suspension;
5 ml
10 ml
3 x 5ml
5.
METHOD AND ROUTE OF ADMINISTRATION
Ocular use.
Read the package leaflet before use.
Shake well 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
16
8.
EXPIRY DATE
EXP:
Discard four weeks after first opening.
Opened:
Opened (1):
Opened (2):
Opened (3):
9.
SPECIAL STORAGE CONDITIONS
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
Alcon Laboratories (UK) Ltd.
Pentagon Park
Boundary Way
Hemel Hempstead
Herts, HP2 7UD
United Kingdom.
12.
EU/1/00/129/001 1 x 5 ml
EU/1/00/129/002 1 x 10 ml
EU/1/00/129/003 3 x 5 ml
13.
BATCH NUMBER
Lot.:
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
17
16
INFORMATION IN BRAILLE
azopt
18
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
BOTTLE LABEL, 5 ml & 10 ml
1.
AZOPT 10 mg/ml eye drops, suspension.
Brinzolamide
Ocular use.
2.
METHOD
OF ADMINISTRATION
Read the package leaflet before use.
Discard 4 weeks after first opening.
Opened:
3.
EXPIRY DATE
EXP:
4.
BATCH NUMBER
Lot.:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
5 ml
10 ml
6
OTHER
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZOPT 10 mg/ml eye drops, suspension
Brinzolamide
Read all of this leaflet carefully
before you start using this medicine.
- Keep this leaflet.
You may need to read it again.
-
If you have any further questions after reading it, please ask your doctor or your 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 gets serious, or if you notice any
side effects not listed in this leaflet, please tell you doctor or pharmacist.
In this leaflet
1.
What AZOPT is and what it is used for
2.
Before you use AZOPT
4.
Possible side effects
5.
How to Store AZOPT
6.
Further information
1.
WHAT AZOPT IS AND WHAT IT IS USED FOR
AZOPT contains brinzolamide which belongs to a group of medicines
called carbonic anhydrase
inhibitors. It reduces pressure within the eye.
AZOPT eye drops are used to treat high pressure in the eye.
This pressure can lead to an illness called
glaucoma.
If the pressure in the eye is too high, it can damage your sight.
2.
BEFORE YOU USE AZOPT
Do not use AZOPT
- if you have severe kidney problems.
- if you are allergic
to any of the ingredients of AZOPT. For a full list of ingredients please see section
6.
- if you are allergic to medicines called sulphonamides.
EXAMPLES include medicines used to treat
diabetes and infections and also diuretics (water tablets). AZOPT may cause the same allergy.
- if you have too much acidity in your blood
(a condition called hyperchloraemic acidosis).
If you have further questions, ask your doctor for advice.
Take special care with AZOPT
Talk to your doctor
- if you have liver problems.
- if you have dry eyes or cornea problems.
21
3.
How to use AZOPT
-
if you are taking other sulphonamide medicines
AZOPT is not to be used by people under 18 of years of age unless advised by your doctor.
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 are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see
section 1 WHAT AZOPT IS AND WHAT IT IS USED FOR), talk to your doctor.
Pregnancy and breast-feeding
You should not use AZOPT if you are pregnant, or might get pregnant.
Talk to your doctor before
you use AZOPT.
If you are breast-feeding,
ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving or using machines
Do not drive or use machines
until your vision is clear. You may find that your vision is blurred for a
time just after using AZOPT.
AZOPT may impair the ability of elderly patients to perform tasks requiring mental alertness and/or
physical coordination. If affected, take care when driving or using machines.
Important information about some of the ingredients of AZOPT
If you wear soft contact lenses.
.
AZOPT contains benzalkonium chloride which may cause eye
irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided.
Remove contact lenses prior to the application of AZOPT and wait at least 15 minutes after instillation of
the dose before reinsertion.
3.
HOW TO USE AZOPT
Always use AZOPT exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is 1 drop in the affected eye or eyes, twice a day
-morning and night.
Use this much unless your doctor told you to do something different. Only use AZOPT in both eyes if
your doctor told you to. Take it for as long as your doctor told you to.
Only
use AZOPT for dropping in your eyes.
Turn the page for more advice.
Now turn over.
22
3.
HOW TO USE AZOPT (
continued)
1
2
3
How much to use
see side 1
•
Get the AZOPT bottle and a mirror
•
Wash your hands
•
Shake the bottle and twist off the cap
•
Hold the bottle, pointing down, between your thumb and middle finger
•
Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between
the eyelid and your eye. The drop will go in here (picture 1)
•
Bring the bottle tip close to the eye. Use the mirror if it helps
•
Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
It
could infect the drops
•
Gently press on the base of the bottle to release one drop of AZOPT at a time.
•
Do not squeeze the bottle:
it is designed so that a gentle press on the bottom is all that it needs
(picture 2)
•
After using AZOPT, press a finger to the corner of your eye, by the nose (picture 3). This helps to
stop AZOPT getting into the rest of the body.
•
If you take drops in both eyes, repeat the steps for your other eye.
•
Put the bottle cap back on firmly immediately after use
•
Use up one bottle before opening the next bottle.
If a drop misses your eye
, try again.
If you get too much in your eyes,
rinse it all out with warm water. Do not put in any more drops until
it’s time for your next regular dose.
If you forget to use AZOPT,
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.
If you stop using AZOPT without speaking to your doctor, the pressure in your eye will not be controlled
which could lead to loss of sight.
If you are using other eye drops,
leave at least 5 minutes between putting in AZOPT and the other drops.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, AZOPT can cause side effects, although not everyone gets them.
You can usually carry on taking the drops, unless the effects are serious.
Common side effects
(Affects 1 to 10 users in 100)
23
Effects in the eye
: blurred vision, eye irritation, eye pain, eye discharge, itchy eye, dry eye, abnormal eye
sensation, redness of the eye, eyelid itching, redness, or swelling.
General side effects
: bad taste, headache, dry mouth.
Uncommon side effects
(Affects 1 to 10 users in 1,000)
Effects in the eye
: increased pressure in eye, damage to the optic nerve, abnormal, double, or reduced
vision, sensitivity to light, inflammation or infection of the conjunctiva, eye allergy, eye swelling, corneal
disorder, inflammation of the eyelid glands, decreased eye sensation, growth on surface of eye, increased
pigmentation of the eye, tired eyes, eyelid crusting, or increased tear production.
General side effects
: decreased or irregular heart rate, reduced heart function, palpitations, chest pain,
asthma, difficulty breathing, shortness of breath, decreased red blood cell count in blood, increased
chlorine level in blood, dizziness, drowsiness, difficulty with memory, depression, difficulty sleeping,
nervousness, irritability, fatigue, generalized weakness, feeling abnormal, pain, shaking, ringing in ears,
decreased sex drive, male sexual difficulty, cold symptoms, chest congestion, cough, sinus infection,
throat irritation, abnormal or decreased sensation in mouth, inflammation of the lining of the oesophagus,
abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhoea, intestinal gas,
digestive disorder, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, dry nose, runny nose,
stuffy nose, sneezing, rash, abnormal skin sensation, itching, loss of hair.
Additional side effects that have been reported include:
Effects in the eye:
eyelid abnormality, decreased growth or number of eyelashes.
General side effects
: increased allergic symptoms, increased blood pressure, increased heart rate,
abnormal liver blood tests, , frequent urination, swelling of the extremities, decreased sensation, decreased
taste sensation, joint pain, pain in extremity, skin redness, inflammation, or itching.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5.
HOW TO STORE AZOPT
Keep out of the reach and sight of children.
Do not use AZOPT after the expiry date which is stated on the bottle and box after “EXP”. The expiry
date refers to the last day of the month.
This medicine does not require any special storage conditions.
You must throw away a bottle four weeks after you first opened it,
to prevent infections. Write down
the date you opened each bottle in the space below and in the space on the bottle label and box. For a
pack containing a single bottle, write only one date.
Opened (1):
Opened (2):
Opened (3):
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 protect the environment.
24
6
FURTHER INFORMATION
What AZOPT contains
The active substance
is brinzolamide 10 mg/ml.
The other ingredients are:
benzalkonium chloride, carbomer 974P, edetate disodium, mannitol (E421),
purified water, sodium chloride, tyloxapol. Tiny amounts of hydrochloric acid or sodium hydroxide are
added to keep acidity levels (pH levels) normal.
What AZOPT looks like and the contents of the pack
AZOPT is a milky liquid (a suspension) supplied in a pack containing a 5 ml or a 10 ml plastic
(droptainer) bottle with a screw cap, or in a pack containing three 5 ml plastic (droptainer) bottles with
screw caps. Not all pack sizes may be marketed.
The marketing authorisation
Manufacturer
Manufacturer
holder
Alcon Laboratories (UK) Ltd.,
S.A. Alcon - Couvreur N.V.,
Alcon Cusí, S.A.,
Pentagon Park
Rijksweg 14,
Camil Fabra 58,
Boundary Way,
B-2870 Puurs,
08320 El Masnou,
Hemel Hempstead,
Belgium
Spain
Herts., HP2 7UD,
United Kingdom.
25
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
België/Belgique/Belgien
Luxembourg/Luxemburg
SA Alcon-Couvreur NV
+ 32 (0)3 890 27 11 (België/Belgique/Belgien)
Lietuva
Alcon Pharmaceuticals Ltd. atstovybė
+ 370 5 2 314 756
България
Алкон България ЕООД
+ 359 2 950 15 65
Magyarország
Alcon Hungária Gyógyszerkereskedelmi Kft.
+ 36-1-463-9080
Česká republika
Alcon Pharmaceuticals (Czech Republic) s.r.o
.
+ 420 225 377 333
Nederland
Alcon Nederland BV
+ 31 (0) 183 654321
Danmark
Alcon Danmark A/S
+ 45 3636 3434
Norge
Alcon Norge AS
+ 47 23 25 25 50
Deutschland
Alcon Pharma GmbH
+ 49 (0)761 1304-0
Österreich
Alcon Ophthalmika GmbH
+ 43 (0)1 596 69 70
Ελλάδα
Κύπρος
Άλκον Λαμποράτορις Ελλάς ΑΕΒΕ
+ 30 210 68 78 300 (Ελλάδα)
Polska
Alcon Polska Sp. z o.o.
+ 48 22 820 3450
Eesti
Alcon Eesti
+ 372 6 313 214
Portugal
Alcon Portugal-Produtos e Equipamentos
Oftalmológicos, Lda.
+ 351 214 400 300
España
Alcon Cusí, S.A.
+ 34 93 497 7000
România
S.C. Alcon Romania S.R.L
: + 40 21 203 93 24
France
Laboratoires Alcon
+ 33 (0)1 47 10 47 10
Slovenija
Alcon d.o.o
+ 386 1 422 5280
Ireland
Malta
United Kingdom
Alcon Laboratories (UK) Ltd.
+ 44 (0) 1442 34 1234 (United Kingdom)
Slovenská republika
Alcon Pharmaceuticals Ltd – oz
+ 421 2 5441 0378
Ísland
Alcon Danmark A/S
+ 45 3636 3434
Suomi/Finland
Alcon Finland Oy
+358 207 871 600
26
Italia
Alcon Italia S.p.A.
+ 39 02 81803.1
Sverige
Alcon Sverige AB
+ 46 (0)8 634 40 00
E-post: receptionen@alconlabs.com
Latvija
Alcon Pharmaceuticals Ltd
+ 371 7 321 121
This leaflet was last approved on
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu
27
Source: European Medicines Agency
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