Download INFORMATION FOR THE USER Brimonidine tartrate 2 mg/ml eye

1.3.1. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Brimonidine tartrate 2 mg/ml eye drops, solution
Active substance: brimonidine tartrate
Read all of this leaflet carefully before you start using this medicine.
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Keep this leaflet. You may need to read it again.
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If you have further questions, please ask your doctor or your pharmacist.
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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.
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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.
In this leaflet:
1.
2.
3.
4.
5.
6.
1.
What Brimonidine tartrate 2 mg/ml eye drops, solution is and what it is used for
Before you use Brimonidine tartrate 2 mg/ml eye drops, solution
How to use Brimonidine tartrate 2 mg/ml eye drops, solution
Possible side effects
How to store Brimonidine tartrate 2 mg/ml eye drops, solution
Further information
WHAT BRIMONIDINE TARTRATE 2 MG/ML EYE DROPS SOLUTION IS AND
WHAT IT IS USED FOR
Brimonidine tartrate 2 mg/ml eye drops, solution is a medicine for reducing intra-ocular
pressure (pressure within the eye) in patients with open-angle glaucoma or ocular hypertension (high fluid pressure in the eye).
Brimonidine tartrate 2 mg/ml eye drops solution may be used alone or in combination
with other medicines to reduce intra-ocular pressure.
2.
BEFORE YOU
SOLUTION
USE
BRIMONIDINE
TARTRATE
2
MG/ML
EYE
DROPS
Do not use Brimonidine tartrate 2 mg/ml eye drops, solution:
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If you are allergic (hypersensitive) to brimonidine tartrate or to any of the ingredients
of Brimonidine tartrate 2 mg/ml eye drops, solution,
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If you are being treated with a medicine classified as a monoamine oxidase inhibitor
(MAO inhibitor),
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If you are being treated with certain antidepressant medicines (such as tricyclic ant idepressants or mianserin).
You must inform your doctor if you are taking any anti-depressant medicines.
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In the case of newborn babies and infants (from birth until 2 years). .
Take special care with Brimonidine tartrate 2 mg/ml eye drops, solution:
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If you suffer from severe or unstable and untreated heart disease,
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If you suffer from depression,
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If you suffer from a disorder of reduced blood supply to the brain (cerebral insuf ficiency) or to the heart (heart failure),
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If you suffer from a fall in blood pressure which causes vertigo and dizziness when
you sit up or stand up after lying down (orthostatic hypotension),
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If you suffer from a constriction of the blood vessels, principally of the hands and
arms (Raynaud’s disease), or a chronic inflammatory vascular disease with an o bstruction of the blood vessels as a result of clotting (thrombangiitis obliterans),
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If you have liver or kidney problems.
Consult your doctor if any of these circumstances apply to you!
Brimonidine is not recommended for use in children (from 2 – 12 years).
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.
Substances that affect the central nervous system (CNS): the effect of substances
that affect the central nervous system (CNS) (alcohol, barbiturates, opiates, sedatives or
anaesthetics) may be increased by Brimonidine tartrate 2 mg/ml eye drops, solution.
Medicines that treat disorder of the nervous system (chlorpromazine,
methylphenidate), antihypertensive medication (reserpine): caution is recommended in the case of patients treated with medicines that can affect the absorption and
metabolism of adrenaline, noradrenaline and other so-called biogenic amines in the blood.
Antihypertensive agents, heart drugs: a slight fall in blood pressure is detected in
some patients after administration of Brimonidine tartrate 2 mg/ml eye drops, solution.
Caution should be exercised if Brimonidine tartrate 2 mg/ml eye drops, solution is used
at the same time as antihypertensive agents and/or heart drugs from the group of dig italis glycosides.
Adrenoreceptor agonists or antagonists: Caution should be exercised when a systemically administered medicine is first given at the same time, or there is a change in the dose
(regardless of the method of administration) which may cause interactions with adrenoreceptor agonists or can affect their action, such as adrenoreceptor agonists or
antagonists (isoprenaline or prazosin) for example.
Pregnancy and breast-feeding
Studies have not yet been conducted to determine whether it is safe to use Brimonidine
tartrate 2 mg/ml eye drops, solution during pregnancy. Brimonidine tartrate 2 mg/ml eye
drops, solution should therefore be used with caution during pregnancy, and only if the
expected benefit to the mother outweighs the possible risk to the foetus.
It is not known whether brimonidine passes into human breast milk. Brimonidine tartrate
2 mg/ml eye drops, solution should therefore not be used in breast -feeding mothers.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Brimonidine tartrate 2 mg/ml eye drops, solution can cause tiredness and / or drowsiness. This can affect the ability to drive or use machines safely.
Brimonidine tartrate 2 mg/ml eye drops, solution can cause blurred vision and / or abnormal vision. This can affect your ability to drive or use machines safely, particularly in
the dark and under poor lighting conditions.
Wait until these effects have cleared before driving or using machines.
Important information about some of the ingredients of Brimonidine tartrate 2 mg/ml eye
drops, solution
Brimonidine tartrate 2 mg/ml eye drops, solution contains the preservative benzalkonium
chloride which can cause eye irritation. Avoid contact with soft contact lenses. Be nzalkonium chloride can cause discolouration of soft contact lenses. You should remove
contact lenses before using Brimonidine tartrate 2 mg/ml eye drops. Wait at least 15
minutes after using the medicine before putting your lenses back in.
3.
HOW TO USE BRIMONIDINE TARTRATE 2 MG/ML EYE DROPS, SOLUTION
Always use Brimonidine tartrate 2 mg/ml eye drops, solution exactly as your doctor has
told you. You should check with your doctor or pharmacist if you are not sure.
It is very important to use Brimonidine tartrate 2 mg/ml eye drops, solution for the period of time prescribed by your doctor.
If you have the impression that the effect of Brimonidine tartrate 2 mg/ml eye drops,
solution is too strong or too weak, talk to your doctor.
Unless your doctor has instructed otherwise, the usual dose is one drop in the affected
eye/eyes twice daily approximately 12 hours apart.
Instructions for use
Brimonidine is for use as eye drops only. Do not swallow.
Always wash your hands before applying eye drops.
Apply your eye drops in the following way:
1. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Squeeze the upturned dropper bottle to release a drop into your eye.
Immediately after applying each drop, you should close your eye and press your fingertip
against the inside corner of the closed eye (near the nose) for 1 minute. This helps to
reduce the absorption of Brimonidine into your body.
If you are using more than one eye medicine, the products should be applied at an inte rval of at least 5–15 minutes.
Newborn babies and children: Brimonidine eye drops must not be used in new-born babies and infants (from birth until 2 years).
If you use more Brimonidine tartrate 2 mg/ml eye drops, solution than you
should
Side effects as listed in section 4 of the leaflet have been reported fo r adults who have
used more Brimonidine tartrate 2 mg/ml eye drops, solution than recommended.
Low blood pressure was reported for adult s who had accidentally swallowed Brimonidine
tartrate 2 mg/ml eye drops, solution. This was followed by a steep increase in blood
pressure.
Contact your doctor immediately it you have swallowed Brimonidine tartrate 2 mg/ml eye
drops, solution as it may cause low blood pressure, unusual weakness, vomiting, tire dness, reduced consciousness, slow heart rate, changes in heart rate, constriction of the
pupil of the eye, decreased muscle tone, suppression of your breathing, low body te mperature and seizure. Cases of overdose have been reported in children who had acc identally swallowed Brimonidine tartrate 2 mg/ml eye drops, solution. Symptoms include
temporary coma or low level of consciousness, tiredness, sleepiness, floppiness, slow
heart rate, low body temperature, pale skinand breathing difficulties. If any of these o ccur, contact your doctor immed iately.
If you suspect an overdose contact your doctor or a duty doctor. Bring the packaging of
the medicine with you so that the doctor can be aware of the active substance that has
been taken.
If you forget to use Brimonidine tartrate 2 mg/ml eye drops, solution
If you forget to apply Brimonidine tartrate 2 mg/ml eye drops, solution, apply the forgotten dose instead as soon as you realise this. If however you do not remember the forgo tten dose until shortly before the time for the next dose, omit the forgotten dose and co ntinue with the next application at the usual time. Do not use more drops to make up for a
forgotten dose.
If you are in any doubt, ask your doctor or pharmacist.
Do not change the prescribed dose yourself.
If you stop using Brimonidine tartrate 2 mg/ml eye drops, solution
Do not interrupt or stop treatment with Brimonidine tartrate 2 mg/ml eye drops, solution
without having talked to your doctor!
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Brimonidine tartrate 2 mg/ml eye drops, solution can have side effects, although not everybody gets them. 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.
The most commonly occurring side effects (in 22 to 25% of patients) are dry mouth, red
eyes and burning and itchy eyes. These side effects are usually te mporary and rarely
serious enough to require treatment with Brimonidine tartrate 2 mg/ml eye drops, solution to be stopped.
Allergic reactions in the eyes occurred in 12.7% of patients during clinical trials. These
occurred in most cases after three to nine months. In the event of allergic reactions,
treatment with Brimonidine tartrate 2 mg/ml eye drops, solution should be stopped.
An analysis of the side effects was based on the f ollowing incidence rate:
Very common:
affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known
frequency cannot be estimated from the available data
During treatment with Brimonidine tartrate 2 mg/ml eye drops, solution the
following side effects were observed:
Topical side effects:
Very common:
− Eye irritation, including allergic reactions (flushing, pain and burning, itching, the
feeling of a foreign body in the eye, conjunctival follicles), blurred vision.
Common:
− Topical irritation (red and swollen eyelids, inflamed eyelids, conjunctival o edema and
discharge, eye pain and runny eyes), hypersensitivity to light, superficial damage or
colouration of the cornea, dry eyes, conjunctival blisters, abnormal vision, conjunct ivitis.
Very rare:
− Iritis, contraction of the pupils.
Not known :
Inflammation of the eye, itchy eyelid
Systemic side effects:
Very common:
− Headache, dry mouth, tiredness/drowsiness
Common:
− Symptoms in the upper airways, vertigo, gastro-intestinal pain, weakness, altered
taste.
Uncommon:
− Pounding heart beat / irregular heart rate (including slow or fast heart rate), general
allergic reactions, depression, dry nose.
Rare:
− Dyspnoea.
Very rare:
− Fainting, hypertension, hypotension, sleeplessness.
Not known:
- facial swelling, skin redness, itchy skin, rash, low blood pressure
5.
HOW TO
SOLUTION
STORE
BRIMONIDINE
TARTRATE
2
MG/ML
EYE
DROPS,
Keep out of the reach and sight of children.
Do not use Brimonidine tartrate 2 mg/ml eye drops, solution after the expiry date which
is stated on the carton and on the bottle. The expiry date refers to the last day of that
month.
Once opened, Brimonidine tartrate 2 mg/ml eye drops, solution may be stored for a maximum of 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pha rmacist how to dispose of medicines no longer required. These measures will help to protect the environment
6.
FURTHER INFORMATION
What Brimonidine tartrate 2 mg/ml eye drops, solution contains
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The active substance is: brimonidine tartrate.
1 ml solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
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The other ingredients are:
benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid
monohydrate, purified water, and sodium hydroxide and hydrochloric acid for pH a djustment.
What Brimonidine tartrate 2 mg/ml eye drops, solution looks like and contents
of the pack
Brimonidine tartrate 2 mg/ml eye drops, solution is a clear, slightly greenish-yellow solution. The eye drops solution is available in 5 ml or 10 ml bottle with a dropper tip in
packs of 1, 3 or 6.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following
names:
<Name of the Member State>
<Name of the medicinal product>
This leaflet was last approved in