Brimonidine Tartrate 2 Mg/Ml Eye Drops Solution
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BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
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.
- Keep this leaflet. You may need to read it again.
- If you have further questions, 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 your doctor or pharmacist.
In this leaflet:
1. What Brimonidine eye drops are and what they is are used for
2. Before you use Brimonidine eye drops
3. How to use Brimonidine eye drops
4. Possible side effects
5. How to store Brimonidine eye drops
6. Further information
1. WHAT BRIMONIDINE EYE DROPS ARE AND WHAT THEY ARE USED FOR
Brimonidine Tartrate 2 mg/ml Eye Drops, Solution (also referred to as Brimonidine eye drops in this patient information leaflet) 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 eye drops may be used alone or in combination with other medicines to reduce intra-ocular pressure.
2. BEFORE YOU USE BRIMONIDINE EYE DROPS Do not use Brimonidine eye drops:
- If you are allergic (hypersensitive) to brimonidine tartrate or to any of the ingredients of Brimonidine eye drops
- If you are being treated with a medicine classified as a monoamine oxidase inhibitor (MAO inhibitor),
- If you are being treated with certain antidepressant medicines (such as tricyclic antidepressants or mianserin). You must inform your doctor if you are taking any antidepressant medicines.
- In the case of newborn babies and infants (from birth until 2 years).
Take special care with Brimonidine eye drops
- If you suffer from severe or unstable and untreated heart disease,
- If you suffer from depression,
- If you suffer from a disorder of reduced blood supply to the brain (cerebral insufficiency)
BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
or to the heart (heart failure),
- 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),
- 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 obstruction of the blood vessels as a result of clotting (thrombangiitis obliterans),
- 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 eye drops.
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 eye drops. Caution should be exercised if brimonidine eye drops is used at the same time as antihypertensive agents and/or heart drugs from the group of digitalis 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 a-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 this medicine during pregnancy. Brimonidine eye drops 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 eye drops 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 eye drops can cause tiredness and / or drowsiness. This can affect the ability
BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
to drive or use machines safely.
Brimonidine eye drop 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.
If you experience any of these symptoms, do not drive or use machinery until the symptoms are cleared.
Important information about some of the ingredients of Brimonidine eye drops
Brimonidine eye drops contains the preservative benzalkonium chloride which can cause eye irritation. Avoid contact with soft contact lenses. Benzalkonium chloride can cause discolouration of soft contact lenses. You should remove contact lenses before using Brimonidine eye drops. Wait at least 15 minutes after using the medicine before putting your lenses back in.
3. HOW TO USE BRIMONIDINE EYE DROPS
Always use this medicine 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 this medicine for the period of time prescribed by your doctor.
If you have the impression that the effect of Brimonidine eye drops 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 interval 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).
BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
If you use more Brimonidine eye drops than you should
Adults
In adults who were instilling more drops than prescribed, the side effects were those already known to occur with Brimonidine eye drops (see section 4).
Adults who accidentally swallowed Brimonidine eye drops experienced decrease in blood pressure, which in some patients was followed by the increase in blood pressure.
Contact your doctor immediately if you have accidentally swallowed Brimonidine eye drops as it may cause low blood pressure, feeling of weakness, being sick, lack of energy, feeling numb, slower heartbeat, irregular heartbeat, tiny pupils, breathing difficulties including stop of breathing, floppiness/floppy muscles, low body temperature and fits.
Children
Serious side effects were reported in children who accidentally swallowed Brimonidine eye drops. Signs included temporary coma, low level of consciousness, lack of energy, sleepiness, floppiness/floppy muscles, slower heartbeat, low body temperature, paleness and breathing difficulties including stop of breathing. Should this happen, contact your doctor immediately.
Adults and Children
If you suspect an overdose contact your doctor immediately. 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 eye drops
If you forget to apply Brimonidine eye drops, apply the forgotten dose instead as soon as you realise this. If however you do not remember the forgotten dose until shortly before the time for the next dose, omit the forgotten dose and continue 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 eye drops
Do not interrupt or stop treatment with Brimonidine eye drops without having talked to your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Brimonidine eye drops 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.
BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
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 temporary and rarely serious enough to require treatment with Brimonidine eye drops 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 eye drops should be stopped.
An analysis of the side effects was based on the following 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 eye drops, 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, follicles or white spots on the see-through layer which covers the surface of the eye (conjunctival follicles)), blurred vision.
Common:
- Topical irritation (red and swollen eyelids, inflamed eyelids, conjunctival oedema and discharge, eye pain and runny eyes), hypersensitivity to light, superficial damage or colouration of the cornea, dry eyes, conjunctival blisters, abnormal vision, conjunctivitis.
Very rare:
- Iritis, contraction of the pupils.
Not known:
- Itching of eyelids
- Inflammation within the eye Systemic side effects:
Very common:
- Headache, dry mouth, tiredness/drowsiness Common:
- Symptoms in the upper airways, vertigo, gastrointestinal pain, weakness, altered taste.
BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
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:
- Skin reactions including redness, face swelling, itching, rash and widening of blood vessels
5. HOW TO STORE BRIMONIDINE EYE DROPS
Keep out of the reach and sight of children.
Do not use Brimonidine eye drops 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 eye drops may be stored for a maximum of 28 days.
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 Brimonidine eye drops contains
- The active substance is: brimonidine tartrate.
1 ml solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
- 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 adjustment.
What Brimonidine eye drops look like and contents of the pack
Brimonidine eye drops are 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
Genus Pharmaceuticals,
Linthwaite,
Huddersfield,
HD7 5QH,
UK
BRIMONIDINE TARTRATE 2mg/ml EYE DROPS SOLUTION
Manufacturer
Pharma Stulln GmbH, WerksstraPe 3, 92551, Stulln, Germany STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany Cantrafarm Services B.V, Nieuwe Donk 9, 4879 AC Etten-Leur, Netherlands UAB Santonika, Veiveriu Street 134B, 46352 Kaunas, Lithuania