Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Warnings and precautions
Talk to your doctor or pharmacist before using Brimonidine tartrate 2 mg/ml Eye drops, solution
brimonidine tartrate Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Brimonidine tartrate 2 mg/ml Eye drops, solution contains the active ingredient brimonidine tartrate, which works by 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.
− If you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6) − If you are being treated with a medicine classified as a monoamine oxidase inhibitor (MAO inhibitor), used to treat depression or Parkinson's disease e.g. selegiline, phenelzine − If you are being treated with certain antidepressant medicines (such as tricyclic antidepressants e.g. clomipramine, amitriptyline or mianserin). You must inform your doctor if you are taking any anti-depressant medicines. − In the case of newborn babies and infants (from birth until 2 years).
− If you suffer from severe or unstable heart disease, which is not under control with treatment
Children and adolescents
Other medicines and Brimonidine tartrate 2 mg/ml Eye drops, solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
Pregnancy
− If you suffer from depression, − If you suffer from a disorder of reduced blood supply to the brain (cerebral insufficiency) or to the heart, e.g. angina or blocked blood vessels, − 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.
Do not use Brimonidine tartrate 2 mg/ml Eye drops, solution in new-born babies and infants (from birth until 2 years).
Brimonidine tartrate 2 mg/ml Eye drops, solution is not normally recommended for use in children (from 2 – 12 years), due to an increased risk of side effects (e.g. sleepiness) occurring.
Do not use Brimonidine tartrate 2 mg/ml Eye drops, solution if you are treated with MAO (monoamine oxidase inhibitor), a tricyclic antidepressant or mianserin (see section 'Do not use').
Substances that affect the central nervous system (CNS): the effect of substances that affect the central nervous system (CNS) (such as alcohol, barbiturates, e.g. used in epilepsy such as phenobarbital, opiates used in pain relief e.g. codeine, sedatives used to make you feel sleepy e.g. diazepam or anaesthetics) may be increased by brimonidine tartrate.
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. Caution should be exercised if Brimonidine tartrate 2 mg/ml Eye drops, solution is used at the same time as antihypertensive agents (used to treat high blood pressure) and/or heart drugs from the group of digitalis glycosides.
Adrenoreceptor agonists or antagonists: Caution should be exercised if you are taking adrenoreceptor agonists such as phenylephrine (used in e.g. eye drops, nasal sprays) or antagonists (isoprenaline or prazosin (which may be used to treat high blood pressure or other circulatory problems)) for example.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Breast-feeding
Driving and using machines
Wait until these effects have cleared before driving or using machines.
Adults (including the elderly)
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.
Studies have not yet been conducted to determine whether it is safe to use brimonidine tartrate during pregnancy. Brimonidine tartrate 2 mg/ml Eye drops, solution should 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 tartrate passes into human breast milk. Brimonidine tartrate 2 mg/ml Eye drops, solution should not be used in breast-feeding mothers.
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.
Brimonidine tartrate 2 mg/ ml Eye drops solution contains benzalkonium chloride This medicine contains 0.05 mg benzalkonium chloride in each millilitre of eye drop solution. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Always use this medicine exactly as your doctor or pharmacist has told you. 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 recommended dose is one drop in the affected eye/eyes twice daily approximately 12 hours apart.
Adults and children
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 as soon as you remember. If however it is almost time for the next dose, omit the forgotten dose and continue with the next application at the usual time. Do not use a double dose to make up for a forgotten dose. Do not change the prescribed dose yourself.
If you stop using Brimonidine tartrate 2 mg/ml Eye drops, solution
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 tartrate into your body.
If you are using more than one eye medicine, the products should be applied at least 5–15 minutes apart.
Replace and tighten cap straight after use. Avoid touching the dropper tip against your eye or anything else. If you use more Brimonidine tartrate 2 mg/ml Eye drops, solution than you should
Adults Side effects as listed in section 4 of the leaflet have been reported for adults who have used more brimonidine tartrate than recommended in the eye. Low blood pressure was reported for adults who had accidentally swallowed brimonidine tartrate. This was followed by a steep increase in blood pressure in some patients. Contact your doctor immediately it you have swallowed Brimonidine tartrate 2 mg/ml Eye drops, solution. The following side effects have been reported in other medicines which have a similar way of working to brimonidine when swallowed: unusual weakness, being sick (vomiting), tiredness, reduced consciousness, slow heart rate , changes in heart rate, decrease in size of the of the pupil of the eye, decreased muscle tone, breathing difficulties, low body temperature and fits. Children Cases of overdose have been reported in children who had accidentally swallowed brimonidine tartrate. Symptoms include temporary coma or low level of consciousness, tiredness, sleepiness, floppiness, slow heart rate, low body temperature, pale skin and breathing difficulties. If any of these occur, contact your doctor immediately.
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 what has been taken.
Do not interrupt or stop treatment with Brimonidine tartrate 2 mg/ml Eye drops, solution without having talked to your doctor.
If you notice any of the following side effects, or they become severe during treatment with Brimonidine tartrate 2 mg/ml Eye drops, solution, contact your doctor or hospital immediately:
Uncommon: may affect up to 1 in 100 people
Very rare: may affect up to 1 in 10,000 people
Other side effects include:
− Headache, dry mouth, tiredness/drowsiness,
− Symptoms in the upper airways, dizziness, stomach and gut pain, weakness, altered taste.
Uncommon: may affect up to 1 in 100 people − Pounding heart beat / irregular heart rate (including slow or fast heart rate), depression, dry nose.
Rare: may affect up to 1 in 1,000 people − Shortness of breath (dyspnoea).
Very rare: may affect up to 1 in 10,000 people − Reduction in pupil size (miosis).
Not known: frequency cannot be estimated from the available data
Very common: may affect more than 1 in 10 people − Eye irritation, including allergic reactions (flushing (redness), pain, stinging, burning, itching, the feeling of a foreign body in the eye).
Common: may affect up to 1 in 10 people − Discolouration/staining of the cornea (the surface of the eye), blisters, swelling or severe damage (which may be seen by an eye doctor or cause eye discomfort or pain) on the surface of the eye (corneal erosion and staining).
− Allergic reactions, which may cause difficulty breathing, breathlessness, swelling of face, throat or tongue
− Inflammation of the coloured part of the eye, which may cause redness, blurred vision and changes in the shape of the pupils (black part of the eye) and headache (iritis).
Very common: may affect more than 1 in 10 people − Redness, watering of the eyes and itching of the eye with a sticky discharge (conjunctivitis, which may be due to allergy or infection), blurred vision, swelling and redness of the eyelid (which may due to allergy (blepharitis)), raised surface of the eye, which may be seen by an optician (conjunctival follicles)
Common: may affect up to 1 in 10 people − Runny eyes, sensitivity to light, damage to the front part of the eye (superficial damage to the cornea), dry eyes, abnormal vision
− Fainting, increased blood pressure (hypertension), decreased blood pressure (hypotension), sleeplessness (insomnia)
− Skin reactions including facial swelling, skin redness (which may be due to dilation of the blood vessels), itchy skin, rash, itchy eyelid
Additional side effects in children and adolescents
Very common: may affect more than 1 in 10 children − Sleepiness (somnolence). This can affect more than 1 in every 2 children.
Reporting of side effects
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions
Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK. Manufacturer
Viatris Santé, 1 rue de Turin, 69007 Lyon, France Famar A.V.E. Alimos Plant, 63 Agiou Dimitriou str., Alimos Attiki, 17456, Greece This leaflet was last revised in November 2023
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.
After first opening, Brimonidine tartrate 2 mg/ml Eye drops, solution is to be used within 28 days of opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Brimonidine tartrate 2 mg/ml Eye drops, solution 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 (see section 2 Brimonidine tartrate 2 mg/ml Eye drops, solution contains benzalkonium chloride), poly(vinyl) alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water and sodium hydroxide and hydrochloric acid for pH adjustment. 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 plastic bottle with a dropper tip in packs of 1, 3 or 6. Not all pack sizes may be marketed. Marketing Authorisation Holder
Brimonidine Tartrate 2 mg/ml Eye Drops, Solution comes as eye drops containing 2mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Brimonidine Tartrate 2 mg/ml Eye Drops, Solution is brimonidine tartrate.
Medicines with the same active substance, strength and form include: Alphagan 0.2% w/v (2 mg/ml) eye drops, solution, Brimonidine Tartrate 2 mg/ml Eye drops, solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Brimonidine Tartrate 2 mg/ml Eye Drops, Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
• As monotherapy in patients in whom topical beta-blocker therapy is contraindicated.
• As adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single agent (see section 5.1).
Posology
Adults (including the elderly)
The recommended dose is one drop of Brimonidine tartrate in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.
Patients with renal and hepatic impairment
Brimonidine tartrate has not been studied in patients with hepatic or renal impairment (see section 4.4).
Paediatric population
No clinical studies have been performed in adolescents (12 to 17 years).
Brimonidine tartrate is not recommended for use in children below 12 years and is contraindicated in neonates and infants (less than 2 years of age) (see section 4.3, section 4.4 and section 4.9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of brimonidine tartrate have not been established in children.
Method of administration
For ocular use.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart.
– Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
– Neonates and infants (see section 4.8).
– Patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin).
Paediatric population
Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing ≤ 20 Kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence (see section 4.8).
Cardiovascular disease
Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease.
Allergic reactions
Some (12.7%) patients in clinical trials experienced an ocular allergic type reaction with brimonidine tartrate (see section 4.8 for details). If allergic reactions are observed, treatment with Brimonidine tartrate should be discontinued.
Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate, with some reported to be associated with an increase in IOP.
Other special patient populations
Brimonidine tartrate should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Patients with renal/hepatic impairment
Brimonidine tartrate has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
Excipients
This medicinal product contains benzalkonium chloride. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should remove contact lenses before using this medicinal product and put them back 15 minutes afterwards.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface. It should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
Brimonidine tartrate is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenagic transmission (e.g. tricyclic antidepressants and miaserin) (see section 4.3).
Although specific drug interactions studies have not been conducted with brimonidine tartrate, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
No data on the level of circulating catecholamines after brimonidine tartrate administration are available. Caution, however, is advised in patients taking medications which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.
After the application of brimonidine tartrate, clinically insignificant decreases in blood pressure were noted in some patients. Caution is advised when using drugs such as antihypertensives and/or cardiac glycosides concomitantly with Brimonidine tartrate.
Caution is advised when initiating (or changing the dose of) a concomitant systemic agent (irrespective of pharmaceutical form) which may interact with α-adrenergic agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, prazosin).
Pregnancy
The safety of use during human pregnancy has not been established. In animal studies, brimonidine tartrate did not cause any teratogenic effects. In rabbits, brimonidine tartrate, at plasma levels higher than are achieved during therapy in humans, has been shown to cause increased preimplantation loss and postnatal growth reduction. Brimonidine tartrate should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus.
Breast-feeding
It is unknown whether brimonidine tartrate metabolites are excreted in human milk. The compound is excreted in the milk of the lactating rat. Brimonidine tartrate should not be used during breast-feeding.
Brimonidine has minor or moderate influence on the ability to drive and use machines
Brimonidine tartrate may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. Brimonidine tartrate may cause blurred and/or abnormal vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. The patient should wait until these symptoms have cleared before driving or using machinery.
The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring in 22 to 25% of patients. They are usually transient and not commonly of a severity requiring discontinuation of treatment.
Symptoms of ocular allergic reactions occurred in 12.7% of subjects (causing withdrawal in 11.5% of subjects) in clinical trials with the onset between 3 and 9 months in the majority of patients.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following frequencies have been used in order to classify the occurrence of undesirable effects:
Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Immune system disorders
Uncommon:
- systemic allergic reactions
Psychiatric disorders
Uncommon:
- depression
Very rare:
- insomnia
Nervous system disorders
Very common:
- headache
- drowsiness
Common:
- dizziness
- abnormal taste
Very rare:
- syncope
Eye disorders
Very common
- ocular irritation (hyperaemia, burning and stinging, pruritis, foreign body sensation, conjunctival follicles)
- blurred vision
- allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reaction, and follicular conjunctivitis
Common:
- local irritation (eyelid hyperaemia and oedema, blepharitis, conjunctival oedema and discharge, ocular pain and tearing).
- photophobia
- corneal erosion and staining
- ocular dryness
- conjunctival blanching
- abnormal vision
- conjunctivitis.
Very rare:
- iritis
- miosis
Cardiac disorders
Uncommon
- palpitations/arrythmias (including bradycardia and tachycardia)
Vascular disorders
Very rare:
- hypertension
- hypotension
Respiratory, thoracic and mediastinal disorders
Common:
- upper respiratory symptoms
Uncommon:
- nasal dryness
Rare:
- dyspnoea
Gastrointestinal disorders
Very common:
- oral dryness
Common:
- gastrointestinal symptoms
General disorders and administration site conditions
Very common:
- fatigue
Common:
- asthenia
The following adverse reactions have been identified during post-marketing use of brimonidine tartrate in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made:
Not known:
Eye disorders
- iridocyclitis (anterior uveitis)
- eyelid pruritus
Skin and subcutaneous tissue disorders
- Skin reaction including erythema, face oedema, pruritus, rash and vasodilatation
Paediatric population
In cases where brimonidine tartrate has been used as part of the medical treatment of congenital glaucoma, symptoms of brimonidine tartrate overdose such as loss of consciousness, lethargy, somnolence, hypotension, hypotonia, bradycardia, hypothermia, cyanosis, pallor, respiratory depression and apnoea have been reported in neonates and infants receiving brimonidine tartrate (see section 4.3).
In a 3-month, phase 3 study in children aged 2-7 years with glaucoma, inadequately controlled by beta-blockers, a high prevalence of somnolence (55%) was reported with brimonidine tartrate as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%. The incidence of somnolence decreased with increasing age, being least in the 7-year-old age group (25%), but was more affected by weight, occurring more frequently in those children weighing ≤ 20 kg (63%) compared to those weighing >20 kg (25%) (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ophthalmic overdose (Adults):
In those cases received, the events reported have generally been those already listed as adverse reactions.
Systemic overdose resulting from accidental ingestion (Adults):
There is very limited information regarding accidental ingestion of brimonidine tartrate in adults.
The only adverse event reported to date was hypotension. It was reported that the hypotensive episode was followed by rebound hypertension.
Treatment of an oral overdose includes supportive and symptomatic therapy; patient's airway should be maintained.
Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Paediatric population
Reports of serious adverse effects following inadvertent ingestion of brimonidine tartrate by paediatric subjects have been published or reported. The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated. All subjects were reported to have made a full recovery, usually within 6-24 hours.
Ask anything about Brimonidine Tartrate 2 mg/ml Eye Drops, Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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