Brimonidine Tartrate 2 Mg/Ml Eye Drops Solution
PACKAGE LEAFLET
Package leaflet: Information for the patient
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.
What is in this leaflet
1. What Brimonidine tartrate 2 mg/ml Eye drops, solution is and what it is used for
2. What you need to know before you use Brimonidine tartrate 2 mg/ml Eye drops, solution
3. How to use Brimonidine tartrate 2 mg/ml Eye drops, solution
4. Possible side effects
5. How to store Brimonidine tartrate 2 mg/ml Eye drops, solution
6. Contents of the pack and other information
1. What Brimonidine tartrate 2 mg/ml Eye drops, solution is and what it is used for
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.
2. What you need to know before you use Brimonidine tartrate 2 mg/ml Eye drops, solution Do not use Brimonidine tartrate 2 mg/ml Eye drops, solution:
- 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).
Warnings and precautions
Talk to your doctor or pharmacist before using Brimonidine tartrate 2 mg/ml Eye drops, solution
If you suffer from severe or unstable heart disease, which is not under control with treatment 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.
Children and adolescents
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.
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.
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 a-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.
Pregnancy and breast-feeding
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.
Pregnancy
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.
Breast-feeding
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.
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.
Brimonidine tartrate 2 mg/ ml Eye drops solution contains benzalkonium chloride
Brimonidine tartrate 2 mg/ml Eye drops, solution contains the preservative benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses. Benzalkonium chloride can cause discolouration of soft contact lenses. Remove contact lenses before using Brimonidine tartrate 2 mg/ml Eye drops, solution and 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 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.
Adults (including the elderly)
Unless your doctor has instructed otherwise, the recommended 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 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.
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 what 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 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
Do not interrupt or stop treatment with Brimonidine tartrate 2 mg/ml Eye drops, solution without having talked to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:
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).
Uncommon: may affect up to 1 in 100 people
- Allergic reactions, which may cause difficulty breathing, breathlessness, swelling of face, throat or tongue
Very rare: may affect up to 1 in 10,000 people
- 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).
Other side effects include:
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)
- Headache, dry mouth, tiredness/drowsiness,
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
- 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).
- Fainting, increased blood pressure (hypertension), decreased blood pressure (hypotension), sleeplessness (insomnia)
Not known: frequency cannot be estimated from the available data
- 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
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/vellowcard . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Brimonidine tartrate 2 mg/ml Eye drops, solution
Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions
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.
6. Contents of the pack and other information
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 or 10 ml plastic bottle with a dropper tip in packs of 1, 3 or 6.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK. Manufacturer
Pharma Stulln GmbH, WerksstraPe 3, 92551 Stulln, Germany Mylan SAS, 117 allee des parcs, 69800 Saint Priest, France AB Sanitas, Veiveriu Street 134B, 46352 Kaunas, Lithuania