Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

NAME OF THE MEDICINAL PRODUCT

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml solution contains:
Brimonidine tartrate, equivalent to
brimonidine…………………………….2mg

Excipient(s): Contains benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Eye drops, solution.

Clear, greenish-yellow to light greenish-yellow solution.

CLINICAL PARTICULARS

4.1 Therapeutic indications

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).

4.2 Posology and method of administration

Recommended dosage in adults (including the elderly)

The recommended dose is one drop of Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.

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.

Use in renal and hepatic impairment

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma has not been studied in patients with hepatic or renal impairment (see section 4.4).

Use in paediatric subjects

No clinical studies have been performed in adolescents (12 to 17 years).

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is not recommended for use in children below 12 years and is contraindicated in neonates and infants (less than 2 years of age) (see sections 4.3, 4.4 and 4.9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma have not been established in children.

4.3 Contraindications

− Hypersensitivity to the active substance or to any of the excipients.

− 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).

4.4 Special warnings and precautions for use

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).

Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease.

Some (12.7%) patients in clinical trials experienced an ocular allergic type reaction with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma (see section 4.8 for details). If allergic reactions are observed, treatment with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma should be discontinued.

Delayed ocular hypersensitivity reactions have been reported with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma 0.2%, with some reported to be associated with an increase in IOP.

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangiitis obliterans.

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.

The preservative in Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma, benzalkonium chloride, may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

4.5 Interaction with other medicinal products and other forms of interaction

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma 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 Ophthalmic Solution 0.2% w/v Taj Pharma, 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 Ophthalmic Solution 0.2% w/v Taj Pharma 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 Ophthalmic Solution 0.2% w/v Taj Pharma, 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 Ophthalmic Solution 0.2% w/v Taj Pharma.

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).

4.6 Pregnancy and lactation

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 Ophthalmic Solution 0.2% w/v Taj Pharma should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus.

It is not known if brimonidine is excreted in human milk. The compound is excreted in the milk of the lactating rat. Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma should not be used by women nursing infants.

4.7 Effects on ability to drive and use machines

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma 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.

4.8 Undesirable effects

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 terminologies 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).

Cardiac disorders

Uncommon: palpitations/arrhythmias (including bradycardia and tachycardia)

Nervous system disorders

Very common: headache, drowsiness

Common: dizziness, abnormal taste

Very rare: syncope

Eye disorders

Very common:

− ocular irritation (hyperaemia, burning and stinging, pruritus, 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

Respiratory, thoracic and mediastinal disorders

Common: upper respiratory symptoms

Uncommon: nasal dryness

Rare: dyspnoea

Gastrointestinal disorders

Very common: oral dryness

Common: gastrointestinal symptoms

Vascular disorders

Very rare: hypertension, hypotension

General disorders and administration site conditions

Very common: fatigue

Common: asthenia

Immune system disorders

Uncommon: systemic allergic reactions

Psychiatric disorders

Uncommon: depression

Very rare: insomnia

The following adverse reactions have been identified during post-marketing use of Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma 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

In cases where brimonidine has been used as part of the medical treatment of congenital glaucoma, symptoms of brimonidine 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 (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 Ophthalmic Solution 0.2% w/v Taj Pharma 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.

4.9 Overdose

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 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 oral overdose includes supportive and symptomatic therapy; patient’s airways 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 Ophthalmic Solution 0.2% w/v Taj Pharma by paediatric subjects have been published or reported to Allergan. 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.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics in glaucoma therapy

Brimonidine is an alpha-2 adrenergic receptor agonist that is 1000-fold more selective for the alpha-2 adrenoceptor than the alpha-1 adrenoreceptor.

This selectivity results in no mydriasis and the absence of vasoconstriction in microvessels associated with human retinal xenografts.

Topical administration of brimonidine tartrate decreases intraocular pressure (IOP) in humans with minimal effect on cardiovascular or pulmonary parameters.

Limited data are available for patients with bronchial asthma showing no adverse effects.

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma has a rapid onset of action, with peak ocular hypotensive effect seen at two hours post-dosing. In two 1 year studies, Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma lowered IOP by mean values of approximately 4-6 mmHg.

Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action. It is thought that Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma may lower IOP by reducing aqueous humour formation and enhancing uveoscleral outflow.

Clinical trials show that Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is effective in combination with topical beta-blockers. Shorter term studies also suggest that Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma has a clinically relevant additive effect in combination with travoprost (6 weeks) and latanoprost (3 months).

5.2 Pharmacokinetic properties

a) General characteristics

After ocular administration of a 0.2% solution twice daily for 10 days, plasma concentrations were low (mean Cmax was 0.06 ng/ml). There was a slight accumulation in the blood after multiple (2 times daily for 10 days) instillations. The area under the plasma concentration-time curve over 12 hours at steady state (AUC₀-12h) was 0.31 ng·hr/ml, as compared to 0.23 ng·hr/ml after the first dose. The mean apparent half-life in the systemic circulation was approximately 3 hours in humans after topical dosing.

The plasma protein binding of brimonidine after topical dosing in humans is approximately 29%.

Brimonidine binds reversibly to melanin in ocular tissues, in vitro and in vivo. Following 2 weeks of ocular instillation, the concentrations of brimonidine in iris, ciliary body and choroid-retina were 3- to 17-fold higher than those after a single dose. Accumulation does not occur in the absence of melanin.

The significance of melanin binding in humans is unclear. However, no significant ocular adverse reaction was found during biomicroscopic examination of eyes in patients treated with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma for up to one year, nor was significant ocular toxicity found during a one year ocular safety study in monkeys given approximately four times the recommended dose of brimonidine tartrate.

Following oral administration to man, brimonidine is well absorbed and rapidly eliminated. The major part of the dose (around 75% of the dose) was excreted as metabolites in urine within five days; no unchanged drug was detected in urine. In vitro studies, using animal and human liver, indicate that the metabolism is mediated largely by aldehyde oxidase and cytochrome P450. Hence, the systemic elimination seems to be primarily hepatic metabolism.

Kinetics profile:

No great deviation from dose proportionality for plasma Cmax and AUC was observed following a single topical dose of 0.08%, 0.2% and 0.5%.

b) Characteristics in patients

Characteristics in elderly patients:

The C_max, AUC, and apparent half-life of brimonidine are similar in the elderly (subjects 65 years or older) after a single dose compared with young adults, indicating that its systemic absorption and elimination are not affected by age.

Based on data from a 3 month clinical study, which included elderly patients, systemic exposure to brimonidine was very low.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium Chloride

Poly(vinyl alcohol), Sodium chloride, Sodium citrate, Citric acid monohydrate, Purified water, Hydrochloric acid (for pH-adjustment) or Sodium hydroxide (for pH-adjustment)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Before first opening:	2 years for the 2.5 ml container.
	3 years for the 5 ml and 10 ml containers.
After first opening:	Use within 28 days.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

White low density polyethylene dropper bottles with a 35 microlitre tip. The cap is either a conventional polystyrene screw cap or a Compliance Cap (C-Cap).

2.5 ml, 5 ml and 10 ml bottles in packs of 1, 3 or 6.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

BRIMONIDINE TARTRATE
OPHTHALMIC SOLUTION
0.2% W/V
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 any further questions, ask your doctor or 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:

What Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is and what it is used for
Before you use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma
How to use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma
Possible side effects
How to store Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma
Further information

WHAT BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% W/V TAJ PHARMA IS AND WHAT IT IS USED FOR

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is used to reduce pressure within the eye.

It can be used either alone, when beta-blocker eye drops are contraindicated, or with another eye drop, when a single medicine is not enough to lower the increased pressure in the eye, in the treatment of open angle glaucoma or ocular hypertension.

The active ingredient in Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is brimonidine tartrate, which works by reducing pressure within the eyeball.

BEFORE YOU USE BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% W/V TAJ PHARMA

Do not use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma.
If you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You must inform your doctor if you are taking any antidepressant drug.
If you are breast-feeding.
In infants/babies (from birth until 2 years).

Take special care with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

Before you take this medicine, tell your doctor:

If you suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, a disturbed blood supply of the limbs or a blood pressure disorder.
If you have or have had in the past kidney or liver problems.
If being given to a child between the age of 2 and 12 years because Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is not recommended for use in this age group.

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.

Tell your doctor if you are taking any of the following medicines:

pain killers, sedatives, opiates, barbiturates or are regularly consuming alcohol
anaesthetics
to treat a heart condition or to lower blood pressure
that can affect the metabolism like chlorpromazine, methylphenidate and reserpine
which work on the same receptor as Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma, for example isoprenaline and prazosin
monoamine oxidase (MAO) inhibitors and other antidepressants
medicines for any condition, even if unrelated to your eye condition
or if the dose of any of your current medicines is changed.

These could affect your treatment with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant.

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma should not be used while breast-feeding.

Driving and using machines

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma may cause blurred or abnormal vision. This effect may seem worse at night or in reduced lighting.
Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma may also cause drowsiness or tiredness in some patients.
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 Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

A preservative in Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses. Therefore, avoid contact with soft lenses. If you wear soft contact lenses take them out before using these eye drops and then wait 15 minutes after using Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma before inserting your lenses.

HOW TO USE BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% W/V TAJ PHARMA

Always use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The usual dose is one drop twice daily in the affected eye(s), approximately 12 hours apart.

Children under 12 years

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma must not be used for infants below 2 years of age.

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is not recommended for use in children (from 2 years until 12 years).

Instructions for use

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma comes as eye drops. Always wash your hands before applying eye drops. Your prescription label tells you how many drops to use at each dose. If you use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma with another eye drop, wait 5-15 minutes before applying the second eye drop.

Apply your eye drops in the following way:

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.
4. Whilst keeping the affected eye closed, press your finger against the corner of the closed eye (the side where the eye meets the nose) and hold for 1 minute.

Avoid touching the dropper tip against your eye or anything else.

Replace and tighten the cap straight after use.

If you use more Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma than you should

Adults

In adults who were instilling more drops than prescribed, the side effects reported were those already known to occur with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma.

Adults who accidentally swallowed Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma experienced decrease in blood pressure, which in some patients was followed by the increase in blood pressure.

Children

Serious side effects were reported in children who accidentally swallowed Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma. Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties. Should this happen, contact your doctor immediately.

Adults and Children

If Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma has been accidentally swallowed or if you have used more Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma than you should, please contact your doctor immediately.

If you forget to use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

If you forget to take a dose, apply it as soon as you remember. If, however, it is almost time for your next dose, you should omit the missed dose altogether and then follow your normal routine.

If you stop using Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma

To be effective Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma must be used every day. Do not stop using Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma until your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma can cause side effects, although not everybody gets them. The chance of having a side effect is described by the following categories:

Very common Occurs in more than 1 out of 10 patients

Common Occurs in fewer than 1 out of 10 patients

Uncommon Occurs in fewer than 1 out of 100 patients

Rare Occurs in fewer than 1 out of 1,000 patients

Very rare Occurs in fewer than 1 out of 10,000 patients

The following eye side effects may be seen with Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma.

Affecting the eye

Very common:

Irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye, itching, follicles or white spots on the see-through layer which covers the surface of the eye)
Blurred vision
An allergic reaction in the eye

Common:

Local irritation (inflammation and swelling of the eyelid, swelling of the see-through layer which covers the surface of the eye, sticky eyes, pain and tearing)
Sensitivity to light
Erosion on the surface of the eye and staining
Eye dryness
Whitening of the see-through layer which covers the surface of the eye
Abnormal vision
Inflammation of the see-through layer which covers the surface of the eye

Very rare:

Inflammation within the eye
Reduction in pupil size

Side effects where the occurrence is unknown:

Itching of eyelids

Affecting the body

Very common:

Headache
Dry mouth
Tiredness/drowsiness

Common:

Dizziness
Cold-like symptoms
Symptoms involving the stomach and digestion
Abnormal taste
General weakness

Uncommon:

Depression
Palpitations or changes in heart rate
Dry nose
General allergic reactions

Rare:

Shortness of breath

Very rare:

Sleeplessness
Fainting
High blood pressure
Low blood pressure

Side effects where the occurrence is unknown:

Skin reactions including redness, face swelling, itching, rash and widening of blood vessels

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% W/V TAJ PHARMA

Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use the bottle if the tamper-proof seal on the bottle is broken before first use.
Do not use Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma after the expiry date which is stated on the bottle label and the carton after EXP:. The expiry date refers to the last day of that month.
Throw the bottle away 28 days after opening, even if there is solution remaining.

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.

FURTHER INFORMATION

What Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma contains

Each ml solution contains:
Brimonidine tartrate, equivalent to
Brimonidine…………………………….2mg

The other ingredients are benzalkonium chloride as a preservative, poly(vinyl alcohol), sodium chloride, sodium citrate, citric acid monohydrate, purified water and sodium hydroxide or hydrochloric acid for pH-adjustment.

What Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma looks like and contents of the pack

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is a clear, greenish-yellow to light greenish-yellow eye drop solution in a plastic bottle.

Each bottle contains either 2.5 ml, 5 ml or 10 ml of the medicine.

Brimonidine Tartrate Ophthalmic Solution 0.2% w/v Taj Pharma is available in packs of 1, 3 or 6 bottles.

Not all pack sizes may be marketed.