Combigan

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/05/19

files-icon(Click to Download)

XPIL

Summary of Product Characteristics last updated on medicines.ie: 15/10/2015
print

Print ViewKeyword Search SmPC

Allergan Ltd

Allergan Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Acular Active Ingredients Ketorolac Trometamol
Medicine Name Alphagan Active Ingredients brimonidine tartrate
Medicine Name Betagan Active Ingredients Levobunolol hydrochloride
Medicine Name Betagan Unit Dose Active Ingredients Levobunolol hydrochloride
Medicine Name BOTOX 100 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 200 Units Active Ingredients Botulinum Toxin Type A
Medicine Name BOTOX 50 Units Active Ingredients Botulinum Toxin Type A
Medicine Name Celluvisc 0.5% Active Ingredients Carmellose sodium
Medicine Name Celluvisc 1.0% w/v Eye drops, solution Active Ingredients Carmellose sodium
Medicine Name Combigan Active Ingredients brimonidine tartrate, Timolol Maleate
Medicine Name Exocin Active Ingredients Ofloxacin
Medicine Name FML Active Ingredients Fluorometholone
Medicine Name Ganfort Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Ganfort SD Active Ingredients Bimatoprost, Timolol Maleate
Medicine Name Lacri-Lube Active Ingredients No Active Ingredients
Medicine Name Liquifilm Tears Active Ingredients Polyvinyl Alcohol
Medicine Name Lumigan 0.1mg/ml Active Ingredients Bimatoprost
Medicine Name Ozurdex Active Ingredients Dexamethasone
Medicine Name Pred Forte Active Ingredients Prednisolone Acetate
Medicine Name Pred Mild Active Ingredients Prednisolone Acetate
Medicine Name Refresh Ophthalmic Active Ingredients Polyvinyl Alcohol, Povidone
Medicine Name Relestat 0.5 mg/ml, eye drops, solution Active Ingredients Epinastine Hydrochloride
Medicine Name Vistabel Active Ingredients Botulinum Toxin Type A
1 - 0 of 23 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 24 May 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 October 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 15 October 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 October 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 -    Reformatting of information regarding Paediatric population
                        Additional advice regarding method of administration

Section 4.4 -    Additional information regarding cardiac reactions

Section 4.8 -    Addition of adverse reactions reported in eye drops containing phosphates
                        Addition of information related to the reporting of suspected adverse reactions


Updated on 15 October 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 11 January 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2  Posology and method of administration

As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctual occlusion) or eyelids are closed for two minutes. This should be performed immediately following the instillation of each drop. This may result in a decrease of systemic side effects and an increase in local activity.

4.3  Contraindications

§   Sinus bradycardia, sick sinus syndrome sino-atrial block, second or third degree atrioventricular block not controlled with a pace-maker, overt cardiac failure, cardiogenic shock.

4.4  Special warnings and precautions for use

4.4

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. The safety and effectiveness of Combigan in children and adolescents (2 to 17 years of age) have not been established (see section 4.2 and section 4.8).

Some patients have experienced ocular allergic type reactions (allergic conjunctivitis and allergic blepharitis) with Combigan in clinical trials. Allergic conjunctivitis was seen in 5.2% of patients. Onset was typically between 3 and 9 months resulting in an overall discontinuation rate of 3.1%. Allergic blepharitis was uncommonly reported (<1%). If allergic reactions are observed, treatment with Combigan should be discontinued.

Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate ophthalmic solution 0.2%, with some reported to be associated with an increase in IOP.

Like other topically applied ophthalmic agents, Combigan may be absorbed systemically. No enhancement of the systemic absorption of the individual active substances has been observed. Due to beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see section 4.2.

 

Cardiac disorders:

In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.

Due to its negative effect on conduction time, betablockers should only be given with caution to patients with first degree heart block.

Vascular disorders:

Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud’s disease or Raynaud’s syndrome) should be treated with caution.

 

Respiratory disorders:

Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.

Combigan  should be used with caution, in patients with mild/moderate chronic

obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.

 

Hypoglycaemia/diabetes

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia. 

 

Hyperthyroidism

Beta-blockers may also mask the signs of hyperthyroidism.

 

Combigan must be used with caution in patients with metabolic acidosis and untreated phaeochromocytoma. Corneal diseases

Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases  should be treated with caution.

 

Other beta-blocking agents

The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).

 

Anaphylactic reactions

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergans and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

Choroidal detachment

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.

Surgical anaesthesia

Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline. The anaesthetist must be informed if the patient is receiving timolol.

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, , beta-adrenergic blocking agents, anti-arrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics or guanethidine.Also, the application of brimonidine, very rare (<1 in 10,000) cases of hypotension have been reported. Caution is therefore advised when using Combigan with systemic antihypertensives.

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.

4.5  Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with the brimonidine timolol fixed combination. Although specific drug interactions studies have not been conducted with Combigan, the theoretical possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, , beta-adrenergic blocking agents, anti-arrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics or guanethidine.Also, after  the application of brimonidine, very rare (<1 in 10,000) cases of hypotension have been reported. Caution is therefore advised when using Combigan with systemic antihypertensives.

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally. Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask the signs and symptoms of hypoglycaemia (see 4.4 Special warnings and precautions for use).

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.[Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.

Concomitant use of a beta-blocker with anaesthetic drugs may attenuate compensatory tachycardia and increase the risk of hypotension (see section 4.4), and therefore the anaesthetist must be informed if the patient is using Combigan.

Caution must be exercised if Combigan is used concomitantly with iodine contrast products or intravenously administered lidocain. 

Cimetidine, hydralazine and alcohol may increase the plasma concentrations of timolol. 

No data on the level of circulating catecholamines after Combigan administration are available. Caution, however, is advised in patients taking medication which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine .

Caution is advised when initiating (or changing the dose of) a concomitant systemic agent (irrespective of pharmaceutical form) which may interact with a-adrenergic agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, prazosin).

Although specific drug interactions studies have not been conducted with Combigan, the theoretical possibility of an additive IOP lowering effect with prostamides, prostaglandins, carbonic anhydrase inhibitors and pilocarpine should be considered.

Brimonidine 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).Patients who have been receiving MAOI therapy should wait 14 days after discontinuation before commencing treatment with Combigan.

4.6  Pregnancy and lactation

Pregnancy

There are no adequate data for the use of the brimonidine timolol fixed combination in pregnant women. Combigan should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section 4.2.

Lactation

Brimonidine tartrate

Timolol

Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. To reduce the systemic absorption, see section 4.2

4.7  Effects on ability to drive and use machines

Combigan has minor influence on the ability to drive and use machines. Combigan may cause transient blurring of vision, visual disturbance, fatigue and/or drowsiness which may impair the ability to drive or operate machines.  The patient should wait until these symptoms have cleared before driving or using machinery.

4.8  Undesirable effects

Uncommon (>1/1000, <1/100): taste perversion, nausea, diarrhoea.

Eye disorders:Not known: Vision blurred

 

Skin disorders:

Not known: Erythema facial

Brimonidine

Eye disorders: iritis, iridocyclitis (anterior uveitis), miosis

Psychiatric disorders: insomnia

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 (less than 2 years of age) receiving brimonidine (see section 4.3).

A high incidence and severity of somnolence has been reported in children of 2 years of age and above, especially those in the 2-7 age range and/or weighing 20 Kg (see section 4.4).

Timolol

 

 Like other topically applied ophthalmic drugs, Combigan (brimonidine tartrate/ timolol) is absorbed into the systemic circulation. Absorption of timolol may cause similar undesirable effects as seen with systemic  beta-blocking agents.

 

Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.  To reduce the systemic absorption, see section 4.2.

 

Additional adverse reactions that have been seen with ophthalmic beta‑blockers and may potentially occur also with Combigan are listed below:

 

Immune system disorders: Systemic allergic reactions including angioedema, urticaria, localised and generalised rash, pruritis, anaphylactic reaction

 

Metabolism: Hypogycaemia

 

Psychiatric disorders: Insomnia, nightmares, memory loss

 

Nervous system disorders: Cerebrovascular accident, cerebral ischemia, increases in signed and symptoms of myasthenia gravis, paraesthesia

 

Eye disorders: keratitis, choroidal detachment following filtration sugery (see section 4.4 Special warnings and special precautions for use), decreased corneal sensitivity, corneal erosion, ptosis, diplopia

 

Cardiac disorders: chest pain, oedema, atrioventricular block, cardiac arrest, cardiac failure

 

Vascular disorders: Raynaud’s phenomenon, cold hands and feet.

 

Respiratory, thoracic, and mediastinal disorders: Bronchospasm (predominantly in patients with pre-existing bronchospatic disease), dyspnoea, cough.

 

Gastrointestinal disorders: dyspepsia, abdominal pain, vomiting

 

Skin and subcutaneous tissue disorders: Alopecia, psoriasiform rash or exacerbation of psoriasis, skin rash.

 

Musculoskeletal and connective tissue disorders: Myalgia

 

Reproductive system and breast disorders: Sexual dysfunction, decreased libido

General disorders and administration site conditions: Fatigue

4.9  Overdose

Rare reports of overdosage with COMBIGAN® in humans resulted in no adverse outcome.  Treatment of an overdose includes supportive and symptomatic therapy; a patient’s airway should be maintained.

Brimonidine

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. 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 Alphagan 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.

 

Timolol

Symptoms of systemic timolol overdose include: bradycardia, hypotension, bronchospasm, headache, dizziness and cardiac arrest. A study of patients showed that timolol did not dialyse readily.

Updated on 10 January 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration

Updated on 20 May 2009 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Summary of Changes to Combigan® Ireland Summary of Product Characteristics (SPC)

 

The current Combigan® SPC is dated 26 February 2009

This supersedes SPC dated 7 May 2008

 

 

Section Number

Subject

Change

1.0

 

Name of the medicinal product

Text edited:

Combigan 2 mg/ml + 5 mg/ml eye drops, solution

2.0

Qualitative and quantitative composition

Text edited:

Contains benzalkonium chloride 0.05 mg/ml.

For a full list of excipients, see section 6.1

 

4.2

Posology and method of administration

Text edited:

To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface.

 

4.5

Interaction with other medicinal products and other forms of interaction

 

Text edited:

No interaction studies have been performed

 

4.6

Pregnancy and lactation

Text edited:

Brimonidine:

There are no adequate data from the use of brimonidine tartrate in pregnant women. Studies in animals have shown reproductive toxicity at high maternotoxic doses (see section 5.3 Preclinical safety data). The potential risk for humans is unknown.

 

Timolol:

Studies in animals have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see 5.3). However, epidemiological studies have not revealed malformative effects but have shown a risk for intra uterine growth retardation when beta‑blockers are administered by the oral route. In addition, signs and symptoms of beta‑blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. Therefore, if Combigan is administered in pregnancy up to the time of delivery, the neonate should be carefully monitored during the first days of life.

 

 

4.8

Undesirable effects

Deleted text:

Brimonidine

Vascular disorders: hypotension

 

 

5.3

Pre-clinical safety data

Text edited:

The ocular and systemic safety profile of the individual components is well established. Pre-Non-clinical data reveal no special hazard for humans based on conventional studies of the individual components in safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenicity studies.

 

10

Date of revision of the text

26 February 2009

 

 

Key:

 

Words added within the text are in red and underlined eg (see section 4.3).

 

Words deleted are struck through eg hypotension

 

Updated on 7 May 2009 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects

Updated on 1 September 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 28 August 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 28 May 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Summary of Changes to Combigan® UK Summary of Product Characteristics (SPC)

 

The current Combigan® SPC is dated May 2008

This supersedes SPC dated February 2006

 

 

Section Number

Subject

Change

4.2

 

Posology and method of administration

Text edited:

Combigan is contraindicated in neonates and infants (less than 2 years of age).

 

Text edited:

The safety and effectiveness of Combigan in children and adolescents (2 to 17 years of age) have not been established and therefore, its use is not recommended in children or adolescents (see also section 4.4 and section 4.8).

 

4.3

Contraindications

Text edited:

§           Use in neonates and infants (less than 2 years of age) (see section 4.8)

 

 

4.4

Special warnings and precautions for use

Text deleted:

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, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea have been reported in neonates and infants receiving brimonidine. Combigan is therefore contraindicated in these subjects (see section 4.3 Contraindications).

 

Text added:

The safety and effectiveness of Combigan in children and adolescents (2 to 17 years of age) have not been established (see section 4.2 and section 4.8).

 

 

4.8

Undesirable effects

Text edited:

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, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea have been reported in neonates and infants (less than 2 years of age) receiving brimonidine (see section 4.3).

 

A high incidence of somnolence has been reported in children of 2 years of age and above, especially those in the 2-7 age range and/or weighing < 20 Kg (see section 4.4).

 

Text deleted:

Should be treated with caution and closely monitored due to the high incidence of somnolence.

 

4.9

Overdose

Text edited:

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, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea have been reported in neonates and infants (less than 2 years of age) receiving brimonidine.

 

10

Date of revision of text

Amended to 7th May 2008.

 

 

Key:

 

Words added within the text are in red and underlined eg (see section 4.3).

Updated on 21 May 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Summary of Changes to Combigan® UK Summary of Product Characteristics (SPC)

 

The current Combigan® SPC is dated May 2008

This supersedes SPC dated February 2006

 

 

Section Number

Subject

Change

4.2

 

Posology and method of administration

Text edited:

Combigan is contraindicated in neonates and infants (less than 2 years of age).

 

Text edited:

The safety and effectiveness of Combigan in children and adolescents (2 to 17 years of age) have not been established and therefore, its use is not recommended in children or adolescents (see also section 4.4 and section 4.8).

 

4.3

Contraindications

Text edited:

§           Use in neonates and infants (less than 2 years of age) (see section 4.8)

 

 

4.4

Special warnings and precautions for use

Text deleted:

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, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea have been reported in neonates and infants receiving brimonidine. Combigan is therefore contraindicated in these subjects (see section 4.3 Contraindications).

 

Text added:

The safety and effectiveness of Combigan in children and adolescents (2 to 17 years of age) have not been established (see section 4.2 and section 4.8).

 

 

4.8

Undesirable effects

Text edited:

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, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea have been reported in neonates and infants (less than 2 years of age) receiving brimonidine (see section 4.3).

 

A high incidence of somnolence has been reported in children of 2 years of age and above, especially those in the 2-7 age range and/or weighing < 20 Kg (see section 4.4).

 

Text deleted:

Should be treated with caution and closely monitored due to the high incidence of somnolence.

 

4.9

Overdose

Text edited:

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, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea have been reported in neonates and infants (less than 2 years of age) receiving brimonidine.

 

10

Date of revision of text

Amended to 6th May 2008.

 

 

Key:

 

Words added within the text are in red and underlined eg (see section 4.3).

Updated on 14 May 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 September 2006 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 1 September 2006 PIL

Reasons for updating

  • New PIL for new product