Betagan

  • Name:

    Betagan

  • Company:
    info
  • Active Ingredients:

    Levobunolol hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/01/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 19/12/2018

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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 19 December 2018 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 19 December 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 19 December 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

In section 6.5 (nature and contents of container), packs presentation updated to two strips of 5 vials per pouch.

In section 10 (date of revision of the text), the revised date was updated to August 2018

Updated on 31 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 January 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.8 (undesirable effects), foreign body sensation in eyes, alopecia and immune system disorders (hypersensitivity reaction including symptoms or signs of eye allergy and skin allergy) were added.  In additional adverse reactions with other ophthalmic beta-blockers, alopecia was removed.


In section 10 (date of the revision of the text), the revised date of December 2017 was added.

Updated on 29 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 January 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 December 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

IMB name change to HPRA

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 June 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.8 has been amended to read the below :

Adverse reactions reported in eye drops containing phosphates:

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

 

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;

           

            IMB Pharmacovigilance

            Earlsfort Terrace

            IRL - Dublin 2

            Tel: +353 1 6764971

            Fax: +353 1 6762517

            Website: www.imb.ie

            e-mail: imbpharmacovigilance@imb.ie

Section 10 has been amended with date June 2014.

Updated on 23 June 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 17 May 2013 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 4.8 - Undesirable effects
  • 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

Update to SmPC to align with Core Safetly Profile for levobunolol. Major restructing of text presented in sections 4.2, 4.4, 4.5, 4.6 and 4.8.

Updated on 14 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 26 July 2011 SmPC

Reasons for updating

  • 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 Betagan MD Summary of Product Characteristics (SPC)

 

The current Betagan MD SPC is dated 17th August 2010

This supersedes SPC dated  29th September 2009

 

Section Number

Subject

Change

10

DATE OF REVISION OF THE TEXT

Text Removed/Added

 

09/2009 08/2010

 

 

 

Key:

Unchanged text appears as follows: eg Paediatric population

Added text appears as follows: eg Uveitis

Deleted (Removed) text appears as follows: eg Not applicable

Updated on 14 October 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 14 October 2009 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 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 Betagan® ® Irish Summary of Product Characteristics (SPC)

 

The current Betagan® SPC is dated 29th September  2009

This supersedes SPC dated 22nd October 2008

 

 

Section Number

Subject

Change

4.2

Posology and method of administration

Text deleted

Concurrent therapy may be used where necessary.

 

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) for one minute. This should be performed immediately following the instillation of each drop.

 

Text added

If required, Betagan may be used with other agents to lower intra-ocular pressure. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.4).

 

Intraocular pressure should be measured approximately four weeks after starting treatment with Betagan as a return to normal ocular pressure can take a few weeks.

 

 

 

4.3

Contraindications

Revised Text

Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.    

 

Sinus bradycardia, second and third-degree atrioventricular block not controlled with a pace maker, overt cardiac failure or cardiogenic shock.

 

Replaces

Bronchial asthma (or a history of bronchial asthma) or chronic obstructive pulmonary disease.        

 

Uncontrolled cardiac failure.

 

History of sinus bradycardia, second and third-degree atrioventricular block, overt cardiac failure or cardiogenic shock.

 

 

 

 

 

 

 

 

 

4.4

Special warnings and precautions for use

Revised Text

Like other topically applied ophthalmic agents, Betagan may be absorbed systemically so the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur.

 

Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease including first degree atrioventricular block. Cardiac failure should be adequately controlled before beginning therapy. Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked.

 

Cardiac and respiratory reactions, including death due to bronchospasm in patients with asthma, and, rarely, death in association with cardiac failures have been reported following administration of levobunolol.

 

The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be exaggerated when Betagan is given to 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.

 

In patients with angle closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic. Betagan has little or no effect on the pupil. When Betagan is used to reduce elevated intra-ocular pressure in angle-closure glaucoma it should be used with a miotic and not alone.

 

In patients with severe renal impairment on dialysis, treatment with levobunolol has been associated with pronounced hypotension.

 

Levobunolol may impair compensatory tachycardia and increase risk of hypotension when used in conjunction with anaesthetics. The anaesthetist must be informed if the patient is using Betagan.

 

Beta-blockers may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension. Betagan must be used with caution in patients with metabolic acidosis and untreated phaeochromocytoma.

 

Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycaemia or to uncontrolled diabetic patients (especially those with labile diabetes) as beta-blockers may mask the signs and symptoms of acute hypoglycaemia. The indicatory signs of acute hypoglycaemia may be masked, in particular tachycardia, palpitations and sweating.

 

Betagan should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

 

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

 

As with systemic beta-blockers, if discontinuation of treatment is needed in patients with coronary heart disease, therapy should be withdrawn gradually to avoid rhythm disorders, myocardial infarction or sudden death.

 

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

 

In patients with chronic eye inflammation and corneal dystrophy Betagan should only be applied in the event of stringent diagnosis & under continuous monitoring at short intervals.

 

Skin rashes and/or dry eyes associated with the use of beta-blockers have been reported. The incidence is small and symptoms have stopped on withdrawal of the beta-blockers. Discontinuation of the use of beta blockers should be considered if these symptoms are reported but cessation of treatment should be gradual.

 

The preservative in Betagan, benzalkonium chloride, may cause eye irritation. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses.

 

Betagan contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm. 

 

Athletes should be aware that Betagan contains levobunolol that may induce a positive result in anti-doping controls.

 

Replaces

As with other topically applied ophthalmic drugs, Betagan may be absorbed

systemically and adverse reactions typical of oral beta-adrenoceptor agents may occur.

Respiratory and cardiac reactions have been reported including, rarely, death due to bronchospasm or associated with cardiac failure.

 

Congestive heart failure should be adequately controlled before beginning therapy with Betagan. In patients with a history of significant cardiac disease, pulse rates should be monitored.

 

Because these agents may block the systemic effects of hypoglycaemia they should be used with caution in diabetic patients who use insulin or oral hypoglycaemic drugs.

 

Stevens-Johnson syndrome has been reported following the use of levobunolol; however a causal relationship has not been established.

 

Beta-blockers have been associated with alopecia; however, a causal relationship between levobunolol and alopecia has not been established.

 

The preservative in Betagan, 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. Benzalkonium chloride is known to discolour soft contact lenses.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.5

Interactions with other medicinal products and other forms of interaction 

Revised text

No interaction studies have been performed

 

Although specific drug interactions studies have not been conducted with Betagan, the theoretical possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. 

 

There is potential for additive effects resulting in hypotension, and/or marked bradycardia when eye drops with levobunolol are administered concomitantly with oral calcium channel blockers, Rauwolfia alkaloids, guanethidine, beta-blocking agents, anti‑arrhythmics, digitalis glycosides or parasympathomimetics.

 

Caution should be exercised and patients must be monitored when Betagan is used concomitantly with oral beta-adrenergic blocking agents, because of the potential for additive effects on systemic blockade. 

 

Enhanced hypotensive effect is seen when baclofen is given with beta‑blockers. Since some systemic absorption may follow topical application of beta-blockers, regular blood pressure monitoring is advised.

 

Although levobunolol has little effect on the size of the pupil mydriasis has occasionally been reported when levobunolol has been used with mydriatic agents such as adrenaline.

 

Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4)

 

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.

 

Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with quinidine and levobunolol, possibly because quinidine inhibits the metabolism of levobunolol via the P450 enzyme, CYP2D6.

 

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 Betagan.

 

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

 

Cimetidine may increase the plasma concentrations of levobunolol.

 

No data on the level of circulating catecholamines after Betagan 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 because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope or postural hypotension.

 

Although specific drug interactions studies have not been conducted with Betagan, known additive IOP lowering effect with prostamides, prostaglandins, alpha-agonists, carbonic anhydrase inhibitors and pilocarpine should be considered.

 

Replaces

Additive effects may be noted if the product is used in patients taking systemic

antihypertensive drugs. These possible additive effects may include hypotension,

including orthostatic hypotension, bradycardia, dizziness, and/or syncope. Conversely,

systemic beta-adrenoceptor blocking agents may potentiate the ocular hypotensive

effect of Betagan.

 

4.6

Pregnancy and Lactation

Revised Text

Pregnancy

 

There are no adequate data for the use of Betagan in pregnant women. Betagan should not be used during pregnancy unless clearly necessary.

 

Epidemiological studies have not revealed malformative effects but show 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. If Betagan is administered until delivery, the neonate should be carefully monitored during the first days of life. Animal studies with levobunolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice.

 

Lactation

 

Levobunolol is excreted in breast milk. Betagan should not be used by breast-feeding women.

 

 

Replaces

For levobunolol hydrochloride no clinical data on exposed pregnancies are available.

Betagan should not be used during pregnancy unless clearly necessary.

 

If treatment with levobunolol hydrochloride during lactation is considered necessary for the benefit of the mother, consideration should be given to the cessation of breast feeding.

 

 

4.7

Effects on Ability to Drive and use Machines

Revised Text

Betagan has minor influence on the ability to drive and use machines. Betagan may cause transient blurring of vision, 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.

 

Replaces

Betagan may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery.

 

Betagan may cause blurred and/or abnormal vision, which may also 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

Deleted Text:

Immune System Disorders

Not known: Hypersensitivity

 

Revised text

Eye Disorders

Very Common: Eye irritation, Conjunctival irritation

Common: Blepharitis, Conjunctivitis

Not known: Corneal reflex decreased, Iridocyclitis, Keratitis, Visual disturbance, Eye/Eyelids pruritus, Eye/Eyelid oedema, Eye discharge, Lacrimation increased, Ocular hyperaemia., dry eye

 

Revised Text

General Disorders and Administration Site Conditions

Not known: Face oedema, Fatigue

 

The following events have been reported with systemic beta‑blocker formulations and may occur with the topical formulation:

Nervous System Disorders: Sleep disturbance

Psychiatric disorders: Impotence, hallucinations, nightmares

Cardiac Disorders: Cardiac failure,

Vascular disorders: Cold extremities, Raynaud’s phenomenon, worsening intermittent claudication

Gastrointestinal Disorders: Abdominal pain upper, vomiting, diarrhea

Respiratory, Thoracic, and Mediastinal Disorders: Bronchospasm,

Endocrine disorders: Hypoglycaemia

Skin and Subcutaneous Tissue Disorders: Angioedema (Quincke’s oedema), cutaneous (see section 4.4) and psoriasis-like symptom

 

 

Replaces

General Disorders and Administration Site Conditions

Not known: Face oedema, Asthenia

 

The following additional adverse reactions have been reported with ophthalmic use of beta1 and beta2 (non-selective) blocking agents.

 

Cardiovascular: cerebrovascular accident, cerebral ischaemia, congestive heart failure, cardiac arrest.

 

Respiratory: respiratory failure.

 

 

 

 

 

 

 

 

 

10

Date of (partial) revision of text

Updated text

29 September 2009

 

Replaces

22nd October 2008

 

 

 

Updated on 13 November 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 Betagan Irish Summary of Product Characteristics (SPC)

 

The current Betagan SPC is dated 22nd October 2008

This supersedes SPC dated March 2006

 

 

Section Number

Subject

Change

2

Qualitative and quantitative composition

Revised text:

One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol.

 

Excipient(s): Contains benzalkonium chloride 0.04 mg/ml.

 

Replaces:

Levobunolol hydrochloride 0.5% w/v

 

3

Pharmaceutical form

Revised Text:

 A clear, viscous, sterile, colourless to light yellow eye drops solution.

4.2

Posology and method of administration

Revised Text:

Adults (including the elderly): the recommended dosage is one drop of Betagan in the affected eye(s) once or twice daily.

 

Betagan is not recommended for use in children due to lack of safety and efficacy data (see section 5.1).

           

Concurrent therapy may be used where necessary.

 

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) for one minute. This should be performed immediately following the instillation of each drop.

 

Replaces:

Adults (including the elderly): the recommended dosage of Betagan is one drop in the affected eye(s) once or twice daily.

 

Children: use in children is not currently recommended.

 

4.3

Contraindications

Revised Text:

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

 

Bronchial asthma (or a history of bronchial asthma) or chronic obstructive pulmonary disease.         

 

Uncontrolled cardiac failure.

 

History of sinus bradycardia, second and third-degree atrioventricular block, overt cardiac failure or cardiogenic shock.

 

Replaces:

1.         Betagan is contraindicated in patients with severe chronic obstructive

pulmonary disease, bronchospasm, including bronchial asthma, and  uncontrolled        congestive heart failure.

 

2.         Betagan is also contraindicated in those individuals who are hypersensitive to any constituent of this product.

 

3.         History of bronchial asthma, sinus bradycardia, second and third-degree          AV block, overt cardiac failure, cardiogenic shock.

 

4.4

Special warnings and precautions for use

Revised Text:

As with other topically applied ophthalmic drugs, Betagan may be absorbed systemically and adverse reactions typical of oral beta-adrenoceptor agents may occur.

 

Respiratory and cardiac reactions have been reported including, rarely, death due to bronchospasm or associated with cardiac failure.

 

Congestive heart failure should be adequately controlled before beginning therapy with Betagan. In patients with a history of significant cardiac disease, pulse rates should be monitored.

 

Because these agents may block the systemic effects of hypoglycaemia they should be used with caution in diabetic patients who use insulin or oral hypoglycaemic drugs.

 

Stevens-Johnson syndrome has been reported following the use of levobunolol; however a causal relationship has not been established.

 

Beta-blockers have been associated with alopecia; however, a causal relationship between levobunolol and alopecia has not been established.

 

The preservative in Betagan, 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. Benzalkonium chloride is known to discolour soft contact lenses.

 

 

Replaces:

1          As with other topically applied ophthalmic drugs, Betagan may be absorbed

systemically. The product should only be used with great caution in patients with a family or personal history of asthma, heart block, sinus or bradycardia.

 

2          Congestive heart failure should be adequately controlled before beginning therapy with Betagan. In patients with a history of significant cardiac disease, pulse rates should be monitored.

 

3          Respiratory and cardiac reactions, including death due to bronchospasm

in patients with asthma and, rarely, death associated with cardiac failure have  been reported with non-selective beta-blockers. Because these agents may block the systemic effects of hypoglycaemia they should be used with caution in diabetic patients who use insulin or oral hypoglycaemic drugs.

 

4.6

Pregnancy and lactation

Revised Text:

For levobunolol hydrochloride no clinical data on exposed pregnancies are available.

Betagan should not be used during pregnancy unless clearly necessary.

 

If treatment with levobunolol hydrochloride during lactation is considered necessary for the benefit of the mother, consideration should be given to the cessation of breast feeding.

 

Replaces:

The product should not be used during pregnancy or lactation unless considered essential by the physician.

 

4.7

Effects on ability to drive and use machines

Revised Text:

Betagan may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery.

 

Betagan may cause blurred and/or abnormal vision, which may also 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.

 

Replaces:

None known.

 

4.8

Undesirable effects

Revised Text:

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).

 

Immune System Disorders

Not known: Hypersensitivity

 

Psychiatric Disorders

Not known: Depression

 

Nervous System Disorders

Not known: Ataxia, Confusion, Dizziness, Somnolence, Lethargy, Headache

 

Eye Disorders

Very Common: Eye irritation, Conjunctival irritation

Common: Blepharitis, Conjunctivitis

Not known: Corneal reflex decreased, Iridocyclitis, Keratitis, Visual disturbance, Eye/Eyelids pruritus, Eye/Eyelid oedema, Eye discharge, Lacrimation increased, Ocular hyperaemia.

 

Cardiac Disorders

Not known: Syncope, Bradycardia, Atrioventricular block, Palpitations

 

Vascular Disorders

Not known: Hypotension

 

Respiratory, Thoracic, and Mediastinal Disorders

Not known: Asthma, Dyspnoea, Throat irritation, Nasal discomfort

 

Gastrointestinal Disorders

Not known: Nausea

 

Skin and Subcutaneous Tissue Disorders

Not known: Urticaria, Dermatitis, Rash, Erythema, Skin exfoliation, Lichenoid keratosis, Pruritus

 

General Disorders and Administration Site Conditions

Not known: Face oedema, Asthenia

 

The following additional adverse reactions have been reported with ophthalmic use of beta1 and beta2 (non-selective) blocking agents.

 

Cardiovascular: cerebrovascular accident, cerebral ischaemia, congestive heart failure, cardiac arrest.

 

Respiratory: respiratory failure.

 

Replaces:

Ocular:            Transient ocular burning, stinging and itching, blepharoconjunctivitis (including blepharitis and conjunctivitis), visual disturbances, conjunctival hyperaemia and eyelid oedema.

 

Cardiovascular:           Decreased heart rate, decreased blood pressure and change in heart rhythm.

 

Gastrointestinal:Nausea.

 

Immune system: Hypersensitivity / allergic reactions (systemic and ocular).

 

Nervous system:Asthenia, headache, dizziness and depression.

 

Skin:Urticaria.

 

The following additional adverse reactions have been reported with ophthalmic use of

beta1 and beta2 (non-selective) blocking agents.

 

Ocular: Keratitis and decreased corneal sensitivity.

 

Cardiovascular: Syncope, heart block, cerebrovascular accident, cerebral ischaemia, congestive heart failure, palpitation, cardiac arrest.

 

Respiratory: bronchospasm, respiratory failure.

 

4.9

Overdosage

Text Inserted:

There are no data available on human overdosage with Betagan, which is unlikely to occur via the ocular route. Should accidental ocular overdosage occur, flush the eye(s) with water or normal saline. If accidentally ingested, systemic symptoms may result and efforts to decrease further absorption may be appropriate. The symptoms associated with systemic overdosage are most likely to be bradycardia, hypotension, bronchospasm and cardiac failure. Therapy for overdosage of a beta-adrenergic agent should be instituted, such as intravenous administration of atropine sulphate 0.25 to 2 mg to induce vagal blockade. Conventional therapy for hypotension, bronchospasm, heart block and cardiac failure may be necessary.

 

5.1

Pharmacodynamic properties

Text Inserted:

Safety and effectiveness of Betagan in paediatric patients have not been established

 

Betagan has shown to be as effective as Timolol in lowering intraocular pressure.

 

The higher the level of intraocular pressure, the likelihood of optic nerve damage and visual field loss.

 

The blurred vision and night blindness often associated with miotics would not be expected with the use of Betagan.  Patients with cataracts avoid the inability to see around lenticular opacities caused by pupil constriction.

 

5.2

Pharmacokinetic properties

Text added:

A significant decrease can be maintained for up to 24 hours following a single dose.

 

5.3

Preclinical safety data

Not applicable replaces N/A

6.4

Special precautions for storage

Revised Text:

Keep the bottle in the outer carton in order to protect from light.

 

Replaces:

Store the bottle in the original package.

 

6.5

Nature and contents of container

Revised Text:

Bottle and dropper tip made of low density polyethylene. The cap is either a "traditional", high impact, polystyrene cap or a high impact, polystyrene compliance cap (C-Cap) with an external rotating sleeve indicating daily dosage status. Both have a safety seal to ensure integrity.

10 ml bottles.

 

Replaces:

10 ml white bottle and dropper tip made of low density polyethylene. The cap is either a "traditional" green or white, medium impact, polystyrene cap or a white, medium impact, polystyrene compliance cap (C-Cap) with an external rotating sleeve indicating daily dosage status. Both have a safety seal to ensure integrity. The bottle is filled with either 5 or 10 ml of Betagan.

 

10

Date of (partial) revision of the text

22nd October 2008 replaces 23rd March 2006

 

 

Updated on 10 November 2008 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 2 September 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 1 September 2006 PIL

Reasons for updating

  • Change to date of revision
  • Change to storage instructions

Updated on 1 September 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • 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

 
4.8 - Ocular information altered. Under Cardiovascular - radycardia and hypotension deleted. Body as a whole: asthenia, nausea, depression deleted.
 
6.1 - dihydrogen replaced monobasic (in Potassium dihydrogen phosphate)
 
6.2 - major incompatibilities have been reported has been deleted.
 
6.3 - the shelf-life for the unopened product is 24 months. once opened the shelf-life for the product is one month has been replace with upopened: 2 years. After first opening: 1 month.
 
6.4 - Protect from light has been replaced with store the bott;e in the original packaging.
 
9 - date has been updated to 5th MArch 1985/5 March 2005
 
10 - date has been updated to 23rd March 2006
 

Updated on 16 August 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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