Alphagan

  • Name:

    Alphagan

  • Company:
    info
  • Active Ingredients:

    brimonidine tartrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/02/15

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/2/2015
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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 16 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 February 2015 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

To update Irish Medicines Board (IMB) name to Health Products Regulatory Authority (HPRA) in sec. 4.8 of the SPC

Updated on 12 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 30 July 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

The following wording have been added to the sec. 4.8 of the SPC:

 

(..)

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

 

Updated on 23 July 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to marketing authorisation holder

Updated on 21 July 2011 SmPC

Reasons for updating

  • 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 4.8 - 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 ALPHAGAN® IE Summary of Product Characteristics (SPC)

 

The current ALPHAGAN® SPC is dated 30th September 2010

This supersedes SPC dated 28th February 2008

 

 

Section Number

Subject

Change

4.4

Special warning and precautions for use

Text Added/Removed

 

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 Alphagan (see section 4.8 for details). If allergic reactions are observed, treatment with Alphagan should be discontinued.

 

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

 

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

 

Alphagan has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.

 

The preservative in Alphagan, 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 interactions

Text Added/Removed

 

Alphagan 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 Alphagan, 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 Alphagan 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 Alphagan, 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 Alphagan.

 

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).

 

 

4.8

Undesirable effects

Text Removed/Text Added

 

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 including allergic reactions (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 (anterior uveitis)

-               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 Alphagan 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

 

Immune systemSkin 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 Alphagan 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).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.9

Overdose

Ophthalmic overdose (Adults):

 

There is no experience in adults with the unlikely case of an overdosage via the ophthalmic route.  However, symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving Alphagan as part of medical treatment of congenital glaucoma.

 

In those cases received, the events reported have generally been those already listed

as adverse reactions.

 

Systemic overdose resulting from accidental ingestion:

 

Two cases of adverse effects following inadvertent ingestion of 9-10 drops of Alphagan by adult subjects have been received. The subjects experienced a hypotensive episode, followed in one instance by rebound hypertension approximately 8 hours after ingestion. Both subjects were reported to have made a full recovery within 24 hours. No adverse effects were noted in a third subject who also ingested an unknown amount of Alphagan orally.

 

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 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.

 

 

 

10

DATE OF REVISION OF THE TEXT

Text Removed/Added

 

02/2008 09/2010

 

 

 

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 20 July 2011 PIL

Reasons for updating

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

Updated on 21 February 2011 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 1 September 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 28 March 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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

 

Section Number

Subject

Change

2

Qualitative and quantitative composition

Word “Excipient(s)” inserted before “Contains benzalkonium chloride 0.05 mg/ml.”

4.2

 

Posology and method of administration

Wording change:

Use in children and neonates

 

Replaced with

Use in paediatric subjects

 

Following text added:

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

 

Words inserted:

Alphagan 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). 

 

4.3

Contraindications

Words inserted:

Neonates and infants (see section 4.8)

 

4.4

Special warnings and precautions for use

Text deleted:

Symptoms of brimonidine overdose have been reported in a few neonates receiving Alphagan as part of medical treatment of congenital glaucoma.

 

Text added:

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 of somnolence (see section 4.8).

 

4.7

Effects on ability to drive and use machines

Text added:

The patient should wait until these symptoms have cleared before driving or using machinery.

 

4.8

Undesirable effects

Punctuation:

a) deleted

 

Section restructured and summary of “common etc” definitions included at beginning:

 

New 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).

 

Restructured text:

 

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 including allergic reactions (hyperaemia, burning and                stinging, pruritus, foreign body sensation, conjunctival follicles)

-             blurred vision

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 (anterior uveitis)

-             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

 

 

Text deleted:

 

c) Symptoms of brimonidine overdose such as hypotension, bradycardia, hypothermia and apnea have been reported in a few neonates receiving Alphagan as part of medical treatment of congenital glaucoma.

 

Text added:

 

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 (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 Alphagan 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).

4.9

Overdose

New information inserted / punctuation amendments

 

Old Text:

Ophthalmic overdose:

There is no experience in adults with the unlikely case of an overdosage via the ophthalmic route.  However, symptoms of brimonidine overdose such as hypotension, bradycardia, hypothermia and apnea have been reported in a few neonates receiving Alphagan as part of medical treatment of congenital glaucoma.

Systemic overdose resulting from accidental ingestion:

One report of accidental human adult ingestion of Alphagan has been received.  The patient ingested about 10 drops of Alphagan.  He experienced a hypotensive episode a few hours after the ingestion and then a rebound hypertension approximately 8 hours after ingestion.

Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnea, hypotonia, hypothermia, respiratory depression and seizure.

 

New text:

Ophthalmic overdose:

There is no experience in adults with the unlikely case of an overdosage via the ophthalmic route.  However, symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving Alphagan as part of medical treatment of congenital glaucoma.

 

Systemic overdose resulting from accidental ingestion:

Two cases of adverse effects following inadvertent ingestion of 9-10 drops of Alphagan by adult subjects have been received. The subjects experienced a hypotensive episode, followed in one instance by rebound hypertension approximately 8 hours after ingestion. Both subjects were reported to have made a full recovery within 24 hours. No adverse effects were noted in a third subject who also ingested an unknown amount of Alphagan orally.

 

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, hypotonia, bradycardia, hypothermia 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.

 

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

6.1

List of excipients

Text added:

 

Hydrochloric acid (for pH-adjustment) or

Sodium hydroxide (for pH-adjustment)

 

6.3

Shelf Life

Text deleted:

After first opening:                  Use within 28 days.

 

6.5

Nature and contents of container

Text deleted / added:

 

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

 

10

Date of revision of text

Amended to 28th February 2008

 

 

 

Updated on 30 August 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

 

All

 

® Removed throughout document

2

Qualitative and Quantitative composition

Text updated

One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

Contains benzalkonium chloride 0.05 mg/ml.

For a full list of excipients, see section 6.1.

Replaces

Brimonidine [(R,R)-tartrate] 0.2% (2.0 mg/ml)

(equivalent to brimonidine base 0.13%, 1.3 mg/ml)

1 drop of Alphaganâ = approximately 35 ml = 70 mg brimonidine tartrate

For excipients, see 6.1.

4.2

Posology and method of administration

Text added

The following heading were added

Recommended dosage in adults

Use in renal and hepatic impairment

Use in children and neonates

Text updated

Alphagan is not recommended for use in children below 12 years and is contraindicated in neonates (see sections 4.3, 4.4 and 4.9) replaces Alphaganâ should not be used in neonates and is not recommended for use in children (see Section 4.3 Contra-indications; Section 4.4 Special warning and precautions for use and Section 4.9 Overdose). 

4.3

Contraindications

Text updated

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

·         Neonates.

·         Patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin).

Replaces

Alphaganâ is contraindicated for use in neonates and in patients with hypersensitivity to brimonidine tartrate or any component of this medication.  Alphaganâ is also contra-indicated in 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

Heading updated (in red)

Special warnings and precautions for use

Text added

Avoid contact with soft contact lenses

4.8

Undesirable effects

Text updated

Heading Eye disorders replaces Ocular effects

 

Text

Immune system disorders

Uncommon (>1/1,000 and <1/100): systemic allergic reactions

 

Psychiatric disorders

Uncommon (>1/1,000 and <1/100): depression

Very rare (<1/10,000): insomnia

 

Nervous system disorders

Very common (>1/10): headache, drowsiness

Common (>1/100 and <1/10): dizziness, abnormal taste

Very rare (<1/10,000): syncope

 

Cardiac disorders

Uncommon (>1/1,000 and <1/100): palpitations/arrhythmias (including bradycardia and tachycardia)

 

Vascular disorders

Very rare (<1/10,000): hypertension, hypotension

 

Respiratory, thoracic and mediastinal disorders

Common (>1/100 and <1/10): upper respiratory symptoms

Uncommon (>1/1,000 and <1/100): nasal dryness

Rare (>1/10,000 and <1/1,000): dyspnoea

 

Gastrointestinal disorders

Very common (>1/10): oral dryness

Common (>1/100 and <1/10): gastrointestinal symptoms

 

General disorders and administration site conditions

Very common (>1/10): fatigue

Common (>1/100 and <1/10): asthenia

Replaces

Systemic effects        

Very Common:(>1 in 10)       

Headache

Oral dryness

Fatigue/drowsiness

 

Common:(>1 in 100 and <1 in 10)    

Upper respiratory symptoms

Dizziness

Gastrointestinal symptoms

Asthenia

Abnormal taste

 

Uncommon:(>1 in 1,000 and<1 in 100)        

Palpitations/arrythmias (including bradycardia and tachycardia)

Systemic allergic reactions

Depression

Nasal dryness

 

Rare:(>1 in 10,000 and<1 in 1,000)

Dyspnoea

 

Very Rare:(<1 in 10,000)       

Syncope

Hypertension

Hypotension

Insomnia

5.1

Pharmacodynamic properties

Text added

Pharmacotherapeutic group: Sympathomimetics in glaucoma therapy

5.3

Preclinical safety data

Text updated

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.

Replaces

The available mutagenicity and carcinogenicity data indicate that Alphaganâ will exert neither mutagenic nor carcinogenic activities under the conditions of clinical use

6.1

List of excipients

Text updated

Poly(vinyl alcohol) replaces Polyvinyl alcohol

Sodium citrate replaces Sodium citrate, dehydrate

Sodium hydroxide for pH adjustment replaces Sodium hydroxide to adjust pH

6.6

Special precautions for disposal of a medicinal product or waste materials derived from such medicinal product and other handling of the product

Heading changed

Special precautions for disposal of a medicinal product or waste materials derived from such medicinal product and other handling of the product replaces Instructions for use and handling

 

9

Date of first authorization/Renewal of the authorisation

Text updated

Date of first authorisation: 14 November 1997

Date of last renewal: 17 September 2006

Replaces 14th November 1997/17th March 2002

 

10

Date of revision of text

Text updated

June 2007 replaces 18th April 2005

 

 

Updated on 28 August 2007 PIL

Reasons for updating

  • Addition of marketing authorisation holder
  • Change of contraindications
  • Change to improve clarity and readability
  • Change to date of revision

Updated on 10 August 2005 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 16 May 2005 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 26 August 2003 SmPC

Reasons for updating

  • 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)

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for new product

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