Piriton 4 mg Tablets

  • Name:

    Piriton 4 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Chlorphenamine Maleate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/08/19

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Summary of Product Characteristics last updated on medicines.ie: 14/8/2019

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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Medicine Name Nicotinell TTS 20, 14 mg/24 hour Transdermal Patch Active Ingredients Nicotine
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Medicine Name Night Nurse Capsules Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Night Nurse Cold Remedy Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
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1 - 0 of 52 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 30 August 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 August 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Updated on 10 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 10 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 10 July 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 22 May 2015 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 - Addition of HPRA reporting statement

Updated on 22 May 2015 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.8 - Addition of HPRA reporting statement

Updated on 30 November 2012 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

In section 3, the pharmaceutical form has been changed from a biconvex tablet with a breakline on one face of the tablet to a biconvex tablet with a breakline on both sides of the tablet.

Updated on 30 November 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 3, the pharmaceutical form has been changed from a biconvex tablet with a breakline on one face of the tablet to a biconvex tablet with a breakline on both sides of the tablet.

Updated on 12 September 2011 PIL

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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

4.2       Posology and Method of Administration

Do not exceed the stated dose or frequency of dosing.

 

Adults and children 12 years and over:

The usual dose is 4mg (1 tablet) every 4 - 6 hours with a maximum of 24mg (6 tablets) in 24 hours.

The usual dose is 1 tablet every 4 - 6 hours (maximum of 6 tablets in 24 hours).

 

In the elderly:

The usual dose is 4 mg (1 tablet) every 4 - 6 hours (3 tablets).

The usual dose is 1 tablet every 4 - 6 hours (maximum of 3 tablets in 24 hours).

Dosage should be as low as possible in view of greater susceptibility to anticholinergic central nervous system effects with a maximum of 12mg (3 tablets) in 24 hours.

 

Children 6 - 12 years:

The usual dose is 0.1mg/kg or 2mg (½ tablet) every 4 - 6 hours with a maximum of 12mg (3 tablets) in 24 hours.

The usual dose is 0.1mg/kg or ½ a tablet every 4 - 6 hours (maximum of 6 half tablets in 24 hours).

 

Children under 6 years:

Not recommended for children under the age of 6 years.

 

Renal impairment population

Medical advice should be sought for those with severe renal impairment.

 

Hepatic impairment population

Medical advice should be sought for those with severe hepatic impairment.

 

4.4       Special Warnings and Special Precautions for Use

Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

 

The effects of alcohol may be increased.

 

Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy, severe hypertension and cardiovascular disease, raised intra-ocular pressure including glaucoma; prostatic hypertrophy, severe hepatic impairment, severe renal impairment, bronchitis, thyrotoxicosis, bronchiectasis and bronchial asthma.

 

Chlorphenamine may increase the effects of alcohol and therefore concurrent use should be avoided.

 

Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

 

Should not be used with other anti-histamine containing products, including anti-histamine containing cough and cold preparations.

The effects of alcohol may be increased.  In common with other drugs having anticholinergic effects, chlorphenamine should be used with caution in epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, bronchitis, bronchiectasis, thyrotoxicosis, raised intra-ocular pressure, severe hypertension or cardiovascular disease and bronchial asthma. 

Keep out of the reach and sight of children.

 

4.8       Undesirable Effects

Blood and lymphatic system disorders

Very rare:                    Haemolytic anaemia, thrombocytopenic purpura. Other blood dyscrasias including agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leucopenia and thrombocytopenia.

 

Cardiac disorders

Very rare:        Arrythmias, palpitations and tachycardia.

 

Ear and labyrinth disorders

Very rare:        Tinnitus

 

Eye disorders

Very rare:        Blurred vision

 

Gastrointestinal disorders

Very rare:        Abdominal pain, diarrhea, dryness of mouth, dyspepsia, nausea and vomiting.

 

General disorders and administration site conditions

Very rare:        Lassitude and tightness of chest.

 

Hepatobiliary disorders

Very rare:        Hepatitis including jaundice

 

Immune system disorders

Very rare:        Allergic reactions.

 

Metabolism and nutrition disorders

Very rare:        Anorexia.

 

Musculoskeletal and connective tissue disorders

Very rare:        Twitching and muscular weakness

 

Nervous system disorders

Very rare:        Dizziness, headache, in-cordination, inability to concentrate and sedation.

 

Psychiatric disorders

Very rare:        Confusional psychosis, depression, irritability and nightmares.

 

Renal and urinary disorders

Very rare:        Urinary retention.

 

Respiratory thoracic and mediastinal disorders

Very rare:        Thickening of bronchial secretions.

 

Skin and subcutaneous tissue disorders

Very rare:                    Angioedema, exfoliative dermatitis, photosensitivity, skin reactions and urticaria.

 

Vascular disorders

Very rare:        Hypotension.

 

Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in ≥1% to <10% of subjects) or very common (occurring in ≥10% of subjects) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown.

 

Blood and Lymphatic system disorders:

Very rare: haemolytic anaemia, thrombocytopenic purpura. Other blood dyscrasias including agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leucopenia and thrombocytopenia

 

Hepatobiliary disorders

Very rare: hepatitis including jaundice

 

 Immune system disorders:

Unknown: allergic reactions, angioedema, anaphylactic reactions

 

Metabolism and nutritional disorders:

Unknown: anorexia

 

Psychiatric disorders:

Unknown: confusion*, excitation*, irritability*, nightmares*

 

Nervous system disorders*:

Very common: sedation, somnolence

Common: disturbance in attention, abnormal coordination, dizziness, headache

 

Eye disorders

Common: blurred vision

 

Vascular disorders:

Unknown: Hypotension

 

Respiratory, thoracic and mediastinal disorders:

Unknown: thickening of bronchial secretions

 

Gastrointestinal disorders:

Common: nausea, dry mouth

Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia

 

Skin and subcutaneous disorders:

Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity

 

 Musculoskeletal and connective tissue disorders:

Unknown: muscle twitching, muscle weakness

 

Renal and urinary disorders:

Unknown: urinary retention

 

General disorders and administration site conditions:

Common: fatigue

Unknown: chest tightness

 

*Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

 

4.9       Overdose

Symptoms and Signs

Overdose is likely to result in effects similar to those listed under adverse reactions.  

Convulsions and marked CNS stimulation should be treated with parenteral diazepam.

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

June 2006 August 2011

Updated on 12 September 2011 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

4.2       Posology and Method of Administration

Do not exceed the stated dose or frequency of dosing.

 

Adults and children 12 years and over:

The usual dose is 4mg (1 tablet) every 4 - 6 hours with a maximum of 24mg (6 tablets) in 24 hours.

The usual dose is 1 tablet every 4 - 6 hours (maximum of 6 tablets in 24 hours).

 

In the elderly:

The usual dose is 4 mg (1 tablet) every 4 - 6 hours (3 tablets).

The usual dose is 1 tablet every 4 - 6 hours (maximum of 3 tablets in 24 hours).

Dosage should be as low as possible in view of greater susceptibility to anticholinergic central nervous system effects with a maximum of 12mg (3 tablets) in 24 hours.

 

Children 6 - 12 years:

The usual dose is 0.1mg/kg or 2mg (½ tablet) every 4 - 6 hours with a maximum of 12mg (3 tablets) in 24 hours.

The usual dose is 0.1mg/kg or ½ a tablet every 4 - 6 hours (maximum of 6 half tablets in 24 hours).

 

Children under 6 years:

Not recommended for children under the age of 6 years.

 

Renal impairment population

Medical advice should be sought for those with severe renal impairment.

 

Hepatic impairment population

Medical advice should be sought for those with severe hepatic impairment.

 

4.4       Special Warnings and Special Precautions for Use

Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

 

The effects of alcohol may be increased.

 

Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy, severe hypertension and cardiovascular disease, raised intra-ocular pressure including glaucoma; prostatic hypertrophy, severe hepatic impairment, severe renal impairment, bronchitis, thyrotoxicosis, bronchiectasis and bronchial asthma.

 

Chlorphenamine may increase the effects of alcohol and therefore concurrent use should be avoided.

 

Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

 

Should not be used with other anti-histamine containing products, including anti-histamine containing cough and cold preparations.

The effects of alcohol may be increased.  In common with other drugs having anticholinergic effects, chlorphenamine should be used with caution in epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, bronchitis, bronchiectasis, thyrotoxicosis, raised intra-ocular pressure, severe hypertension or cardiovascular disease and bronchial asthma. 

Keep out of the reach and sight of children.

 

4.8       Undesirable Effects

Blood and lymphatic system disorders

Very rare:                    Haemolytic anaemia, thrombocytopenic purpura. Other blood dyscrasias including agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leucopenia and thrombocytopenia.

 

Cardiac disorders

Very rare:        Arrythmias, palpitations and tachycardia.

 

Ear and labyrinth disorders

Very rare:        Tinnitus

 

Eye disorders

Very rare:        Blurred vision

 

Gastrointestinal disorders

Very rare:        Abdominal pain, diarrhea, dryness of mouth, dyspepsia, nausea and vomiting.

 

General disorders and administration site conditions

Very rare:        Lassitude and tightness of chest.

 

Hepatobiliary disorders

Very rare:        Hepatitis including jaundice

 

Immune system disorders

Very rare:        Allergic reactions.

 

Metabolism and nutrition disorders

Very rare:        Anorexia.

 

Musculoskeletal and connective tissue disorders

Very rare:        Twitching and muscular weakness

 

Nervous system disorders

Very rare:        Dizziness, headache, in-cordination, inability to concentrate and sedation.

 

Psychiatric disorders

Very rare:        Confusional psychosis, depression, irritability and nightmares.

 

Renal and urinary disorders

Very rare:        Urinary retention.

 

Respiratory thoracic and mediastinal disorders

Very rare:        Thickening of bronchial secretions.

 

Skin and subcutaneous tissue disorders

Very rare:                    Angioedema, exfoliative dermatitis, photosensitivity, skin reactions and urticaria.

 

Vascular disorders

Very rare:        Hypotension.

 

Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in ≥1% to <10% of subjects) or very common (occurring in ≥10% of subjects) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown.

 

Blood and Lymphatic system disorders:

Very rare: haemolytic anaemia, thrombocytopenic purpura. Other blood dyscrasias including agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leucopenia and thrombocytopenia

 

Hepatobiliary disorders

Very rare: hepatitis including jaundice

 

 Immune system disorders:

Unknown: allergic reactions, angioedema, anaphylactic reactions

 

Metabolism and nutritional disorders:

Unknown: anorexia

 

Psychiatric disorders:

Unknown: confusion*, excitation*, irritability*, nightmares*

 

Nervous system disorders*:

Very common: sedation, somnolence

Common: disturbance in attention, abnormal coordination, dizziness, headache

 

Eye disorders

Common: blurred vision

 

Vascular disorders:

Unknown: Hypotension

 

Respiratory, thoracic and mediastinal disorders:

Unknown: thickening of bronchial secretions

 

Gastrointestinal disorders:

Common: nausea, dry mouth

Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia

 

Skin and subcutaneous disorders:

Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity

 

 Musculoskeletal and connective tissue disorders:

Unknown: muscle twitching, muscle weakness

 

Renal and urinary disorders:

Unknown: urinary retention

 

General disorders and administration site conditions:

Common: fatigue

Unknown: chest tightness

 

*Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

 

4.9       Overdose

Symptoms and Signs

Overdose is likely to result in effects similar to those listed under adverse reactions.  

Convulsions and marked CNS stimulation should be treated with parenteral diazepam.

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

June 2006 August 2011

Updated on 7 September 2011 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

Section 2: Addition of details of excipients
Section 3: Addition of instruction "the tablets can be divided into equal halves"

Updated on 7 September 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2: Addition of details of excipients
Section 3: Addition of instruction "the tablets can be divided into equal halves"

Updated on 6 July 2010 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

In section 6.1 (List of excipients) Lactose was changed to lactose monohydrate.

Updated on 6 July 2010 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 6.1 (List of excipients) Lactose was changed to lactose monohydrate.

Updated on 19 August 2008 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Section 6.5 Addition of sentence "Not all pack sizes may be marketed"

Updated on 19 August 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.5 Addition of sentence "Not all pack sizes may be marketed"

Updated on 28 June 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

 

4.4       Special Warnings and Special Precautions for Use

 

The effects of alcohol may be increased.  In common with other drugs having anticholinergic effects, chlorphenamine should be used with caution in epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, bronchitis, bronchiectasis, thyrotoxicosis, raised intra-ocular pressure, severe hypertension or cardiovascular disease and bronchial asthma. 

 

Children and the elderly are more likely to experience the neurological anticholinergic effects.

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

           

 

 

4.8       Undesirable Effects

 

              Blood and lymphatic system disorders

Very rare:       Haemolytic anaemia, thrombocytopenic purpura. Other blood dyscrasias including agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leucopenia and thrombocytopenia.

Cardiac disorders

Very rare:       Arrythmias, palpitations and tachycardia.

Ear and labyrinth disorders

Very rare:       Tinnitus

Eye disorders

Very rare:       Blurred vision

Gastrointestinal disorders

Very rare:       Abdominal pain, diarrhea, dryness of mouth, dyspepsia, nausea and vomiting.

General disorders and administration site conditions

Very rare:       Lassitude and tightness of chest.

Hepatobiliary disorders

Very rare:       Hepatitis including jaundice

Immune system disorders

Very rare:       Allergic reactions.

Metabolism and nutrition disorders

Very rare:       Anorexia.

Musculoskeletal and connective tissue disorders

Very rare:       Twitching and muscular weakness

Nervous system disorders

Very rare:       Dizziness, headache, in-cordination, inability to concentrate and sedation.

Psychiatric disorders

Very rare:       Confusional psychosis, depression, irritability and nightmares.

Renal and urinary disorders

Very rare:       Urinary retention.

Respiratory thoracic and mediastinal disorders

Very rare:       Thickening of bronchial secretions.

Skin and subcutaneous tissue disorders

Very rare:       Angioedema, exfoliative dermatitis, photosensitivity, skin reactions and urticaria.

Vascular disorders

Very rare:       Hypotension.

 

 

Updated on 28 June 2006 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

 

 

4.4       Special Warnings and Special Precautions for Use

 

The effects of alcohol may be increased.  In common with other drugs having anticholinergic effects, chlorphenamine should be used with caution in epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, bronchitis, bronchiectasis, thyrotoxicosis, raised intra-ocular pressure, severe hypertension or cardiovascular disease and bronchial asthma. 

 

Children and the elderly are more likely to experience the neurological anticholinergic effects.

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

           

 

 

4.8       Undesirable Effects

 

              Blood and lymphatic system disorders

Very rare:       Haemolytic anaemia, thrombocytopenic purpura. Other blood dyscrasias including agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leucopenia and thrombocytopenia.

Cardiac disorders

Very rare:       Arrythmias, palpitations and tachycardia.

Ear and labyrinth disorders

Very rare:       Tinnitus

Eye disorders

Very rare:       Blurred vision

Gastrointestinal disorders

Very rare:       Abdominal pain, diarrhea, dryness of mouth, dyspepsia, nausea and vomiting.

General disorders and administration site conditions

Very rare:       Lassitude and tightness of chest.

Hepatobiliary disorders

Very rare:       Hepatitis including jaundice

Immune system disorders

Very rare:       Allergic reactions.

Metabolism and nutrition disorders

Very rare:       Anorexia.

Musculoskeletal and connective tissue disorders

Very rare:       Twitching and muscular weakness

Nervous system disorders

Very rare:       Dizziness, headache, in-cordination, inability to concentrate and sedation.

Psychiatric disorders

Very rare:       Confusional psychosis, depression, irritability and nightmares.

Renal and urinary disorders

Very rare:       Urinary retention.

Respiratory thoracic and mediastinal disorders

Very rare:       Thickening of bronchial secretions.

Skin and subcutaneous tissue disorders

Very rare:       Angioedema, exfoliative dermatitis, photosensitivity, skin reactions and urticaria.

Vascular disorders

Very rare:       Hypotension.

 

 

Updated on 20 December 2005 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 20 December 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only

Updated on 26 June 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 26 June 2003 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie