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

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