PIRITON TABLETS
Active substance: CHLORPHENAMINE MALEATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Piriton Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 milligrams of chlorphenamine maleate Round, circular, biconvex, yellow tablets engraved with a P to one side of the breakline; the reverse face has a breakline only.
3
PHARMACEUTICAL FORM
Tablet. The tablet can be divided into equal doses.
4.
4.1
CLINICAL PARTICULARS
Therapeutic indications Piriton Tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites. Also indicated for the symptomatic relief of itch associated with chickenpox.
4.2
Posology and method of administration Oral Administration only Do no exceed the stated dose or frequency of dosing Adults and children 12 years and over: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24 mg) in any 24 hours
Elderly: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours). Children aged 6 - 12 years: tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours Not recommended for children under 6 years 4.3 Contraindications Piriton Tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Piriton Tablets is therefore contraindicated in patients who have been treated with MAOIs within the last fourteen days.
4.4
Special warnings and precautions for use Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness) The effects of alcohol may be increased and therefore concurrent use should be avoided Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine, Keep out of sight and reach of children
4.5
Interaction with other medicaments and other forms of interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines. Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity. The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).
4.6
Pregnancy and Lactation Pregnancy There are no adequate data from the use of chlorphenamine in pregnant women. The potential risk for humans is unknown, Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essential by a physician. Lactation Chlorphenamine maleate and other antihistamines may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician.
4.7
Effects on ability to drive and use machines The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients ability to drive and use machinery.
4.8
Undesirable Effects 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 trails 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 events identified during post-marketing use is unknown. Blood and lymphatic system disorders: Unknown: haemolytic anaemia, blood dyscrasias Immune system disorders: Unknown: allergic reaction, 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 Ear and labyrinth disorders: Unknown: tinnitus Cardiac disorders: Unknown: palpitations, tachycardia, arrythmias 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 Hepatobiliary disorders: Unknown: hepatitis including jaundice Skin and subcutaneous disorders: Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity, Musculoskeletal and connective tissue disorders: Unknown: muscular 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 (eg increased energy, restlessness, nervousness)
4.9
Overdose Symptoms and signs The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties ATC Code R06AB02 Chlorphenamine is a potent antihistamine (H1-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.
Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis. 5.2 Pharmacokinetic properties Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours. Chlorphenamine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine
5.3
Preclinical safety data No additional data of relevance.
6.
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactose Maize Starch Yellow Iron Oxide (E172) Magnesium Stearate Purified Water
6.2
Incompatibilities None reported.
6.3
Shelf-life 3 years.
6.4
Special precautions for storage Do not store above 30C
6.5
Nature and contents of container The tablets are supplied in securitainers containing 50 or 500 tablets or blister packed into cartons containing 30, 45, 60 or 100 tablets.
6.6
Instruction for use, handling and disposal For detailed instructions for use refer to the Patient Information Leaflet in every pack.
7
MARKETING AUTHORISATION HOLDER
Stafford Miller Limited 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.
8.
MARKETING AUTHORISATION NUMBER PL 00036/0090.
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/10/2005
10
DATE OF REVISION OF THE TEXT
23/11/2012
1
NAME OF THE MEDICINAL PRODUCT
Piriton Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 milligrams of chlorphenamine maleate Round, circular, biconvex, yellow tablets engraved with a P to one side of the breakline; the reverse face has a breakline only.
3
PHARMACEUTICAL FORM
Tablet. The tablet can be divided into equal doses.
4.
4.1
CLINICAL PARTICULARS
Therapeutic indications Piriton Tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites. Also indicated for the symptomatic relief of itch associated with chickenpox.
4.2
Posology and method of administration Oral Administration only Do no exceed the stated dose or frequency of dosing Adults and children 12 years and over: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24 mg) in any 24 hours
Elderly: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours). Children aged 6 - 12 years: tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours Not recommended for children under 6 years 4.3 Contraindications Piriton Tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Piriton Tablets is therefore contraindicated in patients who have been treated with MAOIs within the last fourteen days.
4.4
Special warnings and precautions for use Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness) The effects of alcohol may be increased and therefore concurrent use should be avoided Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine, Keep out of sight and reach of children
4.5
Interaction with other medicaments and other forms of interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines. Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity. The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).
4.6
Pregnancy and Lactation Pregnancy There are no adequate data from the use of chlorphenamine in pregnant women. The potential risk for humans is unknown, Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essential by a physician. Lactation Chlorphenamine maleate and other antihistamines may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician.
4.7
Effects on ability to drive and use machines The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients ability to drive and use machinery.
4.8
Undesirable Effects 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 trails 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 events identified during post-marketing use is unknown. Blood and lymphatic system disorders: Unknown: haemolytic anaemia, blood dyscrasias Immune system disorders: Unknown: allergic reaction, 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 Ear and labyrinth disorders: Unknown: tinnitus Cardiac disorders: Unknown: palpitations, tachycardia, arrythmias 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 Hepatobiliary disorders: Unknown: hepatitis including jaundice Skin and subcutaneous disorders: Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity, Musculoskeletal and connective tissue disorders: Unknown: muscular 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 (eg increased energy, restlessness, nervousness)
4.9
Overdose Symptoms and signs The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties ATC Code R06AB02 Chlorphenamine is a potent antihistamine (H1-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.
Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis. 5.2 Pharmacokinetic properties Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours. Chlorphenamine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine
5.3
Preclinical safety data No additional data of relevance.
6.
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactose Maize Starch Yellow Iron Oxide (E172) Magnesium Stearate Purified Water
6.2
Incompatibilities None reported.
6.3
Shelf-life 3 years.
6.4
Special precautions for storage Do not store above 30C
6.5
Nature and contents of container The tablets are supplied in securitainers containing 50 or 500 tablets or blister packed into cartons containing 30, 45, 60 or 100 tablets.
6.6
Instruction for use, handling and disposal For detailed instructions for use refer to the Patient Information Leaflet in every pack.
7
MARKETING AUTHORISATION HOLDER
Stafford Miller Limited 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.
8.
MARKETING AUTHORISATION NUMBER PL 00036/0090.
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/10/2005
10
DATE OF REVISION OF THE TEXT
23/11/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
