Numark Antihistamine 4mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pollenase 4mg Tablets
Tesco Allergy Relief Chlorphenamine 4mg Tablets Numark Antihistamine Tablets Chlorphenamine Maleate 4mg Vantage Allergy Relief Chlorphenamine 4mg Tablets ASDA Allergy Relief 4mg Tablets
Morrisons Allergy Relief Chlorphenamine Maleate 4mg Tablets Lloyds Pharmacy Allergy Relief Antihistamine 4mg Tablets Careway Allergy Relief 4mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4mg chlorphenamine (as maleate).
Also contains lactose monohydrate as excipient.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Pale yellow uncoated biconvex tablets with a break line on one face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The symptomatic control of allergic conditions responsive to antihistamines eg. hayfever, vasomotor rhinitis, uticaria, angioneurotic oedema, food allergies, drug and serum reactions, pruritus ani or vulvae and insect bites.
4.2 Posology and method of administration
For oral use
Chlorphenamine tablets should be taken orally with a drink of water.
Do not exceed the stated dose or frequency of dosing
Adults and children over 12 years: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24mg in total) 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 3 tablets (12mg in total) in any 24 hours, taken 1 tablet 4 to 6 hourly
Children aged 6 - 12 years: ^ tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg in total) in any 24 hours.
Not recommended for children under the age of 6 years
4.3 Contraindications
Hypersensitivity to chlorphenamine or to any of the excipients.
The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase Inhibitors (MAOIs). The tablets are therefore contra-indicated 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 medicinal products 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 Contraindications).
4.6 Fertility, pregnancy and lactation Pregnancy
There are no adequate data from the use of chlorphenamine maleate 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 antihistamine 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 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 events identified during postmarketing 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*, depression
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).
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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.
5.1 Pharmacodynamic properties
ATC Code R06AB04 Antihistamines for systemic use
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. Only trace amounts have been found in the faeces.
5.3 Preclinical safety data
There is no pre-clinical safety data that could be of relevance to the prescriber, which are not already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate,
Potato Starch,
Magnesium Stearate, Quinoline Yellow (E104).
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Tablets are available in blister packs of 28, 30 and 60 tablets.
Specification details of blister packs :
- PVC (white,rigid,opaque) : 250 microns
- Aluminium foil (hard tempered) : 20 microns
- Primer (nitrocellulose) : 1.5 -2.5 gsm
- Heat seal lacquer : 6.5 - 8.5 gsm
They are also available in Securitainers and Tampertainers in packs of 100, 500 & 1000 tablet. All containers are made up of High Density Polypropylene body and Low Density Polyethylene cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
EAST MIDLANDS PHARMA LIMITED
16 RANCLIFFE AVENUE
KEYWORTH
NOTTINGHAMSHIRE
NG12 5HY
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 22958/0005
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/02/2006
10
DATE OF REVISION OF THE TEXT
15/11/2016