ALLERcalm Allergy Relief Tablets

1. Name Of The Medicinal Product

1. CHLORPHENAMINE TABLETS BP 4mg

2. Alpharma Chlorphenamine Hayfever & Allergy Relief Tablets

3. Vantage Chlorphenamine Hayfever & Allergy Relief Tablets

4. ALLERcalm Allergy Relief Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 4mg Chlorphenamine Maleate.

3. Pharmaceutical Form

Yellow uncoated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

1) For the symptomatic control of all allergic conditions which are responsive to antihistamines, including hay fever, urticaria, vasomotor rhinitis, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.

4.2 Posology And Method Of Administration

Posology

Adults: 1 tablet every four or six hours to a maximum daily dose of 24mg.

Not recommended for children under 12 years of age unless otherwise directed by a practitioner.

Elderly: As in adults, but the elderly are prone to confusional psychosis and other neurological anticholinergic effects.

Method of Administration

For oral administration.

4.3 Contraindications

Hypersensitivity to antihistamines; patients who have received therapy with MAOI's within the previous fourteen days.

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorphenamine may have an additive effect when used concurrently with hypnotics and anxiolytics causing potentiation of drowsiness. A similar additive effect will result from concurrent usage of alcohol with Chlorphenamine. MAOI therapy intensifies the anticholinergic effects of Chlorphenamine. Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

4.6 Pregnancy And Lactation

The safety of Chlorphenamine in pregnancy has not been established. Chlorphenamine should therefore only be used when clearly required and when potential benefits outweigh the potential unknown risks to the foetus. Use during the third trimester may result in reactions in the newborn or premature neonates.

Small amounts of antihistamines are excreted in breast milk. Use by nursing mothers is not recommended because of the risks of adverse effects in the infant.

Antihistamines may inhibit lactation.

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 patient's ability to drive and use machinery.

4.8 Undesirable Effects

Sedation varying from slight drowsiness to deep sleep. Inability to concentrate, lassitude, blurred vision, GI disturbances such as nausea, vomiting and diarrhoea may occasionally occur. Urinary retention, headaches, dryness of the mouth. Dizziness, palpitation, tachycardia, arrhythmias, hypotension, tightness of the chest, abdominal pain, dyspepsia, anorexia, hepatic including jaundice, thickening of the bronchial secretions, haemolytic anaemia and other blood dyscrasias infrequently occur.

Allergic reactions including exfoliative dermatitis, photosensitivity and skin reactions. Urticaria, twitching, muscular weakness and in co-ordination. Tinnitus, depression, irritability and nightmares infrequently occur.

Paradoxical excitation in children and confusional psychosis in the elderly can occur.

The effects of alcohol may be increased. Children and the elderly are more likely to experience the neurological anticholinergic effects.

4.9 Overdose

The estimated lethal dose of Chlorphenamine is 25-50mg/kg body weight.

Symptoms and signs include sedation, paradoxical stimulation of the CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

Treatment includes gastric lavage or emesis using ipecacuanha syrup. Following these measures activated charcoal and cathartics may be administered to minimise absorption. Other symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance.

Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with IV diazepam or phenytoin. Haemoperfusion may be used in severe cases.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorphenamine Maleate is an antihistamine.

5.2 Pharmacokinetic Properties

Chlorphenamine Maleate is an alkylamine derivative with a plasma half-life of up to 42 hours which is extensively metabolised in the liver and excreted almost exclusively in the urine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains: calcium sulphate, magnesium stearate, maize starch, E172, E460.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 7, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/0209

9. Date Of First Authorisation/Renewal Of The Authorisation

9.5.86

Renewed: 20.10.02

10. Date Of Revision Of The Text

June 2007