SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Allergy Relief Antihistamine Tablets Sainsbury’s Allergy Relief Antihistamine Tablets Asda Allergy Relief Antihistamine Tablets Morrisons Allergy Relief Antihistamine Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient    mg per tablet

Chlorphenamine Maleate    4.0

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Pale yellow tablet with breakline.

The tablet can be divided into equal halves.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic control of allergic conditions responsive to antihistamines e.g. hayfever, vasomotor rhinitis, urticaria, pruritus, angioneurotic oedema, food allergies, drug and serum reactions, and insect bites.

4.2. Posology and method of administration

For oral use.

Adults and children 12 years and over:

One tablet every 4 to 6 hours. Do not take more than 4 tablets in 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 12mg in any 24 hours).

Children from 6 - 12 years:

Half a tablet every 4 to 6 hours. Do not give more than 4 half tablets (maximum 2 tablets) in 24 hours.

Do not give to children under 6 years of age.

4.3.    Contraindications

Hypersensitivity to chlorphenamine, other antihistamines, or to any of the other tablet ingredients.

Chlorphenamine should be avoided in severe liver disease due to the sedative effect.

The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs) (see section 4.5). 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

The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.

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 and asthma, hepatic disease, renal impairment and thyrotoxicosis.

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.

Chlorphenamine should be used with caution in urinary retention and/or pyloroduodenal obstruction.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorbtion 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

The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs), therefore chlorphenamine tablets should not be taken by patients who have been treated with MAOIs within the last fourteen days.

Chlorphenamine inhibits phenytoin metabolism due to its anticholinergic properties and this can lead to phenytoin toxicity, therefore concurrent use of phenytoin with chlorphenamine should be avoided.

Use chlorphenamine with caution when taking hypnotics or anxiolytics concurrently as this combination may potentiate drowsiness, therefore medical advice should be sought before takin chlorphenamine concurrently with these medicines. Concurrent use of alcohol may have a similar effect.

4.6.    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 essentially 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 antichlolinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment. If affected, patients should not drive or operate 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 reactions 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*, 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, jaundice 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 likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).

4.9. Overdose

(a)    Symptoms and signs

The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical stimulation of CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

(b)    Management

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 ingestions).

Management also includes:

(i) Treatment with intravenous diazepam for CNS convulsions;

(ii)    Hypotension and arrythmias should be treated vigorously

(iii) Haemoperfusion may be used in severe cases.

(iv) Severe respiratory depression may necessitate the use of mechanical ventilation.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic Group: Antihistamines for systemic use - substituted alkylamines

ATC code: R06AB04

Chlorphenamine is a potent antihistamine (Hi-antagonist). It antagonises various histamine-induced effects such as increased capillary permeability and dilation, the formation of oedema and the constriction of gastrointestinal and respiratory smooth muscle. It has weak antimuscarinic and moderate antiserotonin and local anaesthetic actions. It can cause CNS stimulation or depression. It is an alkylamine derivative and probably achieves its effect by occupying receptor sites in effector cells.

5.2    Pharmacokinetic properties

The drug is readily and rapidly absorbed from the G.I. tract. The effects develop within 30 minutes, are maximal within 1 to 2 hours and 4 to 6 hours. There is significant plasma protein binding. 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.

The drug is largely inactivated in the liver and excreted as metabolites in the urine.

5.3. Pre-clinical Safety Data

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

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose BP Potato Starch BP

Magnesium Stearate BP

Anstead Dispersed Yellow 19248 (15% Quinoline Yellow E104) 6.2. Incompatibilities

None stated.

6.3. Shelf-Life

3 years

6.4. Special Precautions for Storage

Store below 25°C in a dry place.

6.5. Nature and Contents of Container

Chlorphenamine 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 tablets and Pill Packs of 28 tablets. All three containers are made up of High Density Polypropylene body and Low Density Polyethylene cap.

6.6. Instructions for Use, Handling and Disposal

Chlorphenamine Tablets BP 4mg should be taken orally with a drink of water. Always read instructions on the label / carton and the Patient Information Leaflet (PIL) enclosed.

Keep all medicines out of the reach of children.

Do not use after the expiry date.

7. MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Ltd

Wrafton

Braunton

NortH Devon

EX33 2DL

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 12063/0050

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

17 November 2003

10 DATE OF REVISION OF THE TEXT

24/11/2015