NUMARK ANTIHISTAMINE AND ALLERGY RELIEF 4 MG TABLETS, CHLORPHENAMINE TABLETS 4 MG, ALLERIEF 4 MG TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Chlorphenamine Tablets 4 mg

Numark Antihistamine and Allergy Relief 4mg Tablets

Allerief 4 mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 4.00 mg chlorphenamine maleate.

Excipient(s) of known effect: Lactose 105.0 mg per tablet.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

3 PHARMACEUTICAL FORM

Yellow, normal convex tablet engraved with company logo on one side, and a breakline and B094 on the other side.

4.1 Therapeutic indications

Chlorphenamine 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, pruritis and vulvae, and insect bites.

Also indicated for the symptomatic relief of itch associated with chickenpox.

4.2 Posology and method of administration

Posology

Adults and children 12 years and over: 1 tablet every 4–6 hours. Maximum daily dose 24 mg (6 tablets) 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 daily dose of 12mg (3 tablets) in any 24 hours).

Children aged 6–12 years: 4 tablet every 4–6 hours. Maximum daily dose 12 mg (3 tablets) in any 24 hours.

Children under 6 years: Not recommended.

Route of administration:

Oral

Do not exceed the stated dose or frequency of dosing

Minimum dosing interval: 4 hours.

Do not use continuously for more than two weeks without consulting a doctor

Populations

Patients with renal or hepatic impairment should seek doctor’s advise prior to taking this medicine. (See Section 4.4 Special warnings and precautions for use).

4.3 Contraindications

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

The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorphenamine 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 and asthma; hepatic impairment and renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. Increased energy, restlessness, nervousness). Avoid use in elderly patients with confusion.

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.

The effects of alcohol may be increased 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 antihistamine containing products, including antihistamine containing cough and cold medicines.

Patients with rare hereditary problems of galactose intolerance, total 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, concurrent use of alcohol may have a similar effect 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

There is no adequate data from the use of chlorphenamine in human pregnancy. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. Chlorphenamine tablets should not be used during pregnancy unless considered essential by a physician.

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

Administration of chlorphenamine may cause dizziness, drowsiness, blurred vision, and psychomotor impairment which can seriously hamper the patients’ ability to drive and use machinery therefore patients should be advised not to take charge of vehicles or machinery.

4.8 Undesirable effects

The following convention has been utilised for the classification of the frequency of adverse reactions: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse reactions identified during post-marketing use with chlorphenamine are listed below. As these reactions are reported voluntarily from a population of uncertain size, the frequency of some reactions is unknown but likely to be rare or very rare:

Blood and the lymphatic system disorders

Unknown: blood dycrasias (leucopenia, agranulocytosis), haemolytic anaemia

Immune system disorders

Unknown: allergic reactions including allergic dermatitis, angioedema, anaphylactic reactions

Metabolism and nutrition disorders

Unknown: anorexia

Psychiatric disorders

Unknown: depression, nightmares*, irritability*, confusion*, excitation

Nervous system disorders

Very common: sedation, somnolence

Common: inability to concentrate, abnormal coordination, dizziness, headache.

Eye disorders

Common: blurred vision

Ear and labyrinth disorders

Unknown: tinnitus

Cardiac disorders

Unknown: palpitations, tachycardia, arrhythmia

Vascular disorders

Unknown: hypotension

Respiratory, thoracic and mediastinal disorders

Unknown:, thickening of bronchial secretions

Gastrointestinal disorders

Common: nausea, dry mouth

Unknown: vomiting, , diarrhoea, , dyspepsia and abdominal pain

Hepatobiliary disorders

Unknown: hepatitis including jaundice

Skin and subcutaneous tissue disorders

Unknown: exfoliative dermatitis, photosensitivity, rash and urticaria

Musculoskeletal and connective tissue disorders

Unknown: muscle twitching, muscular weakness

Renal and urinary disorders

Unknown: urinary retention

General disorders and administration site conditions

Common: fatigue

Unknown: tightness of the chest

*Children and the elderly are more likely to experience the 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms and signs

The estimated lethal dose of chlorphenamine maleate is 25–50 mg/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.

Treatment

Management should be as clinically indicated or as recommended by the national poisons centre where available.

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

Pharmacotherapeutic classification: Substituted alkylamines; chlorphenamine ATC code: R06A B04.

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 gastrointestinal 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

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.

6.1 List of excipients

Lactose

Pregelatinised starch

Quinoline yellow lake (E104)

Magnesium stearate

Stearic acid

Maize starch

6.2 Incompatibilities

None

6.3 Shelf life

36 months in tablet containers

36 months in blister packs

6.4 Special precautions for storage

Store in the container provided. Do not store above 25°C.

6.5 Nature and contents of container

1. The product is packed in opaque plastic containers composed of polypropylene tubes and polyethylene tamper-evident closures in pack size of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets.

2. The product is packed in opaque plastic containers composed of either, high density polypropylene or high density polyethylene with a tamper evident or child resistant tamper evident closure composed of high density polyethylene with a packing inclusion of standard polyether foam or polyethylene or polypropylene filler in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets.

3. The product is packed in blister packs of aluminium/opaque PVC in pack sizes of 28, 42, 56, 84 and 112 tablets.

6.6 Special precautions for disposal

6.6 Special precautions for disposal

No special instructions for use/handling.