Allergy Relief Antihistamine Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chlorphenamine 4 mg Tablets
Unichem Allergy Relief Antihistamine Tablets
Moss Pharmacy Allergy Relief Antihistamine Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Chlorphenamine Maleate 4 mg For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Yellow uncoated convex tablet with a bar on one side.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
The symptomatic control of allergic conditions which respond to antihistamines including hay fever, urticaria, vasomotor rhinitis, food allergy, drug and serum reactions, pruritis vulvae, pruritis ani, and insect bites.
4.2. Posology and Method of Administration
The route of administration for chlorphenamine tablets is oral.
Adults and the elderly
4 mg every 4-6 hours (maximum of 24mg daily).
Children
6 - 12 years: 2mg every 4-6 hours (maximum of 12mg daily). Not recommended for use in children under 6 years of age.
4.3. Contra-Indications
Use in patients hypersensitive to chlorphenamine or any other constituent of the tablet.
Coma or pre-coma states.
Known brain damage or epilepsy.
4.4 Special warnings and precautions for use
In common with other drugs having anticholinergic effects, chlorphenamine should be used with caution in conditions such as raised intra-ocular pressure including glaucoma, prostatic hypertrophy, urinary retention, severe hypertension or cardiovascular disease, hepatic disease, bronchitis, bronchiectasis, asthma, pyloroduodenal obstruction and thyrotoxicosis.
Children and the elderly are more susceptible to the neurological anticholinergic effects of chlorphenamine.
Excipients
Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Contains the colouring agents Quinoline Yellow (E104) and Sunset Yellow (E110), which can cause hypersensitivity reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
4.5 Interaction with other medicinal products and other forms of interaction
Chlorphenamine may potentiate the sedative effects of alcohol and other CNS depressants.
Increased anticholinergic and sedative effects may occur with concurrent use of monoamine oxidase inhibitors. The effects of other anticholinergic drugs may also be potentiated.
Concurrent use of chlorphenamine may result in increased serum levels of phenytoin.
There is a theoretical interaction (antagonistic effect) between betahistine and other antihistamines.
4.6 Pregnancy and lactation
Pregnancy
There are no adequate controlled studies of chlorphenamine in pregnant women. Chlorphenamine should only be used during pregnancy when clearly needed, and when the potential benefits outweigh the unknown risks to the foetus. Use during the third trimester may result in undesirable effects in neonates.
Lactation
Anticholinergic agents such as chlorphenamine may inhibit lactation and may be secreted in breast milk. The use of chlorphenamine in mothers breast-feeding their babies requires that the therapeutic benefits of the drug should be weighed against the potential hazards to the mother and baby.
Infants may be very sensitive to the effects of anticholinergic medications.
4.7. Effects on Ability to Drive and Use Machines
Patients receiving chlorphenamine should be warned that their ability to drive and operate machinery may be impaired.
4.8 Undesirable effects
Modern clinical data required to determine the frequency of undesirable effects are lacking for chlorphenamine. Sedation is the most common side effect, varying from slight drowsiness to deep sleep.
The following adverse events may also occasionally occur:
Blood and lymphatic system disorders: Blood dyscrasias including haemolytic anaemia
Immune system disorders: Hypersensitivity Metabolism and nutrition disorders: Anorexia Psychiatric disorders: Depression.
Paradoxical stimulation may occur, especially in high dosage or in children, with symptoms such as irritability, nervousness, insomnia and nightmares.
Nervous system disorders: Drowsiness, sedation, disturbance in attention, fatigue, headache, dizziness, abnormal co-ordination, tremor, convulsions
Children and the elderly are more likely to experience neurological anticholinergic effects.
Eye disorders: Blurred vision Ear and labyrinth disorders: Tinnitus
Cardiac disorders: Tachycardia, palpitation, cardiac arrhythmias
Vascular disorders: Hypotension
Respiratory, thoracic or mediastinal disorders: Increased viscosity of bronchial secretions
Gastrointestinal disorders: Dry mouth, dyspepsia, nausea, vomiting, diarrhoea, abdominal pain
Hepatobiliary disorders: Hepatitis, jaundice
Skin and subcutaneous tissue disorders: Skin rash, urticaria, exfoliative dermatitis, photosensitivity
Musculoskeletal and connective tissue disorders: Muscle twitching, muscular weakness
Renal and urinary disorders: Urinary retention General disorders: Chest discomfort, hyperpyrexia
4.9 Overdose
The estimated lethal dose of chlorphenamine is 25 to 50 mg/kg body weight. Symptoms
Overdose with chlorphenamine is associated with antimuscarinic, extrapyramidal, gastrointestinal and central nervous system effects. In infants and children, CNS stimulation predominates over CNS depression, causing hallucinations, excitement, psychosis, ataxia, inco-ordination, athetosis and convulsions. The convulsions, sometimes heralded by muscular tremors and athetoid movements, are of the intermittent tonic-clonic type and difficult to control. Hyperpyrexia, fixed dilated pupils, dry mouth, facial flushing, urinary retention and sinus tachycardia may occur. Deepening coma and cardiorespiratory collapse and death may follow. In adults, CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly arrhythmias and cardiovascular collapse.
Management
Consider the use of activated charcoal if the patient presents within 1 hour of ingestion of a significant overdose.
Protracted or recurrent convulsions may be controlled by lorazepam or diazepam given by slow intravenous injection into a large vein although the risk of further CNS depression should be considered. Vasopressors may be required to control hypotension. Other treatment is supportive and symptomatic and may include artificial respiration, external cooling for hyperpyrexia and intravenous fluids. Forced diuresis, peritoneal dialysis or haemodialysis appear to be of limited benefit.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Chlorphenamine inhibits most responses of histamine to smooth muscle. Within the vascular tree chlorphenamine inhibits both the vasoconstrictor effects of histamine and to a degree the most important vasodilator effects. Chlorphenamine strongly antagonises the action of histamine that results in increased capillary permeability and formation or oedema and weal.
5.2. Pharmacokinetic Properties
Chlorphenamine is well absorbed from the gastrointestinal tract and following oral administration the effects develop within 30 minutes, and are maximal within 1 to 2 hours and last about 4 to 6 hours. The drug is widely distributed throughout the body including the C.N.S. Little if any is excreted unchanged in the urine; most appears there as degradation products that are almost completely excreted within 24 hours. The main site of metabolic transformation is in the liver. The drug is eliminated more rapidly by children than by adults.
5.3. Pre-clinical Safety Data
No data of relevance which is additional to that already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Lactose Maize Starch Magnesium Stearate Colloidal Silicon Dioxide Quinoline Yellow E104 Sunset Yellow E110
6.2. Incompatibilities
Not applicable.
6.3.
Shelf Life
3 years.
Do not use after the expiry date given on the pack.
6.4. Special Precautions for Storage
Store below 25°C, protect from light.
6.5. Nature and Contents of Container
Chlorpheniramine tablets come in polypropylene tubes with low density polyethylene caps in pack sizes of 100, 250, 500 and 1000 tablets.
A1/PVC blister strips enclosed in an outer carton.
Pack sizes of 28 and 30 tablets
Not all pack sizes may be marketed.
6.6. Instructions for Use/Handling Not applicable.
7. MARKETING AUTHORISATION HOLDER
Co-pharma Limited Unit 4, Metro Centre Tolpits Lane Watford Hertfordshire WD1 8SS
8. MARKETING AUTHORISATION NUMBER(S)
PL 13606/0043
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
21st October 1996
10
DATE OF REVISION OF THE TEXT
10/01/2013