(and dosage form):
Each RHINETON tablet contains 4 mg chlorpheniramine maleate. Sugar Free.
RHINETON tablets contain the antihistamine, chlorpheniramine maleate. RHINETON competes reversibly with histamine for H1 receptor sites on effector cells. They suppress those symptoms due to histamine release. Antihistamines have anticholinergic properties and have a drying effect on the nasal mucosa.
RHINETON is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis and mild, uncomplicated allergic skin manifestations of urticaria and angioedema. RHINETON is also indicated as therapy for anaphylactic reactions adjunctive to adrenaline and other standard measures after the acute manifestations have been controlled. Skin conditions such as allergic eczema, atopic dermatitis, insect bites and drug reactions are often relieved by RHINETON.
Hypersensitivity to any of the ingredients. Cross sensitivity to other antihistamines.
RHINETON is contra-indicated in patients receiving MAO inhibitor therapy.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants eg. sedatives and tranquillizers. Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.
Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and anticholinergic effects such as dry mouth and urinary retention. Long term use of antihistamines may decrease salivary flow and contribute to development of caries, periodontal disease, oral candidiasis and discomfort.
RHINETON may cause paradoxical hyperexcitability, nervousness, irritability and insomnia. Do not give this product to children who have breathing problems such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor. RHINETON may cause drowsiness: Sedatives and tranquillizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives and tranquillizers, without first consulting the child's doctor.
All sedatives and alcohol potentiate the central nervous system depressant effects of the antihistamines.
Tricyclic antidepressants or maprotiline potentiate anticholinergic effects if taken with antihistamines.
Monoamine oxidase inhibitors will potentiate both the drowsiness effect and the anticholinergic effects if taken with antihistamines. Concurrent use is not recommended. Anticholinergics or drugs with anticholinergic activity will be potentiated if used concurrently with antihistamines.
Positive skin tests may be suppressed by antihistamines; therefore treatment with antihistamines should be stopped several days before the test.
The action of anticoagulants may be inhibited by antihistamines.
PREGNANCY AND LACTATION:
Safety in pregnancy has not been established.
May inhibit lactation due to anticholinergic effects. Small amounts of antihistamines entering breast milk may cause drowsiness or excitement and/or irritability in infants.
RHINETON is contra-indicated in newborn and premature infants.
DOSAGE AND DIRECTIONS FOR USE:
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.
Adults and children 12 years or older: One 4 mg RHINETON tablet every 4 to 6 hours, up to a maximum of 24 mg in 24 hours.
Children 6 to 12 years: 2 mg (Half a RHINETON tablet) every 4 to 6 hours up to a maximum of 12 mg in 24 hours.
Children up to 6 years: Use is not recommended.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The medical practitioner should be alerted to the possibility of any adverse effects associated with antihistamines.
Slight to moderate drowsiness is the most frequent side-effect of chlorpheniramine maleate. This may include inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination.
General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.
Anti-cholinergic effects: Dryness of the mouth and respiratory passages, thickening of mucous, cough, increased sweating, urinary retention or frequency, dysuria. Headache, tight chest, palpitations, tachycardia, hypotension.
Blood disorders: Agranulocytosis, haemolytic anaemia, leukopenia, thrombocytopenia.
Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles.
Central Nervous system: Sedation, dizziness, fatigue, lassitude, incoordination, tremors, confusion, blurred vision, diplopia, tinnitus, euphoria, nervousness, tingling and weakness of the hands, irritability, nightmares, insomnia, hallucinations, convulsions.
Gastro-intestinal disturbances: Loss of appetite, nausea, vomiting, epigastric distress and diarrhoea. Reduction in tone and motility of the gastro-intestinal tract, resulting in gastric reflux and constipation.
Genito-urinary system: Urinary frequency, difficult urination, urinary retention, early menses.
Hypersensitivity reactions: Allergic dermatitis, drug fever, photosensitization.
Respiratory system: Thickening of bronchial secretions, tightness of chest, wheezing, nasal stuffiness.
RHINETON should be used with caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease including hypertension, in those with increased intraocular pressure or hyperthyroidism. Caution should be used when the following medical conditions exist: severe cardiovascular disorders, epilepsy and during an acute attack of asthma. Antihistamines may cause dizziness, sedation and hypotension in patients over 60 years of age.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT'S TREATMENT:
Symptoms include drowsiness or paradoxical excitement, ataxia, tremors, athetosis, hallucinations and convulsions; hyperpyrexia may also occur. Fixed dilated pupils with a flushed face, sinus tachycardia, dyspnoea; urinary retention, dry mouth and fever. Terminally there may be deepening coma and cardiorespiratory collapse.
Central excitatory effects constitute the greatest danger, particularly in children who are more likely to exhibit central nervous system stimulation. Adults more frequently exhibit cental nervous system depression and the aged are particularly prone to experience hypotension.
Treatment: In the event of overdosage, emergency treatment should be started immediately. The stomach should be emptied by emesis or lavage.
There is no specific antidote and treatment is symptomatic and supportive. Stimulants (analeptic agents) should not be used.
Hyperpyrexia, especially in children, may require treatment with tepid water, sponge baths or hypothermic blanket.
Yellow, round, biconvex tablet, with a diameter of 7,20 mm, and a score on the one side.
Containers of 30, 100 and 1000 tablets. Patient ready packs of different pack sizes.
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
BE-TABS PHARMACEUTICALS (PTY) LTD.
14 LAUTRE ROAD
STORMILL EXT 1
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24 October 2003
JET PRINTERS 3/04 (Z)
New addition to this site: April 2005
Source: Community Pharmacy
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