Rhineton 4 Mg Tablets

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.

Posology

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.

Method of administration

Oral administration.

RHINETON is contra-indicated in:

• RHINETON should not be used in patients with known hypersensitivity to the chlorpheniramine or any of the excipients of RHINETON (listed in section 6.1).
• Patients receiving MAO inhibitor therapy. The anticholinergic properties of chlorpheniramine are intensified by monoamine oxidase inhibitors (MAOIs).

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 childu2019s 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 childu2019s doctor.

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.

RHINETON contains 103,645 mg lactose monohydrate per tablet. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• 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 medicines 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

Safety in pregnancy has not been established.

Breastfeeding

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.

The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.

System Organ Class

Frequency

Adverse reaction

Blood and lymphatic system disorders

Frequency unknown

Haemolytic anaemia, blood dyscrasias, agranulocytosis, leukopenia, thrombocytopenia.

Immune system disorders

Frequency unknown

Allergic reaction, angioedema, anaphylactic reactions.

Metabolism and nutrition disorders

Frequency unknown

Anorexia.

Psychiatric disorders

Frequency unknown

Confusion*, excitation*, irritability*, nightmares*, depression, hallucinations, incoordination, lassitude, tremors.

Nervous system disorders*

Frequent

Sedation, somnolence, Disturbance in attention, abnormal coordination, dizziness, headache

Frequency Unknown

Euphoria, nervousness, insomnia, tingling, convulsions.

Eye disorders

Frequent

Blurred vision, diplopia.

Ear and labyrinth disorders

Frequency unknown

Tinnitus.

Cardiac disorders

Frequency unknown

Palpitations, tachycardia, arrhythmias, extrasystoles

Vascular disorders

Frequency unknown

Hypotension

Respiratory, thoracic and mediastinal disorders

Frequency unknown

Thickening of bronchial secretions, dryness of the mouth and respiratory passages, cough, tightness of chest, wheezing, nasal stuffiness.

Gastrointestinal disorders

Frequent

Nausea

Frequency unknown

Vomiting, abdominal pain, diarrhoea, dyspepsia, loss of appetite, epigastric distress, reduction in tone and motility of the gastro-intestinal tract, resulting in gastric reflux and constipation.

Hepato-biliary disorders

Frequency unknown

Hepatitis, including jaundice.

Skin and subcutaneous tissue disorders

Frequency unknown

Exfoliative dermatitis, rash, urticaria, photosensitivity, allergic dermatitis, fever.

Musculoskeletal and connective tissue disorders

Frequency unknown

Muscle twitching, muscle weakness.

Renal and urinary disorders

Frequency unknown

Urinary retention or frequency, dysuria, difficult urination.

Reproductive system and breast disorders

Frequency unknown

Early menses.

Frequent

Fatigue.

General disorders and administration site conditions

Frequency unknown

Chest tightness, excessive perspiration, chills, dryness of mouth nose and throat, anaphylactic shock

* Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications : https://www.sahpra.org.za/

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 central 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. 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.