RHINETON Tablet Ref.[51191] Active ingredients: Chlorphenamine

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.

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 psychomotorimpairment, which can seriously hamper the patients' ability to drive and use machinery.

^* 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 “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/

Not applicable.