Rhineton Syrup 5 ml Syrup

Treatment of conditions responsive to antihistaminic therapy.

Posology

Adults 5 ml - 20 ml daily in divided doses.

Children

• 1-2 years 2,5 ml ( 1 / 2 medicine measure) orally twice daily.
• 2-5 years 2,5 ml ( 1 / 2 medicine measure) orally every 4 to 8 hours to a maximum of 15 ml daily.
• 6-12 years 5 ml (1 medicine measure) orally every 4 to 8 hours to a maximum of 30 ml daily.

Method of administration

Oral administration.

RHINETON SYRUP is contra-indicated in:

• In neonates and lactation (see Section 4.6).
• Paediatrics u2013 Not recommended for newborn or premature infants because it causes anticholinergic side effects such as excitation of the central nervous system and increased tendency towards convulsions.
• Epilepsy.
• Acute attacks of asthma.

This medicine may lead to drowsiness and impaired concentration that may be aggravated by simultaneous intake of alcohol and other central nervous system depressants. Patients should be advised, particularly in the initiation therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents. Avoid use of alcohol or CNS depressants. Inform your physician if taking other medications (see Section 4.5). Drowsiness may occur (see Section 4.4).

Geriatrics u2013 Dizziness, confusion and hypotension is more likely to occur in geriatric patients taking antihistamines. Except under special circumstances RHINETON SYRUP should not be used when the following medical problems exist and the risk benefit should also be considered: Bladder neck obstruction, prostatic hypertrophy, hypokalaemia, closed angle-glaucoma and open angle glaucoma. RHINETON SYRUP contains 1.6 g of liquid glucose per 5 ml. This should be taken into account in patients with diabetes mellitus. Patients with rare glucose-galactose malabsorption should not take this medicine. RHINETON SYRUP contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

• Sedating antihistamines may enhance the sedative effects of the CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics.
• Sedating antihistamines have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIu2019s).

Pregnancy: RHINETON SYRUP should not be administered during the early months of pregnancy because of foetal abnormalities in studies in animals.

Breast-feeding mothers: Use of RHINETON SYRUP is not recommended; it may cause unusual excitement or irritability in nursing 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

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

Nervous system disorders* Frequent Sedation, somnolence, disturbance in attention, abnormal coordination, dizziness, headache

Eye disorders Frequent Blurred vision

Ear and labyrinth disorders Frequency unknown Tinnitus

Cardiac disorders Frequency unknown Palpitations, tachycardia, arrythmias

Vascular disorders Frequency unknown Hypotension

Respiratory, thoracic and mediastinal disorders Frequency unknown Thickening of bronchial secretions

Gastrointestinal disorders Frequent Nausea, dry mouth Frequency unknown Vomiting, abdominal pain, diarrhoea, dyspepsia

Hepato-biliary disorders Frequency unknown Hepatitis, including jaundice

Skin and subcutaneous tissue disorders Frequency unknown Exfoliative dermatitis, rash, urticaria, photosensitivity

Musculoskeletal and connective tissue disorders Frequency unknown Muscle twitching, muscle weakness

Renal and urinary disorders Frequency unknown Urinary retention

General disorders and administration site conditions Frequent Fatigue Frequency unknown Chest tightness

* 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/

Anticholinergic effects u2013 clumsiness or unsteadiness, severe drowsiness, severe dryness of mouth, nose, or throat, flushing or redness of face, shortness of breath or troubled breathing, cardiac arrhythmias, central nervous system depression and stimulation, hypotension. There is no antidote for overdose with antihistamines. Treatment is symptomatic and supportive.