DIPHAL EXPECTORANT Solution Ref.[50511] Active ingredients: Ammonium chloride Diphenhydramine

The use of DIPHAL EXPECTORANT solution leads to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol.

DIPHAL EXPECTORANT should be used cautiously in:

• patients with cardiac failure, hypertension, peripheral and pulmonary oedema and toxaemia of pregnancy.
• patients with cardiovascular disease, glaucoma, prostatic hypertrophy and patients with urinary retention.
• elderly patients are most susceptible to the central nervous system depressant and hypotensive effects.

The positive results of skin allergy tests may be suppressed.

Extreme caution should be exercised with patients taking DIPHAL EXPECTORANT in conjunction with nervous system depressants such as alcohol, barbiturates, hypnotics, narcotics analgesic sedatives and tranquillisers and anticholinergic medicines and tricyclic antidepressants as their effects may be enhanced by diphenhydramine. Monoamine-oxidase inhibitors may enhance the anticholinergic effects of diphenhydramine hydrochloride. The warning signs of damage caused by ototoxic medicines such as aminoglycosides may be masked by diphenhydramine hydrochloride.

• DIPHAL EXPECTORANT should not be taken for a persistent cough that occurs with smoking, asthma or emphysema.

Children who take DIPHAL EXPECTORANT may experience paradoxical hyperexcitability, nervousness, irritability or insomnia.

DIPHAL EXPECTORANT contains sucrose. Patient with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrose-isomaltase insufficiency should not take DIPHAL EXPECTORANT.

DIPHAL EXPECTORANT contains sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus.

• DIPHAL EXPECTORANT may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsycotics.
• DIPHAL EXPECTORANT should not be used simultaneously with monoamine oxidase inhibitors including linezolid (see section 4.3).
• Warning signs of damage caused by ototoxic medicines such as aminoglycoside antibiotics may be masked by DIPHAL EXPECTORANT (see section 4.4).
• DIPHAL EXPECTORANT may suppress the cutaneous histamine response to allergen extracts. The use of DIPHAL EXPECTORANT should be stopped at least 72 hours before testing begin.

Safety in pregnancy and lactation has not been established.

The use of DIPHAL EXPECTORANT solution leads to drowsiness and impaired concentration and it is unsafe to drive a vehicle or be in charge of machinery while using DIPHAL EXPECTORANT, as impaired decision making could lead to accidents.

Diphenhydramine hydrochloride:

Blood and lymphatic system disorders

Less frequent: haemolytic anaemia, leucopenia.

Nervous system disorders

Frequent: drowsiness, dryness of mouth.

Less frequent: dizziness, muscular weakness and incoordination, heaviness and weakness of the hands, headache, convulsions or seizures, tingling, confusion, nightmares, nervousness, restlessness or irritability.

Frequency unknown: inability to concentrate, lassitude, elation or depression, euphoria, insomnia, tremors, muscle twitching.

Eye disorders

Less frequent: blurred vision.

Ear and labyrinth disorders

Less frequent: tinnitus.

Cardiac disorders

Less frequent: palpitations, dysrhythmias, tachycardia, and hypotension.

Respiratory, thoracic and mediastinal disorders

Less frequent: tightness in chest.

Gastrointestinal disorders

Frequent: stomach pain, nausea.

Less frequent: epigastric pain, diarrhoea, anorexia, constipation, vomiting.

Skin and subcutaneous tissue disorders

Less frequent: skin rash, photo-sensitisation of the skin, hypersensitivity reactions.

Renal and urinary disorders

Less frequent: difficulty in micturition.

Ammonium chloride:

Blood and lymphatic system disorders

Frequency unknown: hyperchloraemic acidosis, hypokalaemia.

Nervous system disorders

Frequency unknown: progressive drowsiness, thirst, headache, hyperventilation, mental confusion.

Gastrointestinal disorders

Frequency unknown: nausea, vomiting.

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/Publications/Index/8

Not applicable.