Solphyllex Syrup 30 mL Syrup.

SOLPHYLLEX SYRUP is indicated for the prompt relief of coughs associated with respiratory infection, asthma and allergy. Being non-narcotic and non-addictive, SOLPHYLLEX SYRUP can be used for prolonged therapy.

Adults: Three medicine measuresful (15 mL) three times daily after meals and at bedtime.
Children (2 to 12 years): Two medicine measuresful (10 mL) three times daily after meals and at bedtime.
Do not exceed the recommended dose (see section 4.9).
Renal impairment: Patients undergoing routine haemodialysis may require increased doses.
Method of administration: Oral administration only. Shake well before use.

Hypersensitivity to theophylline, hydroxyethyltheophylline, diphenylpyraline, ammonium chloride, sodium citrate or any of the excipients listed in section 6.1. SOLPHYLLEX SYRUP is contraindicated in patients suffering from:

• diabetes
• hypersensitivity to antihistamines
• renal or hepatic disease
• severe hypotension
• peptic ulcer
• gout
• alcoholism (rehabilitated alcoholics).

• When given orally in excessive dosage all the constituents may cause gastrointestinal disturbances. However, when the recommended dosage is used, these symptoms are usually infrequent and mild.
• SOLPHYLLEX SYRUP contains 17,13 g of sucrose per 30 mL of syrup which may have an effect on the effects of the glycaemic control of patients with diabetes mellitus.
• SOLPHYLLEX SYRUP contains 0,15 mL of alcohol (ethanol) in each 30 mL of syrup, expressed as 0.5% (v/v). The alcohol in this medicine may alter the effects of other medicines.
• This medicinal product contains 73,6 mg sodium per 30 mL or 2,45 mg/mL of syrup, equivalent to 5,5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

• The bronchodilator and toxic effects of theophylline may be enhanced by sympathomimetics and by administration with other xanthines.
• Smokers may require increased doses.
• Diphenylpyraline hydrochloride has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tricyclic antidepressants may be enhanced.
• This medicine may lead to drowsiness and impaired concentration that may be aggravated by simultaneous intake of alcohol or other central nervous system depressants (see section 4.3 and 4.7).

Safety and/or efficacy in fertility, pregnancy and lactation has not been established.

SOLPHYLLEX SYRUP may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not drive, use machinery, or perform any tasks that require concentration, until they are certain that SOLPHYLLEX SYRUP does not adversely affect their ability to do so (see section 4.8).

Gastrointestinal disturbances.

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 requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Adverse Drug Reactions may also report to Adcock Ingram Limited using the following email: [email protected].

Large doses of theophylline will cause gastric irritation. Large doses of ammonium chloride will cause similar symptoms including nausea, vomiting, thirst, also headache, hyperventilation, progressive drowsiness, mental confusion and hyperchloraemic acidosis. Acidosis and electrolyte loss may be corrected by intravenous administration of sodium bicarbonate and potassium gluconate. Large doses of antihistamines will cause sedation varying from slight drowsiness to deep sleep, also dizziness, muscular weakness and in co-ordination. Paediatric Population: In infants and children the antihistamines often act as cerebral stimulants and may cause hyperpyrexia and convulsions. No fatal effects have ever been reported with the usual therapeutic doses, but rare fatalities have occurred in young children who had ingested large overdoses. Since there is no specific antidote for acute antihistamine poisoning (histamine must not be used) it is important to keep SOLPHYLLEX SYRUP out of the reach of young children. If a large overdose has just been taken, contact the nearest doctor, hospital or poison control center.