Actophlem Cough Syrup

ACTOPHLEM COUGH SYRUP is indicated for the alleviation of cough.

Adults: Three medicine measures (15 mL) three times daily after meals and at bedtime.

Children (7 years and older): Two medicine measures (10 mL) three times daily after meals.

Children (3 to 6 years): One medicine measure (5 mL) three times daily after meals.

Do not exceed the recommended dose (see section 4.9).

Children: Children are particularly sensitive to the effects of theophylline and it should not be administered more frequently than every eight hours.

Elderly or Cardiac patients: Theophylline should be administered with caution to elderly patients and those suffering from cardiac disease.

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.

ACTOPHLEM COUGH SYRUP is contraindicated in patients suffering from:

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

• Diphenylpyraline hydrochloride may precipitate fits in epileptics.
• ACTOPHLEM COUGH 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.
• ACTOPHLEM COUGH 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).
• The concomitant administration of other theophylline containing preparations and ACTOPHLEM COUGH SYRUP may lead to toxic levels of theophylline and patients should be cautioned accordingly.
• The warning symptoms of damage caused by ototoxic drugs may be masked and the metabolism of drugs in the liver may be affected.
• Diphenylpyraline hydrochloride may enhance the sedative effect of the central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillizers.

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

ACTOPHLEM COUGH 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 be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

Tabulated summaries

System organ Class Frequent Undesirable effect

• Blood and lymphatic system disorders Unknown Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur.
• Immune system disorders Unknown Allergy and anaphylaxis may occur.
• Metabolism and nutrition disorders Unknown Anorexia.
• Psychiatric disorders Unknown Anxiety, elation or depression, irritability, nightmares.
• Nervous system disorders Unknown Insomnia, headache, confusion, restlessness, vertigo, nervousness, tremors. Frequent Sedation which can vary from slight drowsiness to deep sleep, and includes the inability to concentrate, lassitude, dizziness, incoordination, convulsions, dryness of the mouth, tingling, heaviness and weakness of the hands may occur.
• Eye disorders Unknown Visual disorders.
• Ear and labyrinth disorders Unknown Tinnitus.
• Cardiac disorders Unknown Palpitations, tachycardia.
• Vascular disorders Frequent Hypotension.
• Respiratory, thoracic, and mediastinal disorders Unknown Hyperventilation, tightness of the chest.
• Gastrointestinal disorders Frequent Nausea, vomiting, gastrointestinal bleeding, diarrhoea or constipation, epigastric pain.
• Musculoskeletal and connective tissue disorders Unknown Muscle twitching, Frequent Muscular weakness.
• Renal and urinary disorders Unknown Difficulty in micturition.
• Paediatric population In infants and children diphenylpyraline hydrochloride may act as a cerebral stimulant.

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]

Ammonium chloride causes symptoms such as nausea, vomiting, thirst, headache, hyperventilation, progressive drowsiness, hypokalaemia, mental confusion and hyperchloraemic acidosis. Overdosage of theophylline may lead to maniacal behaviour, repeated vomiting with extreme thirst, delirium, hyperthermia and convulsions.

Paediatric Population: It is important to keep ACTOPHLEM COUGH SYRUP out of reach of young children. If a large overdose has just been taken, contact the nearest doctor, hospital or poison control center. Treatment is symptomatic and supportive.