Pholtex Forte 15 mg/5 ml Liquid

For the relief of unproductive coughs.

Adults: 5 ml (one medicine measure) two to three times a day.
Children 5 u2013 12 years: 2,5 ml (half a medicine measure) two to three times a day.
Do not exceed the recommended dose.

Pholtex Forte should not be given to patients with or at risk of developing respiratory failure as the sedative properties of pholcodine may exacerbate the condition.
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see 4.5).
Patients with hypersensitivity or idiosyncratic response to pholcodine or to any of the excipients.
Patients with liver disease since pholcodine is metabolised in the liver and the drug may accumulate.
Children under two years of age.
Pregnancy and lactation. Refer to 4.6.

Pholcodine should be used with caution in patients who have decreased respiratory reserve.
Pholcodine depresses the respiratory centre to some extent and should be used with caution in asthmatics.
Since pholcodine is metabolised in the liver, its action may be prolonged in hepatic insufficiency.
The dosage and frequency of administration may need to be reduced in patients with impaired liver function.
Use of pholcodine with alcohol or other central nervous system (CNS) depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.
Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with pholcodine, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.
Contains sorbitol which may have an effect on the glycaemic control of patients with diabetes mellitus.
Medicines containing sorbitol may have a laxative effect. Patients with the rare hereditary condition of sorbitol intolerance should not take Pholtex Forte.

The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have a similar effect.
The sedative effects of central nervous system depressants may be increased by alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
Hypertensive crisis may be caused by concurrent use of pholcodine with monoamine u2013 oxidase inhibitors therefore not to be used in patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

Pregnancy
PHOLTEX FORTE is contraindicated in pregnancy. Refer to 4.3.
Breastfeeding
PHOLTEX FORTE is contraindicated in lactation. Refer to 4.3.
Fertility
No data available.

Pholcodine may cause drowsiness and dizziness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.

Immune system disorders
Frequency unknown: hypersensitivity reactions, anaphylaxis.
Nervous system disorders
Frequency unknown: Dizziness, drowsiness, confusion, excitation, restlessness, ataxia and respiratory depression.
Gastrointestinal disorder
Frequency unknown: Constipation, vomiting, nausea, sputum retention.
Skin and subcutaneous tissue disorder
Frequency unknown: Skin reactions including rash, acute generalized exanthematous pustulosis. (See 4.4).
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/Publications/Index/8publications : Alternately you can contact iNova Pharmaceuticals (Pty) Ltd at +27 11 087 0000. Website: www.inovapharma.co.za.

Symptoms include drowsiness, restlessness, excitement, ataxia and respiratory depression.
Ventilation may be required.
Management: Treatment of overdose should be symptomatic and supportive. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01 mg/kg body weight). Other treatment option is activated charcoal (1 g/kg body weight) if more than 4 mg/kg has been ingested within 1 hour, provided the airway can be protected.