Pholtex Junior 5 mg/5 ml Syrup,

For the relief of unproductive coughs.

Children 5 u2013 12 years: 2,5 to 5 ml (Half to one medicine measure) three to four times a day.

Children 2 u2013 5 years: 2,5 ml (half a medicine measure) three times a day.

Pholtex Junior should not be used in children under 2 years of age. (see 4.3)

Intolerance or hypersensitivity to Pholcodine or any of the ingredients.

Pholtex Junior should not be given to anyone at risk of developing respiratory failure as the sedative properties of pholcodine may exacerbate the condition.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).

Patients with liver disease since pholcodine is metabolised in the liver and the drug may accumulate.

• Pregnancy and Lactation.
• Children under 2 years of age.
• Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Pholcodine should be used with caution in patients who have decreased respiratory reserve. Pholcodine depresses the respiratory center 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 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 If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.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 Junior.

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.

Women of childbearing potential: The safety in women of childbearing potential has not been established.

Pregnancy: The safety in pregnancy has not been established.

Breastfeeding: No information on excretion in the breast milk is available.

Fertility: No data is 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).

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.