4.1. Therapeutic indications

Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infections

4.2. Posology and method of administration

For oral administration

Adults and Children over 12 years

One or two 5ml spoonfuls three or four times daily.

Not more than 4 doses should be given in any 24 hours

Elderly:

Adult dose is appropriate.

4.3. Contraindications

Liver failure.

Should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma.

Patients with chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiolitis or bronchiectasis due to sputum retention.

Patients receiving monoamine oxidase inhibitors or within 2 weeks of cessation of their use (see section 4.5).

Known hypersensitivity to the active substance or to any of the excipients.

Do not give to children under 12 years.

4.4. Special warnings and precautions for use

Should be used with caution in patients with renal, hepatic or respiratory disease, including a history of asthma.

Caution is needed in patients with a history of drug abuse. Pholcodine is an opioid and addiction is observed with opioids as a class.

Covonia Dry Cough Sugar Free Formula and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

Use of pholcodine monohydrate 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 Linctus, 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 If signs and symptoms suggestive of these reactions appear, this medicine should be withdrawn immediately.

Ingredients with specified warnings

This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.

This medicine contains 52.3mg propylene glycol in each 5ml dose.

It also contains sodium methyl, sodium ethyl and sodium propyl parahydroxybenzoates (E219, E215 and E217) which may cause allergic reactions (possibly delayed).

Keep out of the sight and reach of children.

Warning: Do not take more medicine than the label tells you to.

Do not take with other cough and cold medicines.

Do not give to children under 12 years.

If symptoms persist consult your doctor.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:

Concomitant use of codeine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe this medicine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

4.5. Interaction with other medicinal products and other forms of interaction

Not to be used in patients taking MAOIs or within 14 days of stopping treatment (see Section 4.3).

Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

The reduction of blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine monohydrate. Diuretics may have the same effect.

Pholcodine monohydrate may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Sedative medicines such as benzodiazepines or related drugs:

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

4.6. Fertility, pregnancy and lactation

No data available on the use of Covonia Dry Cough Sugar Free Formula in pregnancy or lactation. Covonia Dry Cough Sugar Free Formula should only be used in pregnancy if considered necessary by the physician and should be avoided during the first trimester. Pholcodine monohydrate has been detected in human milk but in amounts unlikely to affect the suckling infant.

4.7. Effects on ability to drive and use machines

Using the dose recommended, it is not considered a hazard, however, the use of pholcodine monohydrate may cause sedation, dizziness and nausea. If affected, driving or operation of machinery would not be advised.

4.8. Undesirable effects

The following side effects may be associated with the use of pholcodine monohydrate:

(frequencies not known: cannot be estimated from the available data)

Immune system disorders:

Hypersensitivity reactions and anaphylaxis, skin reactions including rash.

Psychiatric disorders:

Excitation, confusion.

Nervous system disorders:

Occasional drowsiness, dizziness.

Respiratory, thoracic and mediastinal disorders:

Sputum retention, respiratory depression (in overdose).

Gastrointestinal disorders:

Vomiting, gastrointestinal disturbances (nausea and constipation).

Skin and subcutaneous tissue disorders:

Acute generalized exanthematous pustulosis (see section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms of overdose include respiratory depression, nausea, drowsiness restlessness, excitement and ataxia.

Treatment should be symptomatic to maintain vital functions. Respiratory distress should be treated by supportive means. Airways protective gastric lavage may be used. In severe cases a narcotic antagonist such as naloxone may be considered. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.