For the relief of persistent dry irritant coughs.

Oral administration.

Adults, the elderly and children over 12 years: One 5ml measure up to four times daily.

Children under 12 years: Do not use

Patients suffering from chronic cough, asthma or patients suffering from an acute asthma attack, or where cough is accompanied by excessive secretions should be advised to consult a Healthcare Professional before use.

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/ treated. Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache.

Keep out of the sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.

Not to be used in patients taking monoamine inhibitors or within 14 days of stopping treatment as there is a risk of hyperpyrexic crisis when MOAI are taken in combination with dextromethorphan.

Quinidine can increase serum concentrations of dextromethorphan markedly and some patients have experienced symptoms of dextromethorphan toxicity when the two agents have been used together.

Amiodarone appears to be able to increase serum concentrations of dextromethorphan.

Although  dextromethorphan  has  been  in  widespread  use  for  many  years  without apparent illconsequence, there are no specific data on its use during pregnancy. Caution should   therefore  be  exercised  by balancing the potential  benefit  of  treatment  against any possible 
hazards. It is not known whether dextromethorphan or its metabolites are excreted in human milk.
 

Dextromethorphan has no adverse effects on the patient’s ability to drive and to use machines.

Adverse effects are rare, however the following side effects may be associated with dextromethorphan:

Gastrointestinal Disorders

Rare: Gastrointestinal upset

Nervous System Disorders

Rare: Dizziness

Reporting of suspected adverse reactions

• Saudi Arabia:

− The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662 Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

• Other GCC States: Please contact the relevant competent authority.

Symptoms:

These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression.

Management:

Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.

Pharmacotherapeutic group: Cough suppressant

ATC code: R05DA09

Dextromethorphan is a cough suppressant which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.

Dextromethorphan is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan, which has some cough suppressant activity.

There is no relevant information additional to that already contained elsewhere in the SmPC or of relevance to the prescriber.

• Sodium Benzoate
• Sodium Saccharin
• Sugar
• Glycerin
• Propylene Glycol
• Citric Acid Anhydrous
• FD C Yellow No 6 day
• Orange Liquid Flavor
• Purified Water

Not applicable .

Store below 30°C.
After opening the bottle, keep at room temperature and use within 30 days.
 

PVC amber bottle containing of 120 ml

No special requirements.