For the relief of persistent dry irritant coughs.

Oral administration. Adults, the elderly, and children over 12 years:  -        One 5 ml measure up to four times daily. -        Maximum dose: 40 ml syrup (120 mg dextromethorphan) Children under 12 years: Is contraindicated in children under the age of 12 years (see section 4.3). The Elderly (over 65 years) As for adults above. Hepatic/renal dysfunction Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of moderate to severe hepatic impairment (see Pharmacokinetics). Do not exceed the stated dose. Keep out of the reach and sight of children.

Hypersensitivity to any of the ingredients. Taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription medication contains one of these medicines, ask a doctor or pharmacist before taking this product. (See section 4.5). Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure. Not to be used in children under the age of 12 years.

Patients suffering from chronic cough, asthma or patients suffering from 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 granular sucrose.

There have been no specific studies of Dextromethorphan in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.

Prolonged use of products containing dextromethorphan such as this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with a current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression). Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.

 

Serotonin Syndrome

Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.

Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Robitussin Dry Cough should be discontinued.

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

Potent CYP2D6 enzyme inhibitors including SSRIs such as fluoxetine, paroxetine, and sertraline

can increase the dextromethorphan concentrations in the body to levels multifold higher than normal.

This increases the patient's risk for the toxic effects of dextromethorphan (agitation, confusion, tremor,

 insomnia, diarrhea, and respiratory depression) and the development of serotonin syndrome.

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 ill consequence, 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 hydrobromide 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 hydrobromide: Gastrointestinal Disorders Rare: Gastrointestinal upset Nervous System Disorders Rare: Dizziness Psychiatric disorders: drug dependence (frequency unknown).

Please report adverse drug events to:

The National Pharmacovigilance Centre (NPC):

Fax: +966-11-205-7662

SFDA Call Center: 19999

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

Website: https://ade.sfda.gov.sa

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.

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

Dextromethorphan

Pharmacotherapeutic group: Cough suppressant

ATC code: R05DA09

Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is metabolized 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 SPC or of relevance to the prescriber.

Sodium Benzoate,

Citric Acid Anhydrous,

Orange Flavour Liquid,

Caramel,

Sucrose Granular,

Sorbital Solution 70% Non-Cryst&

Purified Water.

Not Known

48 months (4 years).

Do not store above 30ºC. 

Keep out of reach and sight of children.

This medicine will be expired after 30 days from the first opening.

100 ml amber glass bottle with white plastic child resistant cap with specific LDPE/Coextruded LDPE/LDPE three layered liner and natural-translucent tamper evident ring and 15ml plastic measure cup.

Not Applicable.