Expectorant for the treatment of coughs.
For the relief of persistent dry irritant coughs.

Oral administration.
Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.
Children under12 years: Do not use.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 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). Use in children under 12 years.

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 a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.
Patients suffering from chronic cough as occurs with smoking, 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.
Cases of dextromethorphan abuse have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan. Caution should therefore be exercised in patients who are slow metabolizers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).
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.

Do not use if you are now 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 drugs, ask a doctor or pharmacist before taking this product.
CYP2D6 inhibitors Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels multifold higher than normal. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome.
Potent CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced.

Pregnancy
Although adequate and well-controlled studies in pregnant women have not been performed, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester. An increased occurrence of inguinal hernias was found in the neonates. However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs.
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.
Breastfeeding
Guaifenesin is excreted in breast milk in small quantities.
Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.
It is not known whether dextromethorphan or its metabolites are excreted in human milk.

This medicine can impair cognitive function and can affect a patient's ability to drive safely. When taking this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed taken to treat a medical problem and
o You have taken it according to the information provided with the medicine and
o It was not affecting your ability to drive safely

The following side effects may be associated with the use of

Guaifenesin:
Gastrointestinal Disorders
Nausea, vomiting
Immune System Disorders
Hypersensitivity reactions

Dextromethorphan hydrobromide:
Gastrointestinal Disorders
Rare: Gastrointestinal upset
Nervous System Disorders
Rare: Dizziness, drowsiness, mental confusion
Immune System Disorders
Hypersensitivity

To report any side effects
- The National Pharmacovigilance and Drug Safety Center (NPC)
o Fax: +966-11-205-7662
o Call NPC at : +966-11-2038222 ext.: 2317 – 2356 –2340
o Call Center: 19999
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc

Signs and Symptoms associated with an overdose of
Guaifenesin:
Nausea and vomiting
Treatment:
Appropriate supportive therapy dependent upon individual response to the preparation.
 

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

Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and facilitates the removal of mucus. This changes an unproductive cough to a cough that is more productive and less frequent.
Pharmacotherapeutic group: Expectorant
ATC code: RO5CAO3

Dextromethorphan hydrobromide 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
Pharmacotherapeutic group: Cough suppressant
ATC code: R05DA09

Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite.

Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract.
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration.
Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers.
It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3- hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine.
Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals metabolism proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.

No relevant information additional to that already contained elsewhere in the SPC

Sodium Benzoate
Sorbitol solution 70% non-cryst
Glycerol
Sodium Methyl Hydroxybenzoate
Orange cream Flavour 11022-36
Hydrochloric acid
Purified water

Not applicable.

3 years

Store below 30°C, Keep tightly closed.
Keep in the original pack to protect from light.
Once the pack has been opened the contents should be used within 28 days.

100 ml amber coloured glass bottles with plastic cap.

No special requirements