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Components:
Dextromethorphan Hydrobromide
Method of action:
Antitussive, Cough And Cold Preparations
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.14

Name of the medicinal product

Koffex DM

Qualitative and quantitative composition

Dextromethorphan Hydrobromide

Therapeutic indications

The information provided in Therapeutic indications of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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For the relief of persistent dry irritant coughs.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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Oral administration.

Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.

Children under 12 years: Do not use

Contraindications

The information provided in Contraindications of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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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..

Use in children under 12 years.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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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. 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. These could be signs of serious conditions.

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.).

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.

- This product contains Amaranth (E123), which may cause allergic reactions.

- This medicinal product contains 2.5% v/v ethanol (alcohol), up to 196 mg per dose, (equivalent to approx 1.6 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. 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

Undesirable effects

The information provided in Undesirable effects of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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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, drowsiness, mental confusion

Immune System Disorders

Hypersensitivity

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.

Overdose

The information provided in Overdose of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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Symptoms:

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.

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.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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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

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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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.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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Cough suppressant

Preclinical safety data

The information provided in Preclinical safety data of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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There is no relevant information additional to that already contained elsewhere in the SmPC or of relevance to the prescriber.

Incompatibilities

The information provided in Incompatibilities of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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None stated.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Koffex DM is based on data of another medicine with exactly the same composition as the Koffex DM of the medicine (Dextromethorphan Hydrobromide). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Koffex DM directly from the package or from the pharmacist at the pharmacy.
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No special requirements

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