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BENYLIN DRY COUGHS Syrup (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

BENYLIN DRY COUGHS 7.5mg/5ml Syrup.

Qualitative and quantitative composition

Each 5 ml contains: Dextromethorphan hydrobromide 7.5 mg. Each 5ml also contains: Sucrose 1.6g Liquid glucose 2.38g Sorbitol 325mg Ethanol 240mg For the full list of excipients, see section 6.1.

Pharmaceutical form

Pale brown coloured, peach flavoured syrup.

Therapeutic indications

This product is indicated as an antitussive, for the relief of an unproductive cough.

Posology and method of administration

Adults and Children aged 12 years and over: Posology 10 ml syrup (15 mg dextromethorphan) 4 times a day. Maximum daily dose: 40 ml syrup (60 mg dextromethorphan). Children under 12 years This product is ...

Contraindications

This product is contraindicated in individuals with known hypersensitivity to the active substance or to any of the excipients. This product is contraindicated in individuals who are taking, or have taken, ...

Special warnings and precautions for use

This product should not be administered to patients with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. ...

Interaction with other medicinal products and other forms of interaction

Dextromethorphan should not be used concurrently in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs as there is a risk of serotonin syndrome (e.g. ...

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. Dextromethorphan should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs ...

Effects on ability to drive and use machines

Unlikely to produce an effect. This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine is in the list of drugs included in regulations under ...

Undesirable effects

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with dextromethorphan are included in the table below by System Organ Class (SOC). The frequencies are provided ...

Overdose

Signs and symptoms Dextromethorphan 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 ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Cough Suppressant, Opium alkaloids and derivatives ATC Code: R05DA09 Dextromethorphan is the dextrorotatory isomer of 3-methoxy-N-methyl-morphinan. It is a synthetic morphine ...

Pharmacokinetic properties

Absorption Dextromethorphan is rapidly absorbed from the gastrointestinal tract with peak plasma concentrations reached in approximately 2 to 2.5 hours. The low plasma levels of dextromethorphan suggest ...

Preclinical safety data

General toxicology Acute oral toxicity studies conducted with Dextromethorphan report the following LD<sub>50</sub> values (mg/kg): mouse, 210 and rat, 116. Acute subcutaneous toxicity with Dextromethorphan ...

List of excipients

Liquid glucose Sucrose Sorbitol solution 70% non crystallising Ethanol 96% Glycerol Saccharin sodium Citric acid monohydrate Sodium benzoate Caramel T12 Imitation peach flavour Levomenthol Carbomer Purified ...

Incompatibilities

None known.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 30°C.

Nature and contents of container

125 or 150 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad. ...

Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

Marketing authorization number(s)

15513/0051

Date of first authorization / renewal of the authorization

Date Granted: 16 June 1997

Date of revision of the text

30-Sep-2019

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