Amydramine Expectorant Syrup is indicated for the oral symptomatic relief of common coughs (such as dry and/or tickly, or troublesome cough) associated with upper respiratory tract congestion.

Posology

One to two 5mL teaspoonfuls to be taken every 4 hours

Not suitable for children under 12 years.

Do not take more than 4 doses in 24 hours

Do not exceed the stated dose.

Method of Administration

Oral

§ Do not combine with other treatments for coughs and colds.

§ The syrup should be used with caution in patients with the following conditions:

-    Prostatic hypertrophy,

-    Urinary retention,

-    Susceptibility to 'closed angle' glaucoma

-    Hepatic disease.

§ The syrup may cause drowsiness.

§ Seek medical advice when suffering from chronic or persistent cough and when also suffering from asthma, and acute asthmatic attack or where cough is accompanied by excessive secretions

§ Keep out of the reach and sight of children.

Excipient Warnings:

Amydramine Expectorant Syrup contains:

• Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

§ Additive CNS depressant effects with alcohol and other CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and anti-psychotics.

§ Additive anti-muscarinic effects with other drugs of similar properties such as atropine and some anti-depressants.

§ Not to be taken in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 of stopping treatment as there is a risk of serotonin syndrome.

§ Diphenhydramine can inhibit the oxidative metabolism of some drugs.

§ Diphenhydramine may enhance the effects of ephedrine.

§ Diphenhydramine may mask the response of the skin to allergenic skin tests and also the ototoxic symptoms associated with certain antibiotics.

Pregnancy

In view of the potential risks versus small benefits, it is recommended that the syrup should not be used during pregnancy particularly as the safety of the active ingredients in human pregnancy is not established.

Lactation

In view of the potential risks versus small benefits, it is recommended that the syrup should not be used during lactation particularly as the safety of the active ingredients during lactation is not established.

The syrup may cause drowsiness. Do not drive or operate machinery. Avoid alcoholic drink.

The overall percentage of treated patients expected to experience adverse reactions is unknown.

Common side effects include:

CNS effects such as nervous drowsiness (usually diminishes within a few days), paradoxical stimulation, nervous headache, nervous psychomotor impairment.

Anti-muscarinic effects such as urinary retention, dry mouth, blurred vision, gastrointestinal disturbances and thickened respiratory tract secretions.

Rare side effects include:

Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions, blood disorders and liver dysfunction.

To report any side effect(s):

§ Saudi Arabia:

The National Pharmacovigilance Centre (NPC):

-        SFDA Call Centre: 19999

-        E-mail: npc.drug@sfda.gov.sa

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

§ Other GCC States:

-        Please contact the relevant competent authority.

Symptoms of overdosage include those due to diphenhydramine or menthol (drowsiness, dizziness, ataxia, anti-cholinergic effects, pyrexia, headaches, convulsions, hallucinations, excitement and respiratory depression).

Treatment consists of gastric lavage and aspiration. Administration of activated charcoal may help. Other symptomatic and supportive measures should be provided.

Pharmacotherapeutic group: Antihistamines for systemic use

ATC Code: R06AA52

Diphenhydramine

Possesses antitussive, antihistaminic, and anticholinergic properties and suppresses the urge to cough. It also dries up secretions in the nose and chest. Experiments have shown that the antitussive effect is discrete from its sedative effect. Taken at night will assist sleeping

Ammonium Chloride

"Traditional" Expectorant

Ammonium chloride is an expectorant that helps loosen phlegm and catarrh.

Sodium Citrate

Sodium citrate is a mucolytic, an agent which breaks down the phlegm.

Diphenhydramine

Is a histamine receptor antagonist. Main site of metabolic transformation is the liver. Oral availability - 50%, Plasma bound - 80%, Half-life - 4 hours

Ammonium Chloride

Effectively absorbed from GI tract. Ammonium Ion converted to urea by the liver.

Acid ion released gives mild metabolic acidosis.

Sodium citrate

Is systemically absorbed and renally eliminated, causing metabolic alkalosis and urine alkalisation in sufficient doses.

There are no preclinical data of relevance, within are additional to those already included in other sections of the SmPC.

* The quantity of Saccharin (used as Saccharin Sodium) may be used from 7.5mg to 9.8mg per 5mL syrup.

** Citric acid may be used from 10mg to 11mg per 5mL syrup.

None   

Store below 30°C.

120mL syrup filled in amber glass bottle packed in a printed carton along with a measuring cup & a leaflet.

No special requirements