SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ammonia and Ipecacuanha Mixture BP 1999

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ammonium Hydrogen Carbonate 100.0 mg per 5ml dose Ipecacuanha Tincture BP 1999 0.15 ml per 5 ml dose For full list of excipients, see 6.1

3 PHARMACEUTICAL FORM

Oral solution.

A dark brown liquid

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of productive coughs.

4.2 Posology and method of administration

Oral.

Dose and dosage schedule

Adults, the elderly and children over 12 years: 10- 20ml, repeated after 4 hours if required. Not more than 4 doses to be taken in any 24 hours.

4.3 Contraindications

Contraindicated in patients with known sensitivity to ipecacuanha, ammonium salts or any of the other ingredients. Contraindicated in patients with hepatic or renal impairment, cardiovascular disorders, patients in shock or at risk from seizures.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Keep all medicines away from children.

Discard any unused mixture 2 months after opening.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

As with all medicines, use should be avoided during pregnancy, especially in the first trimester, and in lactation unless recommended by a doctor.

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8    Undesirable effects

Large doses of ipecacuanha or ammonium salts may cause nausea and vomiting, however, these effects would not be expected to occur when this preparation is taken at the recommended dose.

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.

4.9    Overdose

Large doses of ammonium salts irritate the gastric mucosa and may result in nausea and vomiting. Excessive doses of ammonium salts may give rise to hepatic encephalopathy, however, this effect is unlikely to occur after oral administration.

Large doses of ipecacuanha irritate the gastro-intestinal tract and may give rise to persistent bloody vomiting, and diarrhoea.

Absorption of emetine, which is most likely if vomiting does not occur after emetic doses of ipecacuanha, may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction. These, combined with dehydration due to vomiting may cause vasomotor collapse followed by death. Chronic abuse of ipecacuanha may result in cardiotoxicity and myopathy due to the accumulation of emetine, and recovery may be prolonged due to its slow elimination.

After acute overdosage of ipecacuanha, activated charcoal should be given to delay absorption, followed by gastric lavage if necessary. Excessive vomiting should be controlled by administration of an anti-emetic and fluid and electrolyte imbalance corrected if necessary.

Overdose with this preparation is unlikely to occur due to the low concentrations of the active ingredients present.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

R05C A04 - Cough and cold preparations, expectorants

Ammonium Hydrogen Carbonate is an expectorant used to aid relief of productive coughs.

Ipecacuanha is an expectorant, and in larger doses an emetic.

5.2 Pharmacokinetic properties

Ammonium Hydrogen Carbonate is metabolised to produce urea and free bicarbonate.

Emetine, one of the major alkaloids of ipecacuanha is excreted or metabolised slowly, it has been detected in urine 40 - 60 days after discontinuation of treatment.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

List of excipients

Liquorice Liquid Extract

Camphor Water Concentrated Anise Water Concentrated Chloroform Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

18 months unopened.

2 months after first opening.

6.4 Special precautions for storage

Store below 25°C. Discard any unused mixture 2 months after opening.

6.5 Nature and contents of container

200 ml: Amber glass bottle with plastic 28mm tamper evident child resistant closure with EPE /Saranex liner.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd Linthwaite Laboratories Huddersfield HD75QH

8    MARKETING AUTHORISATION NUMBER(S)

PL 00240/6458R

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/06/1998 / 10/11/2003

DATE OF REVISION OF THE TEXT

31/12/2014