MORRISONS CHESTY COUGH ORAL SOLUTION, NUMARK CHESTY COUGH COMPOUND OF GLYCERIN LEMON & IPECACUANHA, WILKO CHESTY COUGH ORAL SOLUTION, CO-OP CHESTY COUGH ORAL SOLUTION, BELLS HEALTHCARE CHESTY COUGH ORAL SOLUTION, WELL PHARMACEUTICALS CHESTY COUGH ORAL - summary of medicine characteristics

Summary of medicine characteristics - MORRISONS CHESTY COUGH ORAL SOLUTION, NUMARK CHESTY COUGH COMPOUND OF GLYCERIN LEMON & IPECACUANHA, WILKO CHESTY COUGH ORAL SOLUTION, CO-OP CHESTY COUGH ORAL SOLUTION, BELLS HEALTHCARE CHESTY COUGH ORAL SOLUTION, WELL PHARMACEUTICALS CHESTY COUGH ORAL

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains

Glycerol

0.5 ml

0.0098 ml

Ipecacuanha Liquid Extract

This product also contains:

Amaranth solution containing amaranth

Syrup containing sucrose and glucose

Nipasept containing Ethylparaben (E214), Propylparaben (E216) and

Methylparaben (E218)

For full list of excipients, see section 6.1

PHARMACEUTICAL FORM

Oral solution

CLINICAL PARTICULARS

4.1 Therapeutic indications

The mixture is taken orally for the symptomatic relief of coughs.

4.2 Posology and method of administration

Adults and children of 12 years and over

One to two 5 ml spoonfuls.

This medicinal product is contraindicated in children under the age of 12 years (see section 4.3)

Sip and swallow three or four times a day.

Not more than 4 doses should be given in any 24 hours.

Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Keep out of the reach and sight of children.

4.3 Contraindications

Patients in shock, at risk of seizure, or with cardiovascular disorders.

Impaired renal hepatic or cardiac function.

Hypersensitivity to the active substances or any of the excipients.

Not to be used in children under the age of 12 years.

4.4 Special warnings and precautions for use

If symptoms persist for more than 5 days a doctor should be consulted. Ipecac is cardio active and so should be avoided by patients on anti-arrhythmic drugs. It should be avoided by diabetics. Parabens may cause allergic reactions (possibly delayed).

Amaranth may cause allergic reactions. Contains 3.2 g sucrose per 10ml. This should be taken into account with patients with diabetes mellitus.

Also contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

Do not exceed the stated dose.

Do not take with any other cough and cold medicine

4.5 Interaction with other medicinal products and other forms of interaction

Whilst unlikely at recommended doses there is a theoretical risk of interaction with anti-arrhythmic drugs.

4.6 Pregnancy and lactation

No information or evidence is available on the safe use of ipecac during pregnancy or lactation is available.

It should not be used with out consulting a doctor and then only if the benefits outweigh the risks.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Ipecac is generally well tolerated at recommended doses but large doses and chronic usage may cause gastric irritation, nausea, vomiting, diarrhoea and cardiac conduction abnormalities.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.

4.9 Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. Treatment should be symptomatic.

Large doses of ipecacuanha may irritate the gastrointestinal tract, and give rise to nausea, persistent bloody vomiting or bloody diarrhoea.

Mucosal erosions of the entire gastrointestinal tract have been reported.

Overdosage is unlikely as a result of the emetic action of ipecacuanha, however, if emetine is absorbed in sufficient amounts it may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction. These symptoms may also be combined with dehydration due to vomiting, and may cause vasomotor collapse followed by death.

Acute overdosage of ipecacuanha should be treated with activated charcoal to delay absorption. Prolonged vomiting should be controlled by intramuscular injection of antiemetics. Supportive measures should be taken to correct fluid and electrolyte imbalance and cardiac effects.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Glycerin is a demulcent.

Ipecac acts according to its principal alkaloids emetine and cephaeline. Namely as a reflex expectorant.

5.2 Pharmacokinetic properties

Ipecac is absorbed as emetine, which may cause adverse effects on the heart such as conduction abnormalities or myocardial infarction. There is the possibility of the accumulation of emetine causing cardiotoxicity and myopathy. Emetine is slowly metabolised and excreted in the urine and faeces.

Glycerin is readily absorbed from the gastro intestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids to glucose or glycogen or oxidised to CO2 and water. It may also be excreted unchanged.

5.3 Preclinical safety data

None available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid Glucose

Sucrose

Citric Acid

Lemon Oil

Acetic Acid 33%

Camphor

Nipasept (methyl/ethyl/propylparaben) Amaranth

Water

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months in unopened bottle.

6.4. Special precautions for storage

Do not store above 25°C. Store away from direct sources of heat and sunlight.

6.5 Nature and contents of container

Bottle: Amber (Type III) glass

Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner

Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner

Sizes: 50 ml, 100 ml, 125 ml, 150 ml, 200 ml and 300 ml.

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Bell, Sons and Co (Druggists) Ltd [Trading Style – Bell’s Healthcare]

Gifford House,

Slaidburn Crescent

Southport

Merseyside

PR9 9AL