SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Allens Pine and Honey Syrup Covonia Herbal Mucus Cough Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of syrup contains:

0.007ml of extract (as liquid extract) from Ipecacuanha root (Cephaelis ipecacuanha (Brot.) A. Rich.)

Extraction solvent: Ethanol 80% v/v

0.125ml of extract (as liquid extract) from Liquorice root (Glycyrrhiza glabra L.)

Extraction solvent: Water

0.26ml of extract (as liquid extract) from Indian Squill bulb (Drimia indica (Roxb.) J P Jessop (1:5)

Extraction solvent: Ethanol 55% v/v

Each 5ml of oral liquid contains 2.3g of sucrose and 147.6mg of ethanol (alcohol) (See section 4.4 Special warnings and precautions for use)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Syrup

A dark brown coloured syrup.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for relief of the symptoms of mucus coughs and colds, based on traditional use only.

4.2 Posology and method of administration

For oral use only

Adults, elderly and children over 12 years:-two 5ml spoonfuls every 4 hours as required, up to a maximum of 4 times per day (40ml).

Duration of use:

Do not use for more than 7 days

If symptoms worsen or persist for more than one week, a doctor or a qualified healthcare practitioner should be consulted.

The use in children and adolescents under 12 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”).

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients. Patients with impaired renal function or cardiovascular disorders. Sensitivity to colophony containing products e.g. some lipsticks and eyeshadows etc.

(possibly due to excipient Pumilio Pine Oil)

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

It also contains 3.7% vol ethanol (alcohol), i.e. up to 295mg per 10 ml dose, equivalent to 7.5ml beer, or 3.1 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in children, pregnant women and high-risk groups such as patients with liver disease or epilepsy’.

The use in children and adolescents under 12 years of age has not been established due to lack of adequate data.

Patients taking liquorice medication should not take other liquorice containing products as serious adverse events may occur such as water retention, hypokalemia, hypertension, cardiac rhythm disorders.

Liquorice medication should be used with caution in patients affected by hypertension, kidney diseases, liver or cardiovascular disorders or hypokalemia as they are more sensitive to the adverse effects of liquorice.

If symptoms worsen or persist for more than one week, a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Liquorice root may counteract antihypertensive action of prescribed medications.

Not to be used concomitantly with thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance.

In view of the potential for Squill to interact with other medicines administered concurrently, the product should not be taken with digoxin or any medicines for a heart condition.

Contains alcohol and should therefore be avoided in patients taking other medication known to interact with alcohol e.g. Metronidazole.

4.6 Fertility, pregnancy and lactation

The safety of Allens Pine & Honey Balsam/Covonia Herbal Mucus Cough Syrup during pregnancy and lactation has not been established. The use during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive or operate machines have been performed.

This product contains alcohol (see section 2)

4.8 Undesirable effects

Adverse effects of both squill and ipecacuanha include nausea and vomiting caused by their irritant effect on the gastrointestinal tract; squill can also cause diarrhoea. Absorption of emetine known to accumulate in muscle after ingestion of larger doses of ipecacuanha may interfere with muscle fibre contractility of heart muscle.

The frequency is not known.

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

The symptoms of overdose of squill and ipecacuanha include nausea and vomiting. Treatment of overdose would depend upon the symptoms, cardiac irregularities, which may be caused by squill, may be treated by emesis or aspiration and lavage. In cases of severe cardiac arrhythmias, potassium and/or anti-arrhythmic agents may be given. Prolonged vomiting may be a symptom of overdose of ipecacuanha alkaloids, which may be controlled by intramuscular injection of 25 -50mg of chlorpromazine or of a comparable dose of a related phenothiazine; fluid and electrolyte imbalance should also be corrected.

Cases of overdose with liquorice root have been reported with prolonged use (more than 4 weeks) and/or intake of high amount of liquorice, with symptoms such as water retention, hypokalaemia, hypertension, cardiac rhythm disorders, hypertensive encephalopathy.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

A study has shown that 18p-glycyrrhetinic acid crosses through the placental barrier and can be detected in the rat foetuses. Following feeding of dams with 100 mg 18p-

glycyrrhetinic acid/kg/day commencing on the 13th day of gestation, on the 17th, 19th and 21st days of gestation the maternal plasma 18p-glycyrrhetinic acid concentrations were approximately 100 pg/ml, whereas the foetal concentrations were 5, 18 and 32 p/ml, respectively.

In developmental toxicity studies, glycyrrhizin (ammonium salt) exhibited some embryotoxicity to the developing rat foetus, but the foetal effects were considered as minor. These effects were shown at the dose of 100 and 250 mg/kg of ammonium glycyrrhizin from 7th to 20th day of pregnancy (soft-tissue abnormalities, mostly renal, and external haemorrhages) and at the dose of 1000 mg/kg of 18p-glycyrrhetinic acid from the 13th day of gestation (significant reduction in lamellar body content of lungs and reduced number alveolar lamellar body and surfactant clusters, but no apparent increase in malformation or foetal death rate).

Another study suggested that 100 mg/kg of liquorice extract repeated for 7 days may also aggravate body weight loss and malformations of foetuses, induced by intrauterine exposure to cyclophosphamide.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Pumilio Pine Oil Anise oil

Capsicum tincture

Arrowroot

Menthol

Peppermint oil

Sucrose

Treacle black

Honey

Acetic Acid Glacial Sodium Benzoate (E211)

Ethanol Purified water

6.2    Incompatibilities

None known

6.3    Shelf life

36 months unopened.

Once opened use within 28 days

6.4 Special precautions for storage

Store below 25°C. Store in original container.

6.5 Nature and contents of container

150ml bottle-amber glass with a child resistant tamper evident 28mm cap with a Melinex/Aluminium/EPE liner.

150ml, 300ml Amber glass bottle embossed “Covonia” with a child resistant tamper evident 28mm cap with Melinex/Aluminium/EPE liner.

6.6 Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd.,

Linthwaite Laboratories,

Huddersfield,

HD75QH

8    MARKETING AUTHORISATION NUMBER(S)

THR 00240/0371

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/04/2013

10    DATE OF REVISION OF THE TEXT

01/04/2015