SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Lypsyl Cold Sore Gel

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Lidocaine hydrochloride 2.0% w/w Zinc sulfate 1.0% w/w Cetrimide 0.5% w/w

Excipients with known effect:

Each tube contains 0.3g of propylene glycol

For the full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Gel

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of cold sores.

4.2    Posology and method of administration

Posology

Adults and children over 12 years: Apply a small amount to the affected area with your fingertips 3-4 times daily.

Paediatric population

Children under 12 years: Not recommended.

Method of administration: Cutaneous use

4.3    Contraindications

Hypersensitivity to the active substances, anaesthetics of the amide-type or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

For external use only.

Contact with the eyes should be avoided.

Not recommended for children under 12 years.

The excipient propylene glycol may cause skin irritation.

4.5    Interaction with other medicinal products and other forms of interaction

No known interactions with other drugs.

4.6    Fertility, pregnancy and lactation

Pregnancy

The safety of this medicinal product for use in human pregnancy has not been established. The product is, therefore, not recommended during pregnancy.

Breast-feeding

Lidocaine enters the mother’s milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.

Fertility

No data on human fertility is available.

4.7    Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency groupings:

Very common: > 1/10 Common: >1/100 to <1/10 Uncommon: >1/1,000 to <1/100 Rare: >1/10,000 to <1/1,000 Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ Class	Undesirable effect and frequency
Immune system disorders	Not known: Hypersensitivity
Skin and subcutaneous tissues disorders	Not known: Skin irritation Skin sensitisation

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

Features

Serious toxicity is unlikely after oral administration of lidocaine due to extensive first pass metabolism, but has been reported after ingestion of large amounts. When ingested the local features are numbness of the mouth, throat and pharynx. Clinical features of toxicity are unlikely if the patient has no local anaesthetic symptoms in the mouth and no other symptoms at presentation, due to low bioavailability. Central Nervous System (CNS) symptoms include increasing restlessness, visual disturbances, agitation, tinnitus, confusion, hallucinations, drowsiness, weakness, shivering, paraesthesia, muscle twitching and can lead to convulsions, which are the major feature of toxicity. Coma and apnoea may develop. Cardiovascular system (CVS) symptoms include transient hypertension and tachycardia followed by arrhythmias. Hypotension may result from depressed myocardial contractility and peripheral vasodilation. Methaemogloginaemia (manifesting as cyanosis and hypoxia). Gastrointestinal (GI) symptoms include nausea and vomiting. Allergic reactions occur rarely and may include urticaria, angioedema, contact dermatitis and pruritis. Acute respiratory distress syndrome (ARDS) has been reported in severe allergic reactions.

Management

If small quantities have been ingested; nil by mouth until oral sensation is returned to normal.

Following ingestion of potentially toxic amounts or in patients with systemic symptoms maintain a clear airway and ensure adequate ventilation. Prolonged resuscitation for cardiac arrest is recommended, continuing for at least 1 hour and only stopped after discussion with a senior clinician. Lidocaine is cardiotoxic and careful assessment of the electrocardiogram (ECG) is required. Perform a 12 lead ECG and measure the QRS duration and QT interval.

Repeat 12 lead ECGs are recommended, especially in symptomatic patients. All patients should be observed for at least 4 hours after exposure. If cardiotoxicity is unresponsive to standard care consider the use of a lipid emulsion. Manage any resulting convulsions, hypotension, bradycardia, metabolic acidosis and haemodynamic compromise in the conventional manner. Methaemoglobinaemia can be treated by methylene blue (methylthioninium chloride). Exchange transfusion may be indicated in cases where methaemoglobinaemia is unresponsive or only partially responsive to methylene blue.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anaesthetics for topical use ATC code: D04AB

Lidocaine hydrochloride is a local anaesthetic of the amide type which is widely used for local application to mucous membranes. It produces surface anaesthesia by diminishing or preventing the conduction of sensory nerve impulses.

Cetrimide is a quaternary ammonium disinfectant. As well as having emulsifying and detergent properties, it is active against gram-positive and some gram-negative organisms.

Zinc sulfate has astringent properties.

5.2 Pharmacokinetic properties

Lidocaine hydrochloride is effectively absorbed from mucous membranes.

5.3    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hydroxyethylmethylcellulose 3000

Polysorbate 20

Nonoxynol 9

Propylene glycol

Menthol

Purified water

6.2    Incompatibilities

None known.

6.3    Shelf life

None known.

6.4    Special precautions for storage

Do not store above 30°C.

6.5    Nature and contents of container

Laminated tube consisting of aluminium foil coated internally and externally with low density polyethylene or high density polyethylene.

Pack size: 3g

6.6 Special precautions for disposal

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

7 MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16853/0146

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23 January 1991.

10 DATE OF REVISION OF THE TEXT

27/05/2016