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LYPSYL COLD SORE GEL

Active substance(s): CETRIMIDE / LIDOCAINE HYDROCHLORIDE / ZINC SULFATE

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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
Immune system
disorders
Skin and subcutaneous
tissues disorders

Undesirable effect and
frequency
Not known:
Hypersensitivity
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

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Source: Medicines and Healthcare Products Regulatory Agency

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