SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Instillagel®

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 100g gel contains:
Lidocaine Hydrochloride	2.0g
Chlorhexidine Digluconate solution.	0.25g
Methyl Hydroxybenzoate	0.06g
Propyl Hydroxybenzoate	0.025g

3.    PHARMACEUTICAL FORM

Gel

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Catheterisation, cystoscopy. Exploratory and intra-operative investigations, exchange of fistula catheters, protection against iatrogenic damage in the rectum and colon. For use during gynaecological investigation.

4.2 Posology and method of administration

Unless otherwise prescribed by a doctor:

a) Urethral sounding and catheterisation: instill 6-11 ml.

After the usual cleaning of the glans and urethra and orifice, Instillagel® is instilled into the urethra and the glans is pressed for a short time between the thumb and index finger until the anaesthetic effect begins. When narrow gauge catheters are being introduced, any blockage of the eye of the catheter by gel can either be eliminated, if the bladder is full, by light pressure on the hypogastrium producing discharge of urine, or re-opened by means of the sterile disposable syringe and instillation of sterile saline solution.

b) Cystoscopy: with a view to considerate and painless introduction of instruments, the entire urethra including the external sphincter must be coated with a film of lubricant and anaesthetised. With a short penis and correspondingly narrow urethra, a dose of 11 ml is sufficient; in other cases an additional instillation of 6-11 ml of Instillagel® is recommended. A penis clamp is applied in the area of the coronary sulcus. The anaesthetic effect begins after 3.5 minutes. In prograde ureterocystoscopy the external sphincter, which is simultaneously anaesthetised, can distinctly be seen opening up when irrigated.

4.3 Contraindications

Instillagel® must not be used in patients with known hypersensitivity to the active ingredients (amide-type anaesthetics, chlorhexidine and alkyl hydroxybenzoates) or any of the excipients. Instillagel® should not be used in patients who have damaged or bleeding mucous membranes because of the risk of systemic absorption of the lidocaine hydrochloride.

4.4    Special warnings and precautions for use

Products containing local anaesthetics should also be used with caution in patients with impaired cardiac conditions, hepatic insufficiency and in epileptics.

Oropharyngeal use of Instillagel may cause difficulty in swallowing and therefore an increased risk of aspiration due to its local anaesthetic effect. Numbness of the tongue and buccal mucosa may also increase the chance of biting trauma.

In case of systemic effects from absorption of lidocaine hydrochloride, please see Section 4.9 ‘Overdose’.

Instillagel contains:

Methyl hydroxybenzoate and propyl hydroxybenzoate, which may cause allergic reactions (possible delayed).

Propylene glycol which may cause skin irritation.

4.5    Interactions with other medicinal products and other forms of interaction

Lidocaine should be used with caution in patients receiving anti arrhythmic drugs.

4.6 Pregnancy and lactation

During the first 3 months of pregnancy, lidocaine should be used only if absolutely necessary.

The amount of lidocaine excreted in breast milk is too small to be harmful.

4.7 Effects on ability to drive and use machines

The ability to drive and operate machinery may be slightly impaired after the use of Instillagel®. If affected, patients should be advised not to drive or use machinery.

4.8 Undesirable effects

In spite of the proven wide safety range of Instillagel, undesirable effects of the local anaesthetic, lidocaine, are possible where there is severe injury to the mucosa and absorption may occur. Examples are anaphylaxis, fall in blood pressure, bradycardia or convulsions.

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

Symptoms

In the event of excessive absorption of lidocaine into the bloodstream, symptoms may include CNS effects (such as convulsions, unconsciousness and possibly respiratory arrest) and cardiovascular reactions (such as hypotension, myocardial depression, bradycardia and possibly cardiac arrest).

Treatment

Treatment of a patient suffering from systemic toxicity of lidocaine consists of arresting the convulsions and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (respiration).

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The anaesthetic ingredient of Instillagel® is lidocaine, which stabilises neuronal membranes and prevents initiation and conduction of nerve impulses, thus effecting local anaesthetic action.

Chlorhexidine and methyl and propyl hydroxybenzoates have antiseptic properties.

5.2 Pharmacokinetic properties

After the product’s application to mucous membranes, lidocaine is absorbed, but its blood concentrations after the instillation of doses of up to 800mg into the urethra remain in the low range, below toxic levels. The metabolism of lidocaine takes place in the liver and unchanged drug is excreted renally.

Very small amounts of chlorhexidine may be absorbed. Chlorhexidine is eliminated almost unchanged although it is hardly absorbed even after high oral doses. Although para-hydroxybenzoates can be absorbed from mucous membranes, they are rapidly eliminated and do not accumulate. The para-hydroxybenzoates are excreted in the form ot para-hydroxybenzoic acid.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hydroxyethylcellulose Propylene Glycol Sodium Hydroxide Purified Water

6.2 Incompatibilities

None

6.3 Shelf life

60 months

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5    Nature and contents of container

Disposable 6ml or 11ml syringes made of polypropylene with butyl rubber stopper, in pack sizes of 1, 10 and 100 syringes.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

The product is for single use only. The syringe and any unused gel must be discarded.

7.    MARKETING AUTHORISATION HOLDER

Farco-Pharma GmbH Gereonsmuhlengasse 1-11 D-50670 Cologne Germany

8.    MARKETING AUTHORISATION NUMBER

PL 03377/0002

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30^th June 1994 / 15^th July 1999

10 DATE OF REVISION OF THE TEXT

21/01/2015