Active substance:
Lidocaine hydrochloride 1 H₂O, Chlorhexidine digluconate, Methyl-4-hydroxybenzoate, Propyl-4-hydroxybenzoate.

Composition:

6 ml/11 ml gel contains	6 ml	11 ml
Lidocaine hydrochloride 1 H2O	125.40 mg	230.00 mg
Chlorhexidine digluconate	3.14 mg	5.75 mg
Methyl 4-hydroxybenzoate (Ph.Eur.)	3.76 mg	6.90 mg
Propyl 4-hydroxybenzoate (Ph.Eur.)	1.57 mg	2.87 mg

Other ingredients:
Hyetellose, propylene glycol, sodium hydroxide, purified water

Indications:
Sterile gel with a local anaesthetic and disinfectant effect. For instillation. As a gel for mucous membrane disinfection and for local anesthesia, e.g., during catheterization, probe insertion, including intra-operatively, all forms of endoscopy, fistula catheter replacement, intubation, including for ventilation, for the prevention of iatrogenic damage to the rectum and colon.

Instillagel 6ml/11ml is suitable for use in adults and children aged 2 years and above.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.

Warnings:
Contains propylene glycol.

FARCO-PHARMA GmbH, Gereonsmühlengasse 1–11, 50670 Cologne, Germany

Active substance:
Lidocaine hydrochloride 1 H₂O, Chlorhexidine digluconate, Methyl-4-hydroxybenzoate, Propyl-4-hydroxybenzoate.

Composition:

6 ml/11 ml gel contains	6 ml	11 ml
Lidocaine hydrochloride 1 H2O	125.40 mg	230.00 mg
Chlorhexidine digluconate	3.14 mg	5.75 mg
Methyl 4-hydroxybenzoate (Ph.Eur.)	3.76 mg	6.90 mg
Propyl 4-hydroxybenzoate (Ph.Eur.)	1.57 mg	2.87 mg

Other ingredients:
Hyetellose, propylene glycol, sodium hydroxide, purified water

Indications:
Urological product: Sterile gel with a local anaesthetic and disinfectant effect for instillation. As a gel for mucous membrane disinfection and for local anaesthesia, e.g. during catheterisation, probe insertion, including intra-operatively, all forms of endoscopy, fistula catheter replacement, intubation, including for ventilation, for the prevention of iatrogenic damage to the rectum and colon and in paediatric patients.

Instillagel 6 ml/11 ml is indicated in adults and children aged 2 years and above.

Contraindications:
Do not use Instillagel 6 ml/11 ml

• in the presence of known hypersensitivity to lidocaine and other local anaesthetics of the amide type,
• in patients with significant disorders of the heart’s conduction system,
• in patients with known hypersensitivity (allergy) to the active substances or to any of the excipients of Instillagel 6 ml/11 ml,
• in children under 2 years.

Undesirable effects:
Very rare: Allergic reactions (in the most serious cases, anaphylactic shock) to a local anaesthetic of the amide type and/or to chlorhexidine; Hypersensitivity reactions, including late-onset reactions, to chlorhexidine and/or methyl- or propyl-4-hydroxybenzoate.
Not known: Corneal erosion, epithelial defect/corneal injury, severe permanent visual impairment; Despite the proven wide safety range of Instillagel 6 ml/11 ml, systemic adverse effects of the local anaesthetic lidocaine, such as anaphylactic shock, a fall in blood pressure, bradycardia or seizures, are possible in the case of severe urethral damage.

Warning:
Contains propylene glycol.
More information: See SmPC and PIL.

FARCO-PHARMA GmbH, Gereonsmühlengasse 1–11, 50670 Cologne, Germany