Consumer information

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
ending in “caine”, or to chlorhexidine or chlorhexidine- Instillagel®
containing medicines or chlorhexidine-coated catheters • there is an infection, cut or rash at or near the area where This leaflet is part III of a three-part "Prescribing Information" published when Instillagel® was approved for sale in Canada and • you have malignant hyperthermia (a hereditary is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Instillagel®. Contact your doctor or pharmacist if you have any questions about the drug. The gel should not be used if it is going to be in contact with damaged membranes. ABOUT THIS MEDICATION

What the medication is used for:
INTERACTIONS WITH THIS MEDICATION
Instillagel® is used for adults and children over 2 years old when putting a tube or instrument into your urethra (the canal leading Drugs that may interact with Instillagel® include:
to your bladder). Instillagel® is used: Some other local anaesthetics, medicines used for treating • During insertion of a medical instrument into your irregular heartbeats, a medicine used for heart problems, an antibiotic and a medicine used for depression or obsessive compulsive disorder. These medicines are:
• During exploration by sound and other operations in the What it does:
Instillagel® contains a local anaesthetic (lidocaine) to prevent pain and an antiseptic (chlorhexidine) to reduce the risk of infection getting in, while lubricating to make the process PROPER USE OF THIS MEDICATION
The gel is available in two package sizes - 6 mL and 11 mL. When it should not be used:
Usually the complete contents of the size suitable for the The gel should not be used if you know that you are allergic or hypersensitive to these or any of the other ingredients, or to any other “-caine” type anaesthetics. Please inform the healthcare Adults: Do not use more Instillagel® than the doctor has
professional who is going to use the gel if this applies to you. recommended. A usual adult dose is one syringe of 11 mL, with possibly an additional syringe of 6 or 11 mL (for men) or one What the medicinal ingredients are:
syringe of 6 mL (for women). During procedures, the doctor Lidocaine hydrochloride (2% w/w) and chlorhexidine gluconate may use as many as 4 syringes (a total of 39 mL) in one dose. Do not use more than 4 doses in a period of 24 hours. What the non-medicinal ingredients are:
Children: Your doctor will instruct you on how much to give Methylparaben, Propylparaben, Hydroxyethylcellulose, Sodium your child as the amount will vary depending on age and weight. Hydroxide, Propylene Glycol and Purified Water. The product should start to work within 5-10 minutes of using it. What dosage forms it comes in:
The gel is available as a sterile syringe, in two package sizes - 6 For self-catheterization: Follow these directions carefully. Clean the urethral area before using Instillagel®. The syringe is removed from its sterile package by tearing off the backing WARNINGS AND PRECAUTIONS
paper. Before removing the blue cap from the end of the syringe, free the plunger by gently pressing it. Remove the cap. Insert the Instillagel® is for topical use only and is not to be injected.
nozzle into the opening of the urethra and press the plunger Before using Instillagel®, tell your doctor if:
The syringe is for single use only. If the complete contents are
not used, the syringe and remaining gel must be thrown away. This medicine has been prescribed for your current medical problem only. Do not give it to other people. you have ever had an unusual or allergic reaction to Instillagel®, to another lidocaine or other medicine IMPORTANT: PLEASE READ
Overdose:
HOW TO STORE IT
Avoid contact with your eyes or ears. Numbness in the eyes may The gel should not be used after the expiry date shown on the prevent you from noticing if you get something in the eye. package. If you are asked to keep a package of gel for use at For symptoms of serious side effects please consult the table entitled “SERIOUS SIDE EFFECTS, HOW OFTEN THEY Keep this medicine out of the reach of children.
In case of drug overdose, contact a health care practitioner, REPORTING SUSPECTED SIDE EFFECTS
hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance
Program by one of the following 3 ways:
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Instillagel® may have, in addition to its beneficial effects, some unwanted effects. You might feel a • Complete a Canada Vigilance Reporting Form and: slight stinging just after the gel is used, but this stops as soon as the anaesthetic starts to work. Most people find that there are no problems after the gel has been used, but of course there may be some soreness when the effect of the local anaesthetic has worn SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Symptom / effect
Talk with your
Stop taking
doctor or
pharmacist
immediate
NOTE: Should you require information related to the
attention
management of side effects, contact your healthcare
Allergic reaction such
professional. The Canada Vigilance Program does not
as: Shortness of breath,
provide medical advice.
beat, not present before using this medicine. MORE INFORMATION
Overdose: Drowsiness,
This document plus the full prescribing information, prepared for health professionals can be obtained by contacting the sponsor, PENDOPHARM, Division of Pharmascience Inc. at: By post: PENDOPHARM, Division of Pharmascience Inc. Other side effects not listed above may also occur in some This leaflet was prepared by PENDOPHARM, Division of patients. If you notice any other effects, tell your doctor If you feel that you have had any reaction to the gel, please tell lnstillagel® is a registered trademark of FARCO-PHARMA GmbH, 50670 Cologne, Germany, used under license by

Lidocaine and Chlorhexidine Gel BP

Instillagel® Post-Marketing Experience

Drug Substance: Lidocaine Hydrochloride

Drug Substance: Chlorhexidine Gluconate

American Hospital Formulary Service Drug Information (AHFS DI), 2004, American Society of Health-System Pharmacists, Bethesda, MD., pp. 3385-3390

Brekkan E, Ehrnebo M, Malmström PU, Norlén BJ, Wirbrant A. A controlled study of low and high volume anaesthetic jelly as a lubricant and pain reliever during cystoscopy. J Urol 1991; 146: 24-27

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Denton DW. Chlorhexidine. In: Block SS, ed. Disinfection, sterilization, and preservation. 4th edition. Philadelphia: Lea & Febiger; 1991:274-89

EMLA® Cream Product Monograph, AstraZeneca Canada Inc., August 31, 2006, AstraZeneca Canada Inc., Mississauga, ON

Günther J. Die Verwendung von Einmal-Anästhesie-Gleitmittel (Instillagel) bei Katheterismus der Harnröhre. [The use of a disposable anesthetic lubricant (Instillagel) in catheterization of the urethra] Münch Med Wschr 1974; 116: 959-960

Hak-Hagir A. Zur Anwendung eines Einmal-Anaesthesie-Gleitmittels (Instillagel) beim Katheterismus. [The application of a disposable anesthetic lubricant (Instillagel) in catheterization] Österr Ärztl Fortbild 1972; 13 (Supplement)

Hibidil 1:2000 Prescribing Information, www.RxMed.com, 2004

Kambal C, Chance J, Cope S, Beck J. Catheter-associated UTIs in patients after major gynaecological surgery. Prof Nurse. 2004 May;19(9):515-8

Martindale: the complete drug reference. 32nd ed. London: Pharmaceutical Press; Parfitt K, ed., 1999:1229-31

Scholtmeijer RJ. Die antiseptische Wirkung von Instillagel bei der Urethro- Zystoskopie von Kindern. [The antiseptic effect of Instillagel during cystoscopy of children.] Urologe B 1988; 28: 169-170

Scholtmeijer RJ, Dzoljic-Danilovic G. Disinfecting effect of a disposable lubricant during cystoscopy. Child Nephrol Urol 1990; 10: 22-25

Sperling H, Rübben H, Bastian H-P, Boeminghaus F, Ludwig G, Terhorst B. Local antiseptic therapy for non-gonococcal urethritis: phase II study with Instillagel. World J Urol 2001; published online: 23 November

Thompson TJ, Thompson N, O’Brien A, Young MRA, McCleane G. To determine whether the temperature of 2% lignocaine gel affects the initial discomfort which may be associated with its instillation into male urethra. BJU Int 1999; 84 (9): 1035-1037

Vogler H. Untersuchungen zur desinfizierenden Wirkung von Gleitmitteln bei transurethralen Elektroresektionen. [Study of the disinfectant action of lubricants in transurethral electroresection] Z Urol Nephrol 1980; 73: 401-405

Wabrosch G, Szolnoki G. Beszámoló a steril, antiszeptikus és érzéstelenitó hatásu Instillagel kírsérleti tapasztalatairol. [Experience report on testing a sterile antiseptic and

anaesthetic lubricant INSTILLAGEL®] Magyar Urológia 1990; 4: 371-375

Wassmann E, Knipper W, Mayr E, Knoke P. Antimikrobielle Wirksamkeit von Gleitmitteln in der Urologie. [Antimicrobial effectiveness of lubricants in urology] Urologe B 1988; 28: 367-369

XYLOCAINE® Jelly 2% Prescribing Information, AstraZeneca Canada Inc., October 19, 2006, AstraZeneca Canada Inc., Mississauga, ON

Source: http://instillagel.ca/wp-content/uploads/2012/09/Consumer.pdf