INSTILLAGEL - Medicines Authority

PATIENT INFORMATION LEAFLET
®
INSTILLAGEL sterile
Instillagel ® is a sterile gel containing a local anaesthetic and
antiseptics presented in a sterile package.
Active ingredients are in 6 ml 11 ml
Lidocaine Hydrochloride (anhydrous) (Local anaesthetic)117.6 mg 215.7 mg
Chlorhexidine Digluconate
(as Chlorhexidine Digluconate Sol. Ph.Eur.) (Antiseptic) 15.7 mg 28.8 mg
Methyl Hydroxybenzoate (E218) (Antiseptic) 3.8 mg 6.9 mg
Propyl Hydroxybenzoate (E216) (Antiseptic) 1.6mg 2.9 m g
in a gel made with Hydroxyethylcellulose, Propylene Glycol, Sodium Hydroxide
and Purified Water.
Disposable syringes each containing 6 ml or 11 ml are available.
Marketing Authorisation Holder: Manufacturer:
Farco-Pharma Almed GmbH
Pharmazeutische Präparate GmbH
Gereonsmühlengasse 1-11 Motzener Str. 41
50670 Köln, Germany 12277 Berlin, Germany
Marketing Authorization Number: 125/00101
Indications:
As a lubricant gel, disinfectant, and local anaesthetic e.g. in catheterizations and
internal examinations, also intraoperatively; all forms of endoscopy, changes of
fistula catheters, intubations, also in artificial respiration, for the prevention of
iatrogenic injuries to the rectum and colon, and in paediatrics.
Pharmaceutical form: Urethral, vaginal and rectal gel.
What the gel does:
Instillagel ® is used when putting a tube or instrument into a body cavity. It contains
a local anaesthetic to prevent pain and antiseptics to reduce the risk of infection
getting in, while lubricating to make the process smooth.
Before the gel is used: The gel should not be used:
• If you have ever had a reaction to a local anaesthetic.
• The gel contains E216 and E218 (also called parabens). The gel
should not be used if you know that you are allergic or hypersensitive
to these or any of the other ingredients.
• If it is going to be in contact with damaged membranes.
Tell the person who is going to use the gel if any of these apply to you.
Take special care with the gel: Tell the person who is going to use the gel
• if you have heart problems
• if you have liver problems
• or if you are epileptic.
Also tell this person if you are taking any medicines for treating irregular heart beats.
Pregnancy and breast feeding:
During the first 3 months of pregnancy Lidocaine should be used only if absolutely
necessary. Since it is not known whether Lidocaine passes into milk, breastfeeding
should be suspended for 12 hours after administration.
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After using the gel:
Driving or using machinery: You may feel a little sleepy after using the gel. In
this case do not drive or use machinery.
After use in the mouth: Take care swallowing or chewing as you may not feel if
you bite yourself.
How the gel is used:
The gel is available in two package sizes – 6 ml and 11 ml. Usually the complete
contents of the size suitable for the procedure will be used. The syringe is removed
from its sterile package by tearing off the backing paper. Before removing the
blue cap from the end of the syringe, free the plunger by gently pressing it. Remove
the cap. Insert the nozzle into the opening of the area to be anaesthetised and press
the plunger slowly to push out the gel.
The anaesthetic takes about 5 minutes to work after the gel has been used.
Does the gel have any side effects?
You might feel a 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 off.
If you feel that you have had any reaction to the gel, please tell your doctor as
soon as possible.
What to do in case of an overdosage:
Treatment of a patient suffering from systemic toxicity of lignocaine consists of
arresting the convulsions and ensuring adequate ventilation with oxygen, if
necessary by assisted or controlled ventilation (respiration). If convulsions occur,
they must be treated promptly by intravenous injection of thiopentone (100 or 200
mg) or diazepam (5 to 10 mg). Alternatively, succinylcholine (30 - 100 mg i.v.)
my be used, providing the clinician is acceptable of performing endotracheal
intubation and managing a fully paralysed patient. If ventricular fibrillation or
cardiac arrest occurs, effective cardiavascular resuscitation must be instituted.
Epinephrine in repeated doses and sodium bicarbonate should be given as rapidly
as possible.
If you forget to take one dose:
That is no problem and without any effect.
Storage of the gel:
The gel should not be used after the expiry date shown on the package.
If you are asked to keep a package of gel for use at another time, do not store
it above 25°C. The syringe is for single use only. If the complete contents are
not used, the syringe and remaining gel must be thrown away.
As with all medicines, keep Instillagel ® away from children.
Farco-Pharma Pharmazeutische Präparate GmbH,
Gereonsmühlengasse 1 - 11, 50670 Köln/Germany
Phone No.: ++49 221 594061; Fax No.: ++49 221 593614
www.farco-pharma.com email: info@farco-pharma.de
Instillagel ® is the registered trademark of Farco-Pharma GmbH.
This leaflet was written in July 2007.
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