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INSTILLAGEL 6ML AND 11ML

Active substance(s): CHLORHEXIDINE DIGLUCONATE SOLUTION / LIDOCAINE HYDROCHLORIDE / METHYL HYDROXYBENZOATE / PROPYL HYDROXYBENZOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Instillagel®

sterile

Active substances: lidocaine hydrochloride, chlor-

hydroxybenzoate or any of the other ingre-

hexidine digluconate, methyl hydroxybenzoate,

dients of Instillagel® (see Section 6 for details).

propyl hydroxybenzoate.

 if the moist lining (mucous membrane) of the

Read all of this leaflet carefully before you start

application site (mouth, bladder, urethra, vagina,

using this medicine because it contains impor-

colon or rectum) is damaged or bleeding.

tant information for you.

Warnings and precautions


Keep this leaflet. You may need to read it again.

Tell the person who is going to give you the Instil-

 If you have any further questions, ask your

lagel®

doctor.

 if you have heart problems (cardiac insufficiency,

 This medicine has been prescribed for you.

heart failure)

Do not pass it on to others. It may harm them,

 if you have liver problems (hepatic insufficiency,

even if their symptoms are the same as yours.

liver failure, cirrhosis)

 If you get any side effects, talk to your doctor,

 if you suffer from epilepsy

pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

When used in the mouth or throat, Instillagel®
may cause difficulty with swallowing because

What is in this leaflet:

of its numbing effect. Numbness of the tongue

1. What Instillagel® is and what it is used for

and lining of the cheeks may increase the chance

2. What you need to know before Instillagel®

of you accidentally biting them.

is used
3. How Instillagel® is used
4. Possible side effects
5. How to store Instillagel®

Other medicines and Instillagel®
Tell your doctor if you are taking or have recently
taken or might take any other medicines, inclu-

6. Contents of the pack and other information

ding medicines obtained without a prescription.

1. WHAT INSTILLAGEL® IS AND WHAT
IT IS USED FOR

gular heartbeat (antiarrhythmic drugs).

Instillagel® is a gel that is used to numb the parts
of the body it is applied to (local anaesthetic). It
is used when examining or putting an instrument

Tell your doctor if you are taking drugs for irre-

Instillagel® with food and drink
You should ask your doctor about what you can
eat or drink.

into a body cavity, such as the mouth, bladder

Pregnancy and breast-feeding

or vagina. It provides lubrication to ease this

Ask your doctor or pharmacist for advice before

process. The gel contains substances (antiseptics)

taking any medicine.

to reduce the risk of infection. These are chlorhexidine digluconate, methyl hydroybenzoate
and propyl hydroxybenzoate.

If you are pregnant, think you may be pregnant
or are planning to have a baby, ask the person
who is going to give you Instillagel® for advice. You

Instillagel® may be used before you have a catheter

should only have Instillagel® applied if absolutely

inserted or replaced. It may also be used in your

necessary during the first three months of preg-

throat, bladder, vagina, rectum or colon. This

nancy. As only very small amounts of lidocaine

makes it easier for your doctor to look inside

get into breast milk, you can continue to breast

these parts of your body without causing you

feed.

discomfort.

Driving and using machines

2. WHAT YOU NEED TO KNOW
BEFORE INSTILLAGEL® IS USED

You may feel drowsy after using Instillagel®. If so,

This medicine is suitable for most people but a

Instillagel® contains:

few should not use it. If you are in any doubt, talk

 Methyl hydroxybenzoate and propyl

to your doctor.

hydroxybenzoate, which may cause allergic

Do not use Instillagel®:

reactions (possible delayed).

 if you are allergic (hypersensitive) to lidocaine,


Propylene glycol which may cause skin irritation. 

do not drive or use machinery.

chlorhexidine, methyl hydroxybenzoate, propyl
Please turn

3. HOW INSTILLAGEL® IS USED

Instillagel® is provided in a single-use tube that

A doctor or nurse will apply the necessary amount

looks like a syringe for injections. Any unused gel

of Instillagel® where it is needed.

remaining in the syringe should be thrown away.

Male adult urethra: Instil 11 ml, and possibly an

water or household waste. Ask your pharmacist

additional 11 ml.

Do not throw away any medicines via wastehow to throw away medicines you no longer

Female adult urethra: Instil 6 ml.

use. These measures will help to protect the

If you use more Instillagel® than you should:

environment.

Normally only small amounts of the active ingredient lidocaine are absorbed into the blood from

6. CONTENTS OF THE PACK AND
OTHER INFORMATION

Instillagel®. Too much lidocaine can be absorbed

What Instillagel® contains (per 100g):

if the surface being treated is damaged. In these

 The active substances are:

cases you may experience:
 fits (convulsions)
 unconsciousness
 stop breathing (respiratory arrest)
 low blood pressure (hypotension)
 changes in your heart rate or rhythm (myocardial

 lidocaine hydrochloride 2.0g
 chlorhexidine digluconate solution 0.25g
 methyl hydroxybenzoate 0.06g
 propyl hydroxybenzoate 0.025g
 The other ingredients are:

depression, bradycardia)

 hydroxyethylcellulose

 your heart stopping beating (cardiac arrest).

 propylene glycol

If you have any further questions on the use of
this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Possible
side effects include:
 serious allergic reaction that might cause dif ficulty with breathing or dizziness (anaphylaxis).
 low blood pressure (hypotension)
 changes in heart rate (bradycardia)

 sodium hydroxide
 purified water
What Instillagel® looks like and contents of
the pack
Instillagel® is supplied in disposable 6ml or 11ml
polypropylene syringes with a rubber stopper.
Pack sizes of 1, 10 and 100 syringes are available.
Marketing Authorisation Holder
Farco-Pharma GmbH
Gereonsmühlengasse 1 - 11
50670 Cologne

 fits (convulsions).

Germany

It is not known how frequently these side effects

Manufacturer

occur.

Almed GmbH

Reporting of side effects

Motzener Str. 41

If you get any side effects, talk to your doctor,

12277 Berlin

pharmacist or nurse. This includes any possible

Germany

side effects not listed in this leaflet. You can also

Sole Distributor in U.K.

report side effects directly via the Yellow Card

CliniMed Ltd.,

Scheme at: www.mhra.gov.uk/yellowcard

Cavell House, Knaves Beech Way,

By reporting side effects you can help provide

Loudwater, High Wycombe, Bucks.,

more information on the safety of this medicine.

HP10 9 QY

5. HOW INSTILLAGEL® IS STORED
Keep out of the sight and reach of children.
Do not use Instillagel® after the expiry date stated
on the folder box. The expiry date refers to the

Is this leaflet hard to see or read?
Telephone +49 221 594061 for an audio-tape,
large print leaflet or other formats.
This leaflet was last revised in November 2014.

last day of that month.
This medicine does not require any special storage conditions.

FARCO-PHARMA GmbH, Gereonsmühlengasse 1-11, 50670 Köln; Telefon: +49(0)221/594061; Fax: +49(0)221/593614,
E-Mail: info@farco-pharma.de, www.farco-pharma.de
XX XXX XXX
10P0414

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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