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GYGEL CONTRACEPTIVE JELLY

Active substance(s): NONOXINOL 9

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Gygel Contraceptive Jelly
Nonoxinol-9
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However you
still need to use it carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist or family planning clinic if you need
more information.
- If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
The name of your medicine is Gygel Contraceptive Jelly.
Throughout the rest of this leaflet, it will be referred to
as Gygel.
In this leaflet:
1. What Gygel is and what it is used for
2. Before you use Gygel
3. How to use Gygel
4. Possible side effects
5. How to store Gygel
6. Further information

1. WHAT GYGEL IS AND WHAT IT IS USED FOR
Gygel is called a spermicidal contraceptive since it kills
sperm. It should be used along with a barrier method of
contraception, such as a vaginal diaphragm or cap, in
order to prevent pregnancy.
How does Gygel work?
Following sex, pregnancy may occur if a sperm travels up
the vagina and through the entrance to the womb (cervix)
and beyond, where it might fertilise an egg.
By using a vaginal diaphragm or cap, access to the cervix is
blocked, preventing the passage of sperm into the womb.
Spermicidal contraceptives such as Gygel will kill any sperm
that may get round a diaphragm, and so will provide more
effective contraception.

2. BEFORE YOU USE GYGEL
Do not use Gygel if you:
• have ever experienced an allergic reaction to nonoxinol-9
or to any of the other ingredients in Gygel (see ‘What
Gygel contains’)
• are paraplegic, quadriplegic or have no sensation in your
vagina for any other reason
• are pregnant or think you may be pregnant.

Speak to your doctor or family planning clinic before
using Gygel if:
• it is important that you do not get pregnant. Spermicidal
contraceptives such as Gygel are intended for use with a
barrier method of contraception, but they may not be the
most appropriate method of contraception for you.
• you have sex more than three times a day since the
nonoxinol-9 present in Gygel may cause genital skin
problems and increase the chance of you getting
HIV (AIDS) infection.
• you are at risk of getting HIV (AIDS) or another sexually
transmitted disease since Gygel does not protect against
HIV (AIDS) or other sexually transmitted diseases. You
should use a latex condom to protect against the spread
of sexually transmitted diseases (STD’s).
If you have any doubts about whether you should use Gygel
then discuss things more fully with your doctor, family
planning clinic or pharmacist.
Taking other medicines
Always tell your doctor, family planning clinic or pharmacist
if you are taking any other medicines because using some
medicines together can be harmful.
Gygel is not known to react with other medicines. However,
some vaginal products and lubricating agents may contain
ingredients that can damage contraceptive diaphragms/caps
made from latex rubber. As a result these may be less
effective as a barrier against pregnancy and as a protection
from sexually transmitted diseases including HIV. If you
are in doubt you should discuss the use of any such vaginal
preparation with your doctor, pharmacist or family planning
clinic.
The following products should NOT be used at the same
time as your vaginal diaphragm or cap.
• Petroleum jelly (Vaseline);
• Mineral oil (baby oil);
• Oil-based vaginal and rectal preparations.
Gygel need not be used with a condom.
Pregnancy and breast-feeding
You should not use Gygel if you are pregnant or think you
may be pregnant.
Do not use Gygel if you are breast-feeding without talking to
your doctor or family planning clinic first.
Driving and using machines
Gygel has not been reported to affect your ability to drive or
operate machinery.
Important skin allergy information
Gygel contains propylene glycol which may cause
skin irritation.
Gygel also contains Sorbic acid (E200) which may cause
local skin reactions, (e.g. contact dermatitis).

3. HOW TO USE GYGEL
• Extra gel may be inserted into the vagina using a
Vaginal Applicator.
Use with a diaphragm
• With clean hands put about two 2cm strips of gel
on each side of your diaphragm.
Make sure you also spread it along the outside rim of
your diaphragm to prevent any sperm from getting past
the edge.
Use with a cap
• Fill one third of the cap with spermicide. Silicone caps have
a groove between the dome and the rim and some gel
should be placed there also. Do not put any spermicide
around the rim as this will stop the cap from staying
in place.
• If using a diaphragm/cap this should be put in place inside
the vagina before sex and left there for at least six
hours after sex.
• If you have sex again during this time, you must apply
more Gygel or another spermicide without removing
the diaphragm or cap.
• If you have sex 3 hours or more after inserting your
diaphragm or cap you will need to insert some extra gel.
Warning: your diaphragm should not be left in your vagina
for longer than 24 hours.
There is no need to wash your vagina (douching) after
sex. However, if you wish to do so, you must wait for at
least six hours after intercourse.
Missed dose
If you forget to use Gygel or another form of contraception
when you have sex you will not be protected against pregnancy
and you should see your doctor if necessary.
Ensure that you use Gygel on future occasions.
If you have any further questions on the use of this product,
ask your doctor, family planning clinic or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gygel can cause side effects, although
not everybody gets them.

What if Gygel Contraceptive Jelly is swallowed?
Gygel should only be used in the vagina. If put in the mouth,
it is likely to taste unpleasant. However, if large quantities
are accidentally swallowed, it may cause stomach irritation.
In this case you should seek immediate help from the
nearest hospital casualty department.

5. HOW TO STORE GYGEL
Keep out of the sight and reach of children.
• Do not use Gygel after the expiry date which is stated
on the pack. The expiry date refers to the last day of that
month.
• Do not use Gygel if you notice that the container has
been damaged.
• Do not store above 25ºC.
• Store in the original package in order to protect
from light.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Gygel contains
The active ingredient in Gygel is nonoxinol-9 2.0% w/w.
The other ingredients are: methyl parahydroxybenzoate
(E 218), Sorbitol solution (E 420), lactic acid, Povidone K30,
propylene glycol, sodium carboxymethylcellulose, Sorbic
acid (E 200) and purified water.
What Gygel looks like and the contents of the pack
Gygel is available in an aluminium tube containing a clear
odourless vaginal gel. A Vaginal Applicator is available
separately.
Gygel is available in a 30g or 81g tube.
Marketing Authorisation holder:
Marlborough Pharmaceuticals Ltd, 35A High Street,
Marlborough, Wilts, SN8 1LW, UK
Tel 01672 514187

• Gygel may cause irritation of the vagina or penis. If this
occurs, you should stop using it immediately. If the
irritation gets worse or carries on for more than 48
hours, contact your doctor or family planning clinic
for advice.
• Other symptoms suggesting an allergy to Gygel include
pain, discomfort, a burning sensation, itching, dryness,
redness or rashes of the vagina or penis.
• If this product affects you in any other way, you should
tell your doctor, family planning clinic or pharmacist.

For information in large print,
tape, CD or Braille,
telephone 01672 514187

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

This leaflet was last prepared in December 2013

Manufacturer: PHARBIL Waltrop GmbH, Im Wirrigen 25,
D-45731, Waltrop, Germany

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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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