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GYNO-DAKTARIN 1200MG VAGINAL CAPSULE

Active substance(s): MICONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2015

1200 mg vaginal capsule
Miconazole nitrate
Gyno-Daktarin is a registered trademark

Read all of this leaŲet carefully
before you start using this
medicine because it contains
important information for you.

• Keep this leaŲet. You may need
to read it again
• If you have any further questions,
ask your doctor or pharmacist
• This medicine has been prescribed
for you only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours
• If you get any side eŮects, talk to your
doctor or pharmacist. This includes any
possible side eŮects not listed in this
leaŲet. See section 4

What is in this leaŲet
1 What Gyno-Daktarin vaginal
capsule is and what it is used for
2 What you need to know before you
use Gyno-Daktarin vaginal capsule
3 How to use Gyno-Daktarin vaginal
capsule
4 Possible side eŮects
5 How to store Gyno-Daktarin
vaginal capsule
6 Contents of the pack and other
information

1 What Gyno-Daktarin vaginal capsule is and what it is
used for
The name of your medicine is
Gyno-Daktarin 1200 mg vaginal capsule.
It is called ‘Gyno-Daktarin vaginal
capsule’ or just ‘capsule’ in this leaŲet.
Gyno-Daktarin vaginal capsule is for
use in adults.
Gyno-Daktarin vaginal capsule is
a white to oŮ white, egg-shaped pessary.
When inserted into the vagina,
it releases a medicine called miconazole
nitrate. This belongs to a group of
medicines called ‘antifungals’.
Gyno-Daktarin vaginal capsule is used
for infections of the vagina. Signs of
these infections include itching,
redness and white discharge.
Gyno-Daktarin vaginal capsule works
by destroying the fungus that causes the
infection and some of the bacteria which
may also be present.
Your sexual partner may also need to be
treated. Ask your doctor for advice.

About vaginal thrush

Vaginal thrush is a very common
problem aŮecting women of all ages.
It has nothing to do with poor hygiene.
It is often caused by a fungus (Candida
albicans) that is present in everybody.
The fungus is normally kept in check
by the body’s defences.
Sometimes the fungus can become
a problem due to:
• Recent use of antibiotics
• Pregnancy
• Use of oral contraceptives
• Wearing tight clothing
• Over use of hot baths and bath additives
You can prevent infections coming back by:
• Washing the infected area in the morning
and evening with plain, warm water.
It is important that you dry thoroughly
• Wiping backwards after visiting the toilet
(away from the vagina)
• Not using medicated and perfumed
bath additives
• Not wearing tight
clothing

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2 What you need to know before you use Gyno-Daktarin
vaginal capsule
Do not use Gyno-Daktarin vaginal
capsule:

• If you are allergic to miconazole nitrate,
any of the other ingredients of this
medicine (listed in section 6) or to
other similar antifungal medicines
Do not use this medicine if this applies
to you. If you are not sure, talk to your
doctor or pharmacist before using
Gyno-Daktarin vaginal capsule.

Warnings and Precautions

Talk to your doctor or pharmacist before
using Gyno-Daktarin vaginal capsule if:
• You are using a ‘barrier’ method of
contraception. This includes condoms
or diaphragms. This is because
Gyno-Daktarin vaginal capsule can
and
stop
them
damage the latex
rubber
and
stop
them
working properly. Talk to your doctor
about using another type of
contraception while you are using this
medicine
• Do not allow other people to use your
Ųannel or towel. This will stop them
from getting your infection.

Children and adolescents

Gyno-Daktarin vaginal capsule is not
recommended for use in children or
adolescents under the age of 18.

Other medicines and GynoDaktarin vaginal capsule

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. This includes
medicines that you buy without
a prescription or herbal medicines.
In particular, tell your doctor if you are
taking:
• Medicines to thin the blood
(anticoagulants) such as warfarin.
Your doctor may want to check that the
anticoagulant is working properly
• Medicines for diabetes, taken by mouth

• Medicines that act on the heart and
blood vessels called ‘calcium channel
blockers’ such as dihydropyridines and
verapamil
• Medicine for epilepsy called phenytoin
• Medicines to lower cholesterol called
lovastatin or simvastatin
Tell your doctor before taking, or if you
are already taking any of the above.
They may need to alter your treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before using
this medicine.
You may still be able to use Gyno-Daktarin
vaginal capsule if your doctor thinks you
need to.

Driving and using machines

This medicine is not likely to aŮect you
being able to drive or use any tools or
machines.

Gyno-Daktarin vaginal capsule
contains

• Sodium ethyl parahydroxybenzoate
(E215) and sodium propyl
parahydroxybenzoate (E217).
These may cause an allergic reaction.
This reaction may happen some time
after you have inserted the capsule

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3 How to use Gyno-Daktarin vaginal capsule
Always use this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.

Using the capsule

• Do not swallow the capsule
• Use the capsule just before going
to bed. This helps it to stay in place

Inserting the capsule

• Wash your hands with soap and warm
water before inserting the capsule
• Remove the capsule from the plastic
packet by pushing it through the foil
• Lie down with your knees bent and
spread apart
• Push the capsule with your foreŰnger
as far as you can into your vagina
(Űgure 1)

• Always wash your hands with soap and
warm water after inserting the capsule
• Once in the vagina, the capsule will
melt and may leak. It will not stain your
skin or clothes but you may want to
use a sanitary towel

If you swallow Gyno-Daktarin
vaginal capsule

If a capsule is eaten or swallowed,
talk to a doctor or go to the nearest hospital
casualty department straight away.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

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4 Possible side eŮects
Like all medicines, this medicine can
cause side eŮects, although not
everybody gets them.
Stop using Gyno-Daktarin vaginal
capsule and tell your doctor straight
away if you notice the following. You
may need urgent medical treatment.
• Severe irritation or reddening of the
skin, swelling of the face, lips, tongue
or throat, light headedness, wheezing
or diůculty breathing or other signs
of allergy during the Űrst few days
of treatment. This only happens in
a small number of people
Other side eŮects:
• Local irritation (around or inside the
vagina), itching or burning sensation
of the treated area. This is much milder
than an allergic reaction. Tell your
doctor or pharmacist if these feelings
continue
• Skin rash or hives (also known as
nettle rash or urticaria)






Stomach pain
Low stomach pains (pelvic cramps)
Headache
Infection of urine or pain in passing
urine
• Vaginal bleeding
• Feeling sick (nausea)
• Redness of the face

Reporting of side eŮects

If you get any side eŮects, talk to your
doctor, pharmacist or nurse. This includes
any possible side eŮects not listed in this
leaŲet. You can also report side eŮects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side eŮects you can help
provide more information on the safety
of this medicine.

© J-C 2015

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5 How to store Gyno-Daktarin vaginal capsule
Keep this medicine out of the sight and
reach of children. Do not store above
30°C.
Do not use Gyno-Daktarin vaginal
capsule:
• After the expiry date which is stated
on the carton or capsule packaging.
The expiry date refers to the last day
of that month
• If the plastic packet is broken or missing
• If the capsule is not white to oŮ white
in colour

Do not throw away any medicines via
wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.

6 Contents of the pack and other information
What Gyno-Daktarin vaginal
capsule contains

The active substance is miconazole
nitrate. Each capsule contains 1200 mg
miconazole nitrate.
The other ingredients are liquid paraůn,
white petrolatum, lecithin, gelatin,
glycerol, titanium dioxide (E171), sodium
ethyl parahydroxybenzoate (E215),
sodium propyl parahydroxybenzoate
(E217) and medium chain triglycerides.

What Gyno-Daktarin vaginal
capsule looks like and contents
of the pack
Gyno-Daktarin vaginal capsule comes
in a pack containing one capsule.
The capsule is egg-shaped and white
to oŮ white in colour.
Marketing Authorisation Holder:
Janssen-Cilag Ltd., 50-100 Holmers
Farm Way, High Wycombe,
Bucks HP12 4EG, UK
Manufacturer:
Janssen-Cilag SA, Campus de
Maigremont 27100, Val-de-Reuil, France
OR
McGregor Cory Ltd, Exel, Middleton
Close, Banbury, Oxon, OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaŲet was last revised in October
July 2015
2015

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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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