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CLOTRIMAZOLE 500MG VAGINAL TABLETS

Active substance(s): CLOTRIMAZOLE

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PATIENT INFORMATION LEAFLET

Clotrimazole 500mg Vaginal Tablet
(Clotrimazole Ph. Eur.)
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 if you need more information or advice.
You must contact your doctor if your symptoms worsen or do not go away after 3 days.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1
2
3

What this medicine is and what it is used to treat
Before you use
How to use

1 What this medicine is and
what it is used for

This medicine contains Clotrimazole which belongs
to a group of medicines called antifungals, which act
to treat infections caused by fungi.
Clotrimazole is used to treat fungal infections of the
vagina known as thrush (candidal vaginitis).
Thrush is a common infection caused by yeast (or
fungus). Transmission of thrush usually occurs
through intestinal excretions and personal contact
and may live harmlessly in the vagina, without you
even noticing it. However, in certain circumstances,
it may develop into an infection in the vagina and
symptoms may spread to the surrounding area.
These symptoms may include one or more of the
following:
itching of the vagina and surrounding area (the
vulva)
redness and swelling of the tissues of the vagina
and vulva
soreness of the vagina and vulva
a white non smelling discharge from the vagina

2 Before you use
Do not use if:
you are allergic to clotrimazole or any of the other
ingredients
Take special care
Talk to your pharmacist or doctor before using
Clotrimazole if:
you are under 16 years or over 60 years
you have thrush for the first time
you or your partner have ever had a sexually
transmitted disease
you have had more than two infections in the last
six months
you are allergic to imidazoles or other vaginal
antifungal products
you have any of the following symptoms:
irregular vaginal bleeding
abnormal vaginal bleeding or a blood stained
discharge
ulcers, blisters or sores of the vagina or vulva
lower abdominal pain
pain or difficulty in passing urine
fever or chills
feeling sick or vomiting
diarrhoea
foul smelling discharge from the vagina

5
6

Possible side effects
How to store
Further information

In particular, tell your doctor or pharmacist if you are
taking the following:
Other drugs used for the treatment of fungal
diseases, such as amphotericin and other
polyene antibiotics e.g. nystatin
Tacrolimus, used to reduce the immune response
to prevent rejection after an organ transplant
Pregnancy
Ask your doctor or pharmacist for advice before
taking or using any medicine.
Clotrimazole can be used during pregnancy but only
under the supervision of a doctor or midwife.
If your doctor tells you that you can use Clotrimazole
during pregnancy, the vaginal tablet can be inserted
without using the applicator.

3 How to use
Follow the instructions below or ask your pharmacist
for help if you are not sure how to use this medicine.
Clotrimazole is a vaginal tablet and is only for
use in the vagina
Treatment consists of only one tablet, which
should be inserted at night before going to sleep
Do not use the tablet at the same time as you are
having a period. Wait until your period has
finished
Unless your doctor advises against it, you may
continue to have sexual intercourse during the
treatment period.
Instructions for inserting the vaginal tablet
Remove the applicator from the packaging
Remove the tablet from the aluminium package
and place it firmly into the open end of the
disposable applicator `B (Diagram 1)
To fit the tablet into the applicator, squeeze the
applicator lightly on either side, whilst pushing
the tablet into the holder far enough to be held in
place during insertion (about 1 cm)

Special precautions rubber (latex) contraceptives:
This product may reduce the effectiveness of rubber
(latex) contraceptives, such as condoms or diaphragms.
Consequently, you should use alternative precautions
for at least five days after using this product.
Taking other medicines
Please tell your pharmacist if you are taking or have
recently taken other medicines, including medicines
obtained without a prescription.

Hard to Read?

4

Phone

Carefully insert the applicator into the vagina as
deeply as is comfortable. This is easiest done
when lying on your back with your legs slightly
bent (Diagram 2)
Continued....

0800 970 6115

for help
Till Ver.4s

Cream/vaginal cream is also suitable for your partner
to use to treat a yeast infection of the penis (candida
balanitis).
Ask your doctor if your partner should be treated at
the same time with cream/vaginal cream. In this case,
the cream/vaginal cream should be applied to the top
of the penis (glans) and foreskin 2 3 times daily.

4 Possible side effects
By carefully pushing the inner plunger A as far as
it will go the tablet is placed in the vagina
(Diagram 3)

Most people will not have problems with this
medicine but, like all medicines it may cause side
effects in a few people.
If you have these side effects contact your doctor
immediately or go to the Accident and Emergency
Department of your nearest hospital:
Allergic reaction such as, itching, itchy rash,
fainting, low blood pressure which may cause
light headedness, fainting or dizziness, swallowing
or breathing problems, swelling of your lips, face,
throat or tongue
Intolerable burning or irritation
Rare side effects
Local mild burning or irritation immediately after
applying the tablet

Remove the disposable applicator from the
vagina and dispose of it in a safe place, out of
the reach of children
The applicator cannot be flushed down the toilet
Wash your hands thoroughly after use
Duration of treatment
Each course of treatment consists of just one
Clotrimazole Vaginal Tablet, which remains effective
for 3 days. After just 1 2 days most of the obvious
symptoms of the infection will disappear (in particular
itching).
If the external symptoms of the disease, e.g.
discharge or itching, have not completely subsided
within three days of using the tablet, consult your
doctor who may want you to repeat the treatment.
If anyone accidentally swallows the tablet
Clotrimazole Vaginal Tablets are for external use
and should be used only in the vagina. If you or
anyone else has accidentally swallowed the vaginal
tablet you must contact your doctor immediately or
go to the accident and emergency department of
your nearest hospital. Take this leaflet with you.

Other possible side effects
Peeling of the genitals, vaginal rash, swelling,
discomfort, burning or irritation or pelvic pain
Stomach pain
If any of the side effects become serious or you
notice any side effects not mentioned, please tell
your doctor or pharmacist.

5 How to store
Keep out of sight and reach of children.
Do not store above 25 C and protect from moisture.
Store in the original container.
Do not use after the expiry date, which is stated on
the carton after EXP. The expiry date refers to the
last day of that month.
If you have any medicines which are out of date,
return them to your doctor or pharmacist who will
dispose of them safely.

6 Further information
What Clotrimazole Vaginal Tablets contain:

Personal hygiene and self help tips
Personal hygiene is very important.

Active ingredient:
500mg Clotrimazole Ph. Eur.

Always wash your hands before and after going
to the toilet
After urinating, wipe carefully with toilet tissue
Occasionally stools may contain infective agents.
To avoid their contact with the vagina you should
always wipe the toilet tissue from front to back
Flannels, hand towels and underwear should be
changed daily
Do not wear underwear made of synthetics, or
tight fitting pants
Avoid wearing tights, nylon knickers and close
fitting jeans too often. These provide warm and
airless conditions which help the thrush fungus to
grow
Wash daily, but use simple bland soaps, not
heavily scented or medicated ones
Do not scrub hard with sponges or flannels, and
avoid hot baths with strong perfumed oils or
disinfectants. The most soothing bath to have, if
you have thrush, is a warm one with salt in it
Combined use with cream/vaginal cream
If your doctor has prescribed vaginal tablets and
cream/vaginal cream for you, the cream/vaginal
cream should be applied to the labia and
surrounding areas.

Hard to Read?

Other ingredients:
lactose, adipic acid, pregelatinised maize starch,
sodium hydrogen carbonate, microcrystalline
cellulose, magnesium stearate, maize starch, stearic
acid, colloidal silicon dioxide and polysorbate 80
What Clotrimazole Vaginal Tablets look like and
the contents of the pack:
Clotrimazole vaginal tablets are white, oblong tablets,
shape of suppositories.
The pack contains 1 vaginal tablet with an applicator.
Marketing Authorisation Holder and
Manufacturer:
Tillomed Laboratories Ltd.
3 Howard Road, Eaton Socon, St Neots
Cambridgeshire,
PE19 8ET
UK
Product Licence Number:
PL 11311/0042
Date of last revision:
April 2013

Phone

0800 970 6115

for help
Till Ver.4s

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Tillomed Clotrimazole
500mg Tablet
PIL
160 x 300 mm
Font SansSerif Min. Text 8pt
Till Ver.4s
29/04/13
Pantone Black CVC

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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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