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BOOTS THRUSH 500MG VAGINAL TABLET

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE / CLOTRIMAZOLE

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Patient Information Leaflet

Thrush 500mg Vaginal Tablet
Clotrimazole 500mg Vaginal Tablet
(Clotrimazole)

Read all of this leaflet carefully before you start using this medicinal product because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product 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 effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Clotrimazole is and what it is used for
2. What you need to know before you use
Clotrimazole
3. How to use Clotrimazole
1. What Clotrimazole is and what it is used for
This medicinal product contains Clotrimazole which
belongs to a group of medicines called imidazoles,
which are used to treat fungal infections.
Clotrimazole 500mg vaginal tablet is a single course
of treatment for vaginal thrush (candidal vaginitis). It
is inserted into the vagina for treatment at the site of
infection (see section 3, “How to use Clotrimazole”).
Thrush is a common infection and is caused by a yeast
(fungus) which lives harmlessly in the vagina without
you even noticing it. However, the natural pH balance
that keeps the yeast under control may become
disrupted due to factors such as hormonal changes.
This can cause the level of yeast to increase and
develop into an infection in the vagina and the
surrounding area (vulva).
Symptoms of thrush may include the following:
• Persistent burning and/or itching around the
vagina and vulva
• Redness, swelling and soreness of the vagina and
vulva
• A white non−smelling discharge from the vagina
2. What you need to know before you use
Clotrimazole
Do not use Clotrimazole if:
• You are allergic (hypersensitive) to Clotrimazole,
imidazoles, other vaginal anti-fungal products or
any of the other ingredients of this medicinal
product (See Section 6 “Contents of the pack and
other information”)
• You suffer from any of the following symptoms:
• Irregular vaginal bleeding
• Abnormal vaginal bleeding or a blood-stained
discharge
• Vulval or vaginal ulcers, blisters or sores
• Lower abdominal pain
• Pain when passing urine (dysuria)
• Any adverse events such as redness, irritation or
swelling associated with the treatment
• Fever or chills
• Feeling sick (nausea) or being sick (vomiting)
• Diarrhoea
• Foul-smelling vaginal discharge
Warnings and precautions
Talk to your doctor before using Clotrimazole:
• If this is first time you have experienced
symptoms of thrush
• If you have had more than 2 infections of thrush
in the last 6 months
• If you have a previous history of sexually
transmitted disease or have been exposed to a
sexually transmitted disease
• If you are or suspect you are pregnant
(see “Pregnancy” section)
• If you are aged under 16 or over 60 years of age

4. Possible side effects
5. How to store Clotrimazole
6. Contents of the pack and other information
Other medicines and Clotrimazole
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
This includes herbal medicines.
Medicines which may interact with Clotrimazole:
• Other medicines used to treat fungal infections
such as amphotericin and nystatin (polyene
antibiotics)
• Medicines used to reduce the body’s immunity
when receiving organ transplant such as
tacrolimus (immunosuppressants)
Pregnancy and Breast-feeding
Pregnancy
You must tell your doctor if you are pregnant or if you
think that you are.
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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. A risk to the suckling child cannot
be excluded and your doctor will decide whether or
not you should continue breast-feeding taking into
account the benefit of breast-feeding for the child and
the benefit of treatment for you.
Clotrimazole contains lactose
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
using this medicinal product.
3. How to use Clotrimazole
Always use this medicinal product exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
• Treatment consists of one vaginal tablet, which
should be inserted into the vagina at night.
• Do not use this product if you are on your period.
Start the treatment once your period has finished.
• Although best avoided, you may continue to
have sexual intercourse during treatment unless
your doctor has advised you not to. However, this
product may cause damage to latex contraceptives
(e.g. condoms or diaphragms) and consequently
may reduce the effectiveness of such contraceptives.
You should use alternative contraception for at least
5 days after using this product.
• Do not use tampons, douches (vaginal washes/
cleansers) or other vaginal products whilst using
this product.
Instructions how to insert Clotrimazole Vaginal
Tablet
• Wash your hands before and after 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 both sides, whilst pushing the
tablet far enough into the holder (about 1cm) to be
held in place during insertion

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

Side effects (frequency not known)
• Mild burning or irritation immediately after inserting
the vaginal tablet
• Peeling of the genitals
• Severe itching (pruritus)
• Rashes (erythema)
• Swelling of parts of the body (oedema)
• Discomfort, burning sensation, irritation or pelvic
pain
• Vaginal bleeding
• Stomach pain
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the internet at
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety
of this medicinal product.
5. How to store Clotrimazole

• Holding the applicator “B” in place, slowly and
carefully push the inner plunger “A” as far as it will
go so the tablet is placed in the vagina (Diagram 3)

• Keep this medicinal product out of the sight and
reach of children.
• Do not use this medicinal product after the expiry
date which is stated on the container after “EXP”.
The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original
package in order to protect from moisture.
• After use, the disposable applicator is to be safely
disposed of. It cannot be flushed down the toilet.
6. Contents of the pack and other information
What Clotrimazole Vaginal Tablets contains:
Each 500mg vaginal tablet contains 500mg
Clotrimazole.

• 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.
Duration of treatment
• Each course of treatment consists of one
Clotrimazole vaginal tablet, which remains
effective for 3 days.
• After 1−2 days, most of the external symptoms
of the infection (e.g. discharge, itching etc) should
have disappeared.
• If the symptoms have not been relieved or if the
infection returns within 7 days of using Clotrimazole
vaginal tablet, treatment may be repeated.
• If the infection recurs more than twice within 6
months, you should consult your doctor
If anyone accidentally swallows the tablet
Clotrimazole vaginal tablets should only be used in
the vagina.
If you or anyone else has accidentally swallowed the
vaginal tablet, you must contact your doctor or
nearest emergency department immediately for
advice. Remember to take this leaflet with you.

The other ingredients are:
Adipic acid, microcrystalline cellulose,
pre-gelatinised maize starch, sodium hydrogen
carbonate, stearic acid, lactose, polysorbate 80,
magnesium stearate, maize starch, colloidal
silicon dioxide
What Clotrimazole Vaginal Tablets look like and the
contents of the pack:
Clotrimazole vaginal tablets are white, oblong
uncoated vaginal tablets with “500” embossed on one
side and plain on the other.
The pack contains 1 vaginal tablet with a disposable
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 approval: June 2016
Till-Ver 5.1sa

If you have any further questions on the use of this
medicinal product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicinal product can cause
side effects, although not everybody gets them.
Seek medical advice immediately if you develop the
following symptoms:
• Allergic reactions: swelling of the face, throat or
tongue, fever, difficulty in breathing, dizziness
(this may also include fainting, low blood
pressure, skin rashes with or without the
formation of wheals)
• Intolerable burning sensation or irritation

V3-170112

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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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