Clotrimazole 500mg Vaginal Tablets
160 mm
160 mm
Information for the user
Thrush.500. mg Vaginal. Tablet (Clotrimazole)'
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
300 mm
Throligh"sexuanhfefcourse.1f your partner “ has penile thrush he may have one or more of the following symptoms:
This medicine is available without prescription to treat thrush. However, you still ireedlouseltr carefully to get: the treat results" from it.
• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible
-side effects not listed fir this leaflet:--------
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days
What this medicine is for
This pessary (also known as a "vaginal tablet") contains Clotrimazole which belongs -te-a-group-of medicines ealled-anti-fungalsr - -which act to treat infections caused by fungi.
It can be used to treat thrush (vaginal candidiasis). Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop intoan infection jn 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 vagma and vulva
• Soreness of the vagina and vuTva
• A white non-smelling discharge from the vagina
Thrush may be aggravated by sexual intercourse, but it is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner
• Soreness and redness of the penis
• Tightness of the foreskin
• A white non-smelling penile discharge
Before you use this medicine
This medicine can be used by women between the ages of 16 and 60 years. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.
\ XDo-notuse:________________________
i • If you are allergic to clotrimazole, or any of ! the ingredients in this medicine (see "What is | in this medicine")
! • If you have an intolerance to some sugars,
| unless your doctor tells you to (this medicine contains lactose)
! • During your period. Wait until your period 7 “ “haslmlshed
• If you or your partner have been exposed to a sexually transmitted disease
»ITyoir havelower stomaetrpain.orpatrT or a “ burning sensation on passing urine
• If you have abnormal or irregular vaginal bleeding, or a blood-stained discharge
• If you have a foul smelling discharge
• If you have sores, ulcers or blisters on your vulva or vagina
•Jtyou-have-fever-or-chillsTyou are-feeling, sick or being sick
• If you have diarrhoea
• If you are pregnant, or think you may be pregnant (see "Other important information")
• If you are breastfeeding
.Other important information____
Pregnancy: This medicine may be used under the supervision of a doctor or midwife during pregnancy. If your doctor or midwife tells you that you can use this medicine, it should be inserted without using an applicator.
Women of childbearing age: The
Jngredientsjn the pessary may.affect the. latex used in contraceptives such as condoms and diaphragms.
This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using the pessary.
Ybu-can-help the-treatment to work if you follow these simple self-help tips:
»Although the infected area will itch, do not scratch as this will damage the surface of the skin and cause the infection to spread further
* Keep the affected areas of skin clean
* Pay particular attention to drying the skin but
. .avoid-excessive rubhing_______________
To help prevent thrush from coming back once you have treated it, follow these simple steps:
* Wash daily
* Wear cotton underwear and loose fitting clothing
* Try to avoid wearing tights, nylon underwear
-and-tight fitting-eiething----------------
* After going to the toilet, wipe yourself from the front to the back, as a thrush infection may be transferred from the bowel
* Try to avoid washing with perfumed soaps or using vaginal deodorants
* Do not rub hard with sponges or flannels and
.avoi.d. hot .baths with .strong perfumedqils___
* Change your sanitary protection regularly
If you take other medicines
Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly if you are taking the TolTowing:
] older
If you are allergic to imidazoles or any other
! Talk to your pharmacist or doctor:
• If this is the first time you have had these symptoms
• If you have had thrush more than twice in the last 6 months
If you are under 16years, or 61 years or_____
antifungal medicines, including those applied into the vagina
Amphotericin, or other antifungal medicines (e.g. nystatin)
1 Tacrolimus or sirolimus (given after transplant surgery, or for psoriasis or rheumatism)
If you are unsure about interactions with any
. xttherjnedicines^talk-to.your pharmacist.___
This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic medicines.
JD2604031
/How to use this medicine
The carton contains a single pessary held inside a foil blister pack and an applicator for insertion of the pessary into the vagina. Check the foil is not broken before use. If it
f If anyone accidentally swallows the pessary: Talk to a doctor straight away or go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
---4. - -
is, do not use the pessary.
Women aged 16 to 60 years: Insert the pessary into the vagina at night using the applicator provided.
If you are pregnant do not use the applicator. Wash and dry your hands, and insert the -pessaty-wilh yourjfingers.______________
Directions for inserting the pessary
• Wash your hands before use
• Remove the applicator from the packaging
• Pull out the plunger ‘A’ until it stops
Possible side effects
Most people will not have problems, but some may get some.
f If you get any of these serious side effect, see a doctor at once:
• Difficulty in breathing, swelling of the face,
- -neek,-tongue or throat: tow blood-pressure,- -fainting (severe allergic reactions)
• Red, raised itchy skin rash, which may include peeling of the skin
• Intolerable irritation or burning sensation after inserting the pessary
If you get any of the following side effects see your pharmacist or doctor:---------
-•-Remove the-pessary-from "the blister paek — and place the pessary firmly into the applicator ‘B’
• To fit the pessary into the applicator, squeeze the applicator lightly on either side. The pessary fits tightly into the applicator and needs to be pushed into the holder about 1 cm
• Mild burning or irritation straight after inserting the pessary
• Other allergic skin reactions such as a rash, swelling of the vagina or vulva, discomfort
• Lower stomach pain, pain in the pelvic area
• Vaginal bleeding
- The-stde effects of this medicine can be very-similar to the symptoms that you are treating.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects
epc
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store this medicine
Do not store above 25°C.
• Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when laying on your back with your knees bent up)
• Holding the applicator in place, slowly press the plunger until it stops so that the pessary
- -is deposited- into- the-vagina: Remove^e — applicator
• Dispose of the applicator in a safe place, out of the reach of children
• The applicator cannot be flushed down the toilet
• Wash your hands thoroughly after use
— i - -The-pessary-isfer-use-in^he vagina onlyr — Do not swallow it.
Do not use tampons or other vaginal products whilst using this pessary.
Do not use for children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.
Store in the original package in order to protect from moisture.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the -carton.----------------------------
Do not use more than one pessary.
After you use this pessary, external symptoms of thrush (e.g. itching, discharge) should improve within 3 days.
If external symptoms have not improved within 3 days, or symptoms worsen, talk to -your doctor.------------------------
If internal symptoms (e.g. discomfort and soreness) do not go away within 7 days, talk to your doctor.
If symptoms clear up but then return after 7 days, you can use another pessary.
Jf you have. t h rus_h more t han .twice, i n six___
months you must see your doctor.
What is in this medicine
This vaginal tablet contains Clotrimazole 500 mg, which is the active ingredient.
As well as the active ingredient, the vaginal tablet also contains adipic acid, -raicrocrystalline cellulose, pregelantised maize starch, sodium hydrogen carbonate, stearic acid, lactose, polysorbate 80, magnesium stearate, maize starch, collodial silicon dioxide.
The pack contains 1 vaginal tablet with an applicator. The vaginal tablet is white, oblong and uncoated with '500' embossed on one side”and plain-on the-other-
Who makes this medicine
Manufactured for The Boots Company PLC Nottingham NG2 3AA,
Marketing Authorisation Holder and
.Manufacturer:.______________________
Ti Homed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire PE19 8ET
Leaflet prepared March 2014
If you would like any further information
-about this medicine, qlease-contact-------
The Boots Company PLC Nottingham NG2 3AA
PL 11311/0042
. Q26Q4Q31___________________________________________________31-5.1.-824.