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GALPHARM SINGLE DOSE THRUSH TREATMENT

Active substance(s): FLUCONAZOLE

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Package Leaflet: Information for the user
Patient Information Leaflet
Galpharm Single Dose Thrush Treatment
Fluconazole
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription for you to treat mild illness without a doctor’s
help. Nevertheless, you still need to use Galpharm Single Dose Thrush Treatment 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 a doctor if your symptoms worsen or do not improve.
In this leaflet:
1. Galpharm Single Dose Thrush Treatment: what it is and what it’s used for
2. Before you take Galpharm Single Dose Thrush Treatment
3. How to take Galpharm Single Dose Thrush Treatment
4. Possible side effects
5. Storing Galpharm Single Dose Thrush Treatment
The name of your medicine is Galpharm Single Dose Thrush Treatment.
• The active ingredient is fluconazole
• Other ingredients are lactose, maize starch, colloidal anhydrous silica, sodium laurilsulfate
and magnesium stearate. The capsule shell contains gelatin and the colours brilliant blue
(E133) and titanium dioxide (E171).
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is: Galpharm Healthcare Limited, Wrafton, Braunton,
Devon, EX33 2DL, United Kingdom.
The company responsible for manufacture is: Galpharm International Limited, Elmhirst Park,
Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.
1. Galpharm Single Dose Thrush Treatment what is it and what it is used for
• Each capsule contains 150 mg of fluconazole. Fluconazole belongs to a group of drugs called
antifungal agents, and is used to treat infections, such as thrush.
• The product is available in a pack containing 1 capsule.
• Galpharm Single Dose Thrush Treatment is used to treat vaginal thrush and can also be used
by your partner if he has thrush on his penis. Thrush is caused by a yeast called Candida
albicans, which lives problem free in the bodies of many women, but occasionally the natural
balance that keeps the yeast under control is disturbed and this results in an infection.
Vaginal Thrush
The most common symptoms are:
• itching around the outside of the vagina
• soreness which becomes worse with rubbing and scratching
• a white, non-smelling discharge from the vagina.
Not every woman who has thrush will have all of these symptoms.
To help prevent thrush coming back it is advised that you:

• wash regularly
• gently dry yourself, as rubbing and scratching can aggravate thrush
• avoid tight synthetic clothing
• wear cotton underwear, stockings and loose fitting clothes
• avoid perfumed soaps and bath additives
• change your sanitary protection frequently.
Thrush may be aggravated by sexual intercourse. Thrush is not VD and is not usually passed
on by sexual contact. However, thrush can be passed to your partner through sexual
intercourse. If your thrush was successfully treated but keeps coming back, it is advised your
partner is seen by a doctor.
Penile Thrush (Candidal Balanitis)
It is important to note that only the male partners of affected women should take this
medicine.
The most common symptoms are:
• soreness and redness of the penis
• tightness of the foreskin
• an abnormal penile discharge.
Not every man who has thrush on his penis will have all of these symptoms.
2. Before you take Galpharm Single Dose Thrush Treatment
Do not take Galpharm Single Dose Thrush Treatment without first consulting your
doctor:
• If you are under 16 or over 60 years of age
• If you are allergic to any of the ingredients in Galpharm Single Dose Thrush Treatment or
other antifungals and other thrush treatments
• If you have been told by your doctor that you have an intolerance to some sugars, as this
product contains lactose
• If you are taking the antihistamine terfenadine or the prescription medicine cisapride
• If you are taking any other medication other than the Pill
• If you have had thrush more than twice in the last six months
• If you have any disease affecting your liver or kidneys or if you have had unexplained
jaundice
• If you suffer from any other chronic disease or illness
• If you or your partner have had exposure to a sexually transmitted disease
• If you are unsure about the cause of your symptoms.
Women only:
• If you have abnormal or irregular vaginal bleeding or a blood stained discharge
• If you have vaginal or vulval sores, ulcers or blisters
• If you are experiencing lower abdominal pain or a burning sensation on passing urine
• If you are pregnant, trying to become pregnant or are breast-feeding.
Men only:
• If your sexual partner does not have thrush
• If you have penile sores, ulcers or blisters
• If you have an abnormal penile discharge (leakage)
• If your penis has started to smell
• If you have pain on passing urine.
Taking Galpharm Single Dose Thrush Treatment with food and drink

This medicine does not interact with alcohol or nicotine and may be taken with or without
food, at any time of the day.
Pregnancy and Breast-feeding
• Do not take Galpharm Single Dose Thrush Treatment if you are pregnant, trying to become
pregnant or breast-feeding.
3. How to take Galpharm Single Dose Thrush Treatment
If your doctor has prescribed this medicine, always follow your doctor’s instructions.
Otherwise, follow the instructions below. If you do not understand these instructions, or you
are in any doubt, ask your doctor or pharmacist.
The capsule should be swallowed whole with a drink of water. One capsule is the complete
course of treatment.
If you take more Galpharm Single Dose Thrush Treatment than you should
If you (or someone else) swallow a lot of the capsules all together, or if you think a child has
swallowed any of the capsules, contact your nearest hospital casualty department or your
doctor immediately.
How quickly will the treatment start to work?
• Your condition should begin to clear up within two days. For some women the effect can be
noticed in one day
• If after seven days or more, thrush recurs, you can take this medicine again
• If your condition does not improve after one week you should tell your doctor
• If the thrush recurs more than twice within six months, you should see your doctor.
4. Possible side effects
Like all medicines, Galpharm Single Dose Thrush Treatment can have side effects.
The most common side effects are:
• Stomach pain
• Diarrhoea
• Wind
• Nausea.
Rarely people have experienced:
• Liver problems
• Headache
• Rash.
As can happen with any medicine, a few people may develop an allergic reaction.
If you experience the following, tell your doctor immediately or go to the casualty department
at your nearest hospital:
• Difficulty breathing
• Swelling of the lips, face and neck.
The following side effects have also been reported rarely, but may not be directly due to
Galpharm Single Dose Thrush Treatment:
• Hair loss
• Skin reactions
• Blood disorders
• Fits.

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 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.
5. Storing Galpharm Single Dose Thrush Treatment
Keep Galpharm Single Dose Thrush Treatment out of the reach and sight of children. Do not
store above 30°C. Do not transfer the capsule to another container. Do not use Galpharm
Single Dose Thrush Treatment after the expiry date on the outer packaging. Return all unused
medicines to your pharmacist for safe disposal.
Text Revised: April 2014

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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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