160 mm

Canesten®

Thrush Oral Capsule

150mg capsule "Fluconazole

iRead all of this leaflet carefully because it contains important information for you.

[This medicine is available without prescription. However, you still need to use Canesten Thrush Oral Capsule [carefully to get the best results from it.

'• Keep this leaflet. You may need to read it again, i* Ask your pharmacist if you need more information | or advice.

]• You must contact a doctor if your symptoms worsen or ' do not improve in 7 days.

i* If you have any unusual effects after using this product, ! tell your doctor or pharmacist.

IN THIS LEAFLET

Colours

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X What is Canesten Thrush Oral Capsule and what is it ] used for?

'J. “Before you" use Canesten Thrush Oral Capsule 3. How to use Canesten Thrush Oral Capsule <4. Possible side effects

[5. How to store Canesten Thrush Oral Capsule 6. Further information

;1. WHAT IS CANESTEN® THRUSH 1 ORAtCAPSULE AND WHAT IS | IT USED FOR?

Canesten Thrush Oral Capsule is a full course of treatment |for thrush.

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'Only use this product if you have been previously diagnosed by your doctor as having thrush.

__I____

[The active substance in Canesten Thrush Oral Capsule is fluconazole. Fluconazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as thrush.

FONT SIZE PANEL

Main Text (body copy):    9 pt

Height (based on lower case x): 1.3 mm

ARTWORK APPROVAL PANEL

Packaging Site Approval:

2.BEFORE YOU USE CANESTEN® j T_HRUSH ORAL CAPSULE

'Do not use Canesten⁸ Thrush Oral Capsule:

i* If you are allergic (hypersensitive) to fluconazole or any | of the other ingredients of Canesten Thrush Oral | Capsule (see Section 6. Further Information).

'* If you are taking the antihistamine terfenadine, i the medicine cisapride or an ergot-derivative (e.g. ergotamine used for migraine).

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^Afomen:

'If you have any of the following symptoms do not use Canesten Thrush Oral Capsule and see your doctor as soon as possible:

[* Irregular vaginal bleeding.

'* Abnormal vaginal bleeding or a blood-stained discharge.

- —-Ulcers, blistersor-sores ofthe vagina orvulva.-------

i* Lower abdominal pain.

[* Pain or difficulty in passing urine.

|* Fever or chills.

'• Feeling sick or vomiting, i* Diarrhoea.

|* A foul smelling discharge from the vagina.

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“ “Th"ls”is Because Canesten Thrush Oral Caps“u1e“rhayriof Be the right treatment for you.

[Men:

[Do not use Canesten Thrush Oral Capsule without talking to your doctor first if:

'• Your sexual partner does not have thrush.

_ _You_haye.soies^ulcersjQrblisters.orLyouLpenis______

[• You have an abnormal discharge from your penis.

[• Your penis has started to smell.

'• You have pain or difficulty in passing urine.

This is because Canesten Thrush Oral Capsule¹ may not be the right treatment for you.    '

Before using Canesten⁸ Thrush Oral    [

Capsule, you should see your doctor if:

•    You are unsure whether you have thrush or this is the first time you have had these symptoms.

•    You have had more than two infections of thrush in the last six months.

•    You or your partner have ever had a sexually transmitted disease.

•    You are aged under 16 or over 60.

•    You have ever had an allergic reaction to fluconazole or any other vaginal antifungal products.

•    You have had any disease or illness affecting the liver or kidneys, or have had any unexplained jaundice.

•    You have heart problems, including heart rhythm problems.

-    ^_You“sufferfrom“any other^-chrontc“dtsease or illness.

Important information about some ofthe ingredients:

The capsule contains lactose monohydrate, so if you have an intolerance to some sugars contact your doctor before taking this medicinal product.

Using other medicines:

■ “Pleasetelt your doctoror pharmacist if yotrare taking oi---

have recently taken any other medicines, including medicines obtained without a prescription.

Do not use Canesten Thrush Oral Capsule if you are taking the antihistamine terfenadine, the medicine cisapride or an ergot-derivative (e.g. ergotamine used for migraine).

-    -Inform your doctorif-you are-taktngr Anticoagulants-----

(to prevent blood clots), Sulphonylureas (to control diabetes), Hydrochlorothiazide (used to treat fluid retention and high blood pressure), Benzodiazepines (used as tranquilisers), Phenytoin, Carbamazepine or Phenobarbital (used to control epilepsy), Rifampicin, Rifabutin or Rifapentine (antibiotics), Cidosporin, Sirolimus

-    -orTaerelimus-(used to-reduce the-immune response),----

Theophylline (used to control asthma), Zidovudine

(used to treat HIV infection), Astemizole (antihistamine), Anti-arrhythmics (to control irregular heart beats), Losartan (to reduce blood pressure), Fentanyl or Methadone (to treat pain).

Taking Canesten⁸ Thrush Oral Capsule with food " “and drink:^- “

Canesten Thrush Oral Capsule should be swallowed whole with a glass of water. It can be taken with or without food. There is no known interaction with alcohol or nicotine.

Pregnancy and breast-feeding:

Do not use Canesten Thrush Oral Capsule if you are . _pregnant,_trying_fQLa_baby or breast-feeding__________

Driving and using machines:

Canesten Thrush Oral Capsule may cause dizziness.

If dizziness occurs after taking your capsule, you should not drive or use machines.

3.HOWTO USE CANESTEN® THRUSH ORAL CAPSULE

If Canesten Thrush Oral Capsule has been prescribed for you by your doctor, follow any instructions he/she may have given you. If you purchased this product without a prescription, follow these directions closely:

The full course of treatment consists of a single Canesten Thrush Oral Capsule. The capsule is to treat thrush at the ' “site oflnfection ancLshould be~swallowed whole with“a“gia"ss “ of water (with or without food).

Country Approval:

[The symptoms ofthrush sFiouTcf disappear within two days [of treatment. If no improvement is seen after seven days, you must tell your doctor. If the infection returns after seven days another capsule may be taken but if you have more than two infections within six months you should see your doctor.

Direction of reading

IT you fake mbfe~Cahesteri®Thrush TJral [Capsule than you should:

i|f more than one capsule is taken, tell your doctor straight away or contact the Accident and [Emergency Department of your nearest [hospital.

4.POSSIBLE SIDE EFFECTS

[Like all medicines, Canesten Thrush Oral Capsule can cause Side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the Capsule. If you are allergic, a reaction will occur soon after you have taken it. If you experience an allergic reaction, stop Rising this product and tell your doctor straight away or contact the Accident and Emergency Department of/our nearest hospital.

£igns of an allergic reaction may include:

[• Rash.

i* Swallowing or breathing problems, i* Swelling of your lips, face, throat or tongue.

[• Weakness, feeling dizzy or faint.

[• Nausea.

ilf you experience any of the following, please contact your doctor or pharmacist immediately - you may need urgent [medical attention:

'* Severe condition with blistering and peeling of the skin, i mouth, eyes or genitals.

_ -T- .Liver disorders with, symptams-suchzis yellowing ofthe _ [ skin or eyes, dark urine or pale stools.

'• Seizures

'• Change in heart rhythm or rate.

[The following side effects have also been reported - tell your doctor if these persist or become troublesome:

'• Feeling sick or being sick, stomach discomfort, change

~ “i^_ “in sensq cftaste:------------------------

i* Diarrhoea and wind.

[• Headaches.

'* Rash, itching, hair loss.

i* Recurrent infections (e.g. cold and flu).

[The following effects have been reported following medical Jor laboratory tests:

* Abnormal ECG (electrocardiogram) heart tracing, i* High blood levels of cholesterol or fat. i* Reduction in number of blood cells and platelets [• Low levels of potassium.

Reporting of side effects

Jf you get any side effects, talk to your doctor, pharmacist or [nurse.-This-includes-any possible side effects net-listed in-this-leaflet. You can also report side effects directly via the Vellow 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.HOWTO STORE CANESTEN®

1 THRUSH ^DRAL CAPSULE

[Keep this medicine out ofthe sight and reach of [children.

Do not use Canesten Thrush Oral Capsule after the expiry date which is stated at one end ofthe carton and on the blister pack. The expiry date refers to the last day of |hat month.

iMedicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of [medicines no longer required. These measures will help to 'protect the environment.

The printing ink contains shellac, black iron oxide (El72)i and propylene glycol. See Section 2 'Important    ,

information about some ofthe ingredients’    [

for lactose monohydrate advice.    ¹

What Canesten⁸ Thrush Oral Capsule looks like and i

' ^_cohfehfs~oT the”pack:    1

Each pack contains a single light blue capsule [ with ‘Canesten®’ printed on it in black between [ two black lines.    '

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Marketing Authorisation Holder:    i

Bayer pic, Consumer Care Division    [

. -BayerJiouse, Strawberry Hill___________J , _    _

Newbury, Berkshire RG141JA, UK.    [

Manufacturer:    i

Wasdell Packaging Ltd., Euroway Industrial Estate, Blagrove, [ Swindon, Wiltshire, SN5 8YW, UK.    [

Remember: If you have any doubts about using Canesten® i

. Thrush Ora! Capsule correctly^ seek______________i

the advice of your doctor or pharmacist.    [

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Further information about thrush:    '

Vaginal thrush (candidiasis) is a common infection that i most women suffer from at some time in their lives and is i not caused by lack of personal hygiene.    [

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Thrush js caused by a yeast (fungus) called Candjda_____

which lives harmlessly in the vagina and other parts of i the body, without you even noticing it. However, the , natural balance that keeps Candida under control can [ be upset by many factors such as hormonal changes ' (menstruation, contraceptive pill, pregnancy, menopause),    i

poor health, antibiotics, perfumed soaps, bath additives    i

and tight clothing.    [

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If the natural pH balance is altered, the level of yeast    '

increases and can develop into a thrush infection causing i any of the following symptoms: persistent burning and/or , itching around the vagina and vulva, redness, swelling and [ soreness ofthe tissues ofthe vagina and vulva and a whitish,' odourless discharge from the vagina. Not everybody who i - -has thrush has-all these-symptornsj-you may have only one- -i - -of them.    [

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In men, Candida can also cause thrush - a condition called ' balanitis (inflammation of the end of the penis). It causes i any ofthe following symptoms: soreness and redness ofthe! penis, tightness of the foreskin and a white, odourless [ discharge from the penis.    '

How to avoid future recurrences:    i

/ Wear cotton knickers and loose clothing.    i

/ Wash daily.    !

</ After going to the toilet, wipe yourself from the front i to back as a thrush infection may be transferred from [ the bowel.    '

' / “Change your sanitary protection^-regularly.

X Try to avoid wearing tights, nylon knickers and close ' fitting jeans.    i

X Try to avoid washing with perfumed soaps or using i vaginal deodorants.    i

X Do not wash or rub yourself hard with sponges or i flannels and avoid hot baths with strong perfumed oils. [

If you are still worried or have any questions about the i symptoms or the treatment of thrush, do not hesitate to asl^ your doctor or pharmacist for advice.    [

For UK residents only: if you have any questions or would i like more information, call our Canesten Advice Line on , 0845 758 5030. Calls charged at local rate.    [

This leaflet was last revised in July 2016.

Canesten is a registered trademark of Bayer AG, Germany.i

^.FURTHER INFORMATION

What Canesten¹⁹ Thrush Oral Capsule contains: i* The active substance is fluconazole at a strength of [    150mg.

[* The other ingredients are colloidal silicon dioxide, lactose i monohydrate, magnesium stearate, maize starch and i sodium lauryl sulphate. The capsule shell contains brilliant [ _ _blue_F_CF_(El33), titaniumdioxide (E171) and gejatin.___

BAYLFT01-4[

Bayer;