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If your sexual partner is treated with this cream, the cream should be applied to the end of the penis 2 or 3 times a day for up to two weeks. .HOW TO STORE CANESTEN® THRUSH DUO® Thrush Duo® Oral The cream is for external use only: Keep this medicine out of the sight and reach of children. Do not put the cream in your mouth or swallow it. If the cream is Do not store above 25°C. Canesten Capsule & External Cream swallowed accidentally, tell your doctor straight away or contact the Do not use Canesten Thrush Duo after the expiry date which is stated 150mg capsule & 2% w/w cream Accident and Emergency Department of your nearest hospital. at one end of the carton, on the blister pack and on the end of the & Clotrimazole If you take more Canesten® Thrush Duo® than you should: tube of cream. The expiry date refers to the last day of that month. If more than one capsule is taken, tell your doctor straight away or Medicines should not be disposed of via wastewater or household contact the Accident and Emergency Department of your nearest waste. Ask your pharmacist how to dispose of medicines no longer hospital. required. These measures will help to protect the environment. Read all of this leaflet carefully because it contains • You are aged under 16 or over 60. important information for you. • You have ever had an allergic reaction to fluconazole, .POSSIBLE SIDE EFFECTS .FURTHER INFORMATION This medicine is available without prescription. However, you still clotrimazole or any other vaginal products. Like all medicines, Canesten Thrush Duo can cause side eects, What Canesten® Thrush Duo® contains: need to use Canesten Thrush Duo Oral & Cream carefully to get • You have had any disease or illness aecting the or although not everybody gets them. The oral capsule: the best results from it. kidneys, or have had any unexplained jaundice. As with all medicines, some people may be allergic to the capsule • The active substance is fluconazole at a strength of 150mg. • You have heart problems, including heart rhythm problems. or the cream. If you are allergic, a reaction will occur soon after you • The other ingredients are colloidal silicon dioxide, lactose • Keep this leaflet. You may need to read it again. • You suer from any other chronic disease or illness. have taken or used the medicine. If you experience an allergic • Ask your pharmacist if you need more information or advice. monohydrate, magnesium stearate, maize starch and sodium reaction or the redness, burning, pain, itching or swelling get worse, lauryl sulphate. The capsule shell contains brilliant blue FCF • You must contact a doctor if your symptoms worsen or do not Important information about some of the ingredients: stop using this product and tell your doctor straight away or improve in 7 days. The capsule contains lactose monohydrate, so if you have been (E133), titanium dioxide (E171) and gelatine. The printing ink told by your doctor that you have an intolerance to some sugars contact the Accident and Emergency Department of your nearest contains shellac, black iron oxide (E172) and propylene glycol. • If you have any unusual eects after using this product, hospital. Signs of an allergic reaction may include: tell your doctor or pharmacist. contact your doctor before taking this medicinal product. See Section 2 ‘Important information about some of the • Rash. ingredients’ for lactose monohydrate advice. The cream contains cetostearyl alcohol which may cause local • Swallowing or breathing problems. IN THIS LEAFLET skin irritation (e.g. rash, itching or redness). • Swelling of your lips, face, throat or tongue. The cream: 1. What is Canesten Thrush Duo and what is it used for? • The active substance is clotrimazole at a strength of 2% w/w. Special precautions: • Weakness, feeling dizzy or faint. BAYER ARTWORK PANEL 2. Before you use Canesten Thrush Duo • Nausea. • The other ingredients are benzyl alcohol, polysorbate 60, 3. How to use Canesten Thrush Duo As with other creams, this product may reduce the eectiveness sorbitan stearate, cetyl palmitate, cetostearyl alcohol, 4. Possible side eects of rubber contraceptives, such as or diaphragms. Capsule octyldodecanol and purified water. 5. How to store Canesten Thrush Duo Consequently, you should use alternative precautions for at least If you experience any of the following, please contact your doctor See Section 2 ‘Do not use’ and ‘Important information about Brand: Canesten 6. Further information five days after using this product. or pharmacist immediately – you may need urgent medical some of the ingredients’ for cetostearyl alcohol advice. Range: Duo Using other medicines: attention: Product: Thrush Duo Oral Capsule & ExtCream 150mg 2percent What Canesten® Thrush Duo® looks like and contents of Please tell your doctor or pharmacist if you are taking or have • Severe condition with blistering and peeling of the skin, Pack Type: Leaflet . WHAT IS CANESTEN® THRUSH the pack: recently taken any other medicines, including medicines obtained mouth, eyes or genitals. Pack Size: 150 mg Canesten Thrush Duo contains: DUO® AND WHAT IS IT USED FOR? without a prescription. • Liver disorders with symptoms such as yellowing of the skin or Canesten Thrush Duo is a complete and convenient treatment for eyes, dark urine or pale stools. • A single light blue capsule with ‘Canesten®’ printed on it in vaginal or penile thrush. Do not use Canesten Thrush Duo if you are taking astemizole, • Seizures black between two black lines. To be taken orally. Country: Malta/UK Only use this product if you have been previously diagnosed by terfenadine, cisapride, pimozide, quinidine or . • Change in heart rhythm or rate. • A tube containing 10g of white external cream your doctor as having thrush. Inform your doctor if you are taking: Anticoagulants (to prevent Additionally, if any of the following side eects gets serious, or if (Canesten® Thrush External Cream). The active substances in the capsule and cream are fluconazole blood clots), Sulphonylureas (to control diabetes), you notice any side eects not listed in this leaflet, please tell your Marketing Authorisation Holder: and clotrimazole, respectively. Fluconazole and clotrimazole Hydrochlorothiazide (to treat fluid retention and high blood doctor or pharmacist. Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK. belong to a group of medicines called and are antifungal pressure), Benzodiazepines (tranquilisers), or Common side eects (may aect up to 1 in 10 people) are: Manufacturer: agents which fight the cause of such as thrush. (to control epilepsy), or Rifabutin • headache Wasdell Packaging Ltd., Euroway Industrial Estate, (), Ciclosporin, , or Tofacitinib (to • stomach discomfort, diarrhoea, feeling sick, vomiting Blagrove, Swindon, Wiltshire, SN5 8YW, UK .BEFORE YOU USE CANESTEN® reduce the immune response), Theophylline (to control asthma), • increases in blood tests of liver function Zidovudine or Saquinavir (to treat HIV ), Losartan (to • rash Remember: If you have any doubts about using Canesten® Thrush Barcode 1 Type: N/A THRUSH DUO® Uncommon side eects (may aect up to 1 in 100 people) are: Duo® correctly, seek the advice of your doctor or pharmacist. 297 mm 297 mm reduce blood pressure), Alfentanil, or Methadone (to Barcode 1 Mag: N/A Do not use Canesten® Thrush Duo®: • reduction in red blood cells which can make skin pale and Barcode 2 Type: N/A • If you are allergic (hypersensitive) to fluconazole, treat pain), Halofantrine (for treating malaria), (to Further information about thrush: cause weakness or breathlessness Barcode 2 Mag: N/A clotrimazole, to other medicines you have taken to treat control irregular heartbeats, 'arrhythmias'), Amitriptyline or Vaginal thrush () is a common infection that most Pharmacode No/NE: N/A fungal infections or to any of the other ingredients, including Nortriptyline (anti-depressants), Ivacaftor (for treating cystic • decreased appetite women suer from at some time in their lives and is not caused cetostearyl alcohol, of Canesten Thrush Duo (see Section 6. fibrosis), Statins like , Atorvastatin or Fluvastatin (for • inability to sleep, feeling drowsy by lack of personal hygiene. Technical & Non Printing Items • fit, dizziness, sensation of spinning, tingling, pricking or Further Information). reducing high cholesterol levels), Non-steroidal Thrush is caused by a yeast (fungus) called which lives Cutter Guides numbness, changes in sense of • If you are taking astemizole or terfenadine (antihistamine Anti-inflammatory Drugs like Ibuprofen, Celecoxib, Diclofenac, harmlessly in the and other parts of the body, without you even Meloxicam or Naproxen, Olaparib (to treat ovarian cancer). • constipation, indigestion, wind, dry mouth Colours medicines for allergies), cisapride (used for stomach upsets), • muscle pain noticing it. However, the natural balance that keeps Candida under PANTONE 485 C PANTONE Cool Gray 11 C pimozide (used for treating mental problems), quinidine Taking Canesten® Thrush Duo® with food and drink: control can be upset by many factors such as hormonal changes 1 2 • wheals, blistering (), itching, increased sweating LTH LTH (used for treating heart arrhythmia), erythromycin (an The oral capsule should be swallowed whole with a glass of water. (menstruation, contraceptive pill, , menopause), poor for treating infections). It can be taken with or without food. • fatigue, general feeling of being unwell, fever Rare side eects (may aect up to 1 in 1,000 people) are: health, antibiotics, perfumed soaps, bath additives and tight clothing. Women: There is no known interaction with alcohol or . • lower than normal white blood cells that help defend against If the natural pH balance is altered, the level of yeast increases If you have any of the following symptoms do not use Canesten Pregnancy and breast-feeding: infections and red blood cells that help to stop bleeding, and can develop into a thrush infection causing any of the Thrush Duo and see your doctor as soon as possible: Do not use Canesten Thrush Duo if you are pregnant, trying for respectively causing recurrent infections like cold and flu and following symptoms: persistent burning and/or itching around the • Irregular vaginal bleeding. a baby or breast feeding. increased bleeding/blood thinning (if you cut yourself) vagina and vulva, redness, swelling and soreness of the tissues of • Abnormal vaginal bleeding or a blood-stained discharge. • red or purple discoloration of the skin which may be caused by the vagina and vulva and a whitish, odourless discharge from the • Ulcers, blisters or sores of the vagina or vulva. Driving and using machines: low platelet count, other blood cell changes vagina. Not everybody who has thrush has all these symptoms; • Lower abdominal pain. Canesten Oral Capsule may cause dizziness. If dizziness occurs • blood chemistry changes (high blood levels of cholesterol, fats) you may have only one of them. • Pain or diculty in passing urine. after taking your capsule, you should not drive or use machines. • low blood potassium • Fever or chills. In men, Candida can also cause thrush - a condition called balanitis • shaking (inflammation of the end of the penis). It causes any of the • Feeling sick or vomiting. .HOW TO USE CANESTEN® • hair loss • Diarrhoea. following symptoms: soreness and redness of the penis, tightness THRUSH DUO® Frequency not known, but may occur (cannot be estimated from of the foreskin and a white, odourless discharge from the penis. • A foul smelling discharge from the vagina. If Canesten Thrush Duo has been prescribed for you by your doctor, the available data): follow any instructions he/she may have given you. If you purchased • hypersensitivity reaction with skin rash, fever, swollen glands, How to avoid future recurrences: This is because Canesten Thrush Duo may not be the right ✓ treatment for you. this product without a prescription, follow these directions closely: increase in a type of white blood cell (eosinophilia) and Wear cotton knickers and loose clothing. inflammation of internal organs (liver, lungs, heart, kidneys and ✓ Wash daily. Men: The capsule is to treat thrush at the site of infection and should be ✓ After going to the toilet, wipe yourself from the front to back swallowed whole with a glass of water (with or without food). large intestine) (Drug Reaction or rash with Eosinophilia and Do not use Canesten Thrush Duo without talking to your Systemic Symptoms (DRESS)). as a thrush infection may be transferred from the bowel. doctor first if: The cream is to treat the itching and soreness of the vulva (). ✓ Change your sanitary protection regularly. • Your sexual partner does not have thrush. • Before use, pierce the tube seal by inverting the cap over the Cream ✗ Try to avoid wearing tights, nylon knickers and close • You have sores, ulcers or blisters on your penis. end of the tube and press. After you apply the cream you might experience: fitting jeans. • You have an abnormal discharge from your penis. • The cream should be thinly and evenly applied to the area • Itching, rash, blisters, burning, discomfort, swelling, redness, ✗ Try to avoid washing with perfumed soaps or using • Your penis has started to smell. around the entrance of the vagina, 2 or 3 times a day and irritation or peeling of skin. vaginal deodorants. • You have pain or diculty in passing urine. smoothed in gently. It should be used until symptoms of the ✗ Do not wash or rub yourself hard with sponges or flannels and infections disappear. Reporting of side eects This is because Canesten Thrush Duo may not be the right If you get any side eects, talk to your doctor, pharmacist or nurse. avoid hot baths with strong perfumed oils. treatment for you. The symptoms of thrush should disappear within two days of This includes any possible side eects not listed in this leaflet. You If you are still worried or have any questions about the symptoms FONT SIZE PANEL treatment. If no improvement is seen after seven days, you must can also report side eects directly via the Yellow Card Scheme at: or the treatment of thrush, do not hesitate to ask your doctor or Before using Canesten® Thrush Duo®, you should see your tell your doctor. If the infection returns after seven days another www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in doctor if: pharmacist for advice. Main Text (body copy): 9pt capsule may be taken but if you have more than two infections the Google Play or Apple App Store. • You are unsure whether you have thrush or this is the first within six months you should see your doctor. For UK residents only: if you have any questions or would like more time you have had these symptoms. information, call our Canesten Advice Line on 0845 758 5030. Height (based on lower case x): 1.3 mm • You have had more than two infections of thrush in the Some women suer from recurrent attacks of thrush. To reduce Calls charged at local rate. last six months. the frequency of these attacks, the sexual partner’s penis can be treated with this cream to prevent re-infection, even if they have no This leaflet was last revised in April 2019. BAYQ • You or your partner have ever had a sexually transmitted Canesten and Duo are registered trademarks. ARTWORK disease. symptoms of thrush. APPROVAL PANEL

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