PACKAGE LEAFLET: INFORMATION FOR THE USER. Fluconazol Nycomed 50 mg, 100 mg, 150 mg and 200 mg Hard Capsules. Fluconazole

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER Fluconazol Nycomed 50 mg, 100 mg, 150 mg and 200 mg Hard Capsules Fluconazole Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. - Throughout this leaflet, Fluconazol Nycomed 50 mg, 100 mg, 150 mg and 200 mg hard capsules will be called Fluconazol Nycomed. In this leaflet: 1. What Fluconazol Nycomed is and what it is used for 2. Before you take Fluconazol Nycomed 3. How to take Fluconazol Nycomed 4. Possible side effects 5. How to store Fluconazol Nycomed 6. Further information 1. WHAT FLUCONAZOL NYCOMED IS AND WHAT IT IS USED FOR Fluconazol Nycomed belongs to a group of medicines called antifungals which are used to treat infections caused by yeast or fungi. Fluconazol Nycomed is used to: Treat yeast infections of mouth, vagina, stomach and intestines, lungs, urinary tracts and in skin and nails as well as to prevent yeast infections in patients with reduced immune response. The urinary tract is the collective name for the bladder, kidney, ureters and urethra. The ureter and urethra are the tubes that take the urine from the kidneys to the bladder and out of the body. Prevent yeast infections in patients with a reduced immune response. Infections in the brain (certain types of meningitis). 2. BEFORE YOU TAKE FLUCONAZOL NYCOMED Do not take Fluconazol Nycomed if: you are allergic (hypersensitive) to fluconazole or other similar substances you are allergic to any of the other ingredients in Fluconazol Nycomed (see section 6 for a list of these) you take terfenadine (used to treat allergic reactions) and the dose of Fluconazole Nycomed is greater than 400 mg per day. you are taking any of the following medicines: cisapride (used to increase the functions of the stomach and bowels) astemizole (used to treat allergic reactions) pimozide (used to treat psychotic illnesses such as schizophrenia) quinidine (used to control problems with your heart rhythm)

2 Take special care with Fluconazol Nycomed Fluconazol Nycomed should be used with caution: if you have a heart condition or any problem that affects your heart rhythm if you have a blood disorder, such as too much potassium, calcium or magnesium in your blood you have HIV or AIDS you have liver problems you have kidney problems you are pregnant, think you may be pregnant or are planning to become pregnant you are breastfeeding. Taking other medicines Do not take Fluconazol Nycomed if you are taking any of the following medicines: cisapride (used to increases the functions of the stomach and bowels) terfenadine (used to treat allergic reactions) and the dose of Fluconazole Nycomed is greater than 400 mg per day. If you take terfenadine and the dose of Fluconazol Nycomed is lower than 400 mg per day, your doctor should follow you closely. astemizole or terfenadine (used to treat allergic reactions) pimozide (used to treat psychotic illnesses such as schizophrenia) quinidine (used to control problems with your heart rhythm) There may be an increased risk of abnormal heart rhythms if Fluconazol Nycomed is taken in combination with erythromycin (used to treat bacterial infections). You should avoid this combination. Tell your doctor before you take Fluconzol Nycomed if you are taking any of the following medicines. They may have an effect on how Fluconazol Nycomed works: rifampicine (antibiotics) hydrochlorothiazide (a diuretic used to make you pass water more often) Tell your doctor before you take Fluconazol Nycomed if you are taking any of the following medicines. Fluconazol Nycomed may affect how well these other medicines work and the doctor may have to adjust your dose: alfetanil or fentanyl (used as a painkiller) amitriptyline or nortriptyline (used as an anti-depressant) amphotericine B or azithromycin (used to treat fungal infections) anti-coagulants such as warfarin (used to thin your blood) atorvastatin, fluvastatin or simvastatin (used to treat high cholesterol) benzodiazepines (used as a tranquillizer to treat anxiety and insomnia for example) calcium channel antagonists and losartan (used to treat high blood pressure) carbamazepine (used to treat epilepsy) celecoxib (used to treat arthritis) cyclophosphamide (used for treating cancer) ciclosporin, tacrolimus or sirolimus (used to reduce the immune response) didanosine (used against HIV) ergot alkaloids (used to treat various illnesses, including migraines) halofantrin (used to treat malaria) methadone (used to treat pain or opioid dependence) non-steroidal anti-inflammatory drugs NSAIDs (used to treat pain, temperature and inflammation) oral contraceptives, such as The Pill phenytoin (used to treat epilepsy) prednisone (used to treat a variety of diseases where the immune response is too strong) rifabutine (an antibiotic used to treat tuberculosis) Saquinavir (used to treat HIV)

3 sulphonylureas such as chlorpropamide, glibenclamide, glipizide or tolbutamide (used to control diabetes) tacrolimus or sirolimus (used to treat some types of skin diseases ) theophylline (used to control asthma) trimetrexate (used to treat a type of pneumonia) vinca alkaloids (used to treat cancer) Vitamin A (a vitamin supplement taken to improve vision and skin health) zidovudine (used to treat HIV) Please tell your doctor or the pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and Breast-feeding Ask you doctor or pharmacist for advice before taking any medicine. Pregnancy Fluconazole should normally not be taken if you are pregnant. Ask your doctor for advice before taking Fluconazole. Breast-feeding Fluconazole should not be taken when you are breast-feeding. Driving and using machines Fluconazol Nycomed may cause dizziness and seizures which may influence your ability to drive safely. If you suffer from any of these symptoms you should not drive or use machinery. Important information about some of the ingredients of Fluconazol Nycomed Fluconazol Nycomed contains lactose. Contact your doctor before taking this medicine if your doctor has told you that you do not tolerate certain types of sugar. Fluconazol Nycomed 150 mg hard capsules contain the colourant Sunset Yellow (E 110) (an azo dye), which may cause allergic reactions. 3. HOW TO TAKE FLUCONAZOL NYCOMED Always take Fluconazol Nycomed exactly as your doctor has told you. You should check with your doctor or pharmacist, if you are not sure. The dose you will be given will depend on the infection you are being treated for and will be calculated by your doctor or pharmacist. Your doctor will also advise how long you should take the medicine for. However, the usual dose is as follows: Adult Vaginal infections: 150 mg as a single dose. Ringworm and fungal infection of the groin area: 50 mg once daily or 150 mg once weekly for 4 6 weeks. Oral (mouth) infections: 50 mg daily for 1-2 weeks, Infections of the stomach, lungs and urinary tract. The urinary tract is the collective name for the bladder, kidney, ureters and urethra - these are tubes that take the urine from the kidneys to the bladder and out of the body: 50 mg once daily for between 14 and 30 days depending on the location and severity of the infection.

4 The dose can be increased to 100 mg daily if necessary. Other, more serious, internal fungal infections: A single dose of 400 mg will be given on the first day, followed by 200 mg daily thereafter. The daily dose may be increased up to a maximum of 400 mg if required. The duration of the treatment depends on how well your body responds to the medicine but it may last up to several weeks. Prevention of fungal infections in patients with a reduced immune system: 400 mg once daily for as long as required. Brain infections (Cryptococcal meningitis) in patients whose immune system is suppressed, for example, AIDS patients: 400 mg in the first day followed by mg once daily at least for 6-8 weeks. The capsules should be swallowed whole with a glass of water without food. It is important to take the whole course of treatment to avoid recurrence of the infection. Elderly: The normal adult dose applies. Patients with renal impairment: The doctor will adjust your dose according to the severity of your kidney problems. Children: Fluconazole Nycomed should not be used in children without the doctor s recommendation. If you take more Fluconazol Nycomed than you should Contact your doctor or pharmacist if you have taken more Fluconazol Nycomed than stated in this information leaflet, or more than prescribed by your doctor, and you are not feeling well. If you forget to take Fluconazol Nycomed Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Fluconazol Nycomed can cause side effects, although not everybody gets them. If you get any of the following side effects, stop taking these capsules and tell your doctor immediately, or contact the casualty department at your nearest hospital: more frequent infections like sore throat, painful mouth ulcers or anal ulcers and fever. You may have a serious reduction in the number of white blood cells swollen lips, face, tongue and/or throat, difficulties breathing, a fast or irregular heartbeat. You may be having an anaphylactic shock. heart rhythm abnormality with rapid or irregular heartbeat rash, peeling skin, erosion (incl. slight bleeding) of the eyes, nose, mouth/lips or genitals and maybe loss of hair. You may have a serious skin condition. These are rare side effects (fewer than 1 in every 1000 patients gets them). Other known side effects include: Common (occur in fewer than 1 in every 10 patients treated) headache

5 stomach pain, diarrhoea, nausea, vomiting rash Uncommon (occur in fewer than 1 in every 100 patients treated) sleeplessness extreme drowsiness convulsions seizures dizziness pins and needles altered sense of taste shaking vertigo (feeling as if the room is spinning) heartburn flatulence dry mouth poor appetite constipation yellowing of the skin or whites of the eyes (jaundice) itchiness nettle rash increased sweating muscle pain indisposition fever Rare (fewer than 1 in every 1000 patients gets them). hepatitis severe skin reaction causing painful, blistered and red skin swollen mouth, lips or throat hair loss Other side effects identified through blood tests and other medical tests Common (occur in fewer than 1 in every 10 patients treated) an increase in different liver enzymes Uncommon (occur in fewer than 1 in every 100 patients treated) anaemia low concentration of potassium (K+) in the blood. itching, jaundice, pale stools and dark urine increase bilirubin liver cells damage Rare (fewer than 1 in every 1000 patients gets them). a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal higher levels of cholesterol and triglycerides liver cells dead and liver failure If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE FLUCONAZOL NYCOMED Keep out of the reach and sight of children. Do not use Fluconazol Nycomed after the expiry date which is stated on the carton.

6 Medicines 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. 6. FURTHER INFORMATION What Fluconazol Nycomed contains The active substance in Fluconazol Nycomed is fluconazole. Fluconazol Nycomed is available in 4 strengths: 50 mg, 100 mg 150 mg and 200 mg. The other ingredients are lactose monohydrate, magnesium stearate (E 470b), cellulose microcrystalline (E 460), sodium lauryl sulphate, pregelatinised maize starch, waterfree colloidal silica. Capsule shell: Gelatin and titanium dioxide (E 171). Colourants: 50 mg: Yellow iron oxide (E 172), quinoline yellow (E 104), Patent Blue V (E 131). 100 mg: Yellow iron oxide (E 172) 150 mg: Quinoline yellow (E 104), Sunset Yellow (E 110). What Fluconazol Nycomed looks like and contents of the pack Fluconazol Nycomed hard capsules come in blister packs. The capsules are different colours so that you can tell the difference between the strengths as follows: 50 mg: Green/white capsules. 100 mg: Yellowish brown capsules. 150 mg: Yellow capsules. 200 mg: White capsules. The blister packs contain either: 50 mg capsules: 1, 7, 10, 28, 30, 98, 98 (2 x 49 x 1) Unit Dose and 100 capsules. 100 mg capsules: 7, 14, 28 and 98 capsules. 150 mg capsules: 1, 2, 4, 6, 12 and 14 capsules. 200 mg capsules: 7, 28 and 98 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Manufacturer: Pharmathen S.A. 6 Dervenakion Str Pallini, Attiki Greece Nycomed Danmark ApS Langebjerg 1 DK 4000 Roskilde Denmark Nycomed SEFA AS Jaama 55B

7 63308 Pölva Estonia This medicinal product is authorised in the Member States of the EEA under the following names: This leaflet was last approved in {MM/YYYY} <>

8 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1. NAME OF THE MEDICINAL PRODUCT Fluconazol Nycomed 50 mg, hard capusles Fluconazol Nycomed 100 mg, hard capusles Fluconazol Nycomed 150mg, hard capusles Fluconazol Nycomed 200 mg, hard capusle s fluconazole 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsules contains 50 mg fluconazole 1 capsules contains 100 mg fluconazole 1 capsules contains 150 mg fluconazole 1 capsules contains 200 mg fluconazole 3. LIST OF EXCIPIENTS 1 capsule.: Fluconazol 50 mg, Contain lactose monohydrate, see leaflet for further information. Color (E 104, E 131, E 171, E 172) et constit. q.s. 1 capsule.: Fluconazol 100 mg, Contain lactose monohydrate, see leaflet for further information. Color ( E 171, E 172) et constit. q.s. 1 capsule.: Fluconazol 150 mg, Contains lactose monohydrat, color (E 110, susnset yellow FCF ), see leaflet for further information. Color (E 104, E 110, E 171) et constit. q.s. 1 capsule.: Fluconazol 200 mg, Contain lactose monohydrate, see leaflet for further information. Color (E 171) et constit. q.s. 4. PHARMACEUTICAL FORM AND CONTENTS Hard Capsules 50 mg capsules: 1, 7, 10, 28, 30, 98, 98 (2 x 49 x 1) Unit Dose and 100 capsules. 100 mg capsules: 7, 14, 28 and 98 capsules. 150 mg capsules: 1, 2, 4, 6, 12 and 14 capsules. 200 mg capsules: 7, 28 and 98 capsules. 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.

9 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP 9. SPECIAL STORAGE CONDITIONS SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 12. MARKETING AUTHORISATION NUMBER(S) 13. BATCH NUMBER LOT 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription- 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE

10 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Printet on Alu folie 1. NAME OF THE MEDICINAL PRODUCT Fluconazol Nycomed 50 mg, Hard capusles Fluconazol Nycomed 100 mg, Hard capusles Fluconazol Nycomed 150 mg, Hard capusles Fluconazol Nycomed 200 mg, Hard capusles fluconazole 2. NAME OF THE MARKETING AUTHORISATION HOLDER 3. EXPIRY DATE EXP 4. BATCH NUMBER LOT 5. OTHER