Itraconazole 100Mg Capsules, Hard

Package leaflet: information for the user Itraconazole 100mg Capsules, Hard

Read all of this leaflet carefully before • Medicines for an irregular heart beat called you start taking this medicine because it quinidine, disopyramide, dronedarone or contains important information for you. dofetilide • Keep this leaflet. You may need to read it • Medicines used to treat angina (crushing again. chest pain) and high blood pressure called bepridil, felodipine, lercanidipine, • If you have any further questions, ask ivabradine, ranolazine and nisoldipine your doctor or pharmacist. • Medicines for migraine headaches called • This medicine has been prescribed for dihydroergotamine and ergotamine you only. Do not pass it on to others. It • Medicines for the treatment of drug abuse may harm them, even if their symptoms called levacetylmethadol and methadone are the same as yours. • Cisapride - for digestive problems • If you get any of the side effects, talk to • Colchicine (in patients with kidney and liver your doctor or pharmacist. This includes problems as well) – for gout any possible side effects not listed in this • Eplerenone – a diuretic leaflet. See section 4. • Ergometrine (ergonovine) and methylergometrine (methylergonovine) - used after giving birth What is in this leaflet: • Halofantrine – for malaria 1. What Itraconazole capsules are • Irinotecan – for cancer and what they are used for • Dabigatran – a medicine to thin blood 2. What you need to know before • Ticagrelor – a medicine to thin blood • Quetiapine – for conditions affecting you take Itraconazole capsules thoughts, feelings and behaviour 3. How to take Itraconazole capsules • Aliskiren – for high blood pressure 4. Possible side effects • Darifenacin – for urge incontinence and/or 5. How to store Itraconazole increased urinary frequency capsules • Midazolam (by mouth) or triazolam - for anxiety or to help you sleep 6. Contents of the pack and other • Pimozide, lurasidone and sertindole - for information conditions affecting thoughts, feelings and behaviour 1 Do not start taking itraconazole capsules and What Itraconazole capsules are tell your doctor if you are taking any of the and what they are used for above. Itraconazole capsules contain a medicine called itraconazole. This belongs to a group Also, upon completing your course of of medicines called ‘antifungals’. Itraconazole capsules, do not take any of the Itraconazole capsules are used for infections medicines listed above for 2 weeks. caused by fungi or yeasts in adults. They are used for: Tell your doctor if you are taking, any of - Infections of the mouth or vagina causing the following medicines as they are not ‘thrush’ recommended with itraconazole capsules - Skin infections unless your doctor feels it necessary. - In fections affecting other parts of the body • Medicines for the treatment of cancer called axitinib, dabrafenib, dasatinib, Patches of skin may take a few weeks to ibrutinib, lapatinib, nilotinib, sunitinib or completely clear up after you have finished trabectedin your treatment with itraconazole capsules. • Colchicine – for gout Finger and toe nails may take several months • Ebastine – for allergy to completely clear up. This is because your • Eletriptan – for migraine headaches skin or nail will only look normal after new • Everolimus – usually given after an organ skin or nail has grown, even though the transplant medicine has killed the fungus that caused • Fentanyl – a strong painkiller the infection. • Rivaroxaban – a medicine to thin blood • Salmeterol – for asthma and other 2 What you need to know before breathing problems you take Itraconazole capsules • Tamsulosin - for urinary incontinence in Do not take Itraconazole capsules if: men • you are allergic to itraconazole or any • Vardenafil – for erection problems of the other ingredients of this medicine • Ciclesonide - usually given after an organ (listed in section 6). transplant • you are pregnant or could become • Temsirolimus - usually given after an organ pregnant unless your doctor has told you transplant to (see ‘Pregnancy and breastfeeding’ Also, upon completing your course of below) Itraconazole capsules, do not take any of the medicines listed above for 2 weeks. Do not take this medicine if any of the above applies to you. If you are not sure, talk to Do not take any of following medicines your doctor or pharmacist before taking 2 weeks before and while you are taking itraconazole capsules. Itraconazole capsules unless your doctor tells you otherwise: Warnings and precautions Medicines for tuberculosis called rifampicin, Talk to your doctor or pharmacist before rifabutin or isoniazid taking Itraconazole capsules: - Medicines for epilepsy called phenytoin, • if you have ever had kidney problems. Your carbamazepine or phenobarbital dose of itraconazole capsules may have to - Medicines to treat viral infections called be changed efavirenz or nevirapine • if you have ever had liver problems such - St. John’s Wort (a herbal medicine) as yellow skin (jaundice). Your dose of Tell your doctor before taking, or if you are itraconazole capsules may have to be already taking any of the above. They may changed. If after taking this medicine you stop itraconazole capsules from working have a severe lack of appetite, feel sick properly. Your doctor may need to alter the (nausea), are sick (vomiting), feel unusually dose of itraconazole capsules or your other tired, get stomach pain, muscle weakness, medicine: yellowing of the skin or whites of the eyes, • Strong painkillers called alfentanil, unusually dark urine, pale stools or hair loss, buprenorphine (by injection or under your stop taking itraconazole capsules and tell tongue) and oxycodone your doctor straight away • Medicines for indigestion, stomach ulcers • if you have ever had a heart problem or heartburn can affect the stomach including heart failure (also called producing acid. There must be enough congestive heart failure or CHF). acid in your stomach to make sure that Itraconazole capsules could make it worse. your body can use the medicine. For this If after taking this medicine you get any of reason you should wait two hours after the following: taking itraconazole capsules before taking - shortness of breath any of these other medicines. If you take - unexpected weight gain medicines that stop the production of - swelling of your legs or tummy stomach acid, you should take itraconazole - feel unusually tired capsules with a drink of cola (not diet cola) - wake up short of breath at night • Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, stop taking itraconazole capsules and tell alprazolam or brotizolam your doctor straight away. These may be • Medicines used in the treatment of cancer signs of heart failure such as bortezomib, busulphan, docetaxel, • if you have Acquired Immunodeficiency erlotinib, ixabepilone, trimetrexate and Syndrome (AIDS) or your immune system is a group of medicines known as ‘vinca not working as well as it should alkaloids’ • if you have had an allergic reaction to • Medicines for conditions affecting another antifungal product in the past thoughts, feelings and behaviour called • Itraconazole capsules are not normally aripiprazole, haloperidol, perospirone, given to the elderly. However, your doctor ramelteon and risperidone may prescribe them in special cases. • Medicines to thin the blood (anticoagulants) such as warfarin Children and adolescents: • Medicines for HIV infection such Itraconazole capsules are not normally given as ritonavir, darunavir, indinavir, to children under the age of 12. However, fosamprenavir and saquinivir. (They are your doctor may prescribe them in special called ‘antiviral protease inhibitors’). Also cases. maraviroc • Medicines for bacterial infections called ciprofloxacin, clarithromycin or Blood tests: erythromycin If your itraconazole capsules course is for • Medicines that act on the heart and more than one month, your doctor may blood vessels called nadolol, digoxin and want to check your liver by testing your cilostazol or ‘calcium channel-blockers’ such blood. as dihydropyridines and verapamil • Medicines for inflammation, asthma or Other medicines and Itraconazole allergies (given by mouth or injection) capsules called methylprednisolone, fluticasone, Tell your doctor or pharmacist if you are budesonide or dexamethasone taking, have recently taken or might take • Medicines that are usually given after any other medicines.This includes medicines an organ transplant called ciclosporin, that you buy without a prescription or herbal tacrolimus or rapamycin (also known as medicines. sirolimus) In particular, do not take this medicine • Medicines to treat and overactive bladder and tell your doctor if you are taking any – fesoterodine, imidafenacin, solifenacin or of the following: tolterodine • Medicines for hay fever or allergy called • Alitretioin (by mouth) – for eczema terfenadine, astemizole or mizolastine • Aprepitant and domperidone – to stop you • Medicines to lower cholesterol called feeling and being sick atorvastatin, lovastatin or simvastatin • Atorvastatin – to lower cholesterol continued top of next column continued over page BBBA9610

Itraconazole 100mg Capsule PIL - UK

approved for print/date Item number: BBBA9610 Colours Non Printing Colours 1. Black 1. Profile Originator: G. Worth Dimensions: 140x540 2. 2. Origination Date: 05/11/2020 Min Body Text Size: 9pt Revision Date: Supplier: 3. 3. 31/12/2020 Liconsa Revised By: G. Worth 4. 5. Proof Round Technical Date sent: 05/11/2020 6. 2 Approval Date received: 13/11/2020 [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 • Cinacalcet – for an over active parathyroid • Sudden signs of allergy such as rash, hives gland (also known as nettle rash or urticaria), • Mozavaptan or tolvaptan – for low sodium severe irritation of your skin, swelling of the blood levels face, lips, tongue or other parts of the body. • Praziquantel – for treatment of worms These may be signs of a severe allergic • Reboxetine - for depression reaction. This only happens in a small • Repaglinide or saxagliptin - for diabetes number of people • Meloxicam – to reduce inflammation and • Severe skin disorders with peeling and/ pain or rashes with small pustules (with a fever) • Midazolam - to help you relax or sleep or blistering of the skin, mouth, eyes and when given into a vein genitals, with fever, chills, aching muscles • Sildenafil and tadalafil – for erection and generally feeling unwell. (the precise problems frequency of how often these may occur is Tell your doctor before taking, or if you not known) are already taking any of the above. They • A tingling sensation, numbness or may need to alter the dose of itraconazole weakness in your limbs (the precise capsules or your other medicine. frequency of how often this may occur is not known) Itraconazole capsules with food and • Severe lack of appetite, feeling sick drink: (nausea), being sick (vomiting), unusual Always take itraconazole capsules straight tiredness, stomach pain, muscle weakness, after a meal as this helps your body to use yellowing of your skin or whites of your the medicine. eyes (jaundice), unusually dark urine, pale stools or hair loss. These may be signs of a Pregnancy, breast-feeding and liver problem (This only happens in a small fertility: number of people) • Do not take itraconazole capsules if you are • Shortness of breath, unexpected weight pregnant unless your doctor has told you gain, swelling of your legs or abdomen, to. You should use contraception to make feeling unusually tired or waking up short sure that you do not become pregnant of breath at night. These may be signs of when taking this medicine heart failure. Shortness of breath can also • The medicine in itraconazole capsules stays be a sign of fluid on the lungs (this occurs in your body for some time after you have rarely). stopped taking them. After your treatment has finished, you must use contraception Tell your doctor or pharmacist if up until your next period (menstrual bleed). you notice any of the following side Ask your doctor for advice on what type of effects: contraception to use Common (may affect up to 1 in 10 people) • If you become pregnant after starting a • Stomach ache, feeling sick (nausea) course of itraconazole capsules, stop taking • Headache them and tell your doctor straight away • Do not breast-feed if you are taking Uncommon (may affect up to 1 in 100 Itraconazole capsules, as small amounts of people) the medicine could pass into your milk. Ask • Problems with periods your doctor for advice. • Sinusitis, runny nose, coughs and colds Ask your doctor for or pharmacist for advice • Constipation, diarrhoea, wind, being sick before taking this medicine if you are (vomiting), indigestion pregnant or breast-feeding Rare (may affect up to 1 in 1000 people) Driving and using machines: • Increases in liver function tests (shown by Itraconazole capsules can sometimes cause blood tests) dizziness, blurred/double vision or hearing • Unexpected passing of urine or need to loss. If you have these symptoms do not urinate (pass water) more often drive or use machines. • Problems with sight including blurred vision and double vision Itraconazole capsules contains • Change in taste sucrose: • Certain blood disorders which may increase This medicine contains the sugar sucrose. the risk of infections If your doctor has told you that you are • Ringing in your ears intolerant of some sugars, contact them • Hearing loss (may be permanent) before taking this medicine. • Severe upper stomach pain, often with nausea and vomiting (inflammation of the 3 pancreas) How to take Itraconazole capsules • Swelling due to fluid under the skin Always take this medicine exactly as your • Unusual hair loss or thinning (alopecia) doctor has told you. Check with your doctor • Red, itchy, flaking or peeling skin or pharmacist if you are not sure. • High levels of triglycerides in the blood (shown by blood tests) Method and route of administration: • Sensitivity of the skin to light - Always take itraconazole capsules straight • Erection difficulties after a meal as this helps your body to use the medicine Reporting of side effects - Swallow the capsules whole with some If you get any side effects, talk to your doctor, liquid pharmacist or nurse. This includes any - There must be enough acid in your possible side effects not listed in this leaflet. stomach to make sure that your body You can also report side effects directly via can use the medicine. Medicines for the Yellow Card Scheme at: indigestion, stomach ulcers or heartburn www.mhra.gov.uk/yellowcard or search for can affect the stomach producing acid. For MHRA Yellow Card in the Google Play or this reason, you should wait two hours after Apple App Store. taking itraconazole capsules before taking By reporting side effects you can help any of these other medicines. provide more information on the safety of If you do take medicines that stop the this medicine. production of stomach acid, you should take itraconazole capsules with a drink of cola 5 How to store Itraconazole Frequency and duration of treatment: capsules Your doctor will tell you how many Keep this medicine out of the sight and itraconazole capsules to take and for how reach of children. long. The recommended dose is: Do not store above 25ºC. Yeast infection of the vagina (thrush) Do not use this medicine after the expiry - Take 2 capsules in the morning and two date which is stated on the carton. The expiry capsules 12 hours later for one day only date refers to the last day of that month.

Yeast infection of the mouth (oral Do not use this medicine if you notice visible thrush) signs of deterioration. - Take 1 capsule each day for 15 days Do not throw away any medicines via wastewater or household waste. Ask your Fungal infections of the skin pharmacist how to throw away medicines The dosage depends on your infection. you no longer use. These measures will help Your doctor might tell you to take: protect the environment. - 2 capsules each day for 7 days, or - 1 capsule each day for 15 days, or 6 Contents of the pack and other - 1 capsule each day for 30 days information Fungal infections in other parts of the What Itraconazole capsules contain: The active substance is itraconazole. Each body capsule contains 100mg of itraconazole Your doctor will tell you how many (I.N.N.). itraconazole capsules to take and for how The other ingredients are: long depending on your infection. Capsule contents: sugar spheres (maize starch and sucrose), poloxamer 188 and If you take more Itraconazole hypromellose capsules than you should: Capsule shell: indigo carmine (E 132), Immediately consult your doctor or quinoline yellow (E 104), titanium dioxide (E pharmacist if you take more Itraconazole 171) and gelatin. capsules than you should. What Itraconazole capsules look like If you forget to take Itraconazole and contents of the pack: capsules: Itraconazole 100mg Capsules are No. 0 hard Take the missed dose as soon as you gelatin capsules, opaque green cap and remember it. However, if it is almost time body, containing yellowish-beige spherical for the next dose, skip the missed dose and micro-granules . continue your regular dosing schedule. Do not take a double dose to make up for a Pack sizes are available in blister packs of 15 forgotten dose. and 60s

If you stop taking Itraconazole Marketing authorisation holder: capsules Accord Healthcare Limited, Sage House, 319 Pinner Road, Keep taking Itraconazole capsules as long as North Harrow, Middlesex, your doctor has told you. Do not stop your HA1 4HF, United Kingdom treatment just because you feel better. Manufacturer: If you have any further questions on the Laboratorios LICONSA, S.A. use of this medicine, ask your doctor or Avda. Miralcampo, Nº 7, Polígono Industrial pharmacist. Miralcampo 19200 Azuqueca de Henares (Guadalajara), 4 Possible side effects SPAIN Like all medicines, this medicine can cause side effects, although not everybody gets This leaflet was last revised in January 2021 them. Stop using itraconazole capsules and tell If you would like a your doctor straight away if you notice leaflet with larger or suspect any of the following. You may need urgent medical treatment. text, please contact 01271 385257.

continued top of next column BBBA9610 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Itraconazole 100mg Capsule PIL - UK