Patient leaflet - Accord Healthcare Limited Itraconazole, capsules, hard 100 mg
1 What Itraconazole capsules are and what they are used for
Itraconazole capsules contain a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’.
Itraconazole capsules are used for infections caused by fungi or yeasts in adults. They are used for:
- Infections of the mouth or vagina causing ‘thrush’
- Skin infections
- Infections affecting other parts of the body.
Patches of skin may take a few weeks to completely clear up after you have finished your treatment with itraconazole capsules. Finger and toenails may take several months to completely clear up. This is because your skin or nail will only look normal after new skin or nail has grown, even though the medicine has killed the fungus that caused the infection.
2 What you need to know before you take Itraconazole capsules
Do not take Itraconazole capsules if
- you are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6).
- you are pregnant or could become pregnant unless your doctor has told you to (see ‘Pregnancy and breastfeeding’ below).
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Itraconazole capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking Itraconazole capsules:
- if you have ever had kidney problems. Your dose of Itraconazole capsules may have to be changed
- if you have ever had liver problems such as yellow skin (jaundice). Your dose of Itraconazole capsules may have to be changed. If after taking this medicine you have a severe lack of appetite, feel sick (nausea), are sick (vomiting), feel unusually tired, get stomach pain, muscle weakness, yellowing of the skin or whites of the eyes, unusually dark urine, pale stools or hair loss, stop taking Itraconazole capsules and tell your doctor straight away
if you have ever had a heart problem including heart failure (also called congestive heart failure or CHF). Itraconazole capsules could make it worse. If after taking this medicine you get any of the following:
- shortness of breath
- unexpected weight gain
- swelling of your legs or tummy - feel unusually tired
- wake up short of breath at night stop taking Itraconazole capsules and tell your doctor straight away. These may be signs of heart failure
- if you have Acquired Immunodeficiency Syndrome (AIDS) or your immune system is not working as well as it should
- if you have had an allergic reaction to another antifungal product in the past
- Itraconazole capsules are not normally given to the elderly. However, your doctor may prescribe them in special cases.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Itraconazole capsules.
Children and adolescents
Itraconazole capsules are not normally given to children under the age of 12. However, your doctor may prescribe them in special cases.
Blood tests
If your Itraconazole capsules course is for more than one month, your doctor may want to check your liver by testing your blood.
Other medicines and Itraconazole capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
In particular, do not take this medicine and tell your doctor if you are taking any of the following:
- Medicines for hay fever or allergy called terfenadine, astemizole or mizolastine
- Medicines to lower cholesterol called atorvastatin, lovastatin or simvastatin
- Medicines for an irregular heartbeat called quinidine, disopyramide, dronedarone or dofetilide
- Medicines used to treat angina (crushing chest pain) and high blood pressure called bepridil, felodipine, lercanidipine, ivabradine, ranolazine and nisoldipine
- Medicines for migraine headaches called dihydroergotamine and ergotamine
- Medicines for the treatment of drug abuse called levacetylmethadol and methadone
- Cisapride - for digestive problems
- Colchicine (in patients with kidney and liver problems as well) – for gout
- Eplerenone – a diuretic
Ergometrine (ergonovine) and
methylergometrine (methylergonovine) - used after giving birth
- Halofantrine – for malaria
- Irinotecan – for cancer
- Aliskiren – for high blood pressure
- Midazolam (by mouth) or triazolam - for anxiety or to help you sleep
- Pimozide, lurasidone and sertindole - for conditions affecting thoughts, feelings and behaviour.
Do not start taking Itraconazole capsules and tell your doctor if you are taking any of the above.
Also, upon completing your course of Itraconazole capsules, do not take any of the medicines listed above for 2 weeks.
Tell your doctor if you are taking any of the following medicines as they are not recommended with Itraconazole capsules unless your doctor feels it necessary.
- Medicines for the treatment of cancer called dasatinib, lapatinib, nilotinib or trabectedin
- Colchicine – for gout
- Everolimus – usually given after an organ transplant
- Fentanyl – a strong painkiller
- Rivaroxaban – a medicine to thin blood
- Salmeterol – for asthma and other breathing problems
- Tamsulosin - for urinary incontinence in men
- Vardenafil – for erection problems. Also, upon completing your course of Itraconazole capsules, do not take any of the medicines listed above for 2 weeks.
Do not take any of the following medicines 2 weeks before and while you are taking Itraconazole capsules unless your doctor tells you otherwise:
- Medicines for tuberculosis called rifampicin, rifabutin or isoniazid
- Medicines for epilepsy called phenytoin, carbamazepine or phenobarbital
- Medicines to treat viral infections called efavirenz or nevirapine.
Tell your doctor before taking, or if you are already taking any of the following medicines. They may stop Itraconazole capsules from working properly. Your doctor may need to alter the dose of Itraconazole capsules or your other medicine:
- Strong painkillers called alfentanil, buprenorphine (by injection or under your tongue) and oxycodone
- Medicines for indigestion, stomach ulcers or heartburn can affect the stomach producing acid. There must be enough acid in your stomach to make sure that your body can use the medicine. For this reason you should wait two hours after taking itraconazole capsules before taking any of these other medicines. If you take medicines that stop the production of stomach acid, you should take itraconazole capsules with a drink of cola (not diet cola)
- Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, alprazolam or brotizolam
- Medicines used in the treatment of cancer such as bortezomib, busulphan, docetaxel, erlotinib, ixabepilone, trimetrexate and a group of medicines known as ‘vinca alkaloids’
- Medicines for conditions affecting thoughts, feelings and behaviour called aripiprazole, haloperidol, perospirone, quetiapine, ramelteon and risperidone
Medicines to thin the blood
(anticoagulants) such as warfarin and dabigatran
- Medicines for HIV infection such as ritonavir, darunavir, indinavir, fosamprenavir and saquinivir. (They are called ‘antiviral protease inhibitors’). Also maraviroc
- Medicines for bacterial infections called ciprofloxacin, clarithromycin or erythromycin
- Medicines that act on the heart and blood vessels called nadolol, digoxin and cilostazol or ‘calcium channel-blockers’ such as dihydropyridines and verapamil
- Medicines for inflammation, asthma or allergies (given by mouth or injection) called methylprednisolone, fluticasone, budesonide or dexamethasone
- Medicines that are usually given after an organ transplant called ciclesonide, ciclosporin, tacrolimus, rapamycin (also known as sirolimus) or temsirolimus
- Medicines to treat an overactive bladder – fesoterodine, imidafenacin, solifenacin or tolterodine
- Alitretioin (by mouth) – for eczema
- Aprepitant and domperidone – to stop you feeling and being sick
- Atorvastatin – to lower cholesterol
- Cinacalcet – for an over-active parathyroid gland
- Ebastine – for allergy
- Eletriptan – for migraine headaches
- Mozavaptan or tolvaptan – for low sodium blood levels
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BBBB9422 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK
- Praziquantel – for treatment of worms
- Reboxetine - for depression
- Repaglinide or saxagliptin - for diabetes
- Meloxicam – to reduce inflammation and pain
- Midazolam - to help you relax or sleep when given into a vein
- Sildenafil and tadalafil – for erection problems.
Tell your doctor before taking, or if you are already taking any of the above. They may need to alter the dose of Itraconazole capsules or your other medicine.
Itraconazole capsules with food and drink
Always take Itraconazole capsules straight after a meal as this helps your body to use the medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Do not take Itraconazole capsules if you are pregnant unless your doctor has told you to. You should use contraception to make sure that you do not become pregnant when taking this medicine.
- The medicine in Itraconazole capsules stays in your body for some time after you have stopped taking them. After your treatment has finished, you must use contraception up until your next period (menstrual bleed). Ask your doctor for advice on what type of contraception to use.
- If you become pregnant after starting a course of Itraconazole capsules, stop taking them and tell your doctor straight away.
- Do not breast-feed if you are taking Itraconazole capsules, as small amounts of the medicine could pass into your milk. Ask your doctor for advice.
Driving and using machines
Itraconazole capsules can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms do not drive or use machines.
Itraconazole capsules contain sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3 How to take Itraconazole capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking Itraconazole capsules
- Always take Itraconazole capsules straight after a meal as this helps your body to use the medicine
- Swallow the capsules whole with some liquid
- There must be enough acid in your stomach to make sure that your body can use the medicine. Medicines for indigestion, stomach ulcers or heartburn can affect the stomach producing acid. For this reason, you should wait two hours after taking itraconazole capsules before taking any of these other medicines. If you do take medicines that stop the production of stomach acid, you should take Itraconazole capsules with a drink of cola.
Your doctor will tell you how many Itraconazole capsules to take and for how long.
The recommended dose is:
Yeast infection of the vagina (thrush)
- Take 2 capsules in the morning and two capsules 12 hours later for one day only.
Yeast infection of the mouth (oral thrush)
- Take 1 capsule each day for 15 days.
Fungal infections of the skin
The dosage depends on your infection. Your doctor might tell you to take:
- 2 capsules each day for 7 days, or
- 1 capsule each day for 15 days, or
- 1 capsule each day for 30 days.
Fungal infections in other parts of the body
Your doctor will tell you how many Itraconazole capsules to take and for how long depending on your infection.
If you take more Itraconazole capsules than you should
Talk to your doctor or go to the nearest hospital casualty department immediately if you take more Itraconazole capsules than you were told to.
If you forget to take Itraconazole capsules
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Itraconazole capsules
Keep taking Itraconazole capsules as long as your doctor has told you. Do not stop your treatment just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using itraconazole capsules and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
Sudden signs of allergy such as rash, hives (also known as nettle rash or urticaria), severe irritation of your skin, swelling of the face, lips, tongue or other parts of the body. These may be signs of a severe allergic
reaction. This only happens in a small number of people.
- Severe skin disorders with peeling and/ or rashes with small pustules (with a fever) or blistering of the skin, mouth, eyes and genitals, with fever, chills, aching muscles and generally feeling unwell. (the precise frequency of how often these may occur is not known).
- A tingling sensation, numbness or weakness in your limbs (the precise frequency of how often this may occur is not known).
- Severe lack of appetite, feeling sick (nausea), being sick (vomiting), unusual tiredness, stomach pain, muscle weakness, yellowing of your skin or whites of your eyes (jaundice), unusually dark urine, pale stools or hair loss. These may be signs of a liver problem (This only happens in a small number of people).
- Shortness of breath, unexpected weight gain, swelling of your legs or abdomen, feeling unusually tired or waking up short of breath at night. These may be signs of heart failure. Shortness of breath can also be a sign of fluid on the lungs (this occurs rarely).
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):
- Stomach ache, feeling sick (nausea)
- Headache.
Uncommon (may affect up to 1 in 100 people):
- Problems with periods
- Sinusitis, runny nose, coughs and colds
- Constipation, diarrhoea, wind, being sick (vomiting), indigestion.
Rare (may affect up to 1 in 1,000 people):
- Increases in liver function tests (shown by blood tests)
- Unexpected passing of urine or need to urinate (pass water) more often
- Problems with sight including blurred vision and double vision
- Change in taste
- Certain blood disorders which may increase the risk of infections
- Ringing in your ears
- Hearing loss (may be permanent)
- Severe upper stomach pain, often with nausea and vomiting (inflammation of the pancreas)
- Swelling due to fluid under the skin
- Unusual hair loss or thinning (alopecia)
- Red, itchy, flaking or peeling skin
- High levels of triglycerides in the blood (shown by blood tests)
- Sensitivity of the skin to light
- Erection difficulties.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Itraconazole capsules
Keep this medicine out of the sight and reach of children.
Do not store above 25ºC.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Itraconazole capsules contain
The active substance is itraconazole. Each capsule contains 100mg of itraconazole (I.N.N.).
The other ingredients are:
Capsule contents: sugar spheres (maize starch and sucrose), poloxamer 188 and hypromellose.
Capsule shell: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171) and gelatin.
What Itraconazole capsules look like and contents of the pack
Itraconazole 100mg Capsules are No. 0 hard gelatin capsules, opaque green cap and body, containing yellowish-beige spherical micro-granules.
Pack sizes are available in blister packs of 15 and 60s.
Marketing Authorisation holder
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7,
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
This leaflet was last revised in February 2024
If you would like a leaflet with larger text, please contact 01271 385257.