Itraconazole 10 Mg/Ml Oral Solution
Out of date information, search anotherPACKAGE LEAFLET:
INFORMATION FOR THE PATIENT Itraconazole 10mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Itraconazole Oral Solution is and what it is used for
2. What you need to know before you take Itraconazole Oral Solution
3. How to take Itraconazole Oral Solution
4. Possible side effects
5. How to store Itraconazole Oral Solution
6. Contents of the pack and other information
1.What Itraconazole Oral Solution is and what it is used for
Itraconazole 10mg/ml Oral Solution (called Itraconazole Oral Solution throughout the rest of this leaflet) belongs to a group of antifungal medicines called triazole derivatives. Your medicine works by stopping growth of the fungus.
This medicine is used:
to treat fungal infections which may occur in your mouth, throat or gullet, in patients who have HIV or a poorly functioning immune system.
to stop you from getting fungal infections, if your immune system is not working properly due to a reduced level of white blood cells (neutropenia), as a result of a blood disorder or a bone marrow transplant.
■<*)-
2.What you need to know before you take Itraconazole Oral Solution
Do not take Itraconazole Oral Solution
• If you are allergic to itraconazole, or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
o astemizole, mizolastine or terfenadine (antihistamines); o bepridil (which can be used to treat angina); o cisapride (which can be used to treat heartburn and reduce the amount of acid in the stomach); o dofetilide or quinidine (which can be used to treat an irregular heartbeat);
o levacetylmethadol (levomethadyl) (which can be used to treat opioid drug addiction);
o pimozide and sertindole (which can be used to treat certain mental and emotional conditions); o atorvastatin, lovastatin and simvastatin (medicines used to lower cholesterol);
o triazolam or oral midazolam (medicines to help you sleep); o dihydroergotamine and ergotamine (used to help relieve the symptoms of migraine);
o ergometrine (ergonovine) and methylergometrine (methylergonovine) (used during labour or to help control bleeding after childbirth); o eletriptan (used to treat migraines); o nisoldipine (used to treat high blood pressure).
• If you have heart problems, including heart failure (also known as congestive heart failure or CHF), unless you have been specifically prescribed Itraconazole Oral Solution by your doctor (see Talk to your doctor or pharmacist if any of the following apply to you).
• If you are pregnant, thinking of becoming pregnant or breastfeeding.
Take special care with Itraconazole Oral Solution
If you experience any of the following symptoms whilst taking your medicine: severe lack of appetite feeling or being sick extreme tiredness stomach pain
unusually dark urine and/or pale stools
Stop taking Itraconazole Oral Solution and see your doctor immediately, or go to your nearest hospital accident and emergency department. These symptoms could be signs that your liver is not working properly.
Tell your doctor immediately if you experience any of the
following symptoms whilst taking Itraconazole Oral Solution:
• loss of hearing or hearing disturbances;
• tingling, numbness or pain in your hands and feet.
If you suffer from heart problems, including heart failure (also known as congestive heart failure or CHF), and your doctor has prescribed Itraconazole Oral Solution for you, then you should be informed, by your doctor or pharmacist, to look out for the following signs or symptoms whilst you are taking your medicine: shortness of breath
fluid and water retention resulting in swollen ankles, legs and stomach
• unexpected weight gain
• dizziness, extreme tiredness or weakness If you experience any of these symptoms, whilst taking your medicine, then stop taking Itraconazole Oral Solution and inform your doctor immediately, or go to your nearest hospital accident and emergency department straight away.
You should also talk to your doctor or pharmacist if any of the following apply to you:
• if you are allergic to any other antifungal medicines such as fluconazole or ketoconazole;
• if you have, or have had, problems with your liver such as jaundice (yellowing of the skin, or whites of the eyes). Your doctor may want to monitor you carefully whilst you are taking this medicine;
• if you have, or have had, problems with your kidneys;
• if you suffer from diarrhoea after taking your medicine, as your doctor may ask you to stop taking your medicine;
• if you have a very low white blood count and are at risk of developing fungal infections;
• if you have taken any of the following medicines within the last two weeks, as they may stop Itraconazole Oral Solution from working properly: o rifampicin, rifabutin or isoniazid (medicines used to treat
tuberculosis);
o phenobarbitol, phenytoin or carbamazepine (drugs used to treat epilepsy);
o St Johns Wort (a herbal remedy for depression).
Children and the elderly
Itraconazole Oral Solution is not normally given to children and the elderly. If the doctor has prescribed this medicine for a child or for someone who is elderly, it is because it is in their best interests. If you, as the patient or carer, are worried about the effects of taking this medicine, go back and discuss it with your doctor.
Using other medicines
Tell your doctor or pharmacist if you are taking any medicines listed under section 2 Before you take Itraconazole Oral Solution. Please also tell your doctor, or pharmacist, if you are taking any of the medicines listed below as your doctor may need to change the dose of these medicines, or monitor you or your blood carefully. You may also suffer increased side effects: calcium channel blockers such as verapamil or dihydropyridines (used to treat high blood pressure or abnormal heart rhythms);
medicines known to affect the clotting of your blood such as warfarin;
ritonavir, indinavir and saquinavir (for HIV infections); certain drugs used in cancer therapy such as busulfan docetaxel, trimetrexate and vinca alkaloids e.g. vinblastine; clarithromycin and erythromycin (antibiotics); cyclosporine, tacrolimus, rapamycin, also known as sirolimus (often given after organ transplant); glucocorticoids e.g. budesonide, dexamethasone, fluticasone and methylprednisolone (used to treat inflammation, asthma and allergies);
digoxin (used to treat chronic heart failure or irregular heartbeat);
cilostazol (for leg pain that occurs when walking due to poor circulation);
disopyramide (to treat irregular heartbeat); buspirone, alprazolam, brotizolam and midazolam (to treat anxiety or to help you sleep); alfentanil and fentanyl (used to help relieve pain); rifabutin (for tuberculosis); ebastine (an antihistamine); repaglinide (used to treat diabetes); halofantrine (for malaria);
reboxetine (used in the treatment of depression); loperamide (used to treat diarrhoea).
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Taking Itraconazole Oral Solution with food and drink
Do not take Itraconazole Oral Solution with food or drink as it can prevent your medicine from working properly. Always wait at least one hour, after taking your medicine, before you have anything to eat or drink.
Pregnancy and breast-feeding
• Do not take Itraconazole Oral Solution if you are pregnant, think that you might be pregnant, or are breast-feeding (as a very small amount of itraconazole could be present in your milk) Talk to your doctor or pharmacist for advice.
• If you are a woman of childbearing age, you should talk to your doctor about the use of appropriate contraception whilst using this medicine.
• If you stop taking Itraconazole Oral Solution, you must continue to use appropriate contraception until your next period after you have stopped taking the medicine.
Driving and using machines This medicine may make you feel dizzy, or you may find that you have blurred/double vision, or that your hearing is affected. Do not drive or use machines if you feel dizzy, or if your eyesight or hearing are affected.
Important information about some of the other ingredients in Itraconazole Oral Solution
Your medicine contains:
• Sorbitol (E420) - if you have been told by a doctor that youl have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• Sodium saccharin and sodium hydroxide - this medicinal product contains 0.07mmol (or 1.56mg) sodium (salt) per 1ml of solution. To be taken into consideration by patients on a controlled sodium (salt) diet.
Ethanol - the flavouring in this medicinal product contains very small amounts of ethanol (alcohol), less than 1mg per 1ml of oral solution.
3.How to take Itraconazole Oral Solution
Always take Itraconazole Oral Solution exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure. Always wait at least one hour, after taking your medicine, before you have anything to eat or drink.
A 30ml measuring cup is provided with your medicine.
Using the measuring cup provided, pour out the required amount of the liquid.
The liquid should be swished around the mouth for approximately 20 seconds and then swallowed. Do not rinse your mouth after swallowing your medicine.
Wash the measuring cup after use and keep it safe for the next dose.
Adults - Treatment of fungal infections in your mouth, throat or gullet The usual dose is 20ml (200mg itraconazole) per day. The doctor may tell you to take the dose all at once, or take 10ml (100mg itraconazole) in the morning and 10ml (100mg itraconazole) in the afternoon.
If the infection has not cleared within 7 days (1 week) of starting treatment, your doctor may tell you to continue taking your medicine for a further 7 days. If your symptoms persist, speak to your doctor or pharmacist.
Adults - Treatment of fungal infections in your mouth, throat or gullet, which have already been treated with another anti-fungal medicine, but which have not cleared
The usual dose is 10 to 20ml (100 to 200mg itraconazole) twice a day, for 14 days (two weeks).
If the infection has not cleared within 14 days (two weeks) of starting treatment, your doctor may tell you to continue taking your medicine for a further two weeks.
If your doctor has told you to take 20ml (200mg itraconazole), twice a day for 14 days (two weeks) and your infection has not mproved after 14 days, speak to your doctor for advice.
Adults - Prevention of fungal infections
The dose will be calculated depending on your body weight (usually 5mg per kg), given in two divided doses.
Your doctor will tell you how much medicine you need to take. Children and the elderly
Itraconazole Oral Solution is not normally given to children and the elderly.
Patients with liver or kidney problems
If you suffer from problems with your kidneys or liver, your doctor will monitor you carefully if you are taking Itraconazole Oral Solution. The doctor may change the dose, of your medicine, according to your condition.
Your doctor may give you regular blood tests while you are taking this medicine.
If you take more Itraconazole Oral Solution than you should
If you or someone else takes more Itraconazole Oral Solution than has been prescribed, or you think a child has swallowed any Itraconazole Oral Solution, contact your doctor, pharmacist or hospital emergency department immediately and take your Itraconazole Oral Solution with you.
If you forget to take Itraconazole Oral Solution If you forget to take a dose, do not worry. Take the next dose when it is due.
Do not take double the amount to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Other side effects
Common side effects (may affect up to 1 in 10 people)
• Headache
• Shortness of breath
• Stomach pain
• Feeling and/or being sick
• Diarrhoea
• Changes in taste
• Increase in the blood of substances produced by the liver (called liver enzymes)
• Rash
• High temperature (fever)
Uncommon side effects (may affect up to 1 in 100 people):
• Blood disorders which may mean that you get infections more easily than normal, you bleed or bruise more easily, or you start to suffer from tiredness, weakness or fatigue.
• You may have low levels of potassium in your blood (hypokalaemia), which may make your muscles feel weak and you may suffer from extreme tiredness.
• Dizziness
• Upset stomach or indigestion
• Constipation
• Swelling or fluid retention
• Yellowing of the skin and whites of the eyes (jaundice) which could mean that your liver is not working properly (hepatitis).
• Itching
The following side effects have been reported in patients taking Itraconazole Oral Solution with unknown frequency:
• Serum sickness, which may include symptoms such as swollen lymph nodes, fever, general feeling of being unwell
• High levels of triglycerides in the blood
• Pins and needles or a decreased sensitivity to touch
• Difficulty breathing, shortness of breath which can be symptoms of pulmonary oedema
• Abdominal pain, fever, nausea and vomiting, which can be symptoms of pancreatitis
• Skin disorders which may result in hair loss, itching skin lesions, itching, reddening and scaling of the skin
• Muscle or joint pain
• Problems with your periods
• Difficulty in getting, or maintaining, an erection (impotence)
• Temporary or permanent hearing loss
• Liver failure
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Itraconazole Oral Solution
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date stated on the carton or bottle label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in original package in order to protect from light.
Once opened, use within 1 month.
Do not use this medicine if you notice any visible signs of damage to the bottle, or deterioration in your medicine. Return it to your pharmacist. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that have passed their expiry date or that you no longer require. These measures will help to protect the environment.
O-
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following side effects while taking your medicine, stop taking this medicine and tell your doctor mmediately or go to a hospital straight away.
• Severe allergic reaction which may include a red and itchy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
Severe skin rash with peeling skin and blisters, which may also affect the lining of your mouth, eyes or genitals.
Severe lack of appetite, feeling or being sick, extreme tiredness, stomach pain or unusually dark urine. These symptoms could be signs that your liver is not working properly. Shortness of breath, swelling of ankles, legs and stomach, unexpected weight gain, dizziness, fatigue or weakness.
These symptoms could be signs of heart failure (also known as congestive heart failure).
You should also let your doctor know if you experience any of the following side effects: loss of hearing or hearing disturbances blurred or double vision ringing in your ears
inability to control passing water or increased need to pass water
tingling, numbness or pain in your hands and/or feet
sensitivity to light
diarrhoea
6. Contents of the pack and other information What Itraconazole Oral Solution contains
- The active substance is itraconazole. Each 1ml contains 10mg itraconazole.
- The other ingredients are hydroxypropylbetadex, sorbitol (E420), propylene glycol, cherry flavour (containing propylene glycol (E1520)), caramel flavour (containing propylene glyco (E1520) and ethanol), sodium saccharin, hydrochloric acid, concentrated and sodium hydroxide (for pH adjustment) and purified water (see section 2).
What Itraconazole Oral Solution looks like and contents of the pack
Itraconazole Oral Solution is a clear, yellow solution. It is available in an amber glass bottle containing 150ml medicine. The pack also contains a 30ml plastic measuring cup.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st Floor,
85 King William Street, London EC4N 7BL, UK.
Tel: 00 44 (0)1283 495280 Fax: 00 44 (0)1283 495290 Email: medinfo@focuspharma.co.uk
Manufacturer Kleva Pharmaceuticals S.A., 189 Parnithos Avenue 13671 Acharnai, Greece.
Other sources of information
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk.
This leaflet was last revised in 06/2015.