Itraconazole 10 Mg/Ml Oral Solution
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
ITRACONAZOLE 10mg/ml ORAL SOLUTION
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.
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 is one of a group of medicines called "antifungals". These medicines are used to treat and stop you from getting infections caused by fungi including yeasts.
You may be given this medicine:
• To treat yeast infections of the mouth, throat or food pipe (oesophagus) if you have a poor immune system
• To stop you from getting certain fungal infections if you have blood cancer or have had a bone marrow transplant and have a poor immune system.
2. What you need to know before you take Itraconazole oral solution
DO NOT TAKE Itraconazole Oral Solution if you:
• are allergic (hypersensitive) to itraconazole or any of the other ingredients (listed in section 6)
• have, or have a history of, congestive heart failure, unless you have a very serious fungal infection (see under 'Take special care')
• are pregnant, think you might be pregnant or could become pregnant (see the section on Pregnancy)
• are taking any of the following medicines: o terfenadine, astemizole or mizolastine
(antihistamine for allergies) o bepridil used to treat angina (crushing chest pain)
o nisoldipine (used for high blood pressure) o cisapride (used for stomach upsets) o midazolam by mouth or triazolam (used to help you sleep or for anxiety) o lovastatin, simvastatin or atorvastatin (used to lower cholesterol)
o pimozide and sertindole (for conditions affecting thoughts, feelings and/or behaviour)
o levacetylmethadol (used for treatment of drug abuse (opioid-dependency)) o dihydroergotamine, ergotamine and eletriptan (used for migraine headaches) o ergometrine (ergonovine) and methylergometrine (methylergonovine) used after giving birth
o quinidine and dofetilide (used for irregular heart beat rhythms).
TAKE SPECIAL CARE with Itraconazole Oral Solution
Stop taking Itraconazole Oral Solution and see your doctor immediately if any of the
following symptoms of severe liver problems appear during your course of treatment:
• Severe lack of appetite, feeling sick, being sick, unusual tiredness, abdominal (stomach) pain, unusually dark urine or pale stools.
Tell your doctor immediately if you:
• have any unusual feelings of tingling, numbness or weakness in your hands or feet whilst taking Itraconazole Oral Solution
• experience any hearing loss symptoms. In very rare cases patients taking itraconazole have reported temporary or permanent hearing loss.
Tell your doctor if you have:
• had an allergic reaction to any other antifungal medicines
• a heart problem, including heart failure (also called congestive heart failure or CHF), Itraconazole Oral Solution could make it worse. If your doctor decides to give you Itraconazole, you should be told to watch out for any of the symptoms listed below. If you get any of the following stop taking Itraconazole Oral Solution and tell your doctor straight away. These may be signs of heart failure:
o shortness of breath o unexpected weight gain o swelling of your legs or stomach o feel unusually tired o wake up short of breath at night
• a liver problem, such as jaundice (yellowing of the skin), as your dose of Itraconazole may have to be changed. Your doctor should give you instructions on symptoms to watch out for. If you have to take Itraconazole Oral Solution continuously for more than one month, your doctor may want to check your liver by doing blood tests
• a kidney disorder, as your dose of Itraconazole may have to be changed.
OTHER MEDICINES AND ITRACONAZOLE
There are some medicines that you should not take whilst taking Itraconazole Oral Solution. These are listed under the heading "Do not take Itraconazole Oral Solution if you:
• are taking any of the following medicines”
Tell your doctor if you are using the following medicines as they may stop itraconazole from working properly:
• rifampicin, rifabutin and isoniazid (antibiotics used for tuberculosis)
• phenytoin, carbamazepine and phenobarbital (anti-epileptics)
• St. John's wort (a herbal medicine).
Do not use Itraconazole Oral Solution within 2 weeks of taking these medicines.
Tell your doctor before taking any of the
following medicines as the dose of Itraconazole Oral Solution or other treatments may need to be altered:
• clarithromycin and erythromycin (antibiotics for infections)
• medicines that act on the heart and blood vessels (digoxin, disopyramide and calcium channel-blockers such as dihydropyridines, verapamil and cilostazol)
• drugs that slow down blood clotting or thin the blood, such as warfarin
• methylprednisolone, budesonide, fluticasone and dexamethasone, medicines for inflammation, asthma and allergies
• ciclosporin, tacrolimus and rapamycin (also known as sirolimus), which are usually given after an organ transplant
• medicines used in HIV-infected patients, such as ritonavir, indinavir and saquinavir
• medicines for cancer (such as busulfan, docetaxel, trimetrexate and a group of medicines known as vinca alkaloids)
• alfentanil and fentanyl (for pain)
• buspirone, alprazolam, brotizolam and midazolam when given by injection into a vein (for anxiety or to help you sleep)
• reboxetine (for depression)
• loperamide (for diarrhoea)
• an antihistamine containing ebastine
• halofantrine (for malaria)
• repaglinide (for diabetes).
Please 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 reduces your body's ability to absorb the medicine.
• Always take it one hour before any food or drink as this helps the body absorb the medicine.
PREGNANCY AND BREAST-FEEDING Pregnancy
• Do not take Itraconazole Oral Solution if you are pregnant, unless your doctor has told you to.
• If you are of child bearing age and could become pregnant, you should use contraceptives to make sure that you do not become pregnant while you are taking your medicine.
• As itraconazole remains in the body for some time after you stop taking it, you should continue to use some form of contraception until your next period after your treatment has finished.
• If you become pregnant after starting a course of Itraconazole Oral Solution, stop taking it and tell your doctor straight away.
Breastfeeding
• Do not take Itraconazole Oral Solution if you are breast-feeding, as small amounts of the medicine could be present in your breast milk.
DRIVING AND USING MACHINES Itraconazole can sometimes cause dizziness, blurred/double vision or hearing loss. Do not drive or use machines if you have these symptoms.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS
This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking this medicine.
This medicinal product contains a small amount of ethanol (alcohol) less than 100mg per 20ml.
3. How to take Itraconazole oral solution
Always take Itraconazole Oral Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Always take the solution one hour before any food or drink as this helps the body absorb the medicine.
• A graduated measuring cup is provided. Ensure you fill the cup to the correct mark.
• You should swish the oral solution around in your mouth for approximately 20 seconds before swallowing it.
• Do not rinse your mouth after swallowing the oral solution.
Treatment of yeast infections of the mouth, throat or food pipe (oesophagus)
The usual dose is 20 ml per day for one week. This may be taken either all at once or in two divided doses during the day.
If after one week of using the oral solution, your infection has not cleared, your doctor may decide to continue your treatment for one more week.
Treatment of yeast infections of the mouth, throat or food pipe (oesophagus), that have already been treated with another antifungal but have still not cleared
The usual dose is 10-20 ml twice daily for two weeks. If the infection has not cleared, the treatment may be continued for an additional two weeks. The higher dose of 400mg (40 ml) daily should not be used for more than 14 days if there are no signs of improvement during this time.
Prevention of fungal infections
The dose is calculated according to your body weight (5 mg per kg) given in two divided doses. Your doctor will tell you exactly how much you should take.
use in children and the elderly
Itraconazole Oral Solution is not normally given to children or the elderly. Your doctor may prescribe it in special cases.
If you take more Itraconazole Oral Solution than you should contact your doctor or local hospital without delay
If you forget to take Itraconazole Oral Solution, take the next dose as usual and continue your medicine as directed by your doctor. Do not take a double dose to make up for a forgotten dose
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Itraconazole Oral Solution can cause side effects, although not everybody gets them.
serious side effects
Stop taking Itraconazole Oral Solution and contact your doctor immediately if you have:
• any sudden wheeziness, difficulty in breathing, swelling of the face, rash, itching (especially affecting the whole body) OR a severe skin disorder including blistering and peeling of the skin, fever, sore throat and tiredness. These may be symptoms of a severe hypersensitivity or allergic reaction.
• severe lack of appetite, feeling or being sick, unusual tiredness, abdominal (stomach) pain, unusually dark urine, or pale stools. These may be symptoms of severe liver problems
• severe upper stomach pain, often with nausea and vomiting due to inflammation of the pancreas (pancreatitis).
Tell your doctor immediately if you have any of the side effects below:
• symptoms of heart failure such as shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue (tiredness), repeated waking at night
• symptoms of nerve damage such as any unusual tingling sensation, numbness or weakness in the limbs
• blurred vision/double vision
• increased sensitivity of the skin to light
• loss of control of urination or increased need to urinate (pass water)
• any symptoms of hearing loss, ringing in your ears.
other side effects
Tell your doctor if any of the following symptoms get worse or you are worried.
Common side effects (occur in less than 1 in 10 patients) are:
• headache
• stomach ache, feeling sick (nausea), being sick (vomiting), diarrhoea, unpleasant taste
• increases in specific liver function tests (hepatic enzyme increased)
• rash
• fever or high temperature
• shortness of breath.
uncommon side effects (occur in less than 1 in 100 patients) are:
• certain blood disorders which may increase the risk of bleeding, bruising or infections
• muscle weakness (possible symptom of low blood levels of potassium)
• dizziness
• indigestion, constipation
• inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
• itching
• general swelling.
The following side effects have been reported in patients taking itraconazole with unknown frequency:
• excess of triglycerides in the blood
• skin inflammation, hives, sensation of tingling, prickling of the skin, numbness
• pustular rash with fever
• rash or discolouring of the skin due to inflammation of blood vessels
• hair loss
• muscle pain, painful joints
• menstrual disorders
• erectile dysfunction.
Reporting of side effects
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 national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme at:
Ireland
HPRA Pharmacovigilance, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2 Tel: +353 1 6764971; Fax: +353 1 6762517 Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
5. How to store Itraconazole oral solution
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Itraconazole after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
The oral solution should not be used for longer than 1 month after the bottle has first been opened.
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. CONTENTS OF THE PACK AND OTHER
information
What Itraconazole Oral Solution contains
• The active substance is itraconazole 10mg per ml.
• The other ingredients are hydroxypropyl-p-cyclodextrin, sorbitol (E420), propylene glycol, cherry flavour, caramel flavour (contains ethanol and propylene glycol), sodium saccharin dihydrate, hydrochloric acid, sodium hydroxide, purified water.
What Itraconazole Oral Solution looks like and contents of the pack
It is a clear yellow solution, available in bottles containing 150 ml together with a graduated measuring cup, in a cardboard carton.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd, High Street, Tunbridge Wells, Kent TN1 1YG, UK
Manufacturer
Kleva S.A., 189 Parnithos Avenue, 136 75 Acharnai Attiki, Greece
This leaflet was last revised 07/2014
> Beacon
PHARMACEUTICAL!