What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 39307/0069 .


Itraconazole 10mg/ml Sugar Free Oral Solution

Package leaflet: Information for the user

Itraconazole 10mg/ml Sugar Free 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. See section 4.

The name of your medicine is Itraconazole 10mg/ml Sugar Free Oral Solution but it will be referred to as ‘Itraconazole' throughout this leaflet.

What is in this leaflet:

1. What Itraconazole is and what it is used for
2. What you need to know before you take Itraconazole
3. How to take Itraconazole
4. Possible side effects
5. How to store Itraconazole
6. Contents of the pack and other information

1. What Itraconazole 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 Itraconazole to:

  • treat yeast infections of the mouth, throat or gullet if you have a poor immune system
  • stop you from getting certain fungal infections if you have a poor immune system due to a major blood disorder or bone marrow transplantation.

2. What you need to know before you take Itraconazole

Do not use Itraconazole oral solution if you are:

  • allergic (hypersensitive) to itraconazole or to any of the ingredients in Itraconazole oral solution (listed in Section 6)
  • pregnant, think you might be pregnant or could become pregnant (see the section on Pregnancy)
  • taking any of the following medicines:
    • terfenadine, astemizole or mizolastine (antihistamine for allergies)
    • bepridil - used to treat angina (crushing chest pain)
    • nisoldipine (used for high blood pressure)
    • cisapride (used for stomach upsets)
    • midazolam by mouth or triazolam (used to help you sleep or for anxiety)
    • lovastatin, simvastatin or atorvastatin (used to lower cholesterol)
    • pimozide and sertindole (for conditions affecting thoughts, feelings and/or behaviour)
    • levacetylmethadol - for treatment of drug abuse (opioid dependency)
    • dihydroergotamine, ergotamine and eletriptan (for migraine headaches)
    • ergometrine (ergonovine) and methyl-ergometrine (methylergonovine) used after giving birth
    • quinidine and dofetilide (for irregular heart beat rhythms).

Warnings and precautions

Stop taking Itraconazole 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
  • if you 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 could make it worse. If your doctor decides to give you Itraconazole, you should be told about the symptoms listed below to watch out for. If you get any of the following stop taking Itraconazole and tell your doctor straight away. These may be signs of heart failure:
    • shortness of breath
    • unexpected weight gain
    • swelling of your legs or stomach
    • feel unusually tired
    • 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 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

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including medicines obtained without a prescription (including herbal medicines). This is because Itraconazole can affect the way some other medicines work. Also some other medicines can affect the way Itraconazole works. There are some medicines that you should not take whilst taking Itraconazole. These are listed under the heading “Do not use Itraconazole oral solution if you are:”

Tell your doctor if you are using the following medicines as they may stop Itraconazole oral solution from working properly:

  • rifampicin, rifabutin and isoniazid (antibiotics used for tuberculosis)
  • phenytoin, carbamazepine and phenobarbital (anti- epileptics)
  • St John’s wort.

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 given by mouth and injection 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 busulphan, 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.

Itraconazole with food, drinks and alcohol

Do not take Itraconazole with food or drink as it reduces your body’s ability to absorb the medicine. Always take Itraconazole oral solution one hour before any food or drink as this helps the body absorb the medicine.

Children and the elderly

Itraconazole is not normally given to children or the elderly. Your doctor may prescribe it in special cases.

Pregnancy

Do not take Itraconazole 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 with Itraconazole has finished.

If you do find that you are pregnant after starting a course of Itraconazole, stop taking it and tell your doctor straight away.

Before taking any medicine, always tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.

Breast-feeding

If you are breast-feeding do not take Itraconazole, as small amounts of the medicine could be present in your breast milk.

Driving and using machines

Itraconazole oral solution can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms, do not drive or use machines.

Itraconazole contains:

Sorbitol (E420): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium: The product contains 0.03mmol (or 0.7124mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Itraconazole

Always take Itraconazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose for:

  • Treatment of yeast infections of the mouth, throat or gullet
    The usual dose is 200mg (20ml) 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 Itraconazole 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 gullet, that have already been treated with another antifungal but have still not cleared The usual dose is 100 – 200mg (10-20ml) twice daily for two weeks. The treatment may be continued for an additional two weeks, if the infection does not clear in the initial two weeks of treatment. For patients on the higher dose of 400mg (40ml) daily, treatment should be limited to 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 (5mg (0.5ml) per kg) given in two divided doses. Your doctor will tell you exactly how much you should take.

Route and method of administration:

  • This medicinal product must be taken orally.
  • Always take Itraconazole oral solution one hour before any food or drink as this helps the body absorb the medicine.
  • 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.
  • A 30ml measuring cup graduated with 5ml (including 2.5ml and 7.5ml intermediate graduation) markings is provided. Ensure you fill the cup to the required dosing mark.

Directions for opening the bottle

The bottle comes with a child-proof cap, and should be opened as follows: push the plastic screw cap down, while turning it counter clockwise.

If you take more Itraconazole than you should

If you, or anyone else, take more Itraconazole than you were told to, contact your doctor or local hospital without delay. Always take any leftover medicine with you, as well as the container and/or the labelled bottle so that the doctor can easily tell what medicine you have taken.

If you forget to take Itraconazole

If you forget to take your medicine, take the next dose as usual and continue your medicine as directed by your doctor.

Do not take a double dose.

If you have any further questions on the use of Itraconazole, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Itraconazole oral solution can cause side effects, although not everybody gets them. Medicines can cause serious allergic reactions. 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 (widespread rashes with peeling skin and blisters in the mouth, eyes and genitals, or rashes with small pustules or blisters)
  • severe lack of appetite, feeling sick, being sick, unusual tiredness, abdominal (stomach) pain, unusually dark urine, or pale stools. These may be symptoms of severe liver problems.

You should also let your doctor know immediately if you have any of the side effects below:

  • symptoms that resemble heart failure such as shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue (tiredness), repeated waking at night
  • a tingling sensation, sensitivity to light, numbness or weakness in the limbs
  • blurred vision/double vision, ringing in your ears, lose the ability to control your urine or increased need to urinate (pass water)
  • if you experience any hearing loss symptoms.

Other side effects include:

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 oral solution with unknown frequency:

  • excess of triglycerides in the blood
  • hair loss
  • muscle pain, painful joints
  • menstrual disorders
  • erectile dysfunction
  • severe upper stomach pain, often with nausea and vomiting due to inflammation of the pancreas (pancreatitis).

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Yellow Card Scheme Website 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

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
  • Do not store above 25°C.
  • Discard 30 days after first opening.
  • Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
  • Do not throw away any medicine via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Itraconazole oral solution contains:

The active ingredient is itraconazole.

Each ml of oral solution contains 10mg of itraconazole.

The other ingredients are hydroxypropyl-β-cyclodextrin (E459), sorbitol, liquid (non-crystallising) (E420), propylene glycol (E1520), sodium saccharin (E954), concentrated hydrochloric acid (E507), cherry flavor (containing propylene glycol (E1520)), sodium hydroxide (for pH adjustment) and purified water.

What Itraconazole oral solution looks like and the contents of the pack:

Itraconazole oral solution is clear, colourless to yellow colour solution with an odour of cherry and is supplied in amber glass bottles fitted with a tamper evident, child resistant white plastic cap.

Itraconazole is supplied in a bottle containing 150ml oral solution together with a 30ml measuring cup with 5ml graduation (including 2.5ml and 7.5ml intermediate graduation).

Marketing Authorisation Holder and Manufacturer:

SyriMed
Unit 4
Bradfield Road
Ruislip
Middlesex
HA4 0NU
UK

This leaflet was last revised in 05/2021.

POM

PL00865-01