Rafarm S.A.


Hind Wing
Agencia Lei Va Hong
Full Prescribing Info
Each millilitre of oral solution contains 10mg of itraconazole.
Excipients/Inactive Ingredients: The other ingredients are: hydroxypropyl-β-cyclodextrin, hydrochloric acid, propylene glycol, sodium hydroxide, sodium saccharin dihydrate, sorbitol, cherry flavour, caramel flavour, purified water.
Itrazol is one of a group of medicines called "antifungals". These medicines are used to treat and stop the patient from getting infections caused by fungi including yeasts.
The patient may be given Itrazol to: treat yeast infections of the mouth, throat or gullet if the patient has a poor immune system; stop the patient from getting certain fungal infections if the patient has a poor immune system due to a major blood disorder or bone marrow transplantation.
Dosage/Direction for Use
Always take Itrazol oral solution one hour before any food or drink as this helps the body absorb the medicine.
The patient should swish the oral solution around in the mouth for approximately 20 seconds before swallowing it. Do not rinse the mouth after swallowing the oral solution.
Always take Itrazol exactly as advised by the doctor. The patient should check with the doctor or pharmacist if not sure.
A measuring cup graduated to indicate 10ml is provided. Ensure to fill the cup to the 10ml mark.
How to take Itrazol oral solution: Treatment of yeast infections of the mouth, throat or gullet: The usual dose is 2 measuring cups (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 Itrazol, the infection has not cleared, the doctor may decide to continue the 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 1-2 measuring cups (10-20 ml) 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 (4 measuring cups of 10 ml) 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 the body weight (5 mg per kg) given in two divided doses. The doctor will tell exactly how much should be taken.
If the patient forgets to take Itrazol oral solution: If taking the medicine is forgotten, take the next dose as usual and continue the medicine as directed by the doctor. Do not take a double dose.
If there are any further questions on the use of Itrazol, ask the doctor or pharmacist.
If more Itrazol is taken than what was told to, contact the doctor or local hospital without delay.
Do not use Itrazol oral solution if: Allergic (hypersensitive) to itraconazole or to any of the ingredients in Itrazol oral solution (listed in Description).
Pregnant, thinks she might be pregnant or could become pregnant (see Pregnancy under Use in Pregnancy & Lactation).
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 to 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 methylergometrine (methylergonovine) used after giving birth; quinidine and dofetilide (for irregular heart beat rhythms).
Special Precautions
Take special care with Itrazol oral solution: Stop taking Itrazol and see the doctor immediately if any of the following symptoms of severe liver problems appear during the course of treatment: Severe lack of appetite, feeling sick, being sick, unusual tiredness, abdominal (stomach) pain, unusually dark urine or pale stools.
Tell the doctor immediately: If having any unusual feelings of tingling, numbness or weakness in the hands or feet whilst taking Itrazol; If experiencing any hearing loss symptoms. In very rare cases patients taking Itrazol have reported temporary or permanent hearing loss.
Tell the doctor if having: Had an allergic reaction to any other antifungal medicines.
A heart problem, including heart failure (also called congestive heart failure or CHF), Itrazol could make it worse.
If the doctor decides to give Itrazol, the patient should be told about the symptoms listed as follows to watch out for. If getting any of the following stop taking Itrazol and tell the doctor straight away. These may be signs of heart failure: shortness of breath; unexpected weight gain; swelling of the legs or stomach; feel unusually tired; wake up short of breath at night.
A liver problem, such as jaundice (yellowing of the skin) as the dose of Itrazol may have to be changed. The doctor should give instructions on symptoms to watch out for. If the patient has to take Itrazol continuously for more than one month, the doctor may want to check the liver by doing blood tests.
A kidney disorder as the dose of Itrazol may have to be changed.
Driving and using machines: Itrazol can sometimes cause dizziness, blurred/double vision or hearing loss. If having these symptoms, do not drive or use machines.
Important information about some of the ingredients of Itrazol oral solution: Tell the doctor if intolerant to fructose (a type of sugar) as this is in sorbitol, one of the ingredients of Itrazol oral solution.
Use in Children and Elderly: Itrazol is not normally given to children or the elderly. The doctor may prescribe it in special cases.
Use In Pregnancy & Lactation
Pregnancy: Do not take Itrazol if pregnant, unless the doctor has told to. If the patient is of child bearing age and could become pregnant, she should use contraceptives to make sure that she does not become pregnant while she is taking the medicine. As Itrazol remains in the body for some time after the patient stops taking it, she should continue to use some form of contraception until the next period after the treatment with Itrazol has finished. If the patient does find that she is pregnant after starting a course of Itrazol, she must stop taking it and tell the doctor straight away.
Before taking any medicine - the patient must always tell the doctor if she is pregnant, thinks she might be pregnant or is trying to become pregnant.
Breast feeding: If breast-feeding do not take Itrazol, as small amounts of the medicine could be present in the breast milk.
Side Effects
Like all medicines, Itrazol oral solution can cause side effects, although not everybody gets them.
Medicines can cause serious allergic reactions. Stop taking Itrazol and contact the doctor immediately if having: 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.
The patient should also let the doctor know immediately if having any of the following side effects: 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 the ears, lose the ability to control the urine or increased need to urinate (pass water); If experiencing 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 Itrazol 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 noticing any side effects not listed, please tell the doctor or pharmacist.
Drug Interactions
Taking other medicines: There are some medicines that the patient should not take whilst taking Itrazol. These are listed in Contraindications.
Tell the doctor if using the following medicines as they may stop Itrazol 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 Itrazol oral solution within 2 weeks of taking these medicines.
Tell the doctor before taking any of the following medicines as the dose of Itrazol 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 to sleep); reboxetine (for depression); loperamide (for diarrhoea); an antihistamine containing ebastine; halofantrine (for malaria); repaglinide (for diabetes).
Please tell the doctor or pharmacist if taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using Itrazol oral solution with food and drink: Do not take Itrazol with food or drink as it reduces the body's ability to absorb the medicine. Always take Itrazol oral solution one hour before any food or drink as this helps the body absorb the medicine.
Do not store Itrazol oral solution above 25°C.
The oral solution should not be used for longer than 30 days after the bottle has first been opened. After opening the bottle, do not store above 25°C.
MIMS Class
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Oral soln 10 mg/mL x 150 mL x 1's.
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