What Sporanox oral solution is and what it is used for
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Sporanox is one of a group of medicines called “antifungals”. These medicines are used ttreat and stop you from getting infections caused by fungi including yeasts.
You may be given Sporanox 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 ta major blood disorder or bone marrow transplantation.
Before you use Sporanox oral solution
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Do not use Sporanox oral solution if you are:
- allergic (hypersensitive) titraconazole or tany of the ingredients in Sporanox oral solution (listed in Section 6 Further information)
- pregnant, think you might be pregnant or could become pregnant (see the section on Pregnancy)
taking any of the following medicines:
- terfenadine, asternizole or mizolastine (antihistamine for allergies)
- bepridil- used ttreat angina (crushing chest pain)
- nisoldipine (used for high blood pressure)
- cisapride (used for stomach upsets)
- midazolam by mouth or triazolam (used thelp you sleep or for anxiety)
- lovastatin, simvastatin or atorvastatin (used tlower 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).
Take special care with Sporanox oral solution
Stop taking Sporanox 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 Sporanox.
- If you experience any hearing loss symptoms. In very rare cases patients taking Sporanox have reported temporary or permanent hearing loss.
Tell your doctor if you have:
- had an allergic reaction tany other antifungal medicines
- a heart problem, including heart failure (alscalled congestive heart failure or CHF), Sporanox could make it worse. If your doctor decides tgive you Sporanox, you should be told about the symptoms listed below twatch out for. If you get any of the following stop taking Sporanox 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 Sporanox may have tbe changed. Your doctor should give you instructions on symptoms twatch out for. If you have ttake Sporanox continuously for more than one month, your doctor may want tcheck your liver by doing blood tests
- a kidney disorder as your dose of Sporanox may have tbe changed
Taking other medicines
There are some medicines that you should not take whilst taking Sporanox. These are listed under the heading “Dnot use Sporanox oral solution if you are:”
Tell your doctor if you are using the following medicines as they may stop Sporanox 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 Sporanox oral solution within 2 weeks of taking these medicines.
Tell your doctor before taking any of the following medicines as the dose of Sporanox oral solution or other treatments may need tbe 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 (alsknown 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 inta vein (for anxiety or thelp 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.
Using Sporanox oral solution with food and drink
Do not take Sporanox with food or drink as it reduces your body’s ability tabsorb the medicine. Always take Sporanox oral solution one hour before any food or drink as this helps the body absorb the medicine.
Children and the elderly
Sporanox is not normally given tchildren or the elderly. Your doctor may prescribe it in special cases.
Pregnancy
Dnot take Sporanox 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 tmake sure that you dnot become pregnant while you are taking your medicine. As Sporanox remains in the body for some time after you stop taking it, you should continue tuse some form of contraception until your next period after your treatment with Sporanox has finished.
If you dfind that you are pregnant after starting a course of Sporanox, 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 tbecome pregnant.
Breast feeding
If you are breast-feeding dnot take Sporanox, as small amounts of the medicine could be present in your breast milk.
Driving and using machines
Sporanox can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms, dnot drive or use machines.
Important information about some of the ingredients of Sporanox oral solution
Tell your doctor if you are intolerant tfructose (a type of sugar) as this is in sorbitol, one of the ingredients of Sporanox oral solution.
How to use Sporanox oral solution
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Always take Sporanox 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. Dnot rinse your mouth after swallowing the oral solution.
Always take Sporanox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
A measuring cup graduated tindicate 10ml is provided. Ensure you fill the cup tthe 10ml mark.
How to take Sporanox 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 twdivided doses during the day.
If after one week of using Sporanox, your infection has not cleared, your doctor may decide tcontinue 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 1-2 measuring cups (10-20 ml) twice daily for twweeks. The treatment may be continued for an additional twweeks, if the infection does not clear in the initial twweeks of treatment. For patients on the higher dose of 400mg (4 measuring cups) daily, treatment should be limited t14 days, if there are nsigns of improvement during this time.
Prevention of fungal infections
The dose is calculated according tyour body weight (5 mg per kg) given in twdivided doses. Your doctor will tell you exactly how much you should take.
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 tomuch Sporanox oral solution
If you, or anyone else, take more Sporanox than you were told to, contact your doctor or local hospital without delay.
If you forget ttake Sporanox oral solution
If you forget ttake your medicine, take the next dose as usual and continue your medicine as directed by your doctor. Dnot take a double dose.
If you have any further questions on the use of Sporanox, ask your doctor or pharmacist.
Possible side effects
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Like all medicines, Sporanox oral solution can cause side effects, although not everybody gets them.
Medicines can cause serious allergic reactions. Stop taking Sporanox 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.
- 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 alslet 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 tlight, numbness or weakness in the limbs.
- Blurred vision/double vision, ringing in your ears, lose the ability tcontrol your urine or increased need turinate (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
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 Sporanox 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 tinflammation 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.
How to store Sporanox oral solution
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Keep out of the reach and sight of children.
Do not store Sporanox oral solution above 25°C.
Do not use the Sporanox oral solution after the expiry date printed on the packaging. The expiry date refers tthe last day of that month.
The oral solution should not be used for longer than 1 month after the bottle has first been opened.
Always return any left over medicine tyour pharmacist. Only keep it if your doctor tells you to.
Further information
What Sporanox oral solution contains:
The active ingredient is itraconazole (1 Omg of itraconazole per ml).
The other ingredients are hydroxypropyl-p-cyclodextrin, sorbitol, propylene glycol, hydrochloric acid, cherry flavour, caramel flavour, sodium saccharin, sodium hydroxide and water.
What Sporanox oral solution looks like and the contents of the pack:
Sporanox oral solution is a clear, yellow tslightly amber solution. It is available in bottles containing 150 ml together with a measuring cup.
This medicinal product is authorised in the member states of the EEA under the following names:
Austria: SPORANOX
Belgium: SPORANOX
Germany: SEMPERA
Spain: SPORANOX
Finland: SPORANOX
Ireland: SPORANOX
Italy: SPORANOX
Luxembourg: SPORANOX
Netherlands: TRISPORAL
Portugal: SPORANOX
Sweden: SPORANOX
UK: SPORANOX