Sporanox Solution

(Itraconazole)
  • All Strengths

  • 10mg/mL

Brand Choices
Sporanox 10mg/mL

Sporanox 10mg/mL

Oral Solution

Marketed as Sporanox Oral Solution in United Kingdom

Prescription required. Manufactured by Janssen-Cilag Ltd. Product of United Kingdom. Shipped from United Kingdom.

What Sporanox Solution is and what it is used for

Sporanox 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 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 to a major blood disorder or bone marrow transplantation.

How to take Sporanox Solution

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. Do not 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 to indicate 10 ml is provided. Ensure you fill the cup to the 10 ml mark. How to take Sporanox oral solution
• Treatment of yeast infections of the mouth, throat or gullet The usual dose is 2 measuring cups (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 Sporanox, 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 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 400 mg (4 measuring cups) 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 (5 mg per kg) given in two divided 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. Page 6 How to use the measuring cup Use the measuring cup just as it sits on the bottle. Make sure that the side with the graduations (the side that holds less) is uppermost; that is the side you have to fill. When the arrow on the side points up, the correct side is uppermost. If you take too much 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 to take Sporanox oral solution 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 Sporanox, ask your doctor or pharmacist.

Possible side effects

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 (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
• severe upper stomach pain, often with nausea and vomiting due to inflammation of the pancreas (pancreatitis)

Other side effects include: a Fig. 1 1 2 Page 7

Common side effects (occur in less than 1 in 10 patients) are:
• headache
• stomach ache, feeling sick (nausea), being sick (vomiting), diarrhoea, indigestion, unpleasant taste
• rash
• fever or high temperature
• shortness of breath
• dizziness
• cough

Uncommon side effects (occur in less than 1 in 100 patients) are:
• certain blood disorders which may increase the risk of bleeding or bruising (possible symptoms of low levels of platelets), or infections (possible symptom of low levels of white blood cells)
• constipation
• itching, hives
• general swelling
• muscle cramps or irregular heart beat (possible symptoms of low blood levels of potassium)
• muscle pain, painful joints
• abnormal menstrual bleeding
• decreased feeling or sensitivity, especially in the skin

The following side effects have been reported in patients taking Sporanox with unknown frequency:
• excess of triglycerides (fats) in the blood
• hair loss
• increase in blood creatine phosphokinase levels

The following side effects have been reported in patients taking other formulations of Sporanox:
• infection of the upper respiratory tract
• inflammation of the nose
• inflammation of the sinuses
• certain blood disorder which may increase the risk of infections (possible symptom of low levels of granulocytes)
• high blood sugar levels
• muscle cramps or irregular heart beat (possible symptoms of low blood levels of magnesium)
• muscle cramps or irregular heart beat (possible symptoms of high blood levels of potassium)
• confusion
• sleepiness
• tremors
• increase in heart rate
• high blood pressure
• low blood pressure
• fluid in the lungs
• difficulty speaking
• excess gas in the intestinal tract
• increases in specific liver function tests (hepatic enzyme increased)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• excess sweating
• kidney problems
• excessive urine production
• erectile dysfunction
• general swelling Page 8
• facial swelling
• chest pain
• pain
• chills
• fatigue
• increase in blood urea levels
• abnormal urine findings

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. In the UK, you can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store In Ireland, you can also report side effects directly via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: [email protected] By reporting side effects, you can help provide more information on the safety of this medicine.

How to Store Sporanox Solution

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 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. Always return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

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