ORUNGAL syrup 10 mg. / Ml. 150 ml.

WHAT ORUNGAL AND WHAT IT IS USED
ORUNGAL oral solution is medicine for:
treatment of fungal infections in the mouth, throat and esophagus in patients with reduced resistance;
prevent certain fungal infections in people who have a reduced resistance due to underlying disease blood or bone marrow transplantation.

2. BEFORE YOU TAKE ORUNGAL
Do not take ORUNGAL:
if you are allergic (hypersensitive) to itraconazole or any of the other ingredients of Sporanox oral solution;
if you are pregnant (unless your doctor determines that you need Sporanox oral solution, although pregnancy);
if you are of childbearing age and you get pregnant, you must take adequate contraceptive precautions to ensure that you will not become pregnant while taking your medicine. As Sporanox oral solution remains in the body for some time after you stop taking it, you should continue to use contraception until the start of the next menstrual cycle after you have completed treatment with Sporanox oral solution;
if you have a condition called heart failure (also called congestive heart failure), Sporanox oral solution can lead to its deterioration. If your doctor decides that you need to take Sporanox oral solution, although this disease, make sure you can get immediate medical attention if you feel feel short of breath when unexpected weight gain, swelling of feet, unusual tiredness or wake up at night.
Also, do not take the following medicines with Sporanox oral solution:
some allergy medications, and in particular, terfenadine, astemizole and mizolastine;
certain drugs used to treat angina (crushing chest pain) and high blood pressure, such as bepridil and nisoldipine;
cisapride, a medicine used in certain gastrointestinal disorders;
Some of the drugs used to lower blood cholesterol, such as simvastatin and lovastatin, and atorvastatin;
midazolam and triazolam (drugs used for anxiety and insomnia);
certain drugs used for treatment of heart rhythm disorders, particularly quinidine and dofetilide;
pimozide and sertindole, drugs that are used in psychotic disorders;
levatsetilmetadol - a medicine used for the treatment of opioid dependence;
ergot alkaloids such as ergotamine and dihydroergotamine, used for treating migraine;
ergot alkaloids such as ergometrine (ergonovine) and methylergometrine (methylergonovine), used to control bleeding and maintain uterine contraction after child birth;
eletriptan (medicine for the treatment of migraine).
Take special care with Sporanox
Always tell your doctor or pharmacist if you are taking any other medicines, as co-administration of some of them can be harmful;
Tell your doctor if you know you have liver problems. You may need a dose adjustment of Sporanox oral solution.
Stop taking ORUNGAL and contact her doctor immediately if any of the symptoms listed below occur during treatment with Sporanox:
loss of appetite;
nausea;
vomiting;
fatigue;
abdominal pain and very dark urine.
If you need to take Sporanox oral solution continuously for a period longer than one month, the doctor may order the conduct of routine blood tests. The reason for this is to turn off / open timely onset of liver damage, such as may occur very rarely.
Tell your doctor if you suffer from heart disease. If your doctor prescribed Sporanox oral solution should describe your symptoms, the occurrence of which to monitor. Visit your doctor immediately if you notice shortness of breath, sudden weight gain, swelling of the legs or abdomen, unaccustomed for you fatigue, shortness of breath or waking up during the night;
Tell your doctor if you suffer from kidney disease. You have to change the dose of Sporanox oral solution;
Should also inform their doctor if during treatment with Sporanox oral solution have unusual sensation of tingling, numbness or weakness in the arms or legs;
If you have previously had an allergic reaction to any antifungal drug, tell your your doctor;
If you suffer from cystic fibrosis, your doctor may stop treatment with Sporanox oral solution in case that does not respond to it;
Stop taking ORUNGAL and tell your doctor immediately if you experience any symptoms of hearing loss. In very rare cases, patients taking Sporanox oral solution have reported temporary or permanent hearing loss.
Taking other medicines
Be sure to tell your doctor or pharmacist about all the medicines you are taking at the moment. Some medicines should not be taken during treatment with Sporanox oral solution, but if nevertheless accepted such, it must be made certain adjustments (ie. Dosage).

Examples of medicinal products, which in any case should not be taken during treatment with Sporanox oral solution:
some allergy medications, namely terfenadine, astemizole and mizolastine;
some drugs for the treatment of angina pectoris or high blood pressure, namely bepridil and nisoldipine;
cisapride, a medicine used in certain gastrointestinal disorders;
Some of the drugs used to lower blood cholesterol, such as simvastatin and lovastatin, and atorvastatin;
midazolam and triazolam (drugs used for insomnia and anxiety);
some drugs used for the treatment of cardiac arrhythmias, such as quinidine and dofetilide;
pimozide and sertindole, drugs that are used in psychotic disorders;
levatsetilmetadol, a medicine used in the treatment of drug dependency;
ergot alkaloids such as ergotamine and dihydroergotamine, used for treating migraine;
ergot alkaloids such as ergometrine (ergonovine) and methylergometrine (methylergonovine) used to control blood loss and maintaining the contractions of the uterus after childbirth;
eletriptan medicament for the treatment of migraine.
Some medicines can weaken the effect of Sporanox oral solution greatly. This applies to those that are used for the treatment of epilepsy (e. Carbamazepine, phenytoin and phenobarbital) and tuberculosis (eg. Rifampicin, rifabutin and isoniazid). Therefore, always tell your doctor if you are taking any of these medications to be taken in.

Combining with some other medicines may need to change your dose of ORUNGAL oral solution or the other medicine.
Examples include:
certain antibiotics, such as clarithromycin, erythromycin, rifabutin;
some medicines affecting the heart and blood vessels (digoxin, disopyramide and some of the so-called calcium antagonists, cilostazol);
medications to slow the blood clotting such as warfarin;
methylprednisolone, budesonide, fluticasone and dexamethasone, drugs administered orally, by injection or by inhalation for the treatment of inflammatory diseases, asthma and allergies;
cyclosporin A, tacrolimus and rapamycin (also known as sirolimus), which are normally administered to patients after organ transplantation;
some protease inhibitors used in the treatment of AIDS;
certain drugs used in the treatment of cancers (busulfan, docetaxel, trimetrexate, vinca alkaloids);
some medicines used in state of restlessness or helping you sleep (tranquillizers), as buspirone, alprazolam, midazolam and brotizolam;
ebastine, a medicament for treatment of allergy;
reboxetine, a drug to treat depression;
atorvastatin, a drug for lowering cholesterol;
eletriptan, a drug for the treatment of migraine;
halofantrine, a medicament for treatment of malaria;
fentanyl potent drug for the treatment of pain;
repaglinide, a medicine for treating diabetes.
Please tell your doctor if you use one of those drugs.

Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription.

Taking Sporanox with food and drink
Take Sporanox oral solution always fasting since in this way is absorbed very well by the body.
It is desirable to eat and to drink fluids one hour after taking Sporanox oral solution.

Children and the elderly
ORUNGAL oral solution should not be used by children and the elderly, but exceptionally doctor can prescribe it.

Pregnancy and lactation
If you are pregnant, do not use Sporanox oral solution.
If you are of childbearing age and could become pregnant during treatment with Sporanox oral solution should use reliable means of birth control. As Sporanox oral solution remains in the body for some time after you stop taking it, you should continue using contraception until your next period after termination of treatment.
If you are breastfeeding and you are starting treatment with Sporanox oral solution, consult your doctor, as small amounts of the drug can penetrate into human milk.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Sporanox can sometimes cause dizziness. If you feel dizzy, do not drive or operate machinery.

Important information about some of the ingredients of ORUNGAL
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3. HOW TO TAKE Sporanox
Always take Sporanox exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

The usual dose is:
For treatment of fungal infections in the mouth, throat or esophagus:
2 measuring cups Sporanox oral solution per day, taken in one or two doses, for one week.
If necessary, your doctor may decide to double the dose or prolong the treatment.
It is desirable to be izzhaburite with the solution, and hold it down to 20 seconds in your mouth before you swallow without rinsing it.

For the prevention of fungal infections:
0.5 ml of ORUNGAL oral solution per kilogram of body weight per day, divided into two doses. The doctor will tell you exactly how much this means to you.

Instructions for opening the container
The bottle is manufactured with child-resistant closure, which is opened in the following manner:
Push the plastic screw cap down and at the same time turn it counterclockwise.

If you take more dose of ORUNGAL
In case of overdose of Sporanox oral solution is advisable to call your doctor immediately. He (she) will do what is necessary.

Information for doctor in case of overdose
In case of accidental overdose should take supportive measures. In the first hour after ingestion of the drug may be gastric lavage. If deemed necessary may be given activated charcoal. Itraconazole can not be eliminated by dialysis. And there is no specific antidote.

If you forget to take ORUNGAL
Do not take a double dose to make up for a missed dose of Sporanox oral solution.

If you stop taking ORUNGAL
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sporanox oral solution can cause side effects, although not everybody gets them.

Can be observed serious allergic reactions. Immediately stop taking Sporanox and contact your doctor if you:
sudden onset of wheezing, shortness of breath, difficulty breathing, facial swelling, rash, itching (especially if it affects the entire body) or severe skin disorder that involves widespread rash with peeling skin and blisters in the mouth, eyes and genitals, or rashes small pustules or blisters;
pronounced loss of appetite, nausea, vomiting, unusual tiredness, abdominal (stomach) pain, unusually dark urine and pale stools. These may be symptoms of severe liver damage.
It is also important to tell your doctor immediately if you develop any of the following symptoms:
symptoms of heart failure, such as shortness of breath, sudden weight gain, swelling in the legs, unusual tiredness, frequent awakenings during the night;
tingling sensation, sensitivity to light, tingling or weakness in the limbs;
blurred vision / double vision, ringing in the ears, loss of ability to control urination or frequent urination;
Symptoms of hearing loss.
It is possible for the following side effects:
Common (occurs in less than 1 in 10 patients):
headache;
stomach pain, nausea, vomiting, diarrhea, unpleasant taste;
elevation of liver specific functional tests (elevated liver enzymes);
rash;
fever or high temperature.
Uncommon (occurs in less than 1 in 100 patients):
certain blood disorders, which may increase the risk of bleeding, bruising or infection;
muscle weakness (possible symptom of low levels of potassium in the blood);
dizziness;
indigestion, constipation;
inflammation of the liver (hepatitis), yellowing of the skin (jaundice);
itching;
general swelling.
Very rare or not known:
elevated triglycerides in the blood;
hair loss;
aching muscles and joints;
menstrual irregularities;
erectile dysfunction;
severe pain in the upper abdomen, often with nausea and vomiting due to inflammation of the pancreas (pancreatitis).