ORUNGAL 100 mg. 4 capsules JANSSEN CILAG
ORUNGAL 100 mg. 4 capsules JANSSEN - CILAG
What is ORUNGAL capsules and what it is used
ORUNGAL is a drug for the treatment of fungal infections of the vagina, skin, mouth, eye, nail, or internal organs.
2 What you should know before taking ORUNGAL capsules
Do not take ORUNGAL capsules:
if you are allergic to itraconazole or any of the other ingredients of this medicine (listed in Section 6);
if you are pregnant (except in the event that your doctor knows you are pregnant and decide that you need ORUNGAL capsules);
if you are of childbearing age and you can get pregnant, you should take adequate contraceptive precautions to ensure that you will not become pregnant while taking your medicine. As ORUNGAL capsules 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 ORUNGAL capsules;
if you suffer from a medical condition called heart failure (also known as congestive heart failure or CHF), ORUNGAL capsules may get worse. If your doctor decides that you need treatment with ORUNGAL capsules, even in the presence of this condition necessarily seek immediate medical attention if you experience shortness of breath, sudden weight gain, swelling of the legs, unusual tiredness or start wake up at night;
Also, do not use other drugs if you are currently being treated with ORUNGAL capsules. There are many drugs that interact with ORUNGAL capsules. See section "Warnings and Precautions" point "other drugs."
Warnings and Precautions
Talk to your doctor or pharmacist before taking ORUNGAL capsules:
Always tell your doctor or pharmacist if you are taking any other medicines, since concomitant use of some of them can be harmful;
Tell your doctor if you know you have a problem with your liver. You may need a dose adjustment of ORUNGAL capsules;
Stop taking ORUNGAL capsules and see your doctor immediately if any of the following symptoms occur during treatment with ORUNGAL capsules: lack of appetite, nausea, vomiting, fatigue, abdominal pain, yellowing of skin or eyes feces bright or very dark urine. If you need to take ORUNGAL capsules, your doctor may also require you to regularly examine your blood picture. The reason for this is the exclusion of liver damage in a timely manner because such injuries, though rare, may occur in connection with the treatment;
Tell your doctor if you have heart problem. Visit or known your doctor immediately if you experience shortness of breath, sudden weight gain, swelling of the legs, unusual tiredness or start to wake up at night, as this could be symptoms of heart failure;
Tell your doctor if you have kidney damage. You may need a dose adjustment of ORUNGAL capsules;
Tell your doctor or get medical help immediately if you experience a severe allergic reaction (characterized by significant skin rash, itching, hives, difficulty breathing, and / or swelling of the face) while taking ORUNGAL capsules;
Stop taking ORUNGAL capsules and tell your doctor immediately if you develop sensitivity to sunlight;
Stop taking ORUNGAL capsules and tell your doctor immediately if you experience severe skin disorders such as widespread rash with peeling skin and blisters in the mouth, eyes and genitals or rash with small pustules or blisters;
Stop taking ORUNGAL capsules and tell your doctor immediately if you experience numbness, loss of sensation or weakness in the limbs or other problems with the nerves in the arms or legs;
If you have previously had an allergic reaction to another antifungal agent, please discuss this with your doctor;
Tell your doctor if you have neutropenia, AIDS, or have a patient with a transplanted organ. This may require dose adjustment of ORUNGAL capsules;
Stop taking ORUNGAL capsules and tell your doctor immediately if you experience any symptoms of hearing loss. In very rare cases, patients taking ORUNGAL capsules have reported temporary or permanent hearing loss;
Tell your doctor if your vision becomes blurred or double if you hear a noise in the ears, if you lose your ability to control your urine or urinating more than usual.
Other medicines and ORUNGAL capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
There are medicines that should not be combined with ORUNGAL capsules or if other drugs are taken at the same time need to adjust the dose.
Drugs that should never be taken while on ORUNGAL capsules, for example:
certain allergy medications: terfenadine, astemizole, mizolastine;
certain medicines used to treat angina (chest pain) or high blood pressure: bepridil, felodipine, nisoldipine, lercanidipine, ivabradine, ranolazine, eplerenone;
cisapride - a medicine used for certain digestive problems;
certain drugs that lower blood cholesterol: simvastatin, lovastatin;
certain sleeping medications: midazolam (oral), triazolam;
certain drugs for psychotic disorders: lurazidon, pimozide, sertindole;
colchicine - a medicament for the treatment of gout, when used in patients with renal or hepatic impairment;
certain drugs against pain or the treatment of addiction - levatsetilmetadol (levomethadyl), methadone;
halofantrine - a medicament for the treatment of malaria;
irinotecan - a medicament for the treatment of tumors;
drugs called ergot alkaloids: dihydroergotamine, ergotamine, and used for the treatment of migraine headaches;
medicines called ergot alkaloids ergometrine (ergonovine) or methylergometrine (methylergonovine) used to control bleeding and maintain uterine contraction after child birth;
certain medicines used to treat irregular rhythm of the heart: disopyramide, dronedarone, quinidine, dofetilide.
Wait at least 2 weeks after treatment with ORUNGAL capsules before you start taking any of these medicines.
Drugs that weaken the effects of ORUNGAL capsules:
drugs for the treatment of epilepsy - carbamazepine, phenytoin, phenobarbital;
medicines to treat tuberculosis - rifampicin, rifabutin, isoniazid;
drugs for the treatment of HIV / AIDS: efavirenz, nevirapine.
Therefore you should always tell your doctor if you use any of these medicines, so that appropriate measures be taken.
Wait at least 2 weeks after taking these drugs before taking ORUNGAL capsules.
Drugs whose intake is not recommended unless your doctor finds it necessary, such as:
certain drugs for the treatment of cancer, namely, dasatinib, nilotinib, trabectedin;
aliskiren - a medicament for the treatment of hypertension;
rifabutin - a medicament for the treatment of tuberculosis;
Carbamazepine - a medicament for treating epilepsy;
colchicine - a medicine for gout;
Everolimus - a medicine used after organ transplantation;
fentanyl - strong medicine for pain;
rivaroxaban - drug retarding coagulation;
salmeterol - a medicament for the improvement of breathing;
tamsulosin - a medicament for the treatment of urinary incontinence in women;
vardenafil - a medicament for the treatment of erectile dysfunction.
Wait at least 2 weeks after treatment with ORUNGAL capsules before you start taking any of these medicines unless your doctor thinks it is necessary to take them.
Medicines that may require a change in dose (or ORUNGAL capsules or other drug), for example:
certain antibiotics, ciprofloxacin, clarithromycin, erythromycin;
some drugs acting on the heart or blood vessels: digoxin, nadolol, some calcium channel blockers including verapamil;
medications that slow blood clotting: coumarins, cilostazol, dabigatran;
methylprednisolone, budesonide, ciclesonide, fluticasone or dexamethasone (drugs administered orally, by injection or inhalation, in conditions such as inflammation, asthma, and allergies);
cyclosporine, tacrolimus, rapamycin or temsirolimus (also known as sirolimus), which are usually given after an organ transplant;
certain drugs used to treat HIV / AIDS: maraviroc, and protease inhibitors indinavir, ritonavir, darunavir boosted with ritonavir, fosamprenavir boosted with ritonavir, saquinavir;
certain drugs used for treatment of cancer, bortezomib, busulfan, docetaxel, erlotinib, ixabepilone, lapatinib, trimetrexate, vinca alkaloids;
certain medicines for anxiety or to help you sleep (tranquillizers): buspirone, perospirone, ramelteon, midazolam iv, alprazolam, brotizolam;
certain potent drugs for the treatment of pain - alfentanil, buprenorphine, oxycodone;
certain drugs for the treatment of diabetes - repaglinide, saxagliptin;
some drugs for treating psychosis - aripiprazole, haloperidol, quetiapine, risperidone;
certain drugs for the treatment of nausea and vomiting - aprepitant domperidone;
certain medicines to control irritable bladder - fesoterodine imidafenatsin, solifenacin, tolterodine;
certain medications for treatment of erectile dysfunction - sildenafil, tadalafil;
praziquantel - medicine against parasites and tapeworms;
ebastine, against drug allergy;
reboxetine, a drug used to treat depression;
atorvastatin, a drug used to lower cholesterol level;
meloxicam - a medicament for the treatment of joint inflammation, and pain;
cinacalcet - a medicament for the treatment of overactive parathyroid glands;
certain drugs for the treatment of low blood sodium - mozavaptan, tolvaptan;
alitretinoin (oral form) - a medicine for the treatment of eczema;
eletriptan, a medicine used to treat migraine headaches.
If you use any of these medications, please discuss this with your doctor.
To ensure complete resorption ORUNGAL capsules of the body must have enough gastric acid. Therefore, drugs that neutralize stomach acid should be taken at least one hour before or ORUNGAL capsules should not be taken less than two hours after taking ORUNGAL capsules. For the same reason, if you are taking medicines that stop the formation of stomach acid, you should take your capsules ORUNGAL capsules drink as nedietichna car. If you are not sure, ask your doctor or pharmacist.
ORUNGAL capsules with food, beverages and alcohol
See. section 3 "How to take ORUNGAL capsules."
Pregnancy, lactation and fertility
Do not use ORUNGAL capsules if you are pregnant.
If you are of childbearing age can become pregnant, you should take adequate contraceptive precautions to ensure that you will not become pregnant while taking your medicine. As ORUNGAL capsules remains in the body for some time after you stop taking it, you should continue to use some form of contraception until the start of the next menstrual cycle after you have completed treatment with ORUNGAL capsules.
If you are breastfeeding, talk to your doctor before taking ORUNGAL capsules; in your milk can be present trace amounts ORUNGAL capsule. Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
ORUNGAL can sometimes cause dizziness, blurred / double vision or hearing loss. If you have these symptoms, do not drive or operate machinery.
ORUNGAL capsules contain sucrose.
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 ORUNGAL capsules
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
You should always take ORUNGAL capsules immediately after meals, as well he accepted very well by the body. Swallow capsule with some water. How ORUNGAL capsules you need and the length of time depends on the type of fungus and the site of infection. What to do, you will be told by your doctor.
The following doses are used most frequently:
Type of infection CAPSULES PER DAY PERIOD OF TIME
Vaginal infection 2 capsules twice daily
2 capsules once daily 1 day
Skin infection 2 capsules once daily
1 capsule once a day 7 days
If you are affected palms of your hands or feet, you may need two capsules twice daily for 7 days or 1 capsule once a day for 1 month.
Infection of the mouth one capsule once a day
Eye infection 2 capsules once daily
Infection of viscera 1 to 4 capsules per day for long periods
Nail infection: Depending on your personal needs, your doctor will choose either continuous or cyclic therapy.
Prolonged therapy in affecting the toenails 2 capsules once daily
Cyclical therapy for severe nail 2 capsules twice a day one week
Then stop taking ORUNGAL capsules for three weeks. The cycle then repeats once for infections of the nails of the hands and double infections of the nails of the feet (with or without infection of the fingernails) (see table below).
sweep second kap-
No bid ORUNGAL capsules Vze-
sweep second kap-
STOP times a day
's king, of
with or without nok-
ments of ratse-
sweep second kap-
Suli BID Without ORUNGAL capsules Vze-
sweep second kap-
Suli BID Without ORUNGAL capsules
sweep second kap-
In skin infections lesions disappear completely just a few weeks after treatment. This is typical of fungal plaques: the drug kills the fungus itself, but the lesion disappears along with the growth of healthy skin.
Nail lesions disappear only 6 to 9 months after treatment because the drug only kills the fungus. Nails need further growth after treatment, and it takes many months. Therefore, do not worry if you do not notice any improvement during treatment, the drug remains in your nail for a few months and exerts its action. Therefore, you should discontinue the treatment as prescribed by your doctor, even if you do not see any improvement.
Infections of internal organs: may require higher doses for longer periods.
Always stick to your doctor's instructions, which can adapt the treatment to your personal needs.
If you take more than the amount of ORUNGAL capsules
We encourage you to contact your doctor immediately if you take too much ORUNGAL capsules. He / she will take the necessary measures.
Information for the doctor in case of overdose:
In the event of a sudden overdose should implement support measures.
May be given activated charcoal, if it deems appropriate. Itraconazole can not be removed by dialysis. There is no specific antidote.
If you forget to take ORUNGAL capsules
Do not take a double dose to make up for a missed dose of ORUNGAL capsules.
If you stop taking ORUNGAL capsules
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following symptoms may occur: upset stomach, nausea, vomiting, diarrhea, abdominal pain, constipation or flatulence. Shortness of breath, coughing, fluid in the lungs, voice changes, inflammation of the sinus, nasal inflammation, infection of the upper respiratory tract infection, headache, menstrual disorders, erectile dysfunction, dizziness, confusion, tremor, insomnia, fatigue, fever, muscle weakness or pain, painful joints, pain; chest pain, edema, generalized edema, inflammation of the pancreas, an unpleasant taste.