{"id":12773,"date":"2023-06-01T14:12:47","date_gmt":"2023-06-01T10:12:47","guid":{"rendered":"https:\/\/newpharma.ge\/pharma_products\/%e1%83%98%e1%83%a2%e1%83%a0%e1%83%90%e1%83%96%e1%83%98%e1%83%9a%e1%83%98\/"},"modified":"2024-09-30T16:36:14","modified_gmt":"2024-09-30T12:36:14","slug":"%e1%83%98%e1%83%a2%e1%83%a0%e1%83%90%e1%83%96%e1%83%98%e1%83%9a%e1%83%98","status":"publish","type":"product","link":"https:\/\/newpharma.ge\/en\/pharma_products\/%e1%83%98%e1%83%a2%e1%83%a0%e1%83%90%e1%83%96%e1%83%98%e1%83%9a%e1%83%98\/","title":{"rendered":"ITRAZIL"},"content":{"rendered":"

Itrazile <\/strong>100 mg capsules
\nItraconazole<\/p>\n

Read all of this leaflet carefully before you start taking this medicine because it contains
\nimportant information for you.
\n\u2212 Keep this leaflet. You may need to read it again.
\n\u2212 If you have any further questions, ask your doctor or pharmacist or nurse.
\n\u2212 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,even if their
\nsigns of illness are the same as yours.
\n\u2212 If you get any side effects talk to your doctor or pharmacist or nurse.. This includes any possible side
\neffects not listed in this leaflet. See section 4.
\nWhat is in this leaflet:
\n1. What Itrazile100 mg is and what it is used for
\n2. What you need to know before you take Itrazile100 mg
\n3. How to take Itrazile100 mg
\n4. Possible side effects
\n5. How to store Itrazile100 mg
\n6. Contents of the pack and other information
\n1. What Itrazile100 mg is and what it is used for
\n\u2212 Gynecological disorders: vulvovaginal candidiasis;
\n\u2212 Dermatological and ophthalmological diseases: pityriasis versicolor, dermatomycosis, fungal keratitis and oral
\ncandidiasis, onychomycosis caused by dermatophytes and yeasts;
\n\u2212 Mycoses Systemic: aspergillosis and candidiasis systemic, cryptococcosis (including Cryptococcus
\nmeningitis), histoplasmosis, sporotrichoze, paracoccidioidomycosis, blastomycosis and other systemic or
\ntropical mycoses rare.
\n2. What you need to know before you take Itrazile100 mg
\nDo not take Itraconazole capsules if:
\n\u2212 you are allergic (hypersensitive) to itraconazole or any of the other ingredients of this medicine (listed in
\nsection 6);
\n\u2212 you are pregnant, unless your doctor has told you to use it (see \u2018Pregnancy,breast-feeding and fertility\u2019
\nbelow);
\n\u2212 If you are on childbearing age and you become pregnant, you must take appropriate contraception to ensure
\nthat you do not become pregnant while taking this medicine;
\n\u2212 Because Itraconazole Slavia 100 mg remains in the organism for a period of time after stopping treatment,
\nyou should continue to use contraceptive measures until the next menstrual cycle after the end of the
\ntratment with Itraconazole Slavia 100 mg;
\n\u2212 If you have a medical condition called heart failure (also called congestive heart failure), Itrazile100 mg
\nmay make it worse. If your doctor decides that you should take Itraconazole Slavia 100 mg even if you
\nhave this condition, make sure you immediately contact for medical advice if you experience difficulty in
\nbreathing, sudden weight gain, swelling of the limbs, unusual tiredness or awakening of sleep during the
\nnight.
\nDo not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist
\nbefore using Itrazile100 mg.
\nAlso, do not use certain medicines if you take Itraconazole Slavia 100 mg. Many drugs interact with Itraconazole
\nSlavia 100 mg. Please read the section \u201e What you need to know before using Itraconazole Slavia 100mg\u201d, the sub\u0002section \u201e Itraconazole Slavia 100 mg with other medicines\u201d.
\nWarnings and precautions
\nBefore you take Itraconazole Slava 100 mg, ask your doctor or pharmacist if you are taking any other medicines
\nbecause the concomitant administration of some medicines can harm.
\n\u2212 Tell your doctor if you have ever had liver problems. Your dose of Itrazile100 mg may have to be changed.
\n\u2212 If after taking this medicine you have a severe lack of appetite, feel sick (nausea), are sick (vomiting), feel
\nunusually tired, get stomach pain, yellowing of the skin or whites of the eyes, unusually dark urine, pale
\nstools (bowel movements), stop taking Itrazileand tell your doctor straight away. If you have to take
\nItraconazole Slavia 100 mg, your doctor may require regular blood tests. The reason for this check is to
\nhighlight the liver disease in a timely manner, since these conditions occur very rarely.
\n\u2212 Tell your doctor if you have heart problems. Tell your doctor straight away if you get shortness of breath,
\nunexpected weight gain, swelling of your limbs, feel unusually tired or wake up at night. These may be
\nsigns of heart failure.
\n\u2212 Tell your doctor if you have ever had kidney problems. Your dose of Itrazile100 mg may have to be
\nchanged.
\n\u2212 Tell your doctor immediately or contact a health care professional if you have a severe allergic reaction
\n(characterized by significant transient eruption, itching, urticaria, difficulty in breathing, and \/ or swelling
\nof the face) while taking Itraconazole Slavia 100 mg.
\n\u2212 Do not take Itrazile100 mg and contact your doctor immediately if you become sensitive to light.
\n\u2212 Do not take Itrazile100 mg and contact your doctor immediately if you experience severe skin conditions
\nsuch as rash, peeling of the skin and blistering of the mouth, eye or genital area or rash with small pustules
\nor vesicles.
\n\u2212 Do not take Itraconazole Slavia 100 mg and tell your doctor immediately if you experience any tingling
\nsensation, diminished sensitivity or weakness in the limbs or other problems in the nerves of the hands or
\nfeet.
\n\u2212 If you have previously experienced an allergic reaction to another antifungal medicine, please tell your
\ndoctor.
\n\u2212 Tell your doctor if you are a patient with neutropenia, AIDS or organ transplant. The dose of Itraconazole
\nSlavia 100 mg can be adjusted.
\n\u2212 Do not take Itraconazole Slavia 100 mg and contact your doctor immediately if you experience symptoms
\nof hearing loss. In very rare cases, patients taking itraconazole reported temporary or permanent hearing
\nloss.
\n\u2212 Tell your doctor if your vision is blurred, or if you see double, you hear ringing in the ears, lose control of
\nthe urine or urinate more often than usual.
\nOther medicines and Itrazile100 mg :
\nTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including
\nmedicines that you buy without a prescription. In particular, certain medicines should not be taken at the same time,
\nand if are taken at the same time, some changes (e.g., dose changes) should be made.
\nMedicines that should not be taken while you are taking Itraconazole Slavia 100 mg, such as:
\n\u2022 Medicines for hay fever or allergy: terfenadine, astemizole or mizolastine;
\n\u2022 Medicines used to treat angina (crushing chest pain) and high blood pressure: bepridil, felodipine,
\nnisoldipine, lercanidipine, ivabradine, ranolazine, eplerenone;
\n\u2022 Cisapride – for digestive problems;
\n\u2022 Medicines to lower cholesterol called simvastatine, lovastatine;
\n\u2022 Midazolam (by mouth) or triazolam – to help you sleep;
\n\u2022 Medicines used for psychiatric disorders: lurasidone, pimozide, sertindole;
\n\u2022 Colchicine, a medicine for the treatment of gout, when used in patients with renal or hepatic impairment;
\n\u2022 Medicines for the treatment of severe pain or for addiction management: levacetylmetadol (levometadil),
\nmethadone;
\n\u2022 Halofantrine, a medicine for the treatment of malaria;
\n\u2022 Irinotecan, a medicine for the treatment of cancer;
\n\u2022 Medicines for migraine headaches called dihydroergotamine and ergotamine;
\n\u2022 Ergometrine (ergonovine) and methylergometrine (methylergonovine) \u2013 used to control bleeding and
\nmaintain uterine contraction after childbirth;
\n\u2022 Some medicines to treat the irregular heartbeat: disopyramide, dronedarone, quinidine and dofetilide.
\nWait at least 2 weeks after stopping treatment with Itrazile100 mg before taking any of these medicines.
\nMedicines that may decrease the effect of Itrazile100 mg such as:
\n\u2022 Medicines for epilepsy called phenytoin, carbamazepine or phenobarbital;
\n\u2022 Medicines for tuberculosis called rifampicin, rifabutin or isoniazid;
\n\u2022 Medicines for HIV\/AIDS: efavirenz, nevirapine.
\nTherefore, always tell your doctor if you are using any of these medicines to take the appropriate measures.
\nWait at least 2 weeks after stopping treatment with any of these medicines before taking Itrazile100 mg.
\nMedicines that are not recommended, unless the physician considers them necessary, such as:
\n\u2022 Some medicines used in the treatment of cancer, such as: dasatinib, nilotinib, trabectedin;
\n\u2022 Aliskiren, a medicine for the treatment of hypertension;
\n\u2022 Rifabutin, a medicine used for the treatment of tuberculosis;
\n\u2022 Carbamazepine, a medicine used for treatment of epilepsy;
\n\u2022 Colchicine, a medicine for the treatment of gout;
\n\u2022 Everolimus, a medicine that is given after organ transplantation;
\n\u2022 Fentanyl, strong medicine used for pain;
\n\u2022 Rivaroxaban, a medicine that slows blood clotting;
\n\u2022 Salmeterol, a medicine to improve breathing;
\n\u2022 Tamsulosin, a medicine used to treat urinary incontinence in men;
\n\u2022 Vardenafil, a medicine used to treat erectile dysfunction.
\nWait at least 2 weeks after you discontinue treatment with Itraconazole Slavia 100 mg before starting treatment with
\nthese medicines, unless your doctor thinks it necessary to take it.
\nMedicines that may require dose adjustment (either for Itrazile100 mg or for other medicines), such as:
\n\u2022 Some medicines: ciprofloxacin, clarithromycin, erythromycin;
\n\u2022 Medicines that act on the heart and blood vessels called digoxin , nadolol, some \u2018calcium channel-blockers\u2019
\n, including verapamil;
\n\u2022 Medicines that slow blood clotting: coumarins, cilostazol, dabigatran;
\n\u2022 Methylprednisolone, budesonide, ciclesonide, fluticasone or dexamethasone (oral administration, by
\ninjection or inhalation for diseases such as inflammation, asthma bronchial disorders or allergies);
\n\u2022 cyclosporine, tacrolimus, temsirolimus or rapamycin (also called sirolimus), which is usually administered
\nafter organ transplantation;
\n\u2022 Some medicines used to treat HIV \/ AIDS: maraviroc and protease inhibitors: indinavir, ritonavir,
\ndarunavir potentiated with ritonavir, fosamprenavir potentiated with Ritonavir, saquinavir;
\n\u2022 Some medicines used to treat cancer: bortezomib, busulfan, docetaxel, erlotinib, ixabepilone, lapatinib,
\ntrimetrexate, vinca alkaloids;
\n\u2022 Some anxiety medications or to help you sleep (tranquilizers): Buspirone, perospiron, ramelteon,
\nmidazolam administered intravenously, alprazolam, brotizolam;
\n\u2022 Some powerful medicines for the treatment of pain: alfentanil, buprenorphine, oxycodone;
\n\u2022 Some medicines for the treatment of diabetes: repaglinide, saxagliptin;
\n\u2022 Some medicines for the treatment of psychosis: aripiprazole, haloperidol, quetiapine, risperidone;
\n\u2022 Some medicines for the treatment of nausea and vomiting: aprepitant, domperidone;
\n\u2022 Some medicines for the treatment of irritable (overactive) bladder control: Fesoterodine, imidafenacin,
\nsolifenacin, tolterodine;
\n\u2022 Some medicines for the treatment of erectile dysfunction: sildenafil, tadalafil;
\n\u2022 Praziquantel , a medicine used against fluffy worms and tapeworms;
\n\u2022 Ebastine, a medicine for allergy;
\n\u2022 Reboxetine, a medicine used to treat depression;
\n\u2022 Atorvastatin, a medicine used to lower cholesterol;
\n\u2022 Meloxicam, a medicine for the treatment of joint and pain inflammation;
\n\u2022 Cinacalcet, a medicine to treat overactive parathyroid;
\n\u2022 Some medicines to treat low blood sodium: mozavaptan, tolvaptan;
\n\u2022 alitretinoin (oral administration), a medicine for the treatment of eczema;
\n\u2022 Eletriptan, a medicine used to treat migraine.
\nIf you are using any of these medicines, please talk to your doctor.
\nIf you are not sure, talk to your doctor or pharmacist.
\nPregnancy, breastfeeding and fertility:
\nIf you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor
\nor pharmacist for advice before taking any medicine.
\nDo not use Itrazile100 mg during pregnancy.
\nIf you are of childbearing potential and are planning to become pregnant, you must take appropriate contraception
\nmeasures to ensure that you do not become pregnant while taking this medicine. Since Itrazile100 mg remains in
\nthe organism for a period of time after stopping treatment, you must continue to use a contraceptive method until
\nthe next menstrual cycle (menstrual bleeding) after completing treatment with Itrazile100 mg.
\nBreastfeeding
\nIf you are breast-feeding, talk to your doctor before taking Itrazile100 mg; a very small amount of Itrazile100 mg is
\nexcreted in the human milk.
\nDriving and using machines
\nItrazile100 mg may occasionally cause dizziness, blurred vision \/ double vision or loss of hearing. If you have these
\nsymptoms, do not drive or use vehicles or machines.
\nImportant information about some of the ingredients of Itraconazol Slavia
\nItrazilecontains sugar. If you have been told by your doctor that you have an intolerance to some sugars, please ask
\nbefore taking this medicine.
\nItrazilecontains Sunset Yellow FCF (E 110), Ponceau 4R (E 124), methyl parahydroxybenzoate and propyl
\nparahydroxybenzoate. These can cause allergic reactions, even delayed.
\n3. How to take Itrazile100 mg
\nAlways use this medicine as your doctor tells you. If you are nor sure, talk to your doctor or pharmacist.
\nAdministration mode of Itrazile100 mg
\nAlways take Itrazile100 mg immediately after a meal, because this helps your body use this medicine.
\nSwallow whole capsules with a small amount of water.
\nTo ensure proper absorption of medicine in the body, stomach acidity should be sufficient. For this reason, drugs
\nthat neutralize gastric acid should not be taken at least 1 hour before taking Itrazile100 mg or should not be taken
\nmore than 2 hours after administration. For the same reason, if you use medicines that stop acid production in the
\nstomach, you should take Itrazile100 mg with a non- diet cola- type drink.
\nHow much Itrazile100 mg should take and for how long it depends on the type of fungus and the site of the infection.
\nYour doctor will tell you what to do.
\nDosage
\nVaginal candidiasis
\n2 capsules \/ day – one day
\nDermatomycoses
\nThe dose depends on your infection. Your doctor will tell you how to take this medicine:
\n1 capsule \/ day for 15 days or
\nTinea palmaris
\n1 capsule\/day for 30 days
\nPityriasis versicolor
\n2 capsules\/day for 7 days
\nTinea corporis, tinea cruris
\n1 capsule\/day for 15 days
\nor 2 capsule – for 7 days
\nOropharyngeal candidiasis
\n1 capsule\/day for 15 days
\nNail mycosis
\n2 capsules \/ day for 3 months.
\nAspergillosis, Cryptococcosis, Histoplasmosis, Prophylaxis in Neutropenia, associated with AIDS Treatment
\n2 capsules \/ day. The duration of treatment will be determined by the physician based on the response to the
\ntreatment.
\nUse in children and the elderly
\nBecause data on the use of itraconazole in the elderly or children are limited, use of itraconazole in these categories
\nof patients is only recommended if the potential benefits outweigh the risks (see section 4.4).
\nUse in patients with renal impairment
\nA dose adjustment by the physician may be considered.
\nIf you take more Itrazile100 mg than you should
\nIf you take more Itrazile100 mg than recommended, consult your doctor immediately or go to the emergency room
\nof the nearest hospital.
\nInformation for the physician in case of overdose
\nIn the event of an accidental overdose, supportive measures should be instituted.
\nActivated charcoal may be considered. Itraconazole can not be removed by hemodialysis. No specific antidote is
\navailable.
\nIf you forget to take Itraconazole capsules:
\nTake the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed
\ndose and continue your regular dosing schedule.
\nDo not take a double dose to make up for a forgotten dose.
\nIf you stop taking Itraconazole capsules
\nKeep taking Itraconazole capsules as long as your doctor has told you. Do not stop your treatment just because you
\nfeel better.
\nIf you have any further questions on the use of this medicine, ask your doctor or pharmacist.
\n4. Possible side effects
\nLike all medicines, this medicine can cause side effects, although not everybody gets them.
\nThe following side effects have been reported with itraconazole:
\nCommon (may affect up to 1 in 10 people)
\n\u2212 Headache;
\n\u2212 Stomach ache;
\n\u2212 Feeling sick (nausea).
\nUncommon (may affect up to 1 in 100 people)
\n\u2212 Inflammation of the sinuses;
\n\u2212 Inflammation of the nasal mucosa;
\n\u2212 Upper respiratory infections;
\n\u2212 Hypersensitivity reactions;
\n\u2212 Diarrhea;
\n\u2212 Constipation;
\n\u2212 Vomiting;
\n\u2212 Indigestion;
\n\u2212 Flatulence;
\n\u2212 Hepatic disorders;
\n\u2212 Rash;
\n\u2212 Rash with or without itching;
\n\u2212 Itching;
\n\u2212 Problems with periods.
\nRare (may affect up to 1 in 1000 people)
\n\u2212 Decrease of white blood cell;
\n\u2212 Serum sickness;
\n\u2212 Swelling of the face, hands and feet;
\n\u2212 Severe allergic reactions;
\n\u2212 High levels of triglycerides in the blood;
\n\u2212 Decrease in tactile sensitivity;
\n\u2212 Change in taste;
\n\u2212 Numbness or tingling in the hands and feet;
\n\u2212 Blurred vision and double vision;
\n\u2212 Hearing loss (may be permanent);
\n\u2212 Ringing in your ears;
\n\u2212 Poor heart activity;
\n\u2212 Difficulty breathing;
\n\u2212 Inflammation of the pancreas;
\n\u2212 Hepatotoxicity ;
\n\u2212 High levels of bilirubin in the blood;
\n\u2212 Severe skin reactions with ulceration, pain and blistering;
\n\u2212 Hair loss, Sensitivity of the skin to light;
\n\u2212 Urinate more often.
\nIf any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your
\ndoctor or pharmacist.
\nReporting of suspected adverse reactions
\nIf you experience any side effects talk to your doctor or pharmacist. These include any side effects not even
\nmentioned in this leaflet. You can report sid effects via the national reporting system, details of which are published
\non the National Agency for Medicines of Georgia.
\n5. How to store Itrazile100 mg
\nDo not use this medicine after the expiry date which is stated on the carton and blister, after EXP. The expiry date
\nrefers to the last day of that month.
\nStore below 25\u00b0C in the original package.
\nKeep this medicine out of the sight and reach of children.
\nDo not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
\nmedicines you no longer use. These measures will help protect the environment.
\n6. Contents of the pack and other information
\nWhat Itrazile100 mg contains:
\n\u2212 The active substance is itraconazole. Each capsule contains 100 mg of itraconazole.
\n\u2212 The other ingredients are:
\nCapsule contents: sugar spheres, Hypromellose type 2910 (6cP), copolymer butylat-methacrilat basic
\n(Eudragit E 100);
\nCapsule shell: titan dioxide (E 171), quinolone yellow (E 104), Sunset Yellow FCF (E 110), Brilliant Blue FCF (E
\n133), Ponceau 4R (E 124), , methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), Anhydrous
\ncolloidal silica, sodium lauryl sulfate, glacial acetic acid, glycerol, gelatin.
\nWhat Itrazile100 mg look like and contents of the pack:
\nBox with 3 blisters of PVC\/ Al of 5 capsules.
\nMarketing Authorisation Holder and manufacturer
\nMarketing Authorisation Holder
\nS.C. Slavia Pharm S.R.L.
\nB-dul Theodor Pallady nr. 44C, Sector 3 , Bucuresti, Romania<\/p>\n","protected":false},"excerpt":{"rendered":"

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