ITRAZIL

Itrazile 100 mg capsules
Itraconazole

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