ITRAGERM 50 mg Hard Capsules

Зміст інструкції

1. Itragerm 50 mg hard capsules
   1. What is Itragerm and what is it used for
   2. What you need to know before you take Itragerm
   3. How to take Itragerm
   4. Possible side effects
   5. How to store Itragerm
   6. Contents of the pack and other information

Itragerm 50 mg hard capsules

Itraconazole

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1What Itragerm is and what it is used for
2What you need to know before you take Itragerm
3How to take Itragerm
4Possible side effects
5How to store Itragerm
6Contents of the pack and other information

1. What is Itragerm and what is it used for

Itragermbelongs to a group of medicines called systemic antifungals,
also called antifungalmedicines.

Itragermis used to treat fungal infections, including those caused by yeasts.
These infections can affect:

• the skin
• the nails

2. What you need to know before you take Itragerm

Do not take Itragerm if:

• you are allergic(hypersensitive)to itraconazole or any of the other ingredients of this medicine ( listed in section 6).
• you are pregnant, think you may be pregnant or might become pregnant (see the Pregnancy section)
• you suffer from a serious heart condition called heart failure (also called congestive heart failure or CHF) unless your doctor has told you to do so (see the "Warnings and precautions” section below)

Do not use this medicine if any of the above conditions apply to you. If in doubt, consult
your doctor or pharmacist before using Itragerm.
Before using Itragerm, tell your doctor if you are taking any other medicines.
Do not use Itragerm if you are taking any of the following medicines, or within 2 weeks
of stopping Itragerm.

Medicines used to treat heart, blood or circulation problems

• aliskiren, eplerenone, lercanidipine or nisoldipine (for high blood pressure)
• bepridil, ivabradine or ranolazine - (for angina)
• dabigatran or ticagrelor (for blood clots)
• disopyramide, dofetilide, dronedarone or quinidine (for irregular heart rhythms)
• finerenone (used to treat kidney problems in patients with type 2 diabetes)
• lomitapide, lovastatin or simvastatin (to reduce cholesterol)
• sildenafil (for pulmonary arterial hypertension) Medicines used to treat stomach problems or constipation
• cisapride (for stomach disorders)
• domperidone (for nausea and vomiting)
• naloxegol (for constipation caused by taking opioid pain relievers) Medicines for the treatment of headache, sleep or mental health problems
• dihydroergotamine or ergotamine (ergot alkaloids used for migraine)
• midazolam (taken by mouth) or triazolam (for sedation or to help you sleep)
• lurasidone, pimozide, quetiapine or sertindole (for schizophrenia, bipolar disorder or other mental health problems) Medicines to treat urinary problems
• darifenacin (for urinary incontinence)
• fesoterodine or solifenacin (for irritated bladder) when used in patients with some kidney or liver problems Medicines to treat allergies
• astemizole, mizolastine or terfenadine (for allergies) Medicines to treat erectile and ejaculation problems
• avanafil (for erectile dysfunction)
• dapoxetine (for premature ejaculation)
• vardenafil (for erectile dysfunction) when used in men over 75 years of age Other medicines containing:
• colchicine (for gout) when used in patients with kidney or liver problems
• ergometrine (ergonovine) or methylergometrine (methylergonovine) ergot alkaloids used after childbirth
• eliglustat (for Gaucher's disease) if used in patients who are unable to metabolize certain medicines in the body
• alofantrine (for malaria)
• irinotecan (for cancer)
• isavuconazole (for fungal infections)
• ombitasvir, paritaprevir, ritonavir with or without dasabuvir - (to treat hepatitis C)
• venetoclax (for chronic lymphocytic leukemia) when starting treatment with venetoclax or with increasing doses at the beginning of treatment.

Remember: after completing treatment with Itragerm capsules, do not take any of the
medicines listed above for 2 weeks.

Warnings and precautions
Tell your doctor before you start taking Itragerm:

• if you have, or have had, problems with your liver. If your doctor decides to prescribe Itragerm, your dose may be adjusted. You will also need to check for symptoms that may occur while you are being treated with Itragerm. Read section 4,‘Possible side effects’for more information. If you take Itragermcontinuously for more than a month, your doctor may ask you to have regular blood tests.
• if you have, or have had, problems with your heart. If your doctor decides to prescribe Itragerm, they will check for symptoms that may occur while you are being treated. For more information read section 4,‘Possible side effects’.
• if you have, or have had, problems with your kidneys. If your doctor decides to prescribe Itragerm, your dose may be adjusted.
• if you are HIV-positive, or if you have acquired immunodeficiency syndrome (AIDS), or any condition that indicates that your immune system is not working as well as it should.
• if you have ever had an allergicreactionto any other antifungal medicine.
• if you experience any numbness or muscle weakness.
• if you have cystic fibrosis, consult your doctor before taking this medicine.

Very rarely Itragermcan cause hearing loss, which can be permanent, but
usually improves when treatment is stopped.

Other medicines and Itragerm
Tellyour doctor or pharmacistbefore taking Itragerm if you are taking, have
recently taken or might take any other medicines, including herbal medicines or other non-prescription medicines.

Do not take Itragermif you are taking any of the following medicines:
Examples of these medicines are:

Medicines used to treat heart, blood or circulation problems

• apixaban, edoxaban, rivaroxaban or vorapaxar (for blood clots)
• atorvastatin (to reduce cholesterol)
• felodipine (for high blood pressure)
• riociguat or tadalafil (for pulmonary hypertension) Medicines for treating epilepsy, headache or mental health problems
• phenytoin, carbamazepine or phenobarbital (antiepileptics)
• eletriptan (for migraine headache)
• St. John's Wort (Hypericum, perforatum) (a herbal medicine used for mental health problems) Medicines for treating urinary problems
• tamsulosin (for male urinary incontinence)
• tolterodine (for irritated bladder) Medicines for treating cancer
• axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, trabectedine, trastuzumab emtansine, venetoclax (when taking a stable dose of venetoclax for chronic lymphocytic leukemia or at any time during treatment for acute myeloid leukemia) or vinca alkaloids (e.g. vinflunine, vinorelbine) Medicines for treating tuberculosis
• bedaquiline, isoniazid, rifabutin or rifampicin (for tuberculosis) Medicines for treating human immunodeficiency virus (HIV) or hepatitis
• efavirenz or nevirapine (for HIV/AIDS)
• elbasvir/grazoprevir, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) (for HIV or hepatitis) Medicines used after an organ transplant
• everolimus, rapamycin (also known as sirolimus), temsirolimus Medicines for the treatment of benign prostatic hyperplasia
• alfuzosin, silodosin Medicines for treating lung problems, allergies or inflammatory conditions
• ciclesonide (for inflammation, asthma and allergies)
• ebastine (for allergies)
• salmeterol (for asthma or chronic obstructive pulmonary disease - COPD) Medicines for treating erectile and ejaculation problems
• tadalafil or vardenafil (if used in men aged 75 or under) (for erectile dysfunction) Other medicines containing:
• colchicine (for gout)
• fentanyl (for pain)
• lumacaftor/ ivacaftor (for cystic fibrosis)

Remember: after completing treatment with Itragerm, do not take any of the
medicines listed above for 2 weeks.
This is not a complete list, so tell your doctor if you are taking or planning to
take any of these medicines or any other medicine.

You need to be careful when using Itragerm with some other medicines.
You may be more likely to experience side effects or you may need to
adjust the dose of Itragerm capsules or the other medicine. Examples of these medicines are:

Medicines used to treat heart, blood or circulation problems

• bosentan (for pulmonary hypertension)
• calcium channel blockers such as dihydropyridines such as amlodipine, isradipine, nifedipine, nimodipine or diltiazem (for hypertension)
• or verapamil (for high blood pressure)
• cilostazol (for circulation problems)
• ‘coumarins’ such as warfarin (for blood clots)
• digoxin (for atrial fibrillation)
• nadolol (for pulmonary hypertension or angina) Medicines for treating stomach problems or diarrhea
• aprepitant or netupitant (for nausea and vomiting during cancer treatments)
• loperamide (for diarrhea)
• proton pump inhibitors such as lansoprazole, omeprazole, rabeprazole (to treat stomach acidity problems) Medicines for treating sleep problems or mental health problems
• Alprazolam, brotizolam, buspirone, or midazolam (when injected intravenously) (for anxiety or to help you sleep)
• zopiclone (to help you sleep)
• reboxetine or venlafaxine (for depression and anxiety)
• aripiprazole, cariprazine, haloperidol or risperidone (for schizophrenia, bipolar disorder or other mental health problems)
• galantamine (for Alzheimer's disease)
• guanfacine (for attention deficit hyperactivity disorder) Medicines for treating urinary problems
• imidafenacin, fesoterodine, oxybutynin, solifenacin (for irritated bladder) Medicines for treating cancer
• bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib, nintedanib, panobinostat, pemigatinib, ponatinib, ruxolitinib, sonidegib or oral tretinoin Medicines for treating infections
• ciprofloxacin, clarithromycin, or erythromycin (for bacterial infections)
• delamanid (for tuberculosis)
• lumefantrine-artemether or quinine (to treat malaria)
• praziquantel (for trematodes and tapeworms) Medicines for treating human immunodeficiency virus (HIV) or hepatitis
• cobicistat, ritonavir-boosted elvitegravir, maraviroc, ritonavir, darunavir boosted, ritonavir-boosted fosamprenavir, ritonavir-boosted saquinavir or indinavir (for HIV)
• glecaprevir/pibrentasvir (for hepatitis) Medicines used after an organ transplant
• cyclosporine or tacrolimus Medicines for the treatment of benign prostatic hyperplasia
• dutasteride Medicines for treating lung problems, allergies or inflammatory conditions
• bilastine, or rupatadine (for allergies)
• methylprednisolone or dexamethasone, (medicines given by mouth or injection for asthma, allergies or inflammatory conditions)
• budesonide or fluticasone (for asthma, allergies) Medicines for treating erectile and ejaculation problems
• sildenafil (for erectile dysfunction) Medicines for treating pain
• alfentanil, buprenorphine, oxycodone or sufentanil (for pain)
• meloxicam (for inflammation and joint pain) Other medicines containing:
• alitretinoin (taken orally) (for eczema)
• cabergoline (for Parkinson's disease)
• cannabis-based products including medicines (for nausea and vomiting or muscle spasms in patients with multiple sclerosis))
• cinacalcet (for hyperparathyroidism)
• dienogest or ulipristal (contraceptives)
• eliglustat (for Gaucher's disease) if used in patients who are unable to metabolize certain medicines in the body
• ivacaftor; (for cystic fibrosis)
• methadone (for treating drug addiction)
• repaglinide or saxagliptin (for diabetes)

This is not a complete list, so tell your doctor if you are taking or planning to
take any of these medicines or any other medicine. It may be
necessary to adjust the dose of Itragerm capsules or other medicines.

Itragermwith food and drink
Itragerm capsules can be taken with or without food (although you may have been told
previously to take other antifungal medicines after a full meal).

Pregnancy and breastfeeding
Do not take Itragermif you are pregnant.
Tell your doctorand do not take Itragermcapsules if you are pregnant, if you think you may be pregnant
or if you are planning to become pregnant.

If you are able to become pregnant, use reliable contraceptive methods (birth control) while
taking Itragerm. After the end of treatment with Itragermcapsules, continue to
use reliable contraception until after your next menstrual period.

If you are breastfeeding
Ask your doctorbefore taking Itragerm. Small amounts of the medicine may
pass into breast milk.

Children and elderly patients
Itragerm is not recommended for children or for elderly patients unless the potential benefits
outweigh the risks.

Driving and operating machinery
Taking Itragermcapsules normally does not affect the ability to drive or operate
machinery. But, very rarely, Itragermcan cause dizziness, ringing in the ears

(tinnitus)and hearing loss. Do not drive and do not operate machinery if you do not feel well.

3. How to take Itragerm

Take this medicine always exactly as your doctor has instructed. If you have
any doubts, ask your doctor or pharmacist.
Swallow the capsules with water. Itragermcapsulescan be taken with or without food.

How much to take
The capsulesofItragermare specially designed to provide higher levels of active ingredient in the
blood compared to other itraconazole capsule formulations. One capsule of

Itragermcapsulesprovides your body with an amount of medicine similar to a 100 mg capsule of conventional itraconazole, with the same therapeutic efficacy. Take
only as many Itragerm capsules as have been prescribed for you, andif you have any doubts

ask your doctor or pharmacist.

The recommended doseof Itragermcapsules depends on the type of fungal infection you have:
For nail infections, depending on your specific needs, your doctor may
prescribe a cyclical treatment:

Your doctor may prescribe different doses for different periods of time, depending on your
condition. It is important to complete the therapeutic cycle prescribed by your doctor.

What to expect from treatment with Itragermcapsules
Do not worry if you do not see immediate improvement after your treatment.

• With skin infections, signs or spots (lesions)generally disappear a few weeks after you have finished the course of therapy. Even though the medicine kills the fungus, the signs do not disappear until new skin has grown.
• With nail infections, signs on the nails may take 6 to 9 months to disappear, because the new part of the nail must grow. Ask your doctor or pharmacistif you are not sure that the treatment is working.

If you take more Itragermcapsulesthan you should
Contact the nearest Emergency Room or your doctor immediately:

• if you (or someone else) have swallowed too many Itragerm capsules
• if you think a childhas swallowed Itragerm capsules.

Bring this leaflet, the remaining capsules and the boxto the hospital or your doctor, so
they will know which medicine has been swallowed.

If you forget to take Itragerm
If you forget to take a dose, take the next dose as usual. Then,
continue the cycle until all the capsules are finished.
Do not take a double dose to make up for a missed dose.

If you stop taking Itragerm capsules
If you stop taking Itragerm capsules before you have finished all the capsules of your
treatment cycle, your infection may not be completely treated and may recur. Do
not stop until you have finished the treatment cycle, even if you feel better.

4. Possible side effects

Like all medicines, Itragermcapsulescan cause side effects, although not everybody gets them. If you think any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.
Adverse reactions have been classified according to their frequency using the following
convention:

• Very common: may affect more than 1 in 10 people
• Common: may affect up to 1 in 10 people
• Uncommon: may affect up to 1 in 1,000 people
• Rare: may affect up to 1 in 10,000 people
• Very rare: may affect less than 1 in 10,000 people. Not known: the frequency cannot be estimated from the available data.

Infections and infestations
Uncommon: sinusitis (irritation and swelling of the nasal sinuses), upper respiratory tract infection,
rhinitis (inflammation of the nasal lining with fluid mucus production and frequent sneezing).

Blood and lymphatic system disorders
Rare: leucopenia

Immune system disorders
Uncommon: hypersensitivity and excessive allergic reaction
Rare: anaphylactic reaction (allergic), serum sickness (allergy that occurs after the injection
of certain serums and is characterized by the appearance of hives, fluid accumulation, joint pain,
fever and extreme exhaustion), angioedema (swelling due to fluid accumulation that can affect the mouth and upper respiratory tract).

Metabolism and nutrition disorders
Rare: increased triglycerides.

Nervous system disorders
Common: headache
Rare: tremor, tingling sensation in the extremities (paresthesia), decreased sensitivity
(hypoesthesia), unpleasant taste (bad taste in the mouth).

Eye disorders
Rare: visual disturbances (including blurred vision and double vision)

Ear and labyrinth disorders
Rare: transient or permanent hearing loss, subjective sensation of noise in the ear.

Cardiac disorders
Rare: congestive heart failure.

Respiratory, thoracic and mediastinal disorders
Rare: shortness of breath, difficulty breathing (dyspnea)

Gastrointestinal disorders
Common: abdominal pain, nausea
Uncommon: vomiting, food-related discomfort, diarrhea and constipation, gas accumulation
in the intestine (flatulence).
Rare: pancreatitis.

Hepatobiliary disorders
Uncommon: abnormal liver function
Rare: high levels of bilirubin in the blood (hyperbilirubinemia), severe hepatotoxicity (including
some cases of acute fatal liver failure).

Skin and subcutaneous tissue disorders
Uncommon: urticaria, rash, itching.
Rare: toxic epidermal necrolysis (severe skin disease characterized by rash and blistering and scaling), Stevens-Johnson syndrome (severe erythema of the skin, mucous membranes and eyes), a severe skin disease (generalized rash with desquamation of the skin and blisters in the mouth, eyes and genitals, or rash with small pustules or blisters), erythema multiforme (skin disease characterized by the appearance of vesicles, blisters ... etc.), exfoliative dermatitis (skin disease characterized by desquamation), leucocytoclastic vasculitis (inflammation of the blood vessel wall), alopecia (hair loss), photosensitivity (exaggerated skin response to sunlight).

Renal and urinary disorders
Rare: increased frequency of urination.

Reproductive system and breast disorders
Uncommon: menstrual disorders
Rare: erectile dysfunction

Laboratory tests
Rare: increased creatine phosphokinase in the blood (parameter that measures liver function).

Description of some adverse effects
The following side effects have been reported in patients taking other formulations of conventional itraconazole (oral solution or IV)

• Blood and lymphatic system disorders: granulocytopenia, thrombocytopenia (decrease of some blood cells).
• Immune system disorders: anaphylactoid reactions
• Metabolism and nutrition disorders: hyperglycemia (high blood sugar levels), hyperkalemia (high potassium levels in the blood), hypokalemia (low potassium levels in the blood), hypomagnesemia (low magnesium levels in the blood),
• Psychiatric disorders: confusion or disorientation
• Nervous system disorders: peripheral neuropathy (involvement of peripheral nerves with a sensation of tingling, numbness or weakness in the extremities), dizziness, drowsiness
• Cardiac disorders: heart failure, left ventricular failure, tachycardia (accelerated heartbeat).
• Vascular disorders: high blood pressure (hypertension), low blood pressure (hypotension).
• Respiratory, thoracic and mediastinal disorders: pulmonary edema, hoarseness, cough.
• Gastrointestinal disorders: gastrointestinal disturbances
• Hepatobiliary disorders: liver failure, hepatitis, jaundice (yellowing of the skin and eyes, mucous membranes and secretions).
• Skin and subcutaneous tissue disorders: red rash (erythematous rash), excessive sweating.
• Musculoskeletal and connective tissue disorders: muscle pain or weakness (myalgia), joint pain (arthralgia).
• Renal and urinary disorders: renal failure, urinary incontinence (loss of urine).
• Systemic disorders and conditions related to the site of administration: excessive fluid accumulation in the body tissues (generalized edema), fluid accumulation in the face (facial edema), chest pain, fever, pain, fatigue, chills.
• Laboratory tests: increased alanine aminotransferase, increased aspartate aminotransferase, increased alkaline phosphatase in the blood, increased lactate dehydrogenase in the blood, increased urea in the blood, increased gamma glutamyltransferase, abnormal liver enzymes, urine analysis.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Itragerm

Keep this medicine out of the sight and reach of children.
HDPE bottles and soft tempered aluminium blisters:
This medicine does not require any particular storage temperature.
Keep the bottle or blister in the outer packaging to protect the medicine from light and
humidity.
Triplex blisters:
Store at a temperature below 25°C.
Keep the blister in the outer packaging to protect the medicine from light and humidity.
Do not use this medicine after the expiry date which is stated on the pack after “EXP”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Itragerm capsules contain
The active ingredient is itraconazole.
Each hard capsule contains 50 mg itraconazole.
The other ingredients are: hypromellose phthalate, sodium starch glycolate (type A), colloidal
anhydrous silica, magnesium stearate.
The capsule is made of gelatin and FD&C blue FC dyes (E133), titanium dioxide (E171).
The capsule is printed with black ink (SW-9008), consisting of shellac, potassium
hydroxide, black iron oxide (E172) and purified water.

Description of the appearance of Itragermand contents of the pack
Itragerm 50 mg hard capsules are light blue hard gelatin capsules (size 1) with i-
50 printed in black ink.
Itragerm is available in blister packs of 4, 6, 7, 8, 14, 15, 18, 28, 30 and 60 capsules.
Itragerm is available in bottles of 15, 30, 60 and 90 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ISDIN S.r.l.
Via Statuto, 4
20121 Milan
Italy

Manufacturer
Medicofarma S.A.
Tarnobrzeska, 13
26-613 Radom
Poland

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Germany: ITRAISDIN
Spain, Italy: ITRAGERM
Austria: MYTRA

More detailed information on this medicinal product is available on the website