Ipozumax

Package leaflet: Information for the patient

Ipozumax, 100 mg, hard capsules
Itraconazolum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Ipozumax is and what it is used for
2. Important information before taking Ipozumax
3. How to take Ipozumax
4. Possible side effects
5. How to store Ipozumax
6. Contents of the pack and other information

1. What Ipozumax is and what it is used for

Ipozumax 100 mg capsules is a medicine containing itraconazole as the active substance. This
substance belongs to a group of antifungal medicines.
Ipozumax 100 mg capsules are used to treat infections caused by fungi and yeasts in adults. The medicine is used to treat:

• Infections of the mouth or vagina causing "thrush";
• Skin infections;
• Infections occurring in other parts of the body.

Skin lesions may only completely resolve several weeks after completion of treatment with
itraconazole capsules. Lesions of fingernails and toenails may only completely resolve after
several months. This is because the patient's skin and nails will appear normal only after new skin and new nails have grown, even if the medicine has completely destroyed the fungi causing the infection.

2. Important information before taking Ipozumax

When not to take Ipozumax

• If the patient is allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6).
• In women who are pregnant or planning pregnancy, unless otherwise advised by a doctor (see "Pregnancy and breastfeeding").

Do not use this medicine if any of the above points apply to the patient.
If in doubt, talk to a doctor or pharmacist before taking
itraconazole capsules.
Warnings and precautions
Before starting Ipozumax, discuss this with your doctor or pharmacist if:

• the patient has ever had kidney function disorders – it may be necessary to adjust the dose of itraconazole capsules;
• the patient has ever had liver function disorders, such as yellowing of the skin (jaundice). It may be necessary to adjust the dose of itraconazole capsules. Stop taking itraconazole capsules and contact your doctor immediately if, during treatment, you experience a marked decrease in appetite, nausea, vomiting, unusual tiredness, abdominal pain, muscle weakness, yellowing of the skin or whites of the eyes, unusually dark urine, pale stools or hair loss;
• the patient has ever had circulatory disorders, including heart failure (also known as congestive heart failure or CHF), as itraconazole capsules may worsen these conditions. If, after taking itraconazole, any of the following symptoms occur:
  • difficulty breathing;
  • unexpected weight gain;
  • swelling of the legs or abdomen;
  • unusual fatigue;
  • nighttime episodes of breathlessness; stop taking itraconazole capsules and inform your doctor immediately – these may be symptoms of heart failure.
• the patient has acquired immunodeficiency syndrome (AIDS) and their immune system is not functioning properly;
• the patient has previously experienced an allergic reaction to another antifungal medicine;
• itraconazole capsules are generally not given to elderly patients. However, in special cases, a doctor may prescribe this medicine to an elderly patient.

Children and adolescents
Itraconazole capsules are generally not given to children under 12 years of age. However, in special cases, a doctor may prescribe this medicine to this patient group.
Blood tests
If itraconazole capsules are taken continuously for longer than one month, your doctor may order blood tests to monitor liver function.
Ipozumax and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take. This includes medicines available without a prescription and herbal remedies.
In particular, do not take this medicine and inform your doctor if you are taking any of the following medicines:

• medicines used for allergies: terfenadine, astemizole and mizolastine;
• cholesterol-lowering medicines: atorvastatin, lovastatin or simvastatin;
• medicines used for heart arrhythmias: quinidine, disopyramide, dronedarone or dofetilide;
• medicines used to treat angina (chest pain) and high blood pressure: bepridil, felodipine, lercanidipine, ivabradine, ranolazine and nisoldipine;
• medicines used for migraine headaches: dihydroergotamine and ergotamine;
• medicines used in drug addiction treatment: levacetylmethadone and methadone;
• cisapride – used for digestive disorders;
• colchicine (in patients with kidney or liver disease) – a medicine used to treat gout;
• eplerenone – a diuretic medicine;
• ergometrine (ergonovine) and methylergometrine (methylergonovine) – used after childbirth;
• halofantrine – a medicine used against malaria;
• irinotecan – an anticancer medicine;
• dabigatran – a blood-thinning medicine;
• ticagrelor – a blood-thinning medicine;
• quetiapine – a medicine used for conditions affecting thoughts, feelings and behaviour;
• aliskiren – a medicine used to treat high blood pressure;
• darifenacin – a medicine used to treat sudden urinary incontinence and/or increased frequency of urination;
• midazolam (taken orally) or triazolam – used to calm or help sleep;
• pimozide, lurasidone and sertindole – medicines used for conditions involving disturbances in thoughts, feelings and behaviour.

If you are taking any of the medicines listed above, do not start taking itraconazole capsules without first informing your doctor.
Do not take any of the above-listed medicines for 2 weeks after stopping treatment with itraconazole capsules.
If you are taking any of the following medicines, inform your doctor, as taking them together with itraconazole capsules is not recommended unless your doctor considers it necessary:

• anticancer medicines: axitinib, dabrafenib, dasatinib, ibrutinib, lapatinib, nilotinib, sunitinib or trabectedin;
• colchicine, a medicine used for gout;
• ebastine – an antiallergy medicine;
• eletriptan – a medicine used for migraine headaches;
• everolimus, a medicine given after organ transplantation;
• fentanyl, a strong painkiller;
• rivaroxaban, a blood-thinning medicine;
• salmeterol, a medicine used for asthma;
• tamsulosin, a medicine used to treat urinary incontinence in men;
• vardenafil, a medicine used to treat erectile dysfunction;
• cyclosporine, a medicine usually given after organ transplantation;
• temsirolimus – a medicine usually given after organ transplantation.

Do not take any of the above-listed medicines for 2 weeks after stopping treatment with itraconazole capsules.
The following medicines should not be taken for 2 weeks before starting or during treatment with itraconazole capsules, unless otherwise advised by a doctor:

• medicines used to treat tuberculosis: rifampicin, rifabutin and isoniazid;
• medicines used to treat epilepsy: phenytoin, carbamazepine and phenobarbital;
• medicines used to treat viral infections, such as efavirenz and nevirapine;
• herbal remedy (St. John's wort, Hypericum perforatum).

If you are taking or plan to take any of the medicines listed above, inform your doctor. They may cause itraconazole capsules to not work properly.
It may be necessary to adjust the dose of itraconazole capsules or of another medicine taken simultaneously:

• strong painkillers: alfentanil, buprenorphine (given by injection or sublingually) and oxycodone;
• medicines used for indigestion, stomach ulcers or heartburn, which may affect stomach acid secretion. Adequate acidity in the stomach is necessary for this medicine to be absorbed. Therefore, wait two hours after taking itraconazole capsules before taking these medicines. If you are taking medicines that reduce stomach acid production, take itraconazole capsules with a non-diet cola-type drink;
• sedatives and sleeping medicines, such as buspirone, alprazolam or brotizolam;
• anticancer medicines, such as: bortezomib, busulfan, docetaxel, erlotinib, ixabepilone, trimetrexate and vinca alkaloids;
• medicines used for mental, emotional and behavioural disorders: aripiprazole, haloperidol, perospirone, ramelteon and risperidone;
• blood-thinning medicines, such as: warfarin;
• medicines used in HIV infection, such as: ritonavir, darunavir, indinavir, fosamprenavir and saquinavir (known as "protease inhibitor antivirals"). Also maraviroc;
• medicines used for bacterial infections: ciprofloxacin, clarithromycin or erythromycin;
• medicines acting on the heart and blood vessels: nadolol, digoxin and cilostazol, and "calcium antagonists", such as dihydropyridine derivatives and verapamil;
• medicines used for inflammatory conditions, asthma or allergies (orally or by injection): methylprednisolone, fluticasone, budesonide and dexamethasone;
• medicines usually used after organ transplantation, such as: cyclosporine, tacrolimus or rapamycin (also known as sirolimus);
• medicines used to treat overactive bladder – fesoterodine, imidafenacin, solifenacin or tolterodine;
• alitretinoin (taken orally) – a medicine used to treat eczema;
• aprepitant and domperidone – medicines to prevent nausea and vomiting;
• atorvastatin – a medicine to lower cholesterol levels;
• cinacalcet – a medicine used to treat hyperparathyroidism;
• mozavaptan or tolvaptan – medicines used to treat low sodium levels in the blood;
• praziquantel – an antiparasitic medicine;
• reboxetine – a medicine used to treat depression;
• repaglinide or saxagliptin – medicines used to treat diabetes;
• meloxicam – a medicine to reduce inflammation and pain;
• midazolam (given intravenously): a sedative and sleeping medicine;
• sildenafil and tadalafil – medicines used to treat erectile dysfunction.

If you are taking or plan to take any of the medicines listed above, inform your doctor. It may be necessary to adjust the dose of itraconazole capsules or of another medicine taken at the same time.
Ipozumax with food and drink
Itraconazole capsules should always be taken immediately after a meal to ensure optimal absorption of the medicine.
Pregnancy, breastfeeding and fertility

• If the patient is pregnant, she should not take itraconazole capsules unless otherwise advised by a doctor. She should use contraception to ensure she does not become pregnant during treatment with itraconazole.
• Itraconazole in capsule form remains in the body for some time after stopping treatment. After stopping treatment, contraception should be continued until the next menstrual period. Consult your doctor about which type of contraception is appropriate.
• If the patient becomes pregnant after starting treatment, stop taking itraconazole capsules immediately and inform your doctor.
• Do not breastfeed while taking itraconazole capsules, as a small amount of the medicine may pass into human milk. Consult your doctor.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Itraconazole in capsule form may occasionally cause dizziness, blurred or double vision, or hearing loss. If such symptoms occur, the patient should not drive or operate machinery.
Ipozumax contains sucrose
This medicine contains the sugar sucrose. If you have previously been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Ipozumax
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Method and route of administration

• Itraconazole capsules should always be taken immediately after a meal, as this helps the medicine to be absorbed.
• Swallow the capsules whole with liquid.
• Adequate stomach acidity is necessary for the medicine to be absorbed. Medicines used for indigestion, stomach ulcers or heartburn may interfere with stomach acid production. Therefore, wait two hours after taking itraconazole capsules before taking any of these medicines. If you are taking medicines that reduce stomach acid production, take itraconazole capsules with a non-diet cola-type drink.

Frequency of administration and duration of treatment
Your doctor will tell you how many itraconazole capsules to take and for how long to continue treatment. The recommended dose is:
Vaginal yeast infection (candidiasis)

• 2 capsules in the morning and 2 capsules 12 hours later, only for one day.

Oral yeast infection (oral candidiasis)

• 1 capsule daily for 15 days.

Fungal skin infections
The dose depends on the type of infection.
Your doctor may recommend:

• 2 capsules daily for 7 days, or
• 1 capsule daily for 15 days, or
• 1 capsule daily for 30 days.

Fungal infections of other body parts
Depending on the type of infection, your doctor will advise how many itraconazole capsules to take and for how long to continue treatment.
Taking more Ipozumax than prescribed
If you take more than the prescribed dose of Ipozumax, contact your doctor or pharmacist immediately.
Missing a dose of Ipozumax
Take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Ipozumax
Continue taking Ipozumax for as long as your doctor recommends. Do not stop treatment because you feel better.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will
experience them.
If any of the symptoms listed below occur, stop taking itraconazole capsules immediately
and contact your doctor at once. You may need to obtain urgent medical assistance.

• Sudden onset of allergic symptoms such as rash, hives, severe skin irritation, swelling of the face, lips, tongue or other parts of the body. These may be symptoms of a severe allergic reaction. This affects only a small number of patients.
• Severe skin disorders with the formation of small blisters (with fever) or blisters on the skin, around the mouth, eyes and genital organs, accompanied by fever, chills, muscle pain and general malaise (the exact frequency of these symptoms is unknown).
• Sensation of tingling, numbness or weakness of the limbs (the exact frequency of these symptoms is unknown).
• Marked loss of appetite, nausea, vomiting, unusual fatigue, abdominal pain, muscle weakness, yellowing of the skin or whites of the eyes (jaundice), abnormally dark urine, pale stools or hair loss. These may be symptoms of liver function disorders. This affects only a small number of patients.
• Difficulty breathing, unusual weight gain, swelling of legs and abdomen, feeling of unusual fatigue, nocturnal shortness of breath. These may be symptoms of heart failure. Difficulty breathing may be due to fluid in the lungs (these symptoms occur rarely).

Inform your doctor or pharmacist if any of the following adverse reactions occur
Common (may occur in up to 1 in 10 people)

• abdominal pain, nausea;
• headache.

Uncommon (may occur in up to 1 in 100 people)

• menstrual disorders;
• sinusitis, runny nose, cough and cold symptoms;
• constipation, diarrhoea, bloating, vomiting, indigestion.

Rare (may occur in up to 1 in 1000 people):

• increased liver enzyme activity (seen in blood tests);
• unexpected urination or increased frequency of urination;
• visual disturbances, including blurred or double vision;
• change in taste sensation;
• specific blood disorders which may increase the risk of bleeding, bruising or infections;
• ringing in the ears;
• hearing loss (may be permanent);
• acute abdominal pain, often with nausea and vomiting (pancreatitis);
• swelling caused by fluid accumulation under the skin;
• unusual hair loss or thinning (alopecia);
• redness, itching, peeling or blistering of the skin;
• increased blood triglyceride levels (seen in blood tests);
• skin hypersensitivity to light;
• erectile dysfunction.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or
pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of
Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: + 48 22 49 21 30
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ipozumax

Keep this medicine out of sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any visible signs of damage.
Medicines should not be disposed of via 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 packaging and other information

What Ipozumax contains

• The active substance is itraconazole; each capsule contains 100 mg of itraconazole.
• The other ingredients are:
• capsule contents: sugar spheres (corn starch and sucrose), poloxamer 188, hypromellose;
• capsule shell: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171) and gelatin.

What Ipozumax looks like and contents of the pack
Ipozumax is a hard capsule.
Pack sizes contain 4 or 28 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nr 7
Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: Itraconazol Fungizol 100 mg Капсула, твърда
Czech Republic: CONISOR 100 MG TVRDE TOBOLKY
Germany: Itraconazol Heumann  100 mg Hartkapseln
Spain: Itraconazol Normon 100 mg cápsulas duras
Hungary: Itraconazol Medico Uno 100 mg kemény kapszula
Poland: Ipozumax
Portugal: Itraconazol Fungizol 100 mg capsulas
Slovakia: Prokanazol 100 mg
United Kingdom: Itraconazole 100 mg Capsules