Ipozumax

Leaflet attached to the packaging: patient information

Ipozumax, 100 mg, hard capsules

Itraconazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ipozumax and what is it 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 packaging and other information

1. What is Ipozumax and what is it used for

Ipozumax 100 mg hard capsules are a medicine that contains itraconazole as the active substance. This substance belongs to the group of antifungal medicines.
Ipozumax 100 mg hard capsules are used to treat fungal and yeast infections in adults. The medicine is used to treat:

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

Skin changes may not completely disappear until several weeks after the end of itraconazole treatment in capsules. Nail changes on the hands and feet may not completely disappear until several months after the end of treatment. This is because the patient's skin and nails will only look normal when new skin and nails have grown, even if the medicine has completely destroyed the fungi that caused 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 pregnant or breastfeeding women, unless the doctor recommends otherwise (see "Pregnancy and breastfeeding").

This medicine must not be taken if any of the above points apply to the patient.
In case of doubts, consult your doctor or pharmacist before taking itraconazole capsules.

Warnings and precautions

Before starting to take Ipozumax, discuss it with your doctor or pharmacist if:

• the patient has ever had kidney problems - it may be necessary to change the dose of itraconazole capsules;
• the patient has ever had liver problems, such as yellowing of the skin (jaundice). It may be necessary to change the dose of itraconazole capsules. Stop taking itraconazole capsules and consult your doctor immediately if, while taking this medicine, the patient experiences a significant decrease in appetite, nausea (vomiting), vomiting, unusual tiredness, abdominal pain, muscle weakness, yellowing of the skin or whites of the eyes, or unusually dark urine, light stools, or hair loss;
• the patient has ever had circulation problems, including heart failure (also known as congestive heart failure or CHF), itraconazole capsules may worsen them. If, after taking it, the following symptoms appear:
• breathing difficulties;
• unexpected weight gain;
• swelling of the legs or abdomen;
• feeling of unusual tiredness;
• nighttime shortness of breath; stop taking itraconazole capsules and tell your doctor immediately - these may be symptoms of heart failure.
• the patient has AIDS and their immune system is not working properly;
• the patient has had an allergic reaction to another antifungal medicine in the past;
• itraconazole capsules are not usually given to elderly patients. However, in special cases, the doctor may prescribe this medicine to an elderly patient.

Children and adolescents

Itraconazole capsules are not usually given to children under 12 years of age. However, in special cases, the doctor may prescribe this medicine to this group of patients.

Blood tests

If itraconazole capsules are taken continuously for more than a month, the doctor may order a blood test to check liver function.

Ipozumax and other medicines

Tell your doctor about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription and herbal medicines.
In particular, do not take this medicine and inform your doctor if you are taking any of the following medicines:

• allergy medicines: terfenadine, astemizole, and mizolastine;
• cholesterol-lowering medicines: atorvastatin, lovastatin, or simvastatin;
• heart rhythm medicines: quinidine, disopyramide, dronedarone, or dofetilide;
• medicines used to treat angina pectoris (chest pain) and high blood pressure: bepridil, felodipine, lercanidipine, ivabradine, ranolazine, and nisoldipine;
• medicines used to treat migraines: dihydroergotamine and ergotamine;
• medicines used to treat drug abuse: levacetylmethadol and methadone;
• cisapride - used to treat digestive disorders;
• colchicine (in patients with kidney and liver disease) - a medicine used to treat gout;
• eplerenone - a diuretic;
• ergometrine (ergonovine) and methylergometrine (methylergonovine) - used after childbirth;
• halofantrine - an antimalarial medicine;
• irinotecan - an anticancer medicine;
• dabigatran - a blood thinner;
• tikagrelor - a blood thinner;
• quetiapine - a medicine used to treat mental disorders;
• aliskiren - a medicine used to treat high blood pressure;
• darifenacin - a medicine used to treat urinary incontinence and (or) increased frequency of urination;
• midazolam (taken orally) or triazolam - used to calm or facilitate sleep;
• pimozide, lurasidone, and sertindole - medicines used to treat mental disorders.

If you are taking any of the above medicines, do not start taking itraconazole capsules. Also, do not take any of the above medicines for 2 weeks after stopping itraconazole capsules.
Tell your doctor if you are taking or plan to take any of the above medicines. They may cause itraconazole capsules to not work properly:
The dose of itraconazole capsules or another medicine taken at the same time may need to be changed:

• strong painkillers: alfentanil, buprenorphine (given by injection or under the tongue), and oxycodone;
• medicines used to treat nausea and vomiting, such as buspirone, alprazolam, or brotizolam;
• anticancer medicines, such as bortezomib, busulfan, docetaxel, erlotinib, ixabepilone, temsirolimus, and vinca alkaloids;
• medicines used to treat mental disorders: aripiprazole, haloperidol, perospirone, ramelteon, and risperidone;
• blood thinners, such as warfarin;
• medicines used to treat HIV, such as ritonavir, darunavir, indinavir, fosamprenavir, and saquinavir (also known as "antiviral protease inhibitors"); also maraviroc;
• medicines used to treat bacterial infections: ciprofloxacin, clarithromycin, or erythromycin;
• medicines that affect the heart and blood vessels: nadolol, digoxin, and cilostazol, and "calcium antagonists", such as dihydropyridine derivatives and verapamil;
• medicines used to treat inflammation, asthma, or allergies (taken orally or by injection): methylprednisolone, fluticasone, budesonide, and dexamethasone;
• medicines 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 that prevent nausea and vomiting;
• atorvastatin - a medicine that lowers 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 that reduces inflammation and pain;
• midazolam (given intravenously): a sedative and sleep-inducing medicine;
• sildenafil and tadalafil - medicines used to treat erectile dysfunction.

If you are taking or plan to take any of the above medicines, tell your doctor. The dose of itraconazole capsules or another medicine taken at the same time may need to be changed.

Ipozumax with food and drink

Itraconazole capsules should always be taken immediately after a meal to ensure the best absorption of the medicine.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant, she should not take itraconazole capsules unless the doctor recommends otherwise. The patient should use contraception to ensure she does not become pregnant while taking itraconazole.
• Itraconazole remains in the body for some time after stopping the capsules. After stopping treatment, the patient should use contraception until the next menstrual period. The patient should consult their doctor about what type of contraception is suitable.
• If the patient becomes pregnant after starting treatment, she should stop taking itraconazole capsules immediately and tell her doctor.
• While taking itraconazole capsules, the patient should not breastfeed, as a small amount of the medicine may pass into breast milk. The patient should consult their doctor.

If the patient is pregnant or breastfeeding, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines

Itraconazole capsules may occasionally cause dizziness, blurred or double vision, or hearing loss. If the patient experiences any of these symptoms, they should not drive or operate machinery.

Ipozumax contains sucrose

This medicine contains the sugar sucrose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Ipozumax

This medicine should always be taken exactly as the doctor has told you. If you are unsure, 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 work on the body.
• The capsules should be swallowed whole, with a drink of water.
• For the medicine to work on the body, it is necessary to ensure the right acidity in the stomach. Medicines used to treat indigestion, stomach ulcers, or acid reflux may disrupt stomach acid production. Therefore, after taking itraconazole capsules, wait 2 hours before taking any of these medicines. If the patient is taking medicines that reduce stomach acid production, they should take itraconazole capsules with a non-diet "cola" drink.

Frequency of administration and duration of treatment
The doctor will tell the patient how many itraconazole capsules to take and for how long to take the medicine. The recommended dose is:

Vaginal yeast infection (thrush)

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

Oral thrush

• 1 capsule each day for 15 days.

Fungal skin infections

The dose depends on the type of infection.
The doctor may recommend:

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

Fungal infections of other parts of the body

Depending on the type of infection, the doctor will tell the patient how many itraconazole capsules to take and for how long to take the medicine.

Taking more Ipozumax than recommended

If more Ipozumax than recommended is taken, consult a 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, do not take the missed dose and follow the usual dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping Ipozumax treatment

Take Ipozumax for as long as the doctor recommends. Do not stop treatment because of improvement.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking itraconazole capsules and consult your doctor immediately. You may need urgent medical attention.

• Sudden symptoms of an allergic reaction, such as a 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 genitals, with fever, chills, muscle pain, and general malaise (the exact frequency of these symptoms is not known).
• Feeling of tingling, numbness, or weakness in the limbs (the exact frequency of these symptoms is not known).
• Significant loss of appetite, nausea, vomiting, unusual tiredness, abdominal pain, muscle weakness, yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, light stools, or hair loss. These may be symptoms of liver problems. This affects only a small number of patients.
• Breathing difficulties, unexpected weight gain, swelling of the legs and abdomen, feeling of unusual tiredness, nighttime shortness of breath. These may be symptoms of heart failure. Breathing difficulties may be a sign of fluid in the lungs (these symptoms are rare).

Tell your doctor or pharmacist if you experience any of the following side effects

Common (may affect up to 1 in 10 people)

• -abdominal pain, nausea;
• headache.

Uncommon (may affect up to 1 in 100 people)

• menstrual disorders;
• sinusitis, cold, cough, and flu;
• constipation, diarrhea, bloating, vomiting, indigestion.

Rare (may affect up to 1 in 1,000 people):

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ipozumax

Keep the medicine out of the 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 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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ipozumax contains

• The active substance of the medicine is itraconazole; each capsule contains 100 mg of itraconazole.
• The other ingredients are:
• capsule contents: sugar spheres (cornstarch 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.
The pack contains 4 or 28 capsules.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Bulgaria:
Itraconazole Fungizol 100 mg hard capsule
Czech Republic:
CONISOR 100 MG hard capsules
Germany:
Itraconazole Heumann 100 mg hard capsules
Spain:
Itraconazole Normon 100 mg hard capsules
Hungary:
Itraconazole Medico Uno 100 mg hard capsule
Poland:
Ipozumax
Portugal:
Itraconazole Fungizol 100 mg hard capsules
Slovakia:
Prokanazol 100 mg
United Kingdom:
Itraconazole 100 mg Capsules

Date of last revision of the leaflet: March 2023