Lozanoc

Itraconazole
Consumer Medicine Information
 
WARNING: LOZANOC has a higher absorption than other itraconazole capsules. One capsule of LOZANOC 50 mg is therapeutically equivalent to one 100 mg capsule of conventional itraconazole capsules. LOZANOC 50mg capsules and conventional itraconazole 100mg capsules are not interchangeable.
 
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Lozanoc. It does not contain all the information that is known about Lozanoc. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What LOZANOC® Capsules are used for

LOZANOC Capsules are used to treat certain fungal infections which include the following:
persistent infections of the nails, skin, hands, feet or groin;
persistent candida (yeast) infections of the vagina;
eye infections which have not responded to other treatment or which may be affecting vision;
candida (yeast) infections of the mouth or throat in patients with lower resistance to disease;
generalised infections;
LOZANOC works by killing or stopping the growth of the fungus that causes the infection.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.

Before you take LOZANOC® Capsules

When you must not take it

Do not take LOZANOC Capsules if:
you have an allergy to LOZANOC Capsules or any of the ingredients (see Product Description at the end of this Leaflet).
you have a condition called heart failure (also called congestive heart failure or CHF), LOZANOC could make it worse.
you are pregnant or may become pregnant.
Do not take LOZANOC Capsules with any of the following medicines:
certain medicines for allergy or hay fever (e.g. terfenadine);
certain medicines used to treat angina and high blood pressure
certain medicines used to produce calmness or to help you sleep (midazolam or triazolam);
certain medicines used to lower your cholesterol, known as HMG-CoA reductase inhibitors, (e.g. simvastatin, lovastatin, atorvastatin);
dabigatran (used to prevent blood clots)
dronedarone or disopyramide (used to treat irregular heart beats);
eletriptan, dihydroergotamine or ergotamine (used to treat migraine);
ergometrine or methylergometrine (used to control bleeding).
sertindole (used to treat mental disorders);
Do not take LOZANOC Capsules after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
liver or kidney problems;
heart problems
neutropenia (low levels of a type of white blood cells) or AIDS
organ transplant.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or LOZANOC Capsules.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, LOZANOC Capsules must not be taken with some medicines.
Examples are:
certain medicines for allergy or hay fever (e.g. terfenadine);
certain medicines used to treat angina and high blood pressure
certain medicines used to produce calmness or to help you sleep (midazolam or triazolam);
certain medicines used to lower your cholesterol, known as HMG-CoA reductase inhibitors, (e.g. simvastatin, lovastatin, atorvastatin);
dabigatran (used to prevent blood clots)
dronedarone or disopyramide (used to treat irregular heart beats);
eletriptan, dihydroergotamine or ergotamine (used to treat migraine);
ergometrine or methylergometrine (used to control bleeding).
sertindole (used to treat mental disorders);
Certain medicines may be affected by LOZANOC Capsules or may affect how well LOZANOC Capsules work. Your doctor may need to adjust the dose or adapt your treatment.
Examples of these medicines are:
anticoagulants (used to slow blood clotting);
phenytoin or carbamazepine (used to treat fits);
clarithromycin, erythromycin (antibiotics);
certain medicines used to treat AIDS, such as indinavir, saquinavir and ritonavir;
certain calcium channel blockers (used to treat heart or blood pressure problems);
digoxin (used to treat heart failure);
cyclosporin, sirolimus, tacrolimus (used to help prevent organ transplant rejection or to treat certain problems with the immune system);
busulphan, vinca alkaloids, docetaxel (used to treat some cancers);
methylprednisolone, budesonide, fluticasone and dexamethasone (often used for conditions such as inflammations, asthma and allergies);
buspirone, alprazolam, (used to treat anxiety or help you sleep);
medicines taken for diabetes (in particular repaglinide);
reboxetine (used to treat depression);
alfentanil (used in surgery for pain relief and to help anaesthesia);
fentanyl, a strong medicine for pain;
rifampicin, rifabutin or isoniazid (used to treat tuberculosis);

How to Take LOZANOC® Capsules

How much to take

Adults
LOZANOC Capsules are specially designed to give higher blood levels of active ingredient than other formulations of itraconazole capsules. A 50 mg capsule of LOZANOC is therapeutically equivalent to 100 mg of other brands of itraconazole capsules but the capsules are not interchangeable.
Only take as many LOZANOC capsules as you have been prescribed, and ask your doctor or pharmacist if you are not sure.
The usual doses are shown below, but your doctor may decide to adjust them for your individual needs.
Tinea of body & groin:
1 capsule daily for 2 weeks.
Tinea of hands & feet:
1 capsule daily for 4 weeks.
Other skin infections:
2 capsules daily for 1 week.
Eye infections:
2 capsules daily for 3 weeks.
Vaginal infections:
2 capsules morning & evening for 1 day, or 2 capsules daily for 3 days.
Mouth infections:
1 to 2 capsules daily for 4 weeks.
Systemic infections:
1 to 2 capsules once or twice daily for 3 weeks to 8 months, depending on the condition.
Nail infections:
Continuous nail therapy
2 capsules once daily for 3 months.
Cyclic (pulse) nail therapy
2 capsules twice daily for 1 week. After that, stop taking LOZANOC for 3 weeks. Then the cycle is repeated, once for fingernails and twice for toenail infections (with or without fingernail infections).
Children and Elderly
LOZANOC Capsules are not recommended for use in children and in the elderly.

How to take it

Always take LOZANOC exactly as your doctor has told you to.
Check with your doctor or pharmacist if you are not sure. LOZANOC Capsules can be taken before or after a meal.

How long to take it

Don't worry if you don't see an immediate improvement after your treatment.
With skin infections, the marks or spots (lesions) typically disappear a few weeks after you finish the course. Although the medicine kills the fungus, the marks don't disappear until after new skin has grown.
With nail infections, marks on the nail may take 6 to 9 months to disappear, because new nail needs to grow.
Ask your doctor or pharmacist if you're not sure whether the treatment is working.

If you forget to take it

Take the dose you missed as soon as you remember, and then continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the one you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you have taken too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are taking LOZANOC® Capsules

Things you must do

Always follow your doctor's instructions carefully.
If you have to take LOZANOC Capsules continuously for more than 1 month, your doctor may ask you to have your blood checked regularly to make sure that your liver is not affected.
If you become pregnant while taking this medicine, tell your doctor immediately.
If there is any chance of you becoming pregnant, talk to your doctor about the need for adequate contraception.
Tell any other doctors, dentists or pharmacists who treat you that you are taking this medicine.
Always complete the treatment as directed by your doctor, even if the signs of infection have gone.

Things you must not do

Do not take LOZANOC Capsules to treat any other complaint unless your doctor says so.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side Effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following:
upset stomach, stomach pain or discomfort, nausea, vomiting, diarrhoea, constipation, an unpleasant taste in your mouth.
shortness of breath, headache, dizziness, fever.
a change in menstrual pattern.
unusual hair loss or thinning.
erectile dysfunction.
muscle weakness or pain, painful joints.
Tell your doctor immediately if you notice any of the following as you may need urgent medical care:
tingling, numbness or weakness in the hands or feet.
swelling of hands ankles, feet, legs or abdomen.
shortness of breath, unexpected weight gain, unusual fatigue, or begin to wake up at night.
oversensitivity to sunlight.
blurry or double vision, ringing in the ears.
lose the ability to control your bladder or urinate much more than usual.
STOP taking LOZANOC Capsules and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
abnormal tiredness, loss of appetite, nausea, vomiting, dark urine, pale stools, yellowing of the skin or eyes.
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath or difficulty breathing, wheezing or trouble breathing.
a severe skin disorder (widespread rashes with peeling skin and blisters in the mouth, eyes and genitals, or rashes with small pustules or blisters).
you experience any hearing loss symptoms. In very rare cases, patients taking LOZANOC have reported temporary or permanent hearing loss.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

After using LOZANOC® Capsules

Storage

Keep LOZANOC Capsules in the pack until it is time to take them.
If you take the capsules out of the pack they may not keep well.
Keep LOZANOC Capsules in a cool dry place where the temperature is below 25°C.
Keep your medicines where young children cannot reach them.
A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is good place to store medicines.
Do not store LOZANOC Capsules, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills.
Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking LOZANOC Capsules or your medicines has passed its expiry date, ask your pharmacist what to do with any medicine which may be left over.

Product Description

What it looks like

LOZANOC Capsules are blue opaque capsules with i-50 printed in black.
They are supplied in a blister pack or bottle pack.

Ingredients

LOZANOC Capsules contain 50 mg of itraconazole as the active ingredient. It also contains:
hypromellose phthalate
sodium starch glycollate (Type A)
silicon dioxide
magnesium stearate
gelatin
brilliant blue FCF
titanium dioxide
TekPrint SW-9008 Black Ink
LOZANOC Capsules do not contain lactose or gluten.

Sponsor

Mayne Pharma International Pty Ltd
1538 Main North Rd
Salisbury South, SA, 5106
Australia
Australian Registration Number:
Blister pack AUST R 206361
Bottle pack AUST R 206360
This leaflet was prepared July 2014.