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«PACKAGE LEAFLET: INFORMATION FOR THE USER Sporanox®-Pulse Itraconazole Sporanox is a registered trademark Read all of this leaflet carefully before ...»

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sporanox®-Pulse

Itraconazole

Sporanox is a registered trademark

Read all of this leaflet carefully before you start using 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

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Sporanox-Pulse is and what it is used for

2. What you need to know before you use Sporanox-Pulse

3. How to use Sporanox-Pulse

4. Possible side effects

5. How to store Sporanox-Pulse

6. Contents of the pack and other information

1. What Sporanox-Pulse is and what it is used for Sporanox-Pulse contains a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’.

Sporanox-Pulse is used for infections caused by fungi or yeasts. It is used for:

• Nail infections

• Skin infections of the hands or feet Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Sporanox-Pulse. This is because your skin will only look normal after new skin has grown, even though the medicine has killed the fungus that caused the infection.

2. What you need to know before you use Sporanox-Pulse

Do not use Sporanox-Pulse if:

• You are allergic to anything in Sporanox-Pulse (listed in section 6 below)

• You are pregnant or could become pregnant (see ‘Pregnancy and breastfeeding’ below) 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 Sporanox-Pulse.

Warnings and precautions

Check with your doctor or pharmacist before using this medicine if:

• You have ever had kidney problems. Your dose of Sporanox-Pulse may have to be changed

• You have ever had liver problems such as yellow skin (jaundice). Your dose of Sporanox-Pulse 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, muscle weakness, yellowing of the skin or whites of the eyes, unusually dark urine, pale stools or hair loss, stop taking Sporanox-Pulse and tell your doctor straight away

• You have ever had a heart problem including heart failure (also called congestive heart failure or CHF). Sporanox-Pulse could make it worse. If

after taking this medicine you get any of the following:

o shortness of breath o unexpected weight gain o swelling of your legs or tummy o feel unusually tired o wake up short of breath at night stop taking Sporanox-Pulse and tell your doctor straight away. These may be signs of heart failure

• You have Acquired Immunodeficiency Syndrome (AIDS) or your immune system is not working as well as it should

• You have had an allergic reaction to another antifungal product in the past If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Sporanox-Pulse.

Children and the elderly Sporanox-Pulse is not normally given to children under the age of 12 or the elderly. However, your doctor may prescribe it in special cases.

Blood tests If your Sporanox-Pulse course is for more than one month, your doctor may want to check your liver by testing your blood.

Other medicines and Sporanox-Pulse Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular, do not take the following list of medicines with SporanoxPulse and tell your doctor if you are taking any of these:

• Medicines for hay fever or allergy called terfenadine, astemizole or mizolastine

• Medicines to lower cholesterol called lovastatin or simvastatin

• Medicines for an irregular heart beat called quinidine, dronedarone, dofetilide or disopyramide

• Medicines used to treat angina (crushing chest pain) and high blood pressure called bepridil, felodipine, lercanidipine, ivabradine, ranolazine and nisoldipine

• Medicines for migraine headaches called dihydroergotamine and ergotamine

• Medicines for the treatment of drug abuse called levacetylmethadol and methadone

• Cisapride - for digestive problems

• Colchicine (in patients with kidney and liver problems as well) – for gout

• Eplerenone – a diuretic

• Ergometrine (ergonovine) and methylergometrine (methylergonovine) - used after giving birth

• Halofantrine - for malaria

• Irinotecan – for cancer

• Midazolam (by mouth) or triazolam - for anxiety or to help you sleep

• Pimozide, lurasidone and sertindole - for conditions affecting thoughts, feelings and behaviour Do not start taking Sporanox-Pulse and tell your doctor if you are taking any of the above. Also, upon completing your course of Sporanox-Pulse, do not take any of the medicines listed above for 2 weeks.





Tell your doctor if you are using the following medicines as they are not recommended with Sporanox-Pulse unless your doctor feels it is necessary.

• Medicines for the treatment of cancer called dasatinib, nilotinib and trabectedin

• Aliskiren – for high blood pressure

• Colchicine – for gout

• Everolimus – usually given after an organ transplant

• Fentanyl – a strong painkiller

• Rivaroxaban – a medicine to thin blood

• Salmeterol – for asthma and other breathing problems

• Tamsulosin - for urinary incontinence in men

• Vardenafil – for erection problems Also, upon completing your course of Sporanox-Pulse, do not take any of the medicines listed above for 2 weeks.

Do not take any of following medicines 2 weeks before and while you are

taking Sporanox-Pulse unless your doctor tells you otherwise:

• Medicines for tuberculosis called rifampicin, rifabutin or isoniazid

• Medicines for epilepsy called carbamazepine, phenytoin or phenobarbital

• Medicines to treat viral infections called efavirenz or nevirapine Tell your doctor before taking, or if you are already taking, any of the following medicines. They may stop Sporanox-Pulse from working properly Your doctor may need to alter the dose of Sporanox-Pulse or your other

medicine:

• Strong painkillers called alfentanil, buprenorphine (by injection or under your tongue) and oxycodone

• Medicines for indigestion, stomach ulcers or heartburn can affect the stomach producing acid. There must be enough acid in your stomach to make sure that your body can use the medicine. For this reason you should wait at least an hour after taking one of these other medicines before taking Sporanox-Pulse or wait for two hours after taking Sporanox-Pulse before taking any of these other medicines. If you take medicines that stop the production of stomach acid, you should take Sporanox-Pulse with a drink of cola (not diet cola)

• Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, alprazolam or brotizolam

• Medicines used in the treatment of cancer such as bortezomib, busulphan, docetaxel, erlotinib, ixabepilone, lapatinib, trimetrexate and a group of medicines known as ‘vinca alkaloids’

• Medicines for conditions affecting thoughts, feelings and behaviour called aripiprazole, haloperidol, perospirone, quetiapine, ramelteon and risperidone

• Medicines to thin the blood (anticoagulants) such as warfarin, cilostazol and dabigatran

• Medicines for HIV infection such as ritonavir, darunavir, indinavir fosamprenavir and saquinivir. (They are called ‘antiviral protease inhibitors’.) Also maraviroc

• Medicines for bacterial infections called ciprofloxacin, clarithromycin or erythromycin

• Medicines that act on the heart and blood vessels called nadolol, digoxin, cilostazol or ‘calcium channel-blockers’ such as dihydropyridines or verapamil

• Medicines for inflammation, asthma or allergies (given by mouth or injection) called methylprednisolone or fluticasone, budesonide or dexamethasone

• Medicines that are usually given after an organ transplant called ciclesonide, ciclosporin, tacrolimus, rapamycin (also known as sirolimus) or temsirolimus.

• Medicines to treat and overactive bladder – fesoterodine, imidafenacin, solifenacin or tolterodine

• Alitretinoin (by mouth) – for eczema

• Aprepitant and domperidone – to stop you feeling and being sick

• Atorvastatin – to lower cholesterol

• Cinacalcet – for an over active parathyroid gland

• Ebastine - for allergy

• Eletriptan - for migraine headaches

• Mozavaptan or tolvaptan– for low sodium blood levels

• Praziquantel – for treatment of worms

• Reboxetine - for depression

• Repaglinide or saxagliptin - for diabetes

• Midazolam - to help you relax or sleep when given into a vein

• Sildenafil and tadalafil – for erection problems Tell your doctor before taking, or if you are already taking any of the above.

They may need to alter the dose of Sporanox-Pulse or your other medicine.

Taking Sporanox-Pulse with food and drink Always take Sporanox-Pulse straight after a meal as this helps your body to use the medicine.

Pregnancy and breast-feeding

• Do not take Sporanox-Pulse if you are pregnant. You should use contraception to make sure that you do not become pregnant when taking this medicine

• The medicine in Sporanox-Pulse stays in your body for some time after you have stopped taking it. After your treatment has finished, you must use contraception up until your next period (menstrual bleed). Ask your doctor for advice on what type of contraception to use

• If you become pregnant after starting a course of Sporanox-Pulse, stop taking them and tell your doctor straight away

• Do not breast-feed if you are taking Sporanox-Pulse, as small amounts of the medicine could pass into your milk. Ask your doctor for advice Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines Sporanox-Pulse can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms do not drive or use machines.

Important information about some of the ingredients of Sporanox-Pulse Sporanox-Pulse contains sucrose. If your doctor has told you that you are intolerant of some sugars, contact them before taking this medicine.

3. How to use Sporanox-Pulse Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking Sporanox-Pulse

• Always take Sporanox-Pulse straight after a meal as this helps your body to use the medicine

• Swallow the capsules whole with some liquid

• There must be enough acid in your stomach to make sure that your body can use the medicine. Medicines for indigestion, stomach ulcers or heartburn can affect the stomach producing acid. For this reason you should wait two hours after taking Sporanox-Pulse before taking any of these other medicines. If you do take medicines that stop the production of stomach acid, you should take Sporanox-Pulse with a drink of cola How much to take Your doctor will tell you how many Sporanox-Pulse capsules to take and for how long. They may recommend the following treatment courses.

Skin infections on hands or feet

• Take 2 capsules of Sporanox-Pulse twice a day for one week Fingernail infections only (see table below)

• Week 1: take 2 capsules of Sporanox-Pulse twice a day for this week

• Weeks 2, 3 and 4: do not take Sporanox-Pulse for these next 3 weeks

• Week 5: take 2 capsules of Sporanox-Pulse twice a day for this week.

This completes the treatment course Toenail infections with or without fingernail infections (see table below)



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