ITRACONAZOLE 100MG CAPSULES

Active substance: ITRACONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
Sporanox® Capsules / Sporanox® 100mg Capsules / Itraconazole 100mg Capsules
(itraconazole)
Your medicine is known by one of the above names, but will be referred to as
Sporanox Capsules throughout this:
Patient Information Leaflet
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.
In this leaflet:
1) What Sporanox Capsules are and what they are used for
2) What you need to know before you use Sporanox capsules
3) How to use Sporanox Capsules
4) Possible side effects
5) How to store Sporanox Capsules
6) Contents of the pack and other information

1) What Sporanox Capsules are and what they are used for
Sporanox capsules contain a medicine called itraconazole. This belongs to a
group of medicines called ‘antifungals’.
Sporanox capsules are used for infections caused by fungi or yeasts. They
are used for:
 Infections of the mouth or vagina causing ‘thrush’
 Skin infections
 Infections affecting other parts of the body
Patches of skin may take a few weeks to completely clear up after you have
finished your treatment with Sporanox capsules. Finger and toe nails may
take several months to completely clear up. This is because your skin or nail
will only look normal after new skin or nail has grown, even though the
medicine has killed the fungus that caused the infection.

2) What you need to know before you use Sporanox capsules
Do not use Sporanox Capsules if:
 You are allergic to anything in Sporanox capsules (listed in section 6
below)
 You are pregnant or could become pregnant unless your doctor has told
you to (see ‘Pregnancy and breast-feeding’ 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 capsules.
Warnings and precautions
Check with your doctor or pharmacist before using this medicine if:
 You have ever had kidney problems. Your dose of Sporanox capsules
may have to be changed
 You have ever had liver problems such as yellow skin (jaundice). Your
dose of Sporanox capsules 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 capsules and tell your doctor
straight away
 You have ever had a heart problem including heart failure (also called
congestive heart failure or CHF). Sporanox capsules could make it worse.
If after taking this medicine you get any of the following:
 shortness of breath
 unexpected weight gain
 swelling of your legs or tummy
 feel unusually tired
 wake up short of breath at night
stop taking Sporanox capsules 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 capsules.
Children and the elderly
Sporanox capsules are not normally given to children under the age of 12 or
the elderly. However, your doctor may prescribe them in special cases.
Blood tests
If your Sporanox capsules course is for more than one month, your doctor
may want to check your liver by testing your blood.
Other medicines and Sporanox capsules
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 Sporanox
capsules 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, disopyramide,
dronedarone or dofetilide



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 capsules and tell your doctor if you are taking
any of the above. Also, upon completing your course of Sporanox capsules,
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 capsules 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 capsules, 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 capsules 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 capsules from working
properly. Your doctor may need to alter the dose of Sporanox capsules 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 capsules or wait for two hours after taking
Sporanox capsules before taking any of these other medicines. If you
take medicines that stop the production of stomach acid, you should take
Sporanox capsules 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
and cilostazol or ‘calcium channel-blockers’ such as dihydropyridines and
verapamil
 Medicines for inflammation, asthma or allergies (given by mouth or
injection) called methylprednisolone, 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
Meloxicam – to reduce inflammation and pain
Midazolam - to help you relax or sleep when given into a vein
Sildenafil and tadalafil – for erection problems

4) Possible side effects
Like all medicines, Sporanox capsules can cause side effects, although not
everybody gets them.

Pregnancy and breast-feeding
 Do not take Sporanox capsules if you are pregnant unless your doctor
has told you to. You should use contraception to make sure that you do
not become pregnant when taking this medicine
 The medicine in Sporanox capsules stays in your body for some time
after you have stopped taking them. 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 capsules,
stop taking them and tell your doctor straight away
 Do not breast-feed if you are taking Sporanox capsules, as small amounts
of the medicine could pass into your milk. Ask your doctor for advice

Stop using Sporanox capsules and tell your doctor straight away if you
notice or suspect any of the following. You may need urgent medical
treatment.
 Sudden signs of allergy such as rash, hives (also known as nettle rash or
urticaria), severe irritation of your skin, swelling of the face, lips, tongue or
other parts of the body. These may be signs of a severe allergic reaction.
This only happens in a small number of people
 Severe skin disorders with peeling and/or rashes with small pustules (with
a fever) or blistering of the skin, mouth, eyes and genitals, with fever,
chills, aching muscles and generally feeling unwell. (This occurs rarely)
 A tingling sensation, numbness or weakness in your limbs. (This occurs
rarely)
 Severe lack of appetite, feeling sick (nausea), being sick (vomiting),
unusual tiredness, stomach pain, muscle weakness, yellowing of your
skin or whites of your eyes (jaundice), unusually dark urine, pale stools or
hair loss. These may be signs of a liver problem. (This only happens in a
small number of people)
 Shortness of breath, unexpected weight gain, swelling of your legs or
abdomen, feeling unusually tired or waking up short of breath at night.
These may be signs of heart failure. Shortness of breath can also be a
sign of fluid on the lungs. (This occurs rarely)

Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.

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

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

Common (affects less than 1 in 10 people)
 Stomach ache, feeling sick (nausea)
 Headache

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

Uncommon (affects less than 1 in 100 people)
 Problems with periods
 Sinusitis, runny nose, coughs and colds
 Constipation, diarrhoea, wind, being sick (vomiting), indigestion

3) How to use Sporanox Capsules

Rare (affects less than 1 in 1000 people)
 Increases in liver function tests (shown by blood tests)
 Unexpected passing of urine or need to urinate (pass water) more often
 Problems with sight including blurred vision and double vision
 Change in taste
 Certain blood disorders which may increase the risk of infections
 Ringing in your ears
 Hearing loss (may be permanent)
 Severe upper stomach pain, often with nausea and vomiting
(inflammation of the pancreas)
 Swelling due to fluid under the skin
 Unusual hair loss or thinning (alopecia)
 High levels of triglycerides in the blood (shown by blood tests)
 Red, itchy, flaking or peeling skin
 Sensitivity of the skin to light
 Erection difficulties
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

Tell your doctor before taking, or if you are already taking any of the above.
They may need to alter the dose of Sporanox capsules or your other
medicine.
Taking Sporanox capsules with food and drink
Always take Sporanox capsules straight after a meal as this helps your body
to use the medicine.

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 capsules
 Always take Sporanox capsules 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 capsules before taking any of
these other medicines. If you do take medicines that stop the production
of stomach acid, you should take Sporanox capsules with a drink of cola
How much to take
Your doctor will tell you how many Sporanox capsules to take and for how
long. They may recommend the following treatment courses.
Yeast infection of the vagina (thrush)
 Take 2 capsules in the morning and two capsules 12 hours later for one
day only
Yeast infection of the mouth (oral thrush)
 Take 1 capsule each day for 15 days
Fungal infections of the skin
The dosage depends on your infection. Your doctor might tell you to take:
 2 capsules each day for 7 days, or
 1 capsule each day for 15 days, or
 1 capsule each day for 30 days

5) How to store Sporanox Capsules






Keep all medicines out of the sight and reach of children.
Do not use after the expiry date printed on the carton label or blister strip.
The expiry date refers to the last day of that month.
Store below 30°C in a dry place and protected from light.
If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

Fungal infections in other parts of the body
Your doctor will tell you how many Sporanox capsules to take and for how
long depending on your infection.

6) Contents of the pack and other information

If you take too much of your medicine
If you take more Sporanox capsules than you were told to, talk to your doctor
or go to the nearest hospital casualty department straight away.

Each capsule also contains the following: sucrose, maize starch, liquid
glucose, hypromellose, macrogol, gelatin, titanium dioxide (E171), indigo
carmine (E132) and erythrosine (E127)

If you forget to take Sporanox capsules
 If you forget to take your capsules, take them as soon as you remember.
However, if it is nearly time for the next capsules, skip the missed
capsules
 Do not take a double dose to make up for a forgotten dose

What Sporanox Capsules looks like and contents of the pack
Sporanox Capsules are hard gelatin capsules that have a pink transparent
body and opaque blue cap with no print.

When to stop using Sporanox capsules
Keep taking Sporanox capsules for as long as your doctor has told you. Do
not stop your treatment just because you feel better.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

What Sporanox Capsules contains:
Each capsule contains 100mg of the active ingredient itraconazole.

Sporanox Capsules are available as blister packs of 4, 15 or 60 capsules.
PL 10383/0482

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Janssen Biotech N.V., Lammerdries, 55,
B-2250 Olen, Belgium. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue
Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 05.09.2013
Sporanox® is a registered trademark of Janssen-Cilag group of companies.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)