Itraconazole 100mg Capsules
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000
itraconazole
Read all of this leaflet carefully before you start taking 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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 Itraconazole Capsules are and what they are used for
2. What you need to know before you take Itraconazole Capsules
3. How to take Itraconazole Capsules
4. Possible side effects
5. How to store Itraconazole Capsules
6. Contents of the pack and other information
Itraconazole capsules contain a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’.
Itraconazole capsules are used for infections caused by fungi or yeasts. They are used for:
• Infections of the mouth or vagina causing ‘thrush’
• Skin and nail infections
Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Itraconazole. 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.
Do not take Itraconazole
• if you are allergic to itraconazole or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking any of the following medicines:
- medicines that are degraded via the enzyme cytochrome P450 3A4 and which can change the heart rhythm, such as
- astemizole, mizolastine, terfenadine,
medicines against allergies
- bepridil, a medicine against narrowed heart vessels
- quinidine, dofetilide, medicines against disorders in the heart rhythm
- cisapride, a stomach and bowel agent
- levacetylmethadole or levomethadyl,
used for the therapy of opiate dependents
- pimozide and sertindole, used in schizophrenia
- certain medicines to lower cholesterol levels, such as atorvastatin, lovastatin and simvastatin
- triazolam, a medicine against sleep disturbances
- midazolam for oral intake, a medicine for sedation before examinations, or operations or in intensive care units
- dihydroergotamine, used in case of low blood pressure or certain headaches
- ergometrine or ergonovine, methylergometrine or methylergonovine, medicines staunching bleeding used after birth
- ergotamine and eletriptan, medicines against migraine
- nisoldipine a medicine against high blood pressure and narrowed heart vessels
• in case of signs of heart dysfunction or previous heart failure, except for the treatment of life-threatening or serious fungal infections
Warnings and precautions
Talk to your doctor before taking Itraconazole if any of the following items applies to you:
• Taking other medicines
See also section “Other medicines and Itraconazole”
• Heart problems or if you have had heart problems in your medical history. Immediately inform a doctor if shortness of breath, unexpected weight gain, swollen legs or swollen abdomen, unusual exhaustion occur or if an inability to stay asleep newly occurs
• Lowered acid content in the stomach
• In patients with too little gastric juice, in certain AIDS patients or in case of drug use to prevent the production of gastric acid, a coke drink is recommended when taking Itraconazole.
Medicines that neutralize gastric acid, such as aluminium hydroxide, should be taken 2 hours at the earliest after taking Itraconazole.
• Increased liver enzymes or existing liver disease
• Treatment may be started only if the expected benefit is higher than the risk of liver damage. In such cases, your doctor will monitor the liver enzymes and adjust the dose, if necessary.
• Impaired kidney function
• Your doctor will adjust the dose, if necessary.
• Suppressed defence system, such as incase of a reduced number of white blood cells, AIDS or after organ transplantations
• AIDS patients who are treated because of inner fungal infections and who are at risk of relapse.
• The attending physician will check whether continuous therapy is necessary.
• Previous allergic reactions to medicines for the therapy of fungal infections. Medicines the active substances of which end with “azole” are predominantly concerned.
• Children and elderly. No sufficient data is available to recommend the use of Itraconazole in children and elderly patients unless the potential benefit outweighs the
risks.
• Women who may become pregnant need to use contraception while taking Itraconazole (see section ‘Pregnancy and breast-feeding’ below).
Children and the elderly
Itraconazole is not normally given to children or the elderly. However, your doctor may prescribe it in special cases.
Other medicines and Itraconazole
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
• Medicines listed further above under “Do not take Itraconazole”.
Concomitant treatment with these medicines and Itraconazole must not be performed.
• Concomitant use with Itraconazole is not recommended when taking:
- rifampicin, rifabutin, medicines against tuberculosis and leprosy
- phenytoin, a medicine against convulsive attacks and nerve-induced states of pain
- carbamazepine, phenobarbital
medicines against convulsive attacks and certain pain
- isoniazid, a medicine against tuberculosis and leprosy
- medicines containing St. John’s wort, used in mild to moderate depression
• Certain medicines can increase the agent content of itraconazole in the body:
- clarithromycin, erythromycin, so-called antibiotics
- indinavir, ritonavir, medicines against HIV
• Medicines to reduce or neutralize gastric acid. See also section “Take special care with Itraconazole”.
The blood concentrations, effects or side effects should be monitored in association with the following medicines. If necessary, the doctor will reduce their dosage in case of concomitant use with Itraconazole.
• Medicines inhibiting blood coagulation,
such as phenprocoumon or warfarin
• Indinavir, ritonavir, saquinavir and similar medicines against HIV
• Busulfan, docetaxel, trimetrexate and vinca alkaloids. These are medicines for cancer therapy.
• Verapamil, nifedipine and similar medicines against high blood pressure
• Ciclosporin, rapamycin, also known as sirolimus, tacrolimus, medicines to suppress the defence system and to avoid rejection of transplanted organs
• Certain cortisones such as budesonide, dexamethasone, fluticasone and methylprednisolone, used against various inflammations
• Alfentanil, a pain-killer during anaesthesia
• Alprazolam, a medicine against states of excitation and anxiety
• Brotizolam, a medicine against sleep disturbances marked by difficulties in falling asleep and awakening too early
• Buspirone, a medicine against states of excitation and anxiety
• Carbamazepine, a medicine against convulsive attacks and certain pain
• Cilostazole, a medicine against narrowing or occlusions of leg or arm arteries
• Digoxin, a medicine against heart failure
• Disopyramide, a medicine against disturbed heart rhythm
• Ebastine, a medicine against allergies and itching
• Fentanyl, a potent painkiller
• Halofantrine, a medicine against malaria
• Midazolam, injected into the vein, for sedation before examinations or operations
• Reboxetine, a medicine against depression
• Repaglinide, a medicine in case of diabetes
• Rifabutin, a medicine against tuberculosis and leprosy
Pregnancy and breast-feeding
• Itraconazole must not be used during pregnancy, with the exception of life-sustaining therapies of inner fungal infections if the potential benefit outweighs the risks.
Experience regarding use during pregnancy is low; cases of malformations are known. Short-term therapies (in fungal infections of female genital organs) in the first three months of pregnancy did not lead to an increased risk of malformations.
For women who may become pregnant:
Use contraception while taking this medicine and until your next period after the end of treatment.
Tell your doctor straight away if you become pregnant while taking this medicine.
• Itraconazole may be taken during breast-feeding only after the doctor has allowed it. Only very low quantities of itraconazole pass into breast milk.
Ask your doctor or pharmacist for advice before taking/using any medicine.
Continued on the next page >>
Driving and using machines
Itraconazole may make you feel dizzy and you may experience visual disturbances or hearing loss. Do not drive or operate machinery if this applies to you.
Itraconazole contains the sugar sucrose (saccharose)
This medicine contains sucrose (saccharose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Itraconazole.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many Itraconazole capsules to take and for how long.
The recommended dose is:
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 14 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
Fungal infections of the nails
• 2 capsules each day for 3 months
It is recommended for safety reasons to limit the duration of therapy in case of fungal infection of the nails to a maximum of 3 months.
Method of use
• Always take Itraconazole 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 Itraconazole before taking any of these other medicines. If you do take medicines that stop the production of stomach acid, you should take Itraconazole with a drink of cola.
If you take more Itraconazole Capsules than you should
Please immediately consult your doctor in this case.
If you forget to take Itraconazole Capsules
Take the forgotten dose as soon as you remember, unless it is nearly time for the next dose. Do not take a double dose if you have forgotten to take your previous dose.
If you stop taking Itraconazole Capsules
Terminate therapy or change the dosage only after explicit agreement of your doctor. Otherwise, the therapeutic success could be endangered.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
• being sick (vomiting)
• diarrhoea
• constipation
• indigestion
• wind
• disturbed taste sensation
• increase in liver enzymes
• nettle rash (urticaria)
• hair loss
• itching
• problems with menstrual periods
• swelling due to fluid under the skin (oedema)
Rare, occurs in 1 to 10 per 10,000 users
• reduction in the number of white blood cells which may increase the risk of infections
• furry sensation in your skin (hypoaesthesia)
• visual disturbances
• noises in the ear (tinnitus)
• difficulty breathing
• inflammation of the pancreas
• increase in liver function tests
• need to urinate (empty bladder) more often
• fever
Frequency not known, according to available data
• reduced number of blood platelets and certain white blood cells which may increase the risk of bleeding, bruising or infections (thrombocytopenia, neutropenia)
• serum disease; this disease is a hypersensitivity reaction of the body to foreign substances
• elevated blood fat values of triglycerides
• lowered potassium level in the blood
• blurred vision and double vision
• hearing loss (may be permanent)
• accumulation of liquid in the lung (pulmonary oedema)
• sensitivity to light
• muscle or joint pain
• unexpected passing of urine
• erection disturbances in men
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Storage conditions
Do not store above 25°C.
Store in the original package.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Itraconazole Capsules contain
• The active substance is: itraconazole. Each hard capsule contains 100 mg itraconazole.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Itraconazole and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment. The frequency of these side effects is not known to date.
• severe allergic reactions with signs such as:
- sudden difficulty in breathing, speaking and swallowing
- swelling of the lips, tongue, face and neck
- extreme dizziness or collapse
• severe or itchy skin rash, which may show blistering, peeling and pain in the eyes, mouth or genital organs (life-threatening toxic epidermal necrolysis,
Stevens-Johnson syndrome, acute generalised exenthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis)
• liver damage with possible signs such as
- loss of appetite,
- nausea, vomiting,
- unusual tiredness,
- abdominal pain,
- yellowing of your skin or whites of your eyes (jaundice),
- unusually dark urine, pale stools or
- hair loss.
Severe liver damage including some fatal cases of acute liver failure and inflammation of the liver (hepatitis) have been reportet.
• heart failure with signs such as:
- shortness of breath
- unexpected weight gain
- swelling of legs or abdomen
- feeling unusually tired
- waking up short of breath at night
• nerve disturbances called peripheral neuropathy, which manifest themselves as sensation of numbness, furry sensation or tingling in arms and legs.
Other side effects can occur with the following frequencies:
Common, occurs in 1 to 10 per 100 users
• abdominal pain
• feeling sick (nausea)
• skin rash
Uncommon, occurs in 1 to 10 per 1,000 users
• allergic reactions of different severity
• headache
• dizziness
• sensation of numbness (paraesthesia)
• The other ingredients are:
Sugar spheres, poloxamer 188, hypromellose, titanium dioxide (E171), indigo carmine (E132), gelatine and quinolone yellow (E104).
What Itraconazole Capsules look like and contents of the pack
Opaque green capsules, hard containing yellowish-beige beads.
Itraconazole 100 mg capsules are packed in OPA/Aluminium/PVC-Aluminium blisters
Packs containing 4, 6, 14, 15, 18, 28, 60, 84 and 100 capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Liconsa S.A., 19200 Azuqueca de Henares (Guadalajara), Spain
or
Salutas Pharma GmbH, DieselstraGe 5, D-70839 Gerlingen, Germany
This leaflet was last revised in 10/2013.
SZ00000LT000