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SPORANOX tablets
Each capsule contains the active ingredient: itraconazole 100 milligrams.
The other ingredients are: sugar spheres (sucrose, maize starch, starch syrup), hypromellose and macrogol.
The capsule itself is made up of titanium dioxide, indigotin disulphonate sodium, erythrosine and gelatin.
WHAT SPORANOX IS AND WHAT IT IS USED FOR
SPORANOX CAPSULES are supplied in packs of 6 and 18 capsules.
SPORANOX CAPSULES belong to a group of medicines called "antifungals" (pharmacotherapeutic group J02A). SPORANOX capsules are indicated in the treatment of infections caused by fungi. The infection may be affecting your vagina, skin, mouth, eyes, nails or internal organs.
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BEFORE TAKING SPORANOX
Do not take SPORANOX capsules if
you have an allergy to SPORANOX capsules or any of its ingredients.
you are pregnant (only your doctor, who knows you are pregnant, should decide if you need SPORANOX capsules).
Take special care with SPORANOX capsules:
If you have or have had a liver problem. The dose of SPORANOX capsules may have to be adjusted.
See your doctor immediately if any of the following appears during your course of treatment with SPORANOX capsules: lack of appetite, nausea, vomiting, unusual tiredness, abdominal pain or unusually dark urine.
If you have to take SPORANOX capsules continuously for more than one month, your doctor may ask you to have your blood checked regularly. This is to make sure that your liver is not affected because patients taking this medication continuously may rarely develop liver problems
Tell your doctor if you have a heart problem. If he/she decides to prescribe SPORANOX capsules for you, he/she may give you instructions on symptoms to watch out for. See or let your doctor know immediately if you have shortness of breath, unexpected weight gain, swelling of the legs and/or abdomen, unusual fatigue or begin to wake up at night.
If you have a kidney problem as the dose of SPORANOX capsules may have to be adjusted.
You should also tell your doctor immediately if you have any unusual feelings of tingling, numbness or weakness in your hands or feet whilst taking SPORANOX capsules.
If in the past you have had an allergic reaction to another antifungal product.
Taking SPORANOX capsules with food and drink:
Do not take SPORANOX capsules during meals; always take SPORANOX immediately after a main meal.
If you take medicines that suppress the production of stomach acid, you should take your SPORANOX capsules with a cola beverage.
Do not drink alcohol during your course of treatment with SPORANOX capsules.
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Pregnancy:
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take SPORANOX capsules if you are pregnant. If you are of child bearing age and could become pregnant, you should take adequate contraceptive precautions to make sure that you do not become pregnant while you are taking your medicine.
As SPORANOX capsules remains in the body for some time after you stop taking it, you should continue to use some form of contraception until your next period after your treatment with SPORANOX capsules has finished.
Breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
Consult your doctor before taking SPORANOX capsules if you are breastfeeding, as small amounts of the medicine could be present in your milk
Use in children:
SPORANOX capsules should not be prescribed for use in children. However, your doctor may use his judgement to prescribe it in special cases.
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Effects on ability to drive and use machines
SPORANOX capsules should not affect your ability to drive and use machines, unless you feel dizzy.
Taking other medicines with SPORANOX capsules
Inform your doctor or pharmacist if you are taking or have recently taken any other medications including those bought without a prescription.
Always tell your doctor or pharmacist if you are taking any other medications. Some medications cannot be taken at the same time as SPORANOX capsules; if certain medications are taken concomitantly changes may need to be made (for example, your doctor may need to alter the dose).
You should not take SPORANOX capsules if you are taking any of the following medicines:
Certain medications used to treat allergies, namely terfenadine, astemizole and mizolastine.
Cisapride, a medication used to treat digestive problems.
Certain cholesterol lowering drugs, for example, simvastatin and lovastatin.
Medicines taken to help you to sleep, midazolam and triazolam.
Pimozide, a drug used to treat mental disorders.
Certain medicines used to treat irregular heart beat rhythms, namely quinidine and dofetilide.
Certain medications may decrease the action of SPORANOX capsules. This applies mainly to products used to treat epilepsy (for example, carbamazepine, phenytoin and phenobarbital) and certain antibiotics used to treat tuberculosis (such as rifampicin, rifabutin and isoniazid). Therefore you must always inform your doctor if you are using any of these medications, as he/she may need to adjust the dose or adapt your treatment.
Your doctor may need to alter the dose of SPORANOX capsules or certain other medicines when taken concomitantly. These include:
- Certain antibiotics known as clarithromycin and erythromycin.
- Certain drugs that act on the heart and blood vessels (digoxin and some calcium channel-blockers);
- Drugs that slow down blood clotting or thin the blood;
- Methylprednisolone, a drug given by mouth or injection for inflammation;
- Ciclosporin, tacrolimus and rapamycin (also known as sirolimus), which are usually given after an organ transplant;
- Certain HIV protease inhibitors;
- Certain medicines used in the treatment of cancer;
- Certain medicines used to treat anxiety or help you sleep (tranquillisers), namely buspirone, alprazolam and brotizolam;
- Ebastine, a drug used to treat allergies;
- Reboxetine, a drug used to treat depression.
There must be sufficient stomach acid to ensure that SPORANOX capsules is properly absorbed by the body. Therefore, medicines that neutralise stomach acid should not be taken sooner than 2 hours after SPORANOX capsules. For the same reason, if you take medicines that stop the production of stomach acid, you should take your Sporanox with a drink of cola.
If you are unsure, please ask your doctor or your pharmacist.
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HOW TO TAKE SPORANOX
Follow these instructions unless indicated otherwise by your doctor.
Always remember to take your medication.
Your doctor will determine the duration of your treatment with SPORANOX capsules. Do not suspend treatment before the period recommended by your doctor.
If you have the impression that the effect of SPORANOX capsules is too strong or too weak, talk to your doctor or pharmacist.
Always take SPORANOX capsules immediately after a meal as this helps the body absorb the medicine. Swallow the capsules whole with some liquid. The amount of capsules and length of treatment varies depending on the type of infection and where the infection is located. Your doctor will tell you exactly how many SPORANOX capsules you should take.
The most common treatment schedules are as follows:
Nail infections: depending on your individual needs your doctor may choose to prescribe a continuous nail treatment or pulse nail treatment.
- Continuous nail treatment:
- Pulse nail treatment:
A pulse nail treatment consists of two capsules twice daily for one week. After that, stop taking SPORANOX for 3 weeks. Then the cycle is repeated, once for fingernails and twice for toenail infections (with or without fingernail infections). (See below).
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Toenails (with or without fingernails)
Week 1: Take 2 capsules twice daily.
Week 2, 3, 4: No SPORANOX.
Week 5: Take 2 capsules twice daily.
Week 6, 7, 8: No SPORANOX.
Week 9: Take 2 capsules twice daily.
Week 10: Stop treatment.
Fingernails only
Week 1: Take 2 capsules twice daily.
Week 2, 3, 4: No SPORANOX.
Week 5: Take 2 capsules twice daily.
Week 6: Stop.
With skin infections, the patches on your skin may only disappear completely a few weeks after you have finished your treatment with SPORANOX capsules. This is characteristic of the patches produced by fungus. This is because your skin will only appear normal once new skin has grown, even though SPORANOX capsules has already killed the fungus causing the infection.
Improved nails may not be obvious until 6 - 9 months after the treatment period is finished because this medication only kills the fungus itself and it usually takes several months to grow a new nail. Therefore do not worry if you do not notice any improvement: the medication keeps working inside your nail fighting the fungal infection for several months. Therefore discontinue treatment when indicated by your doctor even if you do not notice an improvement.
Internal organ infections: Higher doses and longer treatments may be needed.
Always follow your doctor's instructions; he will adjust your treatment for your individual needs.
If you take more SPORANOX capsulesŪ than you should:
If you, or anyone else, take more SPORANOX capsules than you were told to, contact your doctor immediately.
He/she will take the appropriate steps.
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POSSIBLE SIDE EFFECTS
Like all medicines, SPORANOX capsules can have side effects.
You may experience the following symptoms during treatment with SPORANOX capsules: upset stomach, nausea, abdominal pain and constipation.
Treatment with SPORANOX capsules may also cause headache, changes in menstrual bleeding and dizziness. Hypersensitivity to SPORANOX capsules is very rare. However, skin rash, itching, shortness of breath and/or a swollen face may be experienced. If you notice any of these symptoms stop taking SPORANOX capsules and contact your doctor immediately. Very rarely a tingling sensation in the limbs or a severe skin disorder can occur. If this should happen, stop taking SPORANOX capsules and contact your doctor.
See or let your doctor know immediately if you have shortness of breath, unexpected weight gain, swelling of the legs or abdomen, unusual fatigue or begin to wake up at night.
One or more of the following symptoms may infrequently occur, especially in patients taking SPORANOX capsules for long continuous periods: muscle weakness, yellowing of the skin, dark urine and pale stools or hair loss. In such cases, stop taking the medication and see your doctor immediately.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
STORAGE OF SPORANOX
Keep SPORANOX capsules out of the reach and sight of children.
Store the capsules in their carton at room temperature (15-30°C) in a dry place.
Expiry
Do not use SPORANOX capsules after the expiry date printed on the packaging.
/ Sporanox - Itraconazol BEXAL /
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