FUNGOFUNAL caps. 100 mg. 15 caps

FUNGOFUNAL WHAT IS AND WHAT IT IS USED

Fungofunal belongs to a group of medicines called antifungals.

Fungofunal used in cases of:

 Superficial fungal infections if external treatment is not effective or appropriate.

These include fungal infections:

  Skin

 Tinea versicolor. This is a fungal infection of the skin, which flakes are formed after grooming. Affected parts of the skin are paler or darker than normal skin.

  Fungal infections of the mucous membranes and / or internal organs caused by certain types of fungus.

 WHAT YOU SHOULD KNOW BEFORE YOU TAKE FUNGOFUNAL

Do not take Fungofunal

 if you are hypersensitive (allergic) to itraconazole or any of the other ingredients.

  if you are taking any of the following:

  Medications that are broken down by the enzyme cytochrome P450 ZA4 and which may change heart rhythm, astemizole, mizolastine, terfenadine, bepridil allergy medications, medicine for heart constricted vessels quinidine, dofetilide, medicine for heart rhythm disturbances cisapride, vehicle the stomach and intestines, or levatsetilmetadol levometadir used to treat opiate dependence pimozide and sertindole used in schizophrenia

  Some drugs to lower cholesterol such as atorvastatin, lovastatin and simvastatin

  Triazolam cure for sleep disorders

  Midazolam oral intake, medication to calm (sedation) before examinations or operations or intensive care

Dihydroergotamine used in case of low blood pressure or certain types of headaches

 Ergometrine or ergonovine, methylergonovine or metilergometrin, medicines used to stop bleeding after childbirth

 Ergotamine and eletriptan, medicines for migraine

  Nisoldipine, a medicine for high blood pressure and heart constricted vessels

  Vardenafil in men over 75 years of age, a drug to treat erectile dysfunction

  In case of signs of severe cardiac dysfunction or prior heart failure, except for the treatment of life-threatening or serious fungal infections

Take special care with Fungofunal

Always inform your doctor if any of the following apply to you:

  Taking other medicines

See also section "Taking other medicines"

  Heart problems or if you have heart problems in medical history

Immediately tell the doctor if there is shortness of breath, sudden weight gain, swelling of the legs or abdominal swelling, unusual tiredness or first arises inability to sleep.

  Decreased content of heartburn

In patients with little gastric juice, some AIDS patients or in case of use of drugs that prevent the formation of gastric acid, it is recommended to drink drive when taken Fungofunal. Medicines that neutralize stomach acid, such as aluminum hydroxide, should be taken as early as 2 hours after taking Fungofunal.

  Elevated liver enzymes, or previous liver disease

Treatment can be initiated only if the expected benefit is greater than the risk of liver damage. In these cases, your doctor will monitor liver enzyme levels and adjust if necessary.

  Impaired renal function

Your doctor will adjust the dose if necessary.

  suppress protective system, in order to reduce the number of white blood cells, AIDS or after organ transplants

  Patients with AIDS who are treated for internal fungal infections and are at risk of relapse. Your doctor will determine whether you need treatment.

 Previous allergic reactions to drugs used to treat fungal infections.

It's mostly for drugs, active substances of which end in "azole".

 Children and the elderly.

There is not enough data available to recommend the use of Fungofunal in children and elderly patients unless the potential benefit outweighs the risk.

  Women of childbearing potential must use contraception while taking Fungofunal (see section "Pregnancy" below).

Taking other medicines

Please. tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

  Drugs listed above in "Do not take Fungofunal."

Should not be exercised during concomitant treatment with these drugs and Fungofunal.

 Concomitant use not recommended Fungofunal when taken:

  Rifampicin, rifabutin, medicines against tuberculosis and leprosy

 Phenytoin, a medicine against convulsive seizures and nerve-induced pain conditions

  Carbamazepine, phenobarbital, drugs convulsive seizures, and some painful conditions

  Isoniazid, a medicine against tuberculosis and leprosy

 Medicines containing St. John's wort, which is used for mild to moderate depression

  Vardenafil, a drug to treat erectile dysfunction (see "Do not take Fungofunal")

 Some medications can increase the content of itraconazole in the body:

  Clarithromycin, erythromycin, antibiotics so-called

  Indinavir, ritonavir, AIDS medicines

  Medicines to reduce or neutralize stomach acid.

See also "Take special care with Fungofunal."

Blood concentrations, effects or side effects should be observed in connection with the following medicines. If necessary, your doctor will reduce the dose in the case of concomitant use with Fungofunal.

 Drugs preventing blood clotting, such as warfarin or phenprocoumon

  indinavir, ritonavir, saquinavir and similar medicines against AIDS

  busulfan, docetaxel, trimetrexate and vinca alkaloids.

These are treatments for cancer.

  Verapamil, nifedipine and similar drugs for high blood pressure

  Cyclosporin, rapamycin, also known as sirolimus, tacrolimus, drugs to suppress the body's defense system and prevent rejection of transplanted organs

  Atorvastatin and similar drugs to lower cholesterol

  Some cortisone as budesonide, dexamethasone, methylprednisolone used against various inflammations

  Alfentanil, analgesics during anesthesia

  Alprazolam, a drug against the states of agitation and anxiety

  Brotizolam, medicine for sleep disorder characterized by difficulty in falling asleep and waking up too early

  buspirone, a drug against the states of agitation and anxiety

 Carbamazepine, a drug against convulsive seizures, and some painful conditions

  cilostazol, a medicine against a narrowing or blockage of arteries in the legs or arms

  Digoxin, a medicine against heart failure

 Disopyramide, medicine for heart rhythm disturbances

  Ebastin, cure for allergies and itching

  Eletriptan, a drug for migraine

  Fentanyl, a powerful painkiller

  halofantrine, a medicine against malaria

  Midazolam, injected into a vein, for sedation before examinations or operations

  Reboksetin, a medicine for depression

  Repaglinide medication for diabetes

  Rifabutin, a medicine against tuberculosis and leprosy

Pregnancy and lactation

  Itraconazole should not be used during pregnancy except for life-support therapy for internal fungal infections, the potential benefit outweighs the risks.

Experience in the use during pregnancy is small, some cases of malformations. The short-term treatment (fungal infections of the female genital organs) during the first three months of pregnancy does not lead to an increased risk of malformations.

For women of childbearing age:

Use contraceptive measures during treatment and until your next cycle after the end of therapy.

Tell your doctor immediately if you become pregnant while taking this medicine.

  Fungofunal can be taken during lactation only after the doctor has to do.

Only very small amounts of itraconazole pass into breast milk.

Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery

From Fungofunal may feel dizzy and experience visual disorders or loss of hearing. Do not drive or operate machines if this happens to you.

Important information about some of the ingredients of Fungofunal

This medicine contains sugar (sucrose). If you have been notified by your doctor that you have an intolerance to some sugars, consult your doctor before taking Fungofunal.

 HOW TO TAKE FUNGOFUNAL

Always Fungofunal exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.

Unless otherwise prescribed by a doctor, the usual dose and duration of treatment are:

Superficial fungal infections

 Skin

1 capsule once a day for 2 weeks

 the palms and soles of feet

1 capsule once daily for 4 weeks

  tinea versicolor

2 capsules once daily for 7 days

The doctor can double the dose in the case of repressed defense system, such as reducing the number of white blood cells, AIDS or after organ transplantation.

  Itraconazole remains in the skin significantly longer than in blood. Therefore, fungal skin infections optimum cure is achieved 2-4 weeks after

treatment.

Fungal infections of the mucous membranes and / or internal organs caused by:

  fungus Aspergillus hyphae

2 capsules once daily for 2 to 5 months

If the fungus is spread to adjacent tissues or in the body, 2 capsules twice daily

  Drozhdepodobni fungus Candida

1-2 capsules once daily for 3 weeks to 7 months

If the fungus is spread to adjacent tissues or in the body, 2 capsules twice daily

• Fungi Histoplazma

2 capsules once daily for 8 months

Directions for use:

Take the capsules without chewing them with a glass of water after eating, and if possible, always at the same time of day.

Take the capsules morning and evening if your dose twice daily.

Please consult your doctor or pharmacist if you have the impression that the effect of Fungofunal is too strong or too weak.

If you take more than the dose Fungofunal:

In this case, immediately consult your doctor.

If you forget to take Fungofunal:

Take the missed dose as soon as you remember unless it is soon time for the next dose. Do not take a double dose if you forgot to take the previous dose.

If you stop taking Fungofunal:

Stop treatment or change the dose after the express consent of your doctor. Otherwise, the success of the treatment can be threatened.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

 POSSIBLE SIDE EFFECTS

Like all medicines, Fungofunal can cause side effects, although not everybody gets them.

Immediately stop using Fungofunal and tell your doctor if you notice any of those described below. You may need urgent medical attention. The incidence of these adverse reactions is not known to date.

 severe allergic reactions with symptoms such as:

 Sudden difficulty in breathing, speaking and swallowing

Swelling of the lips, tongue, face and neck

 Extreme dizziness or collapse

  heavy or itchy skin rash that may develop blisters, peeling and pain in the eyes, mouth or genitals (life-threatening toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis)

  liver damage with possible symptoms such as:

 Loss of appetite,

 Nausea, vomiting,

 Unusual fatigue,

Abdominal pain

 Yellowing of the skin or whites of the eyes (jaundice)

 Unusually dark urine, or pale stools

 Hair loss.

There have been severe liver injury, including some fatal cases of acute liver failure and liver inflammation (hepatitis).

  heart failure, with symptoms such as:

 Shortness of breath

 Unexpected weight gain

Swelling of the legs or abdomen

Feeling unusual fatigue

 Wake up short of breath at night

 nerve damage called peripheral neuropathy, which is manifested as a feeling of numbness, decreased sensation or numbness in the hands and feet.

Other side effects may occur with the following frequencies:

Common, seen in about 1 in 10 of 100 patients

 abdominal pain

 nausea

 rash

Uncommon, seen in about 1 in 10 of 1000 patients

 allergic reactions of varying severity

headache

 dizziness

 feeling of numbness (paresthesia)

 vomiting

 diarrhea

 constipation

 indigestion

 flatulence

 impaired taste

 elevated liver enzymes

 hives (urticaria)

 hair loss

 itching

 menstrual disorders

 swelling due to accumulation of fluid beneath the skin (edema)

Rare, seen in about 1 in 10 of 10,000 patients

 reduced number of white blood cells, which can increase the risk of infections

 reduced skin sensation (hypoesthesia)

 visual disturbances

 ringing in the ears (tinnitus)

 inflammation of the pancreas

 elevated results of liver function tests

 more frequent need to urinate (empty your bladder)

 fever

Not known, can not be estimated from available data

 decreased number of platelets and certain white blood cells, which may increase the risk of bleeding, bruising or infection (thrombocytopenia, neutropenia)

 Serum sickness, this disease is a hypersensitivity reaction of the body to foreign substances

 increased levels of triglycerides (fats) in the blood

 low levels of potassium in the blood

 blurred vision and double vision

 hearing loss (may be permanent)

 accumulation of fluid in the lungs (pulmonary edema)

Sensitivity to light

 muscle or joint pain

 unexpected loss of urine

 disorders of erection in men

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 HOW TO STORE FUNGOFUNAL

Keep out of reach of children.

Do not use after the expiry date stated on the carton and outer carton. The expiry date refers to the last day of that month.

Storage Conditions:

 Do not store above 30 ° C.

  Keep the blister in the outer carton to protect from light.

  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.

 ADDITIONAL INFORMATION

What Fungofunal

  The active substance is itraconazole

One capsule contains 100 mg of itraconazole.

  The other ingredients are:

Gelatin, hypromellose, macrogol, sucrose, corn starch, coloring erythrosine (E127), indigo carmine (E132), titanium dioxide (E 171).

Contents of the pack

Hard gelatin capsules, size 0, filled with white to off-white pellets.

Cap capsule: light blue opaque.

Body: pink, transparent.

  Fungofunal 100 mg capsules are packaged in blister of PVC, Aluminium or PVC / Aluminium-RVDS.