Information: Fluconazol

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1. WHAT IS FLUCONAZOL NORMON 150 mg. HARD CAPSULES AND WHAT IS IT USED FOR
FLUCONAZOL NORMON 150 mg. HARD CAPSULES is available as hard gelatin capsules in packs containing 1 or 4 capsules.
Fluconazole is one of a group of medicines called triazole antifungal agents. These medicines are used to treat a great variety of fungal infections.
FLUCONAZOL NORMON 150 mg. HARD CAPSULES is indicated for the treatment of the following conditions:
- Fungal infections caused by Candida species (called candidiasis). This type of infection may occur at mucosal sites causing: candidiasis of the mouth and throat (oropharyngeal candidiasis), oesophageal candidiasis, non-invasive mucocutaneous infections and bronchopulmonary infections, urinary tract candidiasis, chronic oral atrophic candidiasis.
Systemic infections including infections of the peritoneum, endocardium, pulmonary tracts and eyes may also occur.
Normal hosts and patients with compromised immune function may be treated.
Fluconazole can also be used as maintenance therapy to prevent relapse of oropharyngeal candidiasis in patients with AIDS.
- Infections caused by the fungus Cryptococcus (called cryptococcosis), including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous, etc).
Normal hosts and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. FLUCONAZOL NORMON 150 mg. HARD CAPSULES can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.
- For the prevention of fungal infections in patients with cancer or transplants who are predisposed to such infections as a result of the treatment they are receiving.
- Fungal infections (or deep endemic mycosis) in patients with normal immune function, such as coccidiomycosis, paracoccidiomycosis, sporotrichosis and histoplasmosis.
- Dermatomycosis (infection of the skin or its appendages) such as the different types of tinea.
- Genital candidiasis. Vaginal candidiasis, acute or recurrent and prophylaxis to reduce the incidence of recurrent vaginal candidiasis (3 or more episodes a year). Candidal balanitis.


2. BEFORE YOU TAKE FLUCONAZOL NORMON 150 mg. HARD CAPSULES
" Do not take FLUCONAZOL NORMON 150 mg. HARD CAPSULES:
- FLUCONAZOL NORMON 150 mg. HARD CAPSULES should not be used in patients with known hypersensitivity to fluconazole or to related azole compounds or to any other ingredient within the formulation. - If you are taking any of the following medications:
* Cisapride (a medicine used to treat stomach problems)
* Astemizole (a medicine used to treat allergies)
* Terfenadine (a medicine used to treat allergies) in patients receiving
fluconazole at multiple doses of 400 mg. per day or higher.
Take special care with FLUCONAZOL NORMON 150 mg. HARD CAPSULES:
- Because abnormalities in haematological, hepatic, renal function test results have been observed during treatment with fluconazole.
- Because in rare cases, allergic reactions have been reported.

" Pregnancy
Consult your doctor or pharmacist before taking any medication.
The administration of FLUCONAZOL NORMON 150 mg. should be avoided during pregnancy, except in the case of severe fungal infections and only when your doctor considers that the anticipated benefits outweigh the potential risks to the foetus.

" Lactation
Consult your doctor or pharmacist before taking any medication.
Fluconazole must not be given to nursing mothers.

" Effects on ability to drive and use machines
Fluconazole is unlikely to affect your ability to drive or to operate machinery.

Taking FLUCONAZOL NORMON 150 mg. HARD CAPSULES with other medications:
Inform your doctor or pharmacist if you are taking, or have recently taken any other medication including those which you have bought without a prescription. Some medications, when taken concomitantly with fluconazole may affect the action of fluconazole or vice versa.
Inform your doctor if you are taking any of the following medications:
- Terfenadine and astemizole (medicines used to treat allergies)
- Chlorpropamide, glibenclamide, glipizide, tolbutamide (oral medicines to control diabetes)
- Warfarin and other coumarin-type anticoagulants (medicines used to prevent blood clots)
- Phenytoin (medication used to control epilepsy)
- Oral contraceptives
- Rifampicin and rifabutin (medication used for tuberculosis)
- Benzodiazepines (medicines used to treat severe insomnia and stress) such as midazolam, lorazepam, oxazepam, lormetazepam, etc.
- Alfentanil (general anaesthesia)
- Cyclosporin and tacrolimus (medications used in transplant patients)
- Theophylline (medication used to control asthma)
- Cisapride (medications used to treat stomach problems)
- Statins (medications used to reduce cholesterol)
- Zidovudine and other HIV-protease inhibitors (medications used in HIV-infected patients)
- Hydrochlorothiazide (diuretic medication, i.e. used to treat fluid retention and high blood pressure)

3. HOW TO TAKE FLUCONAZOL NORMON 150 mg. HARD CAPSULES
Follow these instructions when taking this medication unless advised otherwise by your doctor. Remember to take your medication.
This medication and its method of administration have been prescribed for you personally. You should never pass it on to others nor use it to treat other conditions. FLUCONAZOL NORMON 150 mg. HARD CAPSULES should be taken exactly as indicated by your doctor. Strictly follow your doctor's instructions with regards to the dosage and duration of the treatment. Your doctor will determine the dose to be taken depending on your weight and the type of infection to be treated. You must not take more the amount recommended by your doctor. Your doctor will determine the duration of your treatment with FLUCONAZOL NORMON 150 mg. HARD CAPSULES. Do not discontinue treatment before the period recommended by your doctor even if you feel better as your condition may worsen. Since this medication remains in the organism for such a long time it allows for a single dose per day to be administered to treat fungal infections. Take FLUCONAZOL NORMON 150 mg. HARD CAPSULES by mouth. The capsules should be swallowed whole and can be taken with food. Swallow the capsules with plenty of water - a glass of water. In adults:
- For the treatment of skin and mucosal infections the usual dose is 50 to 100 mg. once daily. The duration of the treatment ranges from one week to one month depending on the nature and severity of the fungal infection. For the prevention of relapse of candidiasis of the mouth and throat (oropharyngeal candidiasis) in patients with AIDS, after the patient receives a full course of primary therapy, fluconazole may be administered at a 150 mg. once weekly dose. - For the treatment of invasive fungal infections (systemic candidiasis) the usual dose is 400 mg. on the first day followed by 200 mg. daily. Duration of treatment is based upon the patient's clinical response. - The recommended fluconazole dosage for the prevention of candidiasis is 50 mg. to 400 mg. once daily, based on the patient's risk for developing fungal infection. - For cryptococcal meningitis and cryptococcal infections at other sites, the usual dose is 400 mg. on the first day followed by 200 - 400 mg. once daily. Duration of treatment for cryptococcal infections will depend on the response of the patient, but is usually at least 6 - 8 weeks for cryptococcal meningitis. - For the prevention of relapse of cryptococcal meningitis in patients with AIDS, after the patient receives a full course of primary therapy, fluconazole may be administered indefinitely at a daily dose of 200 mg. - For the prevention of fungal infections in patients at risk as a consequence of receiving chemotherapy or radiotherapy, the dose should be 50 to 400 mg. once daily, based on the patient's condition and severity of the fungal infection. - For deep endemic mycoses, 200 to 400 mg. daily may be required during and up to 2 years. The duration of therapy should be individualized. - For the treatment of tineas the recommended dosage is 50 mg. once daily for 2 to 4 weeks or a single weekly dose of 300 mg. for 2 weeks. For the treatment of nail infections caused by Tinea unguium, the recommended dosage is 150 mg. (1 capsule) once weekly. Treatment should be continued until infected nail is replaced (uninfected nail grows in). - For the treatment of vaginal candidiasis FLUCONAZOL NORMON 150 mg. HARD CAPSULES should be administered as a single oral dose. To reduce the incidence of recurrent vaginal candidiasis, a 150 mg. (1 capsule) once monthly dose may be used. The duration of therapy should be individualized, but ranges from 4 - 12 months. For the treatment of Candidial balanitis FLUCONAZOL NORMON 150 mg. HARD CAPSULES should be administered as a single (1 capsule) oral dose. In children:
As with similar infections in adults, the duration of treatment should be determined by your doctor. FLUCONAZOLE NORMON is administered as a single daily dose. The maximum adult daily dosage should not be exceeded in children. The recommended dosage ranges from 3 to 12 mg. / kg. per day depending on the nature and severity of the fungal infection. For the prevention of fungal infections in immunocompromised patients the dose should be 3 to 12 mg. / kg. daily. Children below 4 weeks of age:
In the first two weeks of life the same mg. / kg. dosing as in older children should be used but administered every 72 hours. During weeks 3 and 4 of life the same dose should be given every 48 hours.

In the elderly:
The normal dose should be used if there is no evidence of renal impairment.

In patients with renal impairment:
In these patients (including children) the dosage schedule should be adjusted by your doctor depending on your kidney function. Patients receiving regular dialysis should take their dose after every dialysis session.

* If you take more FLUCONAZOL NORMON 150 mg. HARD CAPSULES than you should:
If you take more than you should consult your doctor or pharmacist.
In the event of overdosage, supportive measures and symptomatic treatment, with gastric lavage if necessary, may be adequate.
In the case of an overdose or accidental ingestion contact your local poison control centre.


* If you forget to take a dose of FLUCONAZOL NORMON 150 mg. HARD CAPSULES:
You should take FLUCONAZOL NORMON 150 mg. HARD CAPSULES as prescribed. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, undesirable events are sometimes experienced with FLUCONAZOL NORMON 150 mg. HARD CAPSULES. Fluconazole is generally well tolerated. The most common side-effects associated with fluconazole are symptoms related to the gastro-intestinal tract. These include nausea, abdominal pain, diarrhoea and flatulence. Headache, skin rash and in rare cases increased sensitivity characterized by paleness, itching and tachycardia (rapid beating of the heart) have also been associated with fluconazole. Exfoliative skin disorders, seizures, abnormalities of haematological function and alopecia (loss of hair), as well as abnormalities of hepatic function, metabolism disorders (hypercholesterolaemia, hypertriglyceridaemia, hypokalaemia) and taste perversion have occurred. If you notice any of these side effects or others not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING FLUCONAZOL NORMON 150 mg. HARD CAPSULES
Keep FLUCONAZOL NORMON 150 mg. HARD CAPSULES out of the reach and sight of children. No special precautions for storage are required. Keep your capsules in the container they came in.

Expiry: Do not use FLUCONAZOL NORMON 150 mg. HARD CAPSULES after the expiry date indicated on the container.



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