MYCOMAX 150 mg. 3 capsules

ZENTIVA
MYCOMAX 150 mg. 3 capsules
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What Mycomax and what it is used
Mykomax belongs to a group of antifungal drugs. The active substance is fluconazole.
Mycomax be used to treat infections caused by fungi and can also be used to protect against candida infection.
Fungal infections are most common cause of yeast called Candida.

Mature
This medication may be prescribed to you by your doctor to treat the following types of fungal infections:
Cryptococcal meningitis - a fungal infection of the brain;
Coccidioidomycosis - a disease of the bronchi and lungs;
Mucosal Candidiasis - infection affecting the lining of the mouth and throat;
Genital thrush - an infection of the vagina or penis;
Skin infections, e. fungal foot infections (athlete's foot), fungal infections of the skin, known as ringworm, fungal infections of the groin infection of nails.
You may be applied Mikomaks in the following cases:
to stop the recurrence of fungal infection of the mucous membranes;
to limit the recurrence of vaginal candidiasis;
to not catch an infection caused by Candida (if your immune system is weak or does not work properly).
Children and adolescents (0 to 17 years)
This medication may be prescribed to you by your doctor to treat the following types of fungal infections:
Fungi on mucous membranes - infection affecting the lining of the mouth, throat;
Infections caused by fungi called Candida (Candida), which are located in the circulation, the body's organs (eg. Heart, lungs) or urinary tract;
Cryptococcal meningitis - a fungal infection of the brain.
Mikomaks can be given to you:
To not develop an infection caused by Candida (if your immune system is weak or does not work properly);
To prevent the recurrence of cryptococcal meningitis.

2. What you should know before using Mykomax
Do not use Mykomax
if you are allergic to fluconazole or any of the other ingredients of this medicine listed in section 6. Symptoms may include itching, reddening of the skin and difficulty breathing;
if you are taking astemizole, terfenadine (antihistamine medicines for allergies);
if you are taking cisapride (used for stomach upsets);
if you are taking pimozide (used for mental illness);
if you are taking quinidine (used for heart arrhythmia);
if you are taking erythromycin (antibiotic to treat infections).
Warnings and Precautions
Talk to your doctor or pharmacist before using Mikomaks.
Please tell your doctor if:
have liver or kidney problems;
suffer from heart disease, including heart rhythm problems;
have abnormal levels of potassium, calcium or magnesium in the blood;
get severe skin reactions (itching, reddening of the skin or difficulty breathing).
Other medicines and Mikomaks
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (for stomach upsets) or pimozide (used to treat mental illness) or quinidine (used to treat cardiac arrhythmia) or erythromycin (an antibiotic for treatment infections) as these medicines should be taken with Mikomaks (see section "Do not use Mykomax").

Some medicines may interact with Mykomax
Please tell your doctor if you are taking any of the following medications:
rifampicin or rifabutin (antibiotics for infections);
alfentanil, fentanyl (pain medication);
amitriptyline, nortriptyline (antidepressants);
amphotericin B, voriconazole (an antifungal medicine);
drugs that prevent the blood from clotting (warfarin or similar drugs);
benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or anxiety;
carbamazepine, phenytoin (to treat seizures);
nifedimin, isradipine, amlodipine, felodipine and losartan (for treatment of hypertension - high blood pressure);
ciclosporin, everolimus, sirolimus or tacrolimus (to prevent organ rejection after transplants);
cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar drugs) used in the treatment of cancer;
halofantrine (in the treatment of malaria);
statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used to lower cholesterol;
methadone (used for pain);
celecoxib, florbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (a non-steroidal anti-inflammatory drug (NSAIDs));
oral contraceptives;
prednisone (steroid);
Zidovudine, also known as AZT; saquinavir (used in patients with HIV);
antidiabetic drugs such as chlorpropamide, glibenclamide, glipizide or tolbutamide;
theophylline (used for asthma);
vitamin A (food additive).
Mikomaks with food and drink
You can take this medicine with or without food.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. You should not take Mykomax while pregnant or breast-feeding, unless your doctor has told you.

Driving and using machines
When driving or operating machinery it must be borne in mind that may occur dizziness or fainting.

Mykomax contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to use Mykomax
Always use this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Swallow the capsules whole with a glass of water. It is best to take the capsules at the same time each day.

The usual doses of this drug in various types of infections are described below:
Dosage disease
For the treatment of cryptococcal meningitis 400 mg na first day, then 200 mg to 400 mg once daily for 6 to 3 weeks or longer if necessary. Sometimes the dosage was increased to 800 mg
For the treatment of coccidioidomycosis
200 mg to 400 mg once daily for 11 to 24 months or longer if necessary. In some cases the dose may be increased to 800 mg
For treatment of mucosal infections of the mouth and throat 200 mg to 400 mg on the first day, then 100 mg to 200 mg until they are told to stop treatment
Fungal infections of the mucous membranes - the dosage depends on the localization of the infection 50 to 400 mg once daily 7 to 30 days until you are told to stop treatment
To prevent infections of the mucous membranes of the mouth and throat 100 mg to 200 mg once daily while you are at risk of developing infection
For the treatment of genital candidiasis 150 mg as a single dose
In order to reduce recurrence of vaginal candidiasis 150 mg every three days a total of 3 doses (days 1, 4 and 7), and then once a week for 6 months while on the risk
Fungal infections of the skin and nails Depending on the site of infection of 150 mg once a week, 300 mg to 400 mg once a week for 1 to 4 weeks (for fungal infections of the foot (foot of an athlete) can last up to 6 weeks for infections nails - while infected fingernail grow again)
To not develop an infection caused by Candida (if your immune system is weak or does not work properly) 200 to 400 mg once daily while you are at risk of developing infection
Adolescents 12 to 17 years
Follow the dose prescribed by your doctor (dosage for children or adults).

Children up to 11 years
The maximum dose for children is 400 mg daily.
The dose is determined by the child's weight in kilograms.
Disease Daily Dose
Fungal infections of the mucous membranes and the throat infections caused by Candida - dose depends on the severity and site of infection of 3 mg per kg of body weight (first day can be administered 6 mg per kg of body weight)
Cryptococcal meningitis or fungal infections of the internal organs caused by Candida 6 mg to 12 mg per kg body weight
In order not to develop child infection caused by Candida (if the immune system is weak or does not work properly) 3 mg to 12 mg per kg body weight
Elderly
Apply the usual dose for adults unless you have kidney problems.

Patients with kidney problems
Your doctor may change your dose depending on your kidney function.

If you take more dose Mykomax
Taking too many capsules at once may make you unwell. Please immediately contact your doctor or go to the nearest hospital. Symptoms of overdose may make you hear, see and think things that are not real (hallucinations and paranoid behavior). It is appropriate to symptomatic treatment (supportive measures and gastric lavage if necessary).

If you forget to take Mykomax
Do not take a double dose to make up the missed dose. If you forget to take a dose, take it as soon as you remember. If it is time for your next dose, do not take the dose that you missed.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people develop allergic reactions although serious allergic reactions occur rarely.
If you experience any of these symptoms, tell your doctor:
sudden shortness of breath, difficulty breathing or chest tightness;
swelling of eyelids, face or lips;
itching, redness of the skin or itchy red spots;
skin rash;
severe skin reactions such as blistering rash (which can affect the mouth and tongue).
Mikomaks can damage your liver.
Signs of liver damage include:
fatigue;
loss of appetite;
vomiting;
yellowing of your skin or the whites of the eyes.
If you experience any of these side effects, stop taking Mikomaks and tell your doctor immediately.

Other adverse reactions:
In addition, if any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

Common side effects which affect 1 to 10 patients in each 100 are described below:
headache;
stomach discomfort, diarrhea, feeling sick, vomiting;
elevated liver function tests;
rash.
Uncommon side effects which affect 1 to 10 patients in each 1000 are described below:
lowering the number of red blood cells, which can cause paleness, cause weakness or shortness of breath;
decreased appetite;
insomnia, drowsiness;
fainting, sleepiness, dizziness, tingling, pricking or numbness, changes in taste;
constipation, indigestion, flatulence, dry mouth;
muscle pain;
liver damage and yellowing of the skin and eyes (jaundice);
rash, blisters, itching, excessive sweating;
fatigue, malaise, fever.
Rare side effects which affect 1 to 10 patients out of 10 000 are described below:
low white blood cells that protect the body from infections and blood cells that help to stop bleeding;
red or violet color on the skin, which may be caused by a decrease in platelet counts, changes in the other blood cells;
changes in blood parameters (high cholesterol levels in blood, fat);
decreases in potassium in the blood;
tremors;
abnormal electrocardiogram (ECG) changes in heart rate;
liver failure;
allergic reactions (sometimes severe), including extensive blistering rash and skin peeling, swelling of the lips or face;
hair loss.
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.

5. How to store Mykomax
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month. The medicinal product does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
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