FLAGYL 250 mg. 20 tablets

SANOFI AVENTIS
FLAGYL 250 mg. 20 tablets
€ 8.00
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FLAGYL WHAT AND WHAT IT IS USED
What is Flagyl
Flagyl belongs to the group of anti-infective imidazole derivatives.
What is
This drug is indicated for the treatment of:
vaginitis caused by Trichomonas vaginalis;
nonspecific vaginitis;
amoebiasis;
giardiaza (giardiasis);
infections caused by drug-sensitive anaerobic microorganisms.

2. WHAT YOU SHOULD KNOW BEFORE YOU USE FLAGYL
Do not use Flagyl:
if you are allergic (hypersensitive) to metronidazole or any of the excipients, or other medicinal products with imidazole derivatives.
In general, this drug should not be used in combination with disulfiram, unless otherwise directed by your physician.

If you think any of these apply to you, or you have any doubts, consult your doctor or pharmacist before taking Flagyl.

Take special care with Flagyl
Using Metronidazole for prolonged treatment should be carefully considered by your doctor.
You should consult with your doctor or pharmacist before taking your medicine.

Treatment with Flagyl should not be prescribed for a period longer than 10 days and should be used more often 2 to 3 times a year.
If you notice that you have poor coordination of voluntary movements, dizziness, mental confusion or stagger must stop treatment and consult your doctor.
You should be careful with this medication if you have severe or chronic diseases of the peripheral and central nervous system.

If you think any of these apply to you, or you have any doubts, consult your doctor or pharmacist before taking Flagyl.

Warnings and Precautions
In the case of blood disorders, high dose and / or prolonged treatment, your doctor may order regular blood tests, especially in terms of white blood cells.
In case of prolonged treatment, it is important to tell your doctor if you have any nerve disorders (tingling, difficult coordination of movements, dizziness, convulsions). During treatment, you can watch reddish-brown discoloration of urine, which is not alarming symptom.
Flagyl should be used with caution in patients with hepatic encephalopathy.

If you think any of these apply to you, or you have any doubts, consult your doctor or pharmacist before taking Flagyl.

Other medicines and Metronidazole
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should not use Flagyl with disulfiram, alcohol and medicinal products containing alcohol. Flagyl can also interact with the following medications: oral anticoagulant drugs (to monitor the prothrombin time and anticoagulant therapy as needed to adjust due to increased risk of bleeding), lithium and cyclosporine (their levels should be monitored as they to increase), phenytoin and phenobarbital (falling levels of metronidazole 5-fluorouracil (should be monitored for signs of toxicity as the clearance may be reduced), busulfan (can lead to toxicity of busulfan).
Taking this medicine may affect the results of certain laboratory tests (for Treponema) and give a false negative TPI test.

Flagyl with food and drink
It is not recommended to drink alcohol during treatment and for at least 24 hours after the end of treatment because of the risk of developing a disulfiram-like reaction (eg. Redness, flushing, vomiting and fast heart rate).

Pregnancy and lactation
Tell your doctor if you are pregnant or think you may be pregnant or plan to become pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Flagyl may be used if necessary during pregnancy unless recommended by your doctor or pharmacist.
The use of this medicine is not recommended during lactation.
Always consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Should be given the likelihood of dizziness, confusion, hallucinations, convulsions or ocular disorders after taking this medicine. In these events to avoid driving or operating machinery.

Flagyl contains wheat starch
Suitable for people with celiac disease (gluten enteropathy).
Patients with wheat allergy (different from celiac disease) should not take this medicine.

3. HOW TO USE FLAGYL
Always use Flagyl exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

How to take this medicine
Take this medicine by mouth.
How much to take
The recommended dose is:
Vaginitis and urethritis caused by Trichomonas vaginalis:
Adults and young people:
2000 mg as a single dose or 200 mg three times daily for 7 days or 400 mg twice daily for 5-7 days.
Your partner should be treated with you even if you do not display any clinical symptoms.
Children under 10 years old: 40 mg / kg orally in a single dose or 15-30 mg / kg / day divided into 2-3 doses for 7 days.
Do not exceed 2000 mg / dose.

nonspecific vaginitis
Adults: 500 mg orally twice daily for 7 days. Your partner should be treated simultaneously.
Children over 12 years: 400 mg twice daily for 5-7 days or 2000 mg as a single dose.

amoebiasis
Adults: 1,50 g / day of 3 doses for 7 days.
Children above the age of 10: 400 to 800 mg, three times a day for 5-10 days.
Children 7 to 10 years old: from 200 to 400 mg, three times a day for 5-10 days.
Children 3 to 7 years of age: from 100 to 200 mg, four times daily for 5-10 days.
Children from 1 to 3 years of age: from 100 to 200 mg, three times a day for 5-10 days.
Alternatively, doses can be expressed according to body weight: 35-50 mg / kg / day of 3 doses for 5-10 days without exceeding 2400 mg / day.

Giardiaza
Adults: 750 mg to 1 g / day for 5 consecutive days.
Children above the age of 10 years: 2000 mg daily for three days, or 400 mg three times daily for 5 days or 500 mg twice daily for 7-10 days.
Children 7 to 10 years: 1000 mg daily for three days.
Children 3 to 7 years of age: from 600 to 800 mg once a day for 3 days.
Children 1 to 3 years: 500 mg once daily for 3 days.
Alternatively expressed in mg / kg body weight: 15-40 mg / kg / day, divided into 2-3 doses.

anaerobic infections
Adults: 1 g to 1.50 g / day.
Children> 8 weeks and 12 years: 20-30 mg / kg / day in a single dose or divided into 3 doses (7.5 mg / kg every 8 hours). The daily dose can be increased to 40 mg / kg according to the severity of the infection. The duration of treatment is usually 7 days.
Children <8 weeks: 15 mg / kg as a single dose per day or divided in 2 doses (7.5 mg / kg every 12 hours).
In infants with gestational age <40 weeks accumulation of metronidazole may occur during the first week of life, because the concentrations of metronidazole in serum should be monitored preferably after several days of treatment.

Eradication of Helicobacter pylori in pediatric patients
As part of a combination therapy, 20 mg / kg / day. Do not exceed 500 mg twice daily for 7 to 14 days. To take into account official recommendations concerning the appropriate use of antibacterial agents before initiating therapy.
In all cases, follow the doctor's prescription.

If you take more dose Flagyl
He is no specific antidote. In case of overdose, which can present with vomiting, poor coordination of movements, poor orientation. Please ask your doctor or pharmacist to symptomatic treatment.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Metronidazole may cause side effects, although not everybody gets them.
The frequency, type and severity of adverse reactions in children is the same as in adults.

It is possible to obtain the following side effects:
Gastrointestinal disorders
epigastric pain, nausea, vomiting, diarrhea;
oral mucositis, taste disturbance, anorexia;
reversible cases of pancreatitis.
Immune system
angioedema, anaphylactic shock.
Nervous system
Peripheral sensory neuropathy;
headache, convulsions, dizziness;
cases of encephalopathy (eg. confusion) and subacute cerebellar syndrome (eg. ataxia, dysarthria, gait disturbances, nystagmus, tremor) that can dissipate when they stop taking the medicine;
aseptic meningitis.
Psychiatric disorders
psychotic disorders including - confusion, hallucinations;
depressed mood.
Violations of eyes
transient visual disturbances such as blurred vision, myopia, blurred vision, decreased visual acuity, changes in color vision;
optic neuropathy / neuritis.
Blood and lymphatic system
Cases of agranulocytosis, neutropenia, thrombocytopenia.
Hepatobiliary disorders
reported elevated levels of liver enzymes (AST, ALAT, alkaline phosphatase, or mixed cholestatic hepatitis and hepatocellular liver injury, accompanied by jaundice;
Cases of hepatic failure requiring liver transplantation in patients treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders
rash, pruritus, flushing, urticaria;
occurrence of pustular rashes.
General disorders and administration site conditions
fever.
other disorders
urine may turn red-brown, as can be found water soluble pigments probably metabolites.
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE FLAGYL
Do not use after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Store at temperatures below 25 ° C in the original package.
Keep out of the reach and sight of children.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
What Flagyl
The active substance is: metronidazole (metronidazole). Each tablet contains 250 mg of metronidazole.

Other ingredients are:
Tablet core: wheat starch, povidone, magnesium stearate;
Tablet coating: hypromellose, macrogol 20000.
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