METRONIDAZOL NORMON 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

Metronidazole Normon 250 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Metronidazole Normon and what is it used for
2. What you need to know before you take Metronidazole Normon
3. How to take Metronidazole Normon
4. Possible side effects
5. Storage of Metronidazole Normon
6. Contents of the pack and other information

1. What is Metronidazole Normon and what is it used for

Metronidazole is a medicine that acts as an antiprotozoal and antibacterial agent.

Metronidazole is used in adults and children for:

• Prevention of postoperative anaerobic bacterial infections.
• Treatment of infections caused by anaerobic microorganisms (peritonitis, brain abscess, osteomyelitis, puerperal fever, pelvic abscess, wound infections after surgery).
• Trichomoniasis in the urogenital tract, in men and women.
• Bacterial vaginitis.
• Diseases caused by protozoa – amoebiasis and giardiasis.
• Acute ulcerative gingivitis; acute periodontal infections.
• Infection by Helicobacter pyloriwith peptic ulcer, in combination with other recommended medications.

2. What you need to know before you take Metronidazole Normon

Do not take Metronidazole Normon

• If you are allergic to metronidazole, to other 5-nitroimidazole derivatives or to any of the other ingredients of this medicine (listed in section 6).
• In the first trimester of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take metronidazole if you have:

• severe liver damage,
• blood disorder or
• brain, spinal cord or nerve disease.

Therefore, your doctor will very carefully determine whether you should be treated with metronidazole.

If convulsive attacks or any other nervous disorder (e.g. numbness in the limbs) become apparent during treatment, your treatment will be reviewed quickly.

Treatment should be discontinued or reviewed immediately if you have severe diarrhea that may be due to a serious disease of the large intestine called "pseudomembranous colitis" (see also section 4).

Since prolonged use of metronidazole may affect blood formation (see section "Possible side effects"), your blood counts will be monitored during treatment.

If you take this medicine, your urine may darken.

There have been reports of severe liver toxicity/liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome with medications containing metronidazole.

If you have Cockayne syndrome, your doctor should also closely monitor your liver function while you are being treated with metronidazole and afterwards.

Tell your doctor immediately and stop taking metronidazole if you experience:

• Stomach pain, loss of appetite, nausea, vomiting, fever, general malaise, fatigue, jaundice, dark urine, clay-colored stools or itching.

Normally, treatment with metronidazole should not be prolonged for more than 10 days; the treatment period will only be extended in exceptional circumstances and if it is absolutely necessary. Repeated treatment with metronidazol will be limited to cases where it is absolutely necessary.

In such a case, you will be closely monitored.

Taking Metronidazole Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Amiodarone (used to treat heart rhythm disorders)

When being treated with this medicine, your heart function should be monitored.

You should go to your doctor if you notice any anomaly in heart function, dizziness or fainting.

Barbiturates (sleeping pills)

The duration of action of metronidazole is reduced by phenobarbital; therefore, your dose of metronidazole may need to be increased.

Contraceptive pills

Your contraceptive pill may be less effective while you are being treated with metronidazole.

Busulfan

Metronidazole should not be administered to patients receiving busulfan because, in this case, toxic effects are more likely to occur.

Carbamazepine (medicine for the treatment of epilepsy)

This combination also requires caution since metronidazole may increase the duration of action of carbamazepine.

Cimetidine (medicine for the treatment of stomach disorders)

Cimetidine may reduce the elimination of metronidazole in isolated cases and subsequently lead to an increase in metronidazole blood levels.

Coumarin derivatives (medicines that inhibit blood coagulation)

Metronidazole may increase the inhibition of blood coagulation caused by coumarins. Therefore, if you are taking a medicine that inhibits blood coagulation (e.g. warfarin), you may need to reduce the dose during treatment with metronidazole.

Cyclosporin (medicine used to reduce unwanted immune reactions)

When cyclosporin is administered together with metronidazole, cyclosporin blood levels may increase; therefore, your doctor will have to adjust your cyclosporin dose as appropriate.

Disulfiram (used in the treatment of alcohol dependence)

If you are taking disulfiram, you should not be given metronidazole, or you should discontinue treatment with disulfiram. The combined use of these two medicines can lead to confusion up to the point of developing a severe mental disorder (psychosis).

Medicines containing alcohol

See the section "Taking Metronidazole Normon with food, drinks and alcohol".

Fluorouracil (anticancer medicine)

The daily dose of fluorouracil may need to be reduced when administered together with metronidazole since it may lead to an increase in fluorouracil blood levels.

Lithium (used to treat mental illnesses)

Treatment with lithium preparations requires particularly close monitoring during treatment with metronidazole and may need to be adjusted. Lithium treatment should be reduced or discontinued before administration of metronidazole.

Myphenolate mofetil (used to prevent organ rejection after transplantation)

Its effect may be weakened by metronidazole, so careful monitoring of its effect is recommended.

Phenytoin (medicine for the treatment of epilepsy)

If you are taking phenytoin, your doctor will treat you with metronidazole with caution since it may increase the duration of action of phenytoin. On the other hand, phenytoin may reduce the effect of metronidazole.

Tacrolimus (medicine used to reduce unwanted immune reactions)

The blood levels of this medicine and its kidney function should be monitored when starting and stopping treatment with metronidazole.

Interference with diagnostic tests

If you are going to have any diagnostic tests (blood tests, urine tests...), tell your doctor that you are being treated with metronidazole, as it may alter the results.

Taking Metronidazole Normon with food, drinks and alcohol

Alcohol

You should not drink alcoholic beverages or take medicines containing alcohol while being treated with metronidazole and up to 48 hours after, as this may cause intolerance reactions such as dizziness and vomiting.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fertility

Animal studies only indicate a possible negative influence of metronidazole on the male reproductive system if high doses are administered that are far above the maximum recommended dose for humans.

Contraception in men and women

If you are taking a contraceptive pill, see the section "Taking Metronidazole Normon with other medicines".

Pregnancy

If you are pregnant, your doctor will not treat you with metronidazole unless it is considered absolutely necessary.

Breast-feeding:

You should not breast-feed during treatment with metronidazole and should not resume breast-feeding for 2-3 days after because metronidazole passes into breast milk.

Driving and using machines

While you are being treated with this medicine, you may feel drowsy, dizzy, confused, see or hear things that are not there (hallucinations), have seizures (convulsions) or have temporary vision problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.

3. How to take Metronidazole Normon

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Due to the lack of evidence on the risk of mutagenicity in humans, the doctor will assess whether it is necessary to use metronidazole for a longer period than usual.

Normally, the recommended dose is as follows:

Prevention of anaerobic bacterial infections (in gynecological or colorectal surgery)

Metronidazole will be administered preventively 24 hours before surgery until at least 4 hours after wound closure, or longer, depending on the risk of contamination.

Adults and adolescents over 12 years:

• First 4 tablets of 250 mg (1,000 mg), followed by 1 tablet three times a day until the preoperative fast.

Children under 12 years:

• 20 to 30 mg/kg as a single dose, administered 1 to 2 hours before the procedure.

Newborns before 40 weeks of gestation:

• 10 mg/kg as a single dose before surgery.

Bacterial infection

Metronidazole can be used therapeutically, only in combination with other antibacterial agents. The average treatment period should not last more than 7 days.

Adults and adolescents over 12 years:

• 1 or 2 tablets of 250 mg three times a day.

Children over 8 weeks to 12 years:

• The usual daily dose is 20 to 30 mg/kg as a single dose or in divided doses of 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection.

Children under 8 weeks:

• 15 mg/kg/day as a single dose or in divided doses of 7.5 mg/kg administered every 12 hours.

In babies born before 40 weeks of gestation, metronidazole accumulation may occur during the first week of life, so after a few days of treatment, metronidazole plasma concentrations should be monitored.

Trichomoniasis

Adults and children over 10 years:

• 8 tablets of 250 mg (2,000 mg) as a single dose or 1 tablet three times a day for seven days or 2 tablets twice a day for 5-7 days.

Note: Treatment is carried out simultaneously in sexual partners.

Children under 10 years:

• 40 mg/kg orally as a single dose or 15 to 30 mg/kg per day divided into 2-3 doses for 7 days. A single dose should not exceed 2,000 mg.

Bacterial vaginitis

Adults:

• 2 tablets of 250 mg (500 mg) in the morning and evening for seven days or 8 tablets (2,000 mg) as a single dose (once).

Adolescents:

• 8 tablets (2,000 mg) as a single dose (once).

Amoebiasis

Adults:

• 3 tablets of 250 mg (750 mg) three times a day for 5-10 days.

Adolescents and children over 10 years:

• 2 or 3 tablets of 250 mg (500 mg to 750 mg) three times a day for 5-10 days.

Children from 7 to 10 years:

• 250 mg three times a day for 5-10 days.

Alternative dosing regimen for this condition (dose expressed in mg per kg): 35 to 50 mg/kg/day in three divided doses for 5 to 10 days, not exceeding 2,400 mg daily.

Giardiasis

Adults:

• 1 tablet of 250 mg three times a day for 5-7 days or 8 tablets (2,000 mg) once a day for 3 days.

Adolescents and children over 10 years:

• 8 tablets (2,000 mg) once a day for 3 days or 2 tablets (500 mg) twice a day for 7 to 10 days.

Children from 7 to 10 years:

• 4 tablets of 250 mg (750 mg) once a day for 3 days.

Children from 1 to 3 years:

• 2 tablets of 250 mg (750 mg) once a day for 3 days.

Alternative dosing regimen for this condition (dose expressed in mg per kg): 15 to 40 mg/kg/day divided into 2-3 doses.

Treatment of Helicobacter pyloribacterial infection (called eradication)

Metronidazole is used for at least 7 days in combination with other medications prescribed for the treatment of Helicobacter pyloriinfections.

Adults:

• 2 tablets of 250 mg (500 mg) 2-3 times a day for 7-14 days.

Children and adolescents:

• 20 mg/kg/day, not more than 2 tablets (500 mg) twice a day for 7-14 days.

Before starting treatment, consult the official guidelines.

Acute ulcerative gingivitis

Adults:

• 1 tablet of 250 mg 2-3 times a day for three days.

Children:

• 35 to 50 mg/kg/day in three divided doses for three days.

Acute periodontal infections

Adults:

• 1 tablet of 250 mg 2-3 times a day for 3-7 days.

Babies and children weighing less than 10 kg:

• Administer proportionally smaller doses.

Use in patients with liver impairment

In patients with liver damage or severe hepatic encephalopathy, drug accumulation may occur in the body, so the doctor will reduce the prescribed daily dose by one-third, administered once a day.

Use in patients with renal impairment

No dose reduction is necessary in these patients.

Use in elderly patients

In elderly patients, this medicine should be used with caution, especially in high doses.

Method of administration

Oral.

For some of the doses described above, there are also other medicines that contain metronidazole with a different concentration (film-coated tablet, 500 mg) and in a different pharmaceutical form (infusion solution, 5 mg/ml, oral solution 25 mg/ml).

If you take more Metronidazole Normon than you should

Consult your doctor immediately if you take more than the recommended dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metronidazole Normon

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the forgotten dose and take the next dose at the scheduled time.

Do not take a double dose to make up for a forgotten dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The frequency, type, and severity of adverse reactions in children are the same as in adults.

If you experience any of the following serious adverse effects, stop taking this medicine and contact your doctor immediately:

Rare (may affect up to 1 in 1,000 people)

• Severe persistent diarrhea (possibly a symptom of a serious intestinal infection called pseudomembranous colitis, see below).
• Acute severe hypersensitivity reactions up to anaphylactic shock.

Very Rare (may affect up to 1 in 10,000 people)

• Decrease during treatment of white blood cell and platelet counts (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia).
• Hepatitis (inflammation of the liver), jaundice, pancreatitis.
• Cerebral disorders, lack of coordination.
• Non-bacterial cerebral fever (aseptic meningitis).
• Severe inflammatory rash on mucous membranes and skin with fever, redness, and blisters, in extremely rare cases up to skin detachment in large areas (Stevens-Johnson Syndrome).

Frequency Not Known (cannot be estimated from available data)

• Mild to moderate hypersensitivity reactions, swelling of the face, mouth, throat, and/or tongue (angioedema).
• Deviation of gaze, damage or inflammation of the eye nerves.
• Decrease in white blood cell count (leukopenia), severe anemia (aplastic anemia).
• Seizures, nervous disorders such as numbness, pain, tingling, or prickling sensation in the arms or legs.
• Toxic epidermal necrolysis.

Other Adverse Effects

Frequent (may affect up to 1 in 10 people)

• Fungal infections (e.g., genital infections).

Infrequent (may affect up to 1 in 100 people)

• Darkened urine (due to metronidazole metabolite).

Rare (may affect up to 1 in 1,000 people)

• Changes in the electrocardiogram (ECG).

Very Rare (may affect up to 1 in 10,000 people)

• Psychotic disorders, including confusion, hallucination.
• Headache, dizziness, drowsiness, fever, alteration of vision and movement, staggering, speech defects, seizures.
• Visual disturbances, e.g., double vision, myopia.
• Disorders of liver function (such as elevated serum levels of certain enzymes and bilirubin).
• Allergic skin reactions such as itching, urticaria.
• Pain in joints and muscles.

Frequency Not Known (cannot be estimated from available data)

• Nausea, feeling of discomfort, diarrhea, inflammation of the tongue or mouth, belching and bitter taste, metallic taste, pressure above the stomach, hairy tongue.
• Difficulty swallowing.
• Anorexia.
• Sad mood (depressed).
• Drowsiness or insomnia, muscle spasms.
• Redness and itching of the skin (erythema multiforme).
• Irritation of the venous wall (up to the point of inflammation of the veins and thrombosis) after intravenous administration, state of weakness, fever.

Emergency Treatment of Pseudomembranous Colitis

In case of severe persistent diarrhea, you should immediately inform your doctor because this may be due to pseudomembranous colitis, a serious disease that must be treated immediately. Your doctor will interrupt treatment with metronidazole and provide you with appropriate treatment.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Metronidazole Normon

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original package.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Metronidazole Normon:

The active ingredient is metronidazole. Each tablet contains 250 mg of metronidazole.

The other components are: povidone, cornstarch, and magnesium stearate.

Appearance of the Product and Package Contents:

Metronidazole Normon 250 mg tablets are presented in the form of round white or slightly cream-colored tablets, biconvex and scored on one side. Each package contains 21 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other Presentations

Metronidazole Normon 5 mg/ml Solution for Infusion EFG.

F:July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.