Leaflet: information for the user

Metronidazol Normon 250 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Metronidazol is a medication that acts as an antiprotozoal and antibacterial agent.

Metronidazol is used in adults and in 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 system, in men and women.
• Bacterial vaginitis.
• Diseases caused by protozoa – amoebiasis and giardiasis.
• Acute ulcerative gingivitis; acute periodontal infections.
• Infection by Helicobacter pylori with peptic ulcer, in combination with other recommended medications.

Do not take Metronidazol Normon

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

Warnings and precautions

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

• Severe liver damage,
• Blood formation disorders, or
• Brain, spinal cord, or nerve disease.

Your doctor will carefully determine whether you should be treated with metronidazol.

If seizures or any other nervous system disorders (e.g., numbness in the extremities) become apparent during treatment, your treatment will be reviewed promptly.

Treatment should be interrupted or reviewed immediately if you have severe diarrhea that may be due to a serious condition called "pseudomembranous colitis" (see also section 4).

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

Your urine may darken while taking this medication.

Severe liver toxicity/acute liver failure, including cases with a fatal outcome, have been reported in patients with Cockayne syndrome taking metronidazol-containing medications.

If you have Cockayne syndrome, your doctor should also closely monitor your liver function while you are on metronidazol treatment and afterwards.

Inform your doctor immediately and stop taking metronidazol if you experience:

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

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

You will be closely monitored in such cases.

Taking Metronidazol Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Amiodarone (used to treat heart arrhythmias)

When taking this medication, your cardiac function should be closely monitored.

Visit your doctor if you notice any abnormalities in cardiac function, dizziness, or fainting.

Barbiturates (sleeping medications)

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

Birth control pills

Your birth control pill may be less effective while taking metronidazol.

Busulfan

Metronidazol should not be administered to patients receiving busulfan because, in this case, it is more likely to cause toxic effects.

Carbamazepine (medication for epilepsy treatment)

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

Cimetidine (medication for stomach disorders)

Cimetidine may reduce metronidazol elimination in isolated cases and, subsequently, lead to an increase in metronidazol blood concentrations.

Coumarin derivatives (medications that inhibit blood coagulation)

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

Ciclosporin (medication used to reduce unwanted immunological reactions)

When ciclosporin is administered with metronidazol, ciclosporin blood levels may increase; therefore, your doctor will need to adjust your ciclosporin dose as necessary.

Disulfiram (used in alcohol dependence treatment)

If you are taking disulfiram, you should not be given metronidazol, or you should discontinue disulfiram treatment. The combined use of these two medications may lead to states of confusion to the point of developing a severe mental disorder (psychosis).

Medications containing alcohol

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

Fluorouracil (anticancer medication)

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

Lithium (used to treat mental disorders)

Lithium treatment requires particularly careful monitoring during metronidazol treatment and may need to be adjusted. Lithium treatment should be reduced or discontinued before metronidazol administration.

Mycophenolate mofetil (used to prevent rejection after organ transplantation)

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

Phenytoin (medication for epilepsy treatment)

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

Tacrolimus (medication used to reduce unwanted immunological reactions)

Tacrolimus blood levels and renal function should be monitored when starting and stopping metronidazol treatment.

Interference with diagnostic tests

Inform your doctor if you are to undergo any diagnostic tests (blood, urine, etc.) since metronidazol may alter the results.

Taking Metronidazol Normon with food, drinks, and alcohol

Alcohol

Do not consume alcoholic beverages or medications containing alcohol while taking metronidazol and for 48 hours afterwards, as this may cause intolerance reactions such as dizziness and vomiting.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Fertility

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

Contraception in men and women

If you are taking a birth control pill, see the section "Taking Metronidazol Normon with other medications."

Pregnancy

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

Breastfeeding:

Do not breastfeed during metronidazol treatment or resume breastfeeding within 2-3 days afterwards because metronidazol passes into breast milk.

Driving and operating machinery

While taking this medication, you may feel drowsy, dizzy, confused, see or hear things that are not there (hallucinations), have seizures, or experience transient vision problems (such as blurred vision or double vision). If this happens, do not drive or operate any machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Normally, the recommended dose is as follows:

Prevention of infections caused by anaerobic bacteria (in gynecological or colorectal surgery)

Metronidazole will be administered preventively 24 hours before surgery until at least 4 hours after wound closure, or more, 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 preoperative fasting.

Children under 12 years:

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

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 median treatment period should not exceed 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 can 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 newborns born before 40 weeks of gestation, metronidazole accumulation may occur during the first week of life, so after a few days of treatment, plasma metronidazole 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 7 days or 2 tablets twice a day for 5-7 days.

Nota: 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 7 days or 8 tablets (2,000 mg) as a single dose (once).

Adolescents:

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

Amebiasis

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 7 to 10 years:

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

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

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 7 to 10 years:

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

Children 1 to 3 years:

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

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

Treatment of bacterial infection byHelicobacter pylori(called eradication)

Metronidazole is used for at least 7 days in combination with other medications prescribed for the treatment of infections byHelicobacter pylori.

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 official guidelines.

Acute ulcerative gingivitis

Adults:

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

Children:

• 35 to 50 mg/kg/day in three divided doses for 3 days.

Acute periodontal infections

Adults:

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

Newborns and children with a weight of less than 10 kg:

• Administer proportionally smaller doses.

Use in patients with liver insufficiency

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

Use in patients with renal insufficiency

No dose reduction is necessary in these patients.

Use in elderly patients

This medication should be used with caution in elderly patients, especially at high doses.

Administration form

Oral administration.

For some of the doses described above, there are also other medications containing metronidazole with a different concentration (film-coated tablet, 500 mg) and in a different pharmaceutical form (intravenous 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Metronidazole Normon

Do not take a double dose to compensate for the missed dose.

If you forget to take a dose, take it as soon as you remember. If there is little time left for the next dose, do not take the missed dose and take the next dose at the time it is due.

Do not take a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

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

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

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

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

Frequency unknown (cannot be estimated from available data)

• Mild to moderate hypersensitivity reactions, facial, oral, pharyngeal, and/or tongue swelling (angioedema).
• Strabismus, nerve damage or inflammation of the eye nerves.
• Reduction in white blood cell count (leucopenia), severe anemia (aplastic anemia).
• Seizures, nervous disorders such as numbness, pain, itching, or tingling in the arms or legs.
• Toxic epidermal necrolysis.

Other side effects

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Dark urine (due to metronidazole metabolite).

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

• Changes in electrocardiogram (ECG).

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

• Psychotic disorders, including confusion, hallucination.
• Headache, dizziness, somnolence, fever, visual disturbances, and movement disorders, drowsiness, speech defects, seizures.
• Visual disturbances, e.g., double vision, myopia.
• Liver function disorders (e.g., elevated levels of certain enzymes and bilirubin in the blood).
• Allergic reactions on the skin, such as itching, urticaria.
• Joint and muscle pain.

Frequency unknown (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.
• Loss of appetite.
• Depressed mood (depression).
• Drowsiness or insomnia, muscle spasms.
• Redness and itching of the skin (erythema multiforme).
• Irritation of the venous wall (up to inflammation of the veins and thrombosis) after intravenous administration, weakness, fever.

Emergency treatment of pseudomembranous colitis

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

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

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

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Metronidazol Normon:

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

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

Appearance of the product and content of the packaging:

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

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

Other presentations

Metronidazol Normon 5 mg/ml Solution for infusion EFG.

Fecha of the last review of the leaflet:july 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http:/www.aemps.gob.es/.