Metronidazole Normon 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metronidazole Normon 250 mg tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Metronidazole is an anti-infective medicine belonging to the group of imidazoles.

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 following surgery).
• Urogenital trichomoniasis in women and men.
• Bacterial vaginosis.
• Diseases caused by protozoa – amoebiasis and giardiasis.
• Acute ulcerative gingivitis; acute periodontal infections.
• Infection by Helicobacter pylori associated with peptic ulcer, in combination with other recommended medications.

2. What you need to know before starting to 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).
• During 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 cell formation disorders, or
• diseases affecting the brain, spinal cord, or nerves.

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

If seizures or any other neurological condition (e.g., numbness in the limbs) become apparent during treatment, your treatment will be rapidly reviewed.

Treatment must be immediately interrupted or reviewed if you develop severe diarrhoea, which may be due to a serious bowel condition called "pseudomembranous colitis" (see also section 4).

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

If you take this medicine, your urine may darken.

Cases of severe hepatotoxicity/acute liver failure, including fatal outcomes, have been reported in patients with Cockayne syndrome treated with metronidazole-containing medicines.

If you have Cockayne syndrome, your doctor should also frequently monitor your liver function during and after treatment with metronidazole.

Immediately inform your doctor and stop taking metronidazole if you experience:

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

Generally, treatment with metronidazole should not last longer than 10 days; the treatment period will only be extended under exceptional circumstances and if absolutely necessary. Repeated treatment with metronidazole will be limited to cases where it is absolutely essential.

In such cases, you will be closely monitored.

Other medicines and Metronidazole Normon

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

Amiodarone (used to treat cardiac arrhythmias)

While being treated with this medicine, your cardiac function should be monitored.

You should see your doctor if you notice any abnormalities in heart function, dizziness, or fainting.

Barbiturates (medicines for sleep)

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

Oral contraceptives

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

Busulfan

Metronidazole should not be administered to patients receiving busulfan, as toxic effects are more likely to occur in such cases.

Carbamazepine (medicine used to treat epilepsy)

This combination also requires caution, as metronidazole may increase the duration of carbamazepine's action.

Cimetidine (medicine used to treat stomach disorders)

Cimetidine may, in isolated cases, reduce the elimination of metronidazole and subsequently lead to increased blood concentrations of metronidazole.

Coumarin derivatives (medicines that inhibit blood coagulation)

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

Cyclosporine (medicine used to reduce unwanted immune reactions)

When cyclosporine is administered together with metronidazole, blood levels of cyclosporine may increase; therefore, your doctor will need to adjust your cyclosporine dose accordingly.

Disulfiram (used in the treatment of alcohol dependence)

If you are taking disulfiram, you should not be given metronidazole, or you must stop taking disulfiram. The combined use of these two medicines may lead to confusion and even result in a severe mental disorder (psychosis).

Medicines containing alcohol

Refer to 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, as this may lead to increased blood levels of fluorouracil.

• Lithium (used to treat mental illnesses)

Treatment with lithium preparations requires particularly careful monitoring during treatment with metronidazole, and dose adjustment of the lithium preparation may be necessary. Treatment with lithium should be reduced or stopped before administering metronidazole.

Mycophenolate mofetil (used to prevent organ transplant rejection)

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

Phenytoin (medicine used to treat epilepsy)

If you are taking phenytoin, your doctor will treat you with metronidazole only with caution, as it could increase the duration of phenytoin's effect. On the other hand, phenytoin may reduce the effect of metronidazole.

Tacrolimus (medicine used to reduce unwanted immune reactions)

Blood levels of this medicine and your kidney function should be monitored when starting and stopping treatment with metronidazole.

Taking Metronidazole Normon with food, drinks, and alcohol

Alcohol

Do not consume alcoholic beverages or take medicines containing alcohol while being treated with metronidazole and for at least 48 hours afterwards, as this may cause intolerance reactions such as dizziness and vomiting.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Fertility

Animal studies indicate only a possible negative effect of metronidazole on the male reproductive system when high doses—much higher than the maximum recommended human dose—are administered.

Contraception in men and women

If you are taking an oral contraceptive, refer to the section "Taking Metronidazole Normon with other medicines".

Pregnancy

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

Breastfeeding:

You must not breastfeed during treatment with metronidazole and should not resume breastfeeding for another 2–3 days afterwards, as metronidazole passes into breast milk.

Driving and use of machines

While being treated with this medicine, 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 or double vision). If this happens, do not drive or operate any machinery or tools.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially "sodium-free".

3. How to take Metronidazol Normon

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

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

The usual recommended dose is as follows:

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

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

Adults and adolescents over 12 years of age:

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

Children under 12 years of age:

• 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 may be used therapeutically, only in combination with other antibacterial agents. The average duration of treatment should not exceed 7 days.

Adults and adolescents over 12 years of age:

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

Children over 8 weeks to 12 years of age:

• The usual daily dose is 20 to 30 mg/kg as a single dose or divided into 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 of age:

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

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

Trichomoniasis

Adults and children over 10 years of age:

• 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 must be carried out simultaneously in sexual partners.

Children under 10 years of age:

• 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 must not exceed 2,000 mg.

Bacterial vaginitis

Adults:

• 2 tablets of 250 mg (500 mg) in the morning and at night 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).

Amebiasis

Adults:

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

Adolescents and children over 10 years of age:

• 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 of age:

• 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 daily for 3 days.

Adolescents and children over 10 years of age:

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

Children 7 to 10 years of age:

• 4 tablets of 250 mg (1,000 mg) once daily for 3 days.

Children 3 to 7 years of age:

• 3 tablets of 250 mg (750 mg) once daily for 3 days.

Children 1 to 3 years of age:

• 2 tablets of 250 mg (500 mg) once daily 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 bacterial infection by Helicobacter pylori (called eradication)

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

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 exceeding 2 tablets (500 mg) twice a day for 7–14 days.

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.

Infants and children weighing less than 10 kg:

• Administer proportionally smaller doses.

Use in patients with hepatic impairment

In patients with hepatic damage or severe hepatic encephalopathy, drug accumulation may occur; therefore, the physician should reduce the prescribed daily dose by one-third, administered once daily.

Use in patients with renal impairment

Dose reduction is not necessary in these patients.

Use in elderly patients

This medicine should be used with caution in elderly patients, especially at higher doses.

Method of administration

Oral use.

For some of the doses described above, other metronidazole-containing medicines with a different concentration or pharmaceutical form may be more appropriate.

If you take more Metronidazol Normon than you should

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

If you forget to take Metronidazol Normon

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

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

If you have any further questions about 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 everyone gets 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 diarrhoea (possibly a symptom of a serious 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 during treatment in white blood cell and platelet counts (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia).
• Hepatitis (inflammation of the liver), jaundice, inflammation of the pancreas.
• Brain disorders, lack of coordination.
• Non-bacterial brain fever (aseptic meningitis).
• Severe inflammatory rash affecting mucous membranes and skin with fever, redness and blisters, in extremely rare cases leading to widespread skin detachment (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.
• Reduction in white blood cell count (leucopenia), severe anaemia (aplastic anaemia).
• Seizures, nervous system disorders such as numbness, pain, tingling or "pins and needles" sensations in arms or legs.
• Toxic epidermal necrolysis.
• Acute liver failure in patients with Cockayne Syndrome (see section 2 “Warnings and precautions”).

Other adverse effects

Frequent (may affect up to 1 in 10 people)

• Fungal infections (e.g., genital infections).
• Burning/urethral discomfort, dysuria, cystitis, polyuria, incontinence.

Uncommon (may affect up to 1 in 100 people)

• Darkened urine (due to metronidazole metabolite).
• Nasal congestion (blocked nose).

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 states, hallucinations.
• Headache, dizziness, somnolence, fever, visual and movement disturbances, vertigo, speech defects, seizures.
• Visual disturbances, e.g., double vision, myopia.
• Disorders of liver function (such as elevated serum levels of certain enzymes and bilirubin).
• Skin allergic reactions such as itching, urticaria.
• Joint and muscle pain.

Frequency not known (cannot be estimated from available data)

• Nausea, malaise, diarrhoea, inflammation of the tongue or mouth, belching and bitter taste, metallic taste, epigastric pressure, hairy tongue.
• Difficulty swallowing.
• Anorexia.
• Depressed mood.
• Hearing impairment/hearing loss.
• Tinnitus (ringing in the ears).
• Somnolence or insomnia, muscle spasms.
• Redness and itching of the skin (erythema multiforme).
• Irritation of the vein wall (up to and including inflammation of the veins and thrombosis) following intravenous administration, weakness, fever.
• Well-defined area of skin with redness and, sometimes, blisters, caused by drug hypersensitivity (fixed drug eruption).

Emergency treatment of pseudomembranous enterocolitis

In case of severe persistent diarrhoea, you must inform your doctor immediately, as this may be due to pseudomembranous colitis, a serious condition requiring immediate treatment. Your doctor will discontinue metronidazole therapy and provide appropriate treatment.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metronidazole Normon

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Metronidazol Normon:

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

The other components are: povidone, corn starch, and magnesium stearate.

Appearance of the product and contents of the container:

Metronidazol Normon 250 mg tablets are presented as white or slightly cream-colored, biconvex, round tablets, scored on one side. Each pack contains 21 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations:

Metronidazol Normon 5 mg/ml Solution for infusion EFG.

Date of the most recent review of this leaflet: January 2026

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