Label: information for the user

Metronidazol Aurovitas 250 mg film-coated tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, 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 alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

Antibiotics are used to treat bacterial infections and do not work to treat viral infections such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotics after treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Metronidazol 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 system, in women and men.
• Bacterial vaginitis.
• Diseases caused by protozoa – amoebiasis and giardiasis.
• Acute ulcerative gingivitis; acute periodontal infections.

Helicobacter pylori infection associated with peptic ulcers, in combination with other recommended medications.

Do not take Metronidazol Aurovitas

• If you are allergic to metronidazole, other 5-nitroimidazole derivatives, or any of the other components of this medication (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 formation disorders, or
• Brain, spinal cord, or nerve disease.

Your doctor will carefully determine if you should be treated with metronidazole.

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

Treatment should be interrupted or reviewed immediately if you have severe diarrhea that may be due to a serious condition 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.

Your urine may darken while taking this medication.

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

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

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

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

Treatment with metronidazole should not usually be prolonged for more than 10 days; the treatment period will only be extended in exceptional circumstances and if absolutely necessary. Repeated treatment with metronidazole will be limited to cases where it is absolutely necessary. In such cases, you will be closely monitored.

Other medications and Metronidazol Aurovitas

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)

Your cardiac function should be closely monitored while you are on this medication.

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

Barbiturates (sleeping medications)

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

Birth control pills

Your birth control pill may be less effective while you are on metronidazole treatment.

Busulfan

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

Carbamazepine (medication for epilepsy treatment)

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

Cimetidine (medication for stomach disorders)

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

Coumarin derivatives (medications that inhibit blood coagulation)

Metronidazole 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 metronidazole treatment.

Ciclosporin (medication used to reduce unwanted immunological reactions)

When ciclosporin is administered with metronidazole, 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 metronidazole, or you should discontinue disulfiram treatment. The combined use of these two medications may lead to states of confusion up to the point of developing a severe mental disorder (psychosis).

Medications containing alcohol

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

Fluorouracil (anticancer medication)

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

Lithium (used to treat mental disorders)

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

Mycophenolate mofetil (used to prevent rejection after organ transplantation)

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

Phenytoin (medication for epilepsy treatment)

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

Tacrolimus (medication used to reduce unwanted immunological reactions)

The blood levels of this medication and your renal function should be closely monitored when starting and stopping metronidazole treatment.

Taking Metronidazol Aurovitas with food, drinks, and alcohol

Alcohol

You should not take alcoholic beverages or medications containing alcohol while on metronidazole treatment 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 or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Fertility

Animal studies only indicate a possible negative influence of metronidazole 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 "Other medications and Metronidazol Aurovitas."

Pregnancy

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

Breastfeeding

You should not breastfeed during metronidazole treatment or resume breastfeeding for 2-3 days afterwards because metronidazole passes into breast milk.

Driving and operating machinery

While on 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.

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

Follow exactly the administration instructions of this medication 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, born 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 in the body 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 7days. 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).

Young people:

• 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.

Young people 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 50mg/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.

Young people 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 (1,000 mg) once a day for 3 days.

Children 3 to 7 years:

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

Children 1 to 3 years:

• 2 tablets of 250 mg (500 mg) once a day for 3 days.

Alternative dosing regimen for this pathology (dose expressed in mg/kg): 15 to 40mg/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 young people:

• 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.

Administration form

Oral route.

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 (solution for infusion, 5 mg/ml).

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.

If you take moreMetronidazole Aurovitasthan you should

Consult your doctor immediately if you take more doses than recommended.

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 takeMetronidazole Aurovitas

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 doubts 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 serious side effects, stop taking this medicine and immediately contact your doctor:

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, pancitopenia, thrombocytopenia).
• Hepatitis (liver inflammation), jaundice, pancreatitis inflammation.
• Cerebral disorders, lack of coordination.
• Non-bacterial 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).

Unknown frequency (cannot be estimated from available data)

• Mild to moderate hypersensitivity reactions, facial, mouth, throat, 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).
• Convulsions, nervous disorders such as numbness, pain, tingling, or a crawling sensation in the arms or legs.
• Toxic epidermal necrolysis.
• Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Other side effects

Frequent (may affect up to 1 in 10 people)

• Fungal infections (e.g., genital infections).
• Urethral burning or discomfort, dysuria, cystitis, polyuria, incontinence.

Occasional (may affect up to 1 in 100 people)

• Dark urine (due to metronidazole metabolite).
• Stuffy nose (nasal congestion).

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

Unknown frequency (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.
• Dysphagia.
• Anorexia.
• Depressed mood (depression).
• Hearing impairment/loss of hearing.
• Tinnitus.
• Somnolence 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.

• A well-defined area of skin with redness and, sometimes, blisters, caused by hypersensitivity to the drug (fixed drug eruption).

Emergency treatment of pseudomembranous colitis

In case of persistent severe diarrhea, you must immediately inform your doctor 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 that any of the side effects you are experiencing is seriousor if you observe any side effect not mentioned in this leaflet, inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://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.

This medication does not require special storage conditions.

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 packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofMetronidazol Aurovitas

• The active ingredient is metronidazol. Each film-coated tablet contains 250 mg of metronidazol.
• The other components are:

Tablet core:microcrystalline cellulose, pregelatinized maize starch, hydroxypropyl cellulose, anhydrous colloidal silica, sodium carboxymethyl starch (type A) (from potato) and stearic acid.

Tablet coating:hypromellose 2910 (5cps) and polyethylene glycol.

Appearance of the product and contents of the package

Film-coated tablets, white to off-white in color, round in shape, marked with “M” and “250” on one face and smooth on the other.

Metronidazol Aurovitas 250 mg film-coated tablets are available in blisters of 20, 21 and 40 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Metronidazol Aurovitas 250 mg film-coated tablets EFG

France:MÉTRONIDAZOLE ARROW 250 mg,film-coated tablet

Italy:Metronidazolo Aurobindo

Netherlands:Metronidazol Auro 250 mg, film-coated tablets

Poland:Metronidazol Aurovitas

Portugal:Metronidazol Generis

Last review date of this leaflet: August 2023

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