Metronidazole Aurovitas 250 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metronidazole Aurovitas 250 mg Film-coated Tablets PLGB

Read this entire leaflet carefully before you start taking this medicine, as 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. Do not give it to other people, 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 leaflet. See section 4.

Leaflet Contents

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

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

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

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, post-surgical wound infections).
• Urogenital trichomoniasis in women and men.
• Bacterial vaginitis.
• Protozoal diseases – amoebiasis and giardiasis.
• Acute ulcerative gingivitis; acute periodontal infections.

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

2. What you need to know before taking Metronidazole Aurovitas

Do not take Metronidazole Aurovitas

• If you are allergic to metronidazole, to other derivatives of 5-nitroimidazole, 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 metronidazole if you have:

• severe liver damage,
• blood 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 promptly 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 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 hepatic toxicity/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.

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

• stomach pain, loss of appetite, nausea, vomiting, fever, 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 monitored particularly closely.

Other medicines and Metronidazole Aurovitas

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)

When taking this medicine, your heart 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 metronidazole dose may need to be increased.

Oral contraceptives

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

Busulfan

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

Carbamazepine (medicine for the treatment of epilepsy)

This combination also requires caution, as 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, subsequently leading 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 disulfiram treatment. 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 Aurovitas with food, drinks, and alcohol".

Fluorouracil (anticancer medicine)

The daily dose of fluorouracil may need to be reduced when administered together with metronidazole, as metronidazole may increase blood levels of fluorouracil.

Lithium (used to treat mental illnesses)

Treatment with lithium preparations requires particularly careful monitoring during metronidazole treatment, and the dose of lithium may need to be readjusted. Treatment with lithium should be reduced or discontinued before administering metronidazole.

Myfortic (mycophenolate mofetil, used to prevent organ transplant rejection)

Its effect may be weakened by metronidazole; therefore, 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 only with caution, as it could 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)

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

Taking Metronidazole Aurovitas with food, drinks, and alcohol

Alcohol

You must not drink 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Fertility

Animal studies indicate that metronidazole may have a possible negative effect on the male reproductive system only when administered at high doses far exceeding the maximum recommended human dose.

Contraception in men and women

If you are taking an oral contraceptive, refer to the section "Other medicines and Metronidazole Aurovitas".

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, nor resume breastfeeding for another 2–3 days afterwards, as metronidazole passes into breast milk.

Driving and using 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 Metronidazole Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 recommended dose is normally as follows:

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

Metronidazole is 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 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 surgery.

Newborns born 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 treatment duration 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 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 of age:

• 15 mg/kg/day as a single dose or in divided 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 aged 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, without 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 aged 7 to 10 years:

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

Children aged 3 to 7 years:

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

Children aged 1 to 3 years:

• 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.

Before starting treatment, consult 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.

Infants and children weighing less than 10 kg:

• Administer proportionally smaller doses.

Method of administration

Oral use.

For some of the doses described above, other medicines containing metronidazole with different concentrations (film-coated tablet, 500 mg) and in different pharmaceutical forms (infusion solution, 5 mg/ml) are also available.

Use in patients with hepatic impairment

In patients with liver damage or severe hepatic encephalopathy, drug accumulation may occur; therefore, the prescribed daily dose should be reduced 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.

If you take more Metronidazole Aurovitas than you should

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

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

If you forget to take Metronidazole Aurovitas

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 the scheduled time.

Do not take a double dose to make up for a missed 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 experiences 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 up to extensive 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).
• Abnormal eye movements, damage or inflammation of the eye nerves.
• Reduction in white blood cell count (leucopenia), severe anaemia (aplastic anaemia).
• Seizures, neurological 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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Darkened urine (due to the metabolite of metronidazole).
• Nasal congestion (stuffy nose).

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 and movement disturbances, drowsiness, 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.

• Ringing in the ears (tinnitus).

• Somnolence or insomnia, muscle spasms.

• Redness and itching of the skin (erythema multiforme).

• Irritation of the vein wall (up to venous inflammation and thrombosis) after 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 stop treatment with metronidazole and provide appropriate therapy.

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

Reporting of adverse effects

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

5. Storage of Metronidazole Aurovitas

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

This medicine does not require any special storage conditions.

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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metronidazol Aurovitas

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

Tablet core: microcrystalline cellulose, pregelatinized corn starch, hydroxypropylcellulose, colloidal anhydrous silica, sodium carboxymethylstarch (type A) (from potato), and stearic acid.

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

Appearance of the product and contents of the pack

Film-coated tablets, white to off-white, round in shape, marked with "M" and "250" on one side and plain on the other.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Metronidazol Aurovitas 250 mg film-coated tablets EFG

France: MÉTRONIDAZOLE ARROW 250 mg, comprimé pelliculé

Italy: Metronidazolo Aurobindo

Netherlands: Metronidazol Auro 250 mg, filmomhulde tabletten

Poland: Metronidazol Aurovitas

Portugal: Metronidazol Generis

Date of the most recent revision of this leaflet: August 2023

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