Metronidazole Normon 5 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Metronidazole Normon 5 mg/ml infusion solution EFG

Read all of this leaflet carefully before you start using 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Metronidazole Normon 5 mg/ml infusion solution is and what it is used for
2. What you need to know before using Metronidazole Normon 5 mg/ml infusion solution
3. How to use Metronidazole Normon 5 mg/ml infusion solution
4. Possible side effects
5. How to store Metronidazole Normon 5 mg/ml infusion solution
6. Contents of the pack and other information

1. What Metronidazol Normon 5 mg/ml infusion solution is and what it is used for

Metronidazole belongs to a group of medicines known as antibiotics and is used to treat serious infections caused by bacteria that can be eliminated by the active substance metronidazole.

Metronidazol Normon is used in both adults and children.

Your doctor may prescribe Metronidazol Normon for the treatment of any of the following conditions:

• Infections of the blood, brain, lungs, bones, genital tract, pelvic area, liver, intestine, and stomach.

If necessary, your treatment may be combined with other antibiotics.

Metronidazol Normon may also be administered as a preventive measure before surgical procedures associated with a high risk of infection by anaerobic bacteria, particularly in gynaecology or surgery of the stomach and intestine.

2. What you need to know before using Metronidazole Normon 5 mg/ml infusion solution

Do not use Metronidazole Normon

• If you are allergic to metronidazole, to other similar substances, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Metronidazole Normon if you have:

• Severe liver damage.
• A blood disorder.
• A brain, spinal cord, or neurological disease.

Therefore, your doctor will carefully determine whether you should receive treatment with Metronidazole Normon.

If, during treatment, clear signs of epileptic seizures or any other type of neurological condition (e.g., numbness in the legs) occur, your treatment will be reviewed as soon as possible. If you develop severe diarrhea, which may be due to a serious condition of the large intestine called "pseudomembranous colitis," treatment must be stopped or reviewed immediately (see also section 4). Since prolonged use of metronidazole may adversely affect blood formation (see section 4), your blood counts will be monitored during treatment.

If you receive this medicine, your urine may darken.

Cases of severe hepatotoxicity/acute liver failure with fatal outcomes have been reported in patients with Cockayne syndrome who received medications containing metronidazole.

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

If you develop any of the following symptoms, inform your doctor immediately and stop taking metronidazole:

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

Generally, treatment with Metronidazole Normon should not continue for more than 10 days. The treatment period may only be extended under exceptional circumstances and only if absolutely necessary. Repeating metronidazole treatment will be restricted to cases where it is absolutely essential. If so, you will be under strict monitoring.

Other medicines and Metronidazole Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Amiodarone (used to treat irregular heartbeats)

If you receive this medicine, your heart function should be monitored. If you notice any abnormalities in heart function, dizziness, or fainting, you must see your doctor.

Barbiturates (active ingredient in medicines used to treat epilepsy or seizures)

Phenobarbital reduces the duration of action of metronidazole; therefore, metronidazole doses may need to be increased.

Busulfan

Metronidazole must not be administered to patients receiving busulfan, as the likelihood of toxic effects is increased in such cases.

Carbamazepine (a medicine used to treat epilepsy)

Extreme caution is required when this combination is used, as metronidazole may prolong the action of carbamazepine.

Cimetidine (a medicine used to treat digestive disorders)

Cimetidine may reduce the elimination of metronidazole in isolated cases, thereby causing an increase in serum concentrations of metronidazole.

Coumarin derivatives (medicines that inhibit blood clotting)

Metronidazole may enhance the blood clotting inhibition effect of coumarins. Therefore, if you are taking a medicine that inhibits clot formation (e.g., warfarin), you may require a lower dose during metronidazole treatment.

Cyclosporine (a medicine used to suppress unwanted immune responses)

When administered simultaneously with metronidazole, blood concentrations of cyclosporine may increase; therefore, your doctor must adjust your cyclosporine dose accordingly.

Disulfiram (used in the treatment of alcohol abstinence)

If you are taking disulfiram, you must not receive metronidazole, or disulfiram treatment must be interrupted. The combined use of these two medicines may cause confusion up to the point of causing a severe mental disorder (psychosis).

Medicines containing alcohol

See the section Use of Metronidazole Normon with food, drinks, and alcohol.

Fluorouracil (an anticancer medicine)

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

Lithium (used to treat mental illness)

Treatment with lithium-containing preparations requires special close monitoring during metronidazole treatment, and the dose of the lithium-containing preparation may need to be readjusted. Before administering metronidazole, lithium treatment should be gradually reduced or discontinued.

Mycophenolate mofetil (used to prevent rejection reactions after organ transplantation)

Metronidazole may weaken its effect; therefore, close monitoring of the medicine's effect is recommended.

Phenytoin (a medicine used to treat epilepsy)

If you are taking phenytoin, your doctor will treat you with metronidazole only with caution, as metronidazole may prolong the action of phenytoin. On the other hand, phenytoin may reduce the effect of metronidazole.

Tacrolimus (used to suppress unwanted immune responses)

When starting or stopping metronidazole treatment, your blood concentrations of this medicine and kidney function must be monitored.

Use of Metronidazole Normon with food, drinks, and alcohol

Alcohol

While receiving metronidazole and for up to 48 hours after administration, you must not consume any alcoholic beverages or medicines containing alcohol, 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 before using this medicine.

Pregnancy

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

Breastfeeding

Breastfeeding must be discontinued during treatment with metronidazole and should not be resumed until 2–3 days after the end of treatment, as metronidazole is excreted in breast milk.

Fertility

Animal studies have shown only a possible negative influence of metronidazole on the male reproductive system when high doses, far exceeding the maximum recommended human dose, were administered.

Driving and use of machines

During treatment with Metronidazole Normon, you may experience drowsiness, dizziness, confusion, see or hear things that are not real (hallucinations), have seizures (convulsions), or temporary vision problems (such as blurred or double vision). If you experience these effects, do not drive or operate tools or machinery.

Metronidazole Normon contains sodium

This medicine contains 359 mg of sodium (main component of table/cooking salt) in each 100 ml. This corresponds to 18% of the maximum daily sodium intake recommended for an adult.

3. How to use Metronidazole Normon 5 mg/ml infusion solution

Dosage

The dose depends on the nature and severity of the disease, age and body weight, as well as the individual response to treatment.

The following dosage regimens are generally prescribed:

Adults and adolescents

• Treatment of amoebiasis

1500 mg per day (500 mg three times a day, intravenous infusions)

• Treatment of infections

Adults

You will be given 100 ml of this medicinal product (500 mg of metronidazole) every 8 hours.

In most cases, treatment will last 7 days.

Only exceptionally may treatment be prolonged, although generally treatment should not exceed 10 days.

The dose will be the same for patients with renal disease.

For patients with hepatic impairment, lower doses may be required. If you have been treated with a haemodialysis machine, your doctor will schedule the infusion after dialysis has finished. It is not necessary to adjust the usual dose.

• Prevention of infections that may occur after surgery

If used to prevent infections arising during surgery, you may be given 500 mg of the medicine before surgery. The dose will be repeated 8 and 16 hours after surgery.

Elderly patients

Your doctor will administer this medicine only with special caution.

Use in children

Dosage in children is based on body weight (BW).

Treatment of amoebiasis

35–50 mg/kg/day intravenously, divided into 3 doses, for 5–10 days. The maximum daily dose of 2,400 mg/day must not be exceeded.

Treatment of infections

Age	Dosage
From 8 weeks to 12 years	20–30 mg of metronidazole per kg of body weight per day, as a single dose or divided into 7.5 mg of metronidazole per kg of body weight every 8 hours. If the infection is severe, the daily dose may be increased up to 40 mg of metronidazole per kg of body weight.
Less than 8 weeks	15 mg of metronidazole per kg of body weight as a single daily dose or divided into 7.5 mg/kg of body weight every 12 hours.
Neonates under 40 weeks gestational age	Since metronidazole may accumulate in these patients during the first weeks of life, blood concentrations of metronidazole will be monitored a few days after treatment.

In general, the treatment will last 7 days.

Prevention of infections that may occur after a surgical procedure.

Age	Posology
Under 12 years	20-30 mg of metronidazole per kg of body weight as a single dose administered 1-2 hours before surgery
Neonates under 40 weeks of gestational age	10 mg of metronidazole per kg of body weight as a single dose before surgery

Method of administration and duration of treatment

Metronidazol Normon 5 mg/ml is administered by direct drip into a vein (intravenous infusion). The infusion from one bottle usually lasts 60 minutes, but must not be given in less than 20 minutes.

The total treatment period with metronidazole is usually 7 days and should not exceed 10 days, unless absolutely necessary (see also section “Warnings and precautions”). If you are simultaneously receiving other antibiotics, your doctor will administer those medications separately.

If you use more Metronidazol Normon than you should

The adverse effects described in the following section may occur as signs or symptoms of an overdose. Cases of suicide attempts and accidental overdoses with single oral doses of metronidazole up to 12 g have been reported. Symptoms were limited to vomiting, ataxia, and mild disorientation. There is no known specific antidote or treatment for massive overdose, but metronidazole can be removed from the body by dialysis (a treatment using a hemodialysis machine).

In case of overdose or accidental administration/ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone: 91 562 04 20), indicating the medication and the amount ingested.

If you forget to use Metronidazol Normon

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

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 will experience them.

Adverse effects mainly occur with high doses or prolonged use.

If you notice any of the following side effects, speak to 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 the section Emergency treatment of pseudomembranous enterocolitis).
• Severe acute allergic reactions, including anaphylactic shock.

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

• White blood cell and platelet counts may decrease during treatment (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia).
• Hepatitis (inflammation of the liver), jaundice, liver inflammation.
• Neurological disorders, lack of coordination.
• Non-bacterial meningitis (aseptic meningitis).
• Severe inflammatory rash affecting mucous membranes and skin, accompanied by fever, redness and blistering (in extreme cases, even extensive skin detachment (Stevens-Johnson syndrome)).

Frequency not known (cannot be estimated from available data):

• Hypersensitivity reactions ranging from mild to moderate, swelling of the face, mouth, throat or tongue (angioedema).
• Eye spasms, damage or inflammation of the eye nerves.
• Reduced white blood cell count (leukopenia), severe anaemia (aplastic anaemia).
• Seizures, neurological disorders such as numbness, pain, tingling 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)

Uncommon (may affect up to 1 in 100 people):

• Darkening of urine (due to a metabolite of metronidazole)

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

• Changes in ECG.

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

• Psychotic disorders such as confusion, hallucinations.
• Headache, dizziness, somnolence, fever, visual and movement disturbances, vertigo, speech disorders, seizures.
• Visual disturbances, e.g., double vision, blurred vision.
• Liver function disorders (such as elevated serum levels of certain enzymes and bilirubin).
• Allergic skin reactions such as itching, urticaria.
• Joint or muscle pain.

Frequency not known (cannot be estimated from available data):

• Dizziness, nausea, diarrhoea, inflammation of the tongue or mouth, belching and bitter taste, metallic taste, pressure above the stomach, coated tongue.
• Difficulty swallowing.
• Anorexia.
• Sadness (depressive state).
• Somnolence or insomnia, muscle spasms.
• Redness and itching of the skin (erythema multiforme).
• Irritation of the venous walls (up to and including inflamed veins and thrombosis) following intravenous administration, weakness, fever.

Emergency treatment of pseudomembranous enterocolitis

If you develop severe persistent diarrhoea, you must inform your doctor immediately, as it may be due to pseudomembranous colitis, a serious condition requiring immediate treatment. Your doctor will stop treatment with metronidazole and provide appropriate therapy.

If any of these adverse effects become severe, or if you experience any adverse effect not listed in this leaflet, inform your doctor.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metronidazole Normon 5 mg/ml infusion solution

Keep out of the sight and reach of children.

Bags: This medicine does not require any special storage temperature. Store in the original packaging to protect from light. Do not freeze or refrigerate.

Since metronidazole is light-sensitive, the overwrap of the bag should only be removed immediately before administration.

Do not use Metronidazole Normon after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Discard if any changes are observed in the container or in the liquid it contains.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metronidazol Normon:

The active substance is metronidazole.

Each 100 ml of solution contains 500 mg of metronidazole.

The other components are: sodium hydrogen phosphate, citric acid monohydrate, sodium chloride and water for injections.

Each 300 ml of solution contains 1.5 g of metronidazole.

The other components are: sodium hydrogen phosphate, citric acid monohydrate, sodium chloride and water for injections.

Appearance of the product and contents of the container:

Metronidazol Normon contains a clear, colourless or slightly yellowish solution.

It is presented in plastic bags of 100 ml and 300 ml.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

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

Other presentations:

Metronidazol Normon 250 mg tablets

Date of the most recent review of the package leaflet: June 2021.

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/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/62224/P_62224.html