Leaflet: Information for the user

Metronidazol Normon 5 mg/ml infusion solution EFG

Metronidazol

Read 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, 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.

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

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

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

4.Possible side effects

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

6.Contents of the pack and additional information

Metronidazol belongs to a group of medicines known as antibiotics and is used to treat severe infections caused by bacteria that can be eliminated by the active ingredient metronidazol.

Metronidazol Normon is used in both adults and children.

You may be administered Metronidazol Normon 5 mg/ml for the treatment of any of the following diseases:

• central nervous system infections such as abscesses (local infection with pus) in the brain, inflammation of the meninges (brain covering)
• lung and lung lining infections, such as tissue-destructive pneumonia, pneumonia following stomach content entry into the lungs, lung abscesses,
• gastrointestinal tract infections, such as inflammation of the internal lining of the pelvic and abdominal walls, liver abscesses, intestinal or rectal surgery, abdominal and pelvic infections with pus,
• female genital organ infections, such as uterine inflammation following procedures such as uterine removal, cesarean section, spontaneous abortion accompanied by blood poisoning (sepsis) or childbirth fever,
• ear, nose, throat, and dental infections, such as acute ulcerative gingivitis (inflammation of the gums with ulcers)
• inflammation of the heart lining
• bone and joint infections, such as bone marrow inflammation
• gas gangrene
• blood poisoning derived from thrombosis or inflammation of the veins

Your treatment may be complemented with other antibiotics if necessary.

Metronidazol Normon 5 mg/ml may be administered as a preventive measure prior to surgeries associated with a higher risk of infection caused by anaerobic bacteria, mainly in gynecology or stomach and intestine surgery

No use Metronidazol Normon

-If you are allergic to metronidazole, other similar substances or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to receive Metronidazol 5 mg/ml.

Be especially careful with metronidazole 5mg/ml if you have:

• severe liver damage,
• a blood formation disorder or
• a brain, spinal cord or nervous system disease.

Your doctor will carefully determine if you should be treated with Metronidazol 5mg/ml.

If seizures or any other nervous problem (such as numbness in the limbs) become apparent during treatment, your treatment will be reviewed immediately.

The treatment with metronidazole 5 mg/ml should generally not be prolonged for more than 10days; the treatment period will only be extended in exceptional circumstances and if absolutely necessary. The repetition of metronidazole therapy will be limited to cases where it is absolutely necessary. In such cases, you will be closely monitored.

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

Severe liver toxicity/acute liver insufficiency, some of which have been fatal, have been described in patients with Cockayne syndrome taking metronidazole-containing medications.

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

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

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

Severe skin blistering reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN) or generalized acute pustular psoriasis (GAP) have been reported with metronidazole (see "Possible side effects"). If symptoms or signs of GAP, SSJ or TEN appear, treatment with Metronidazol Normon should be stopped immediately.

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

Other Medications and Metronidazol Normon

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including those purchased without a prescription.

There is no therapeutic incompatibility with any of the commonly used anti-infectives. It can be administered simultaneously, although separately (i.e., not in the same package) with other anti-infectives.

Amiodarone (used to treat irregular heartbeats)

When you receive this medication, your cardiac function should be monitored. You should consult your doctor if you notice any abnormalities in cardiac function, dizziness or fainting.

Barbiturates (active principle of medications for treating epilepsy or seizures)

Phenobarbital reduces the duration of metronidazole's action; therefore, you may need to increase your metronidazole dose.

Birth control pills

Your birth control pill may be less reliable while you are receiving metronidazole.

Busulfan

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

Carbamazepine (medication for treating epilepsy).

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

Cimetidine (medication for treating stomach disorders)

Cimetidine may reduce metronidazole elimination in isolated cases and, subsequently, lead to an increase in metronidazole serum 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 less of it during metronidazole treatment.

Ciclosporin (medication used to suppress undesirable immune responses)

When ciclosporin is administered with metronidazole, ciclosporin blood levels may increase; therefore, your doctor will need to adjust your ciclosporin dose as necessary - In addition, your renal function will be monitored.

Disulfiram (used for treating alcohol abstinence)

If you are taking disulfiram, you should not receive metronidazole, or you should stop disulfiram treatment. The combined use of these two medications may lead to states of confusion up to a severe mental disorder (psychosis).

Fluorouracil (cancer medication)It may be necessary to reduce the daily dose of fluorouracil when administered with metronidazole because metronidazole may cause an increase in fluorouracil blood levels.

Lithium (used for treating mental illness)

Treatment with lithium preparations requires especially careful monitoring during metronidazole treatment, and the lithium preparation dose may require adjustment.

Mycophenolate mofetil (used for preventing rejection after organ transplantation)

Its effect may be weakened by metronidazole, so careful monitoring of the effect of mycophenolate mofetil is recommended.

Phenytoin (medication for treating epilepsy)

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

Tacrolimus

Tacrolimus blood levels and renal function should be monitored after starting or stopping metronidazole treatment.

Metronidazol 5 mg/ml with alcohol

You should not drink alcoholic beverages while receiving metronidazole, nor during the 48hours after completing treatment. Drinking alcohol during metronidazole 5mg/ml use may cause you to feel unwell, with symptoms such as palpitations, hot flashes, sweating, 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 before using this medication.

Pregnancy

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

Breastfeeding

Breastfeeding should be suspended during metronidazole treatment and should not be resumed until 2-3 days after treatment has been completed because metronidazole is excreted in breast milk.

Fertility

Animal studies have indicated a negative influence on the male reproductive system; however, this was only observed at very high doses that far exceeded the recommended dose for humans.

Driving and operating machinery

You should not drive or operate machinery while receiving metronidazole, as metronidazole may affect your alertness. This may occur especially at the beginning of treatment or in combination with alcohol consumption.

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

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

The dose depends on the nature and severity of your illness, your age and body weight, and your individual response to treatment.

Recommended dose is:

Adults and adolescents

• Treatment of infections

You will be administered 100ml of this medication (corresponding to 500mg of metronidazole) every 8hours. In most cases, treatment will last 7days.

Alternatively, you may receive 300ml of the medication (corresponding to 1500mg of metronidazole) on the first day of treatment.

In most cases, treatment will last 7days. In exceptional cases, treatment may be prolonged, although in general, treatment should not exceed 10days.

The dose will be the same for patients with renal diseases. For patients with liver diseases, lower doses will be required. If you are being treated with hemodialysis, your doctor will adjust the dose on treatment days.

• Prevention of infections that may occur after surgical interventions

When used for the prevention of infection in a surgical operation, you will be administered 500 mg of medication before the intervention. The dose will be repeated 8 and 16 hours after the intervention.

Use in children

The dosage in children is based on body weight

Treatment of infections

In children over 8 weeks to 12 years of age: The usual daily dose is 20-30 mg/kg/day as a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg depending on the severity of the infection. Treatment duration is generally 7 days.

In children under 8 weeks of age: 15 mg/kg as a single daily dose or divided into 7.5 mg/kg every 12 hours.

In newborns with a gestational age less than 40 weeks, metronidazole accumulation may occur during the first week of life, so plasma metronidazole concentrations should be monitored preferably after a few days of treatment.

• Prevention of infections that may occur after surgical interventions

In children under 12 years of age: 20-30 mg/kg as a single dose administered 1-2 hours before surgery.

In newborns with gestational age less than 40 weeks: 10 mg/kg body weight as a single dose before surgery.

Method of administration

Metronidazole Normon 5 mg/ml is administered by direct infusion into a vein (intravenous perfusion). A typical infusion of a bottle usually lasts 60 minutes, but should not be done in less than 30 minutes.

If you are receiving other antibiotics simultaneously, your doctor will administer those medications separately.

If you use more Metronidazole Normon than you should:

Your doctor or nurse will ensure that you receive the correct intravenous dose.

A accidental overdose could produce nausea, vomiting, cravings, metallic taste, headache, dizziness, insomnia, somnolence, oliguria, and dark urine, hearing problems, and seizures.

No specific antidote is known for metronidazole overdose. Treatment will be based on symptoms in cases where a massive ingestion is suspected.

In case of overdose or accidental administration/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 use Metronidazole Normon

Do not use a double dose to compensate for the missed doses.

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.

Side effects are mainly produced at high doses or with prolonged use.

The following terms are used to describe the frequency of side effects:

"Very common" affects more than 1 in 10 patients treated

"Common" affects between 1 and 10 in 100 patients treated

"Uncommon" affects between 1 and 10 in 1,000 patients treated

"Rare" affects between 1 and 10 in 10,000 patients treated

"Very rare" affects less than 1 in 10,000 patients treated

"Unknown" The frequency cannot be estimated from the available data.

The following side effects may be severe and therefore require immediate treatment:

Rare:

• Severe persistent diarrhea (possibly a symptom of a serious intestinal infection called pseudomembranous colitis)

Emergency treatment for pseudomembranous enterocolitis

In case of severe persistent diarrhea, you should immediately inform your doctor because it may be due to pseudomembranous colitis, a serious disease that must be treated immediately.

Your doctor will interrupt the treatment with metronidazole and apply the appropriate treatment.

• Acute and severe hypersensitivity reactions up to anaphylactic shock (swelling of the face, lips, and respiratory tract, as well as low blood pressure, difficulty breathing, syncope, and even death)

Very rare:

• Decreased platelet and white blood cell counts during treatment (granulocytopenia, agranulocytosis, pancytopenia, thrombocytopenia). Regular blood count monitoring is required during prolonged use.
• Hepatitis (liver inflammation), jaundice, pancreatitis (isolated reports)
• Cerebral disorders, lack of coordination
• Severe inflammatory rash on mucous membranes and skin with fever, redness, and blisters, in extremely rare cases up to skin detachment in extensive areas (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Unknown:

• Mild to moderate hypersensitivity reactions, a special type of rapid skin swelling on the face called angioedema
• Eye muscle spasms, nerve damage or inflammation of the eye nerves
• Reduced white blood cell count, severe anemia
• Seizures, nervous system disorders such as numbness, pain, tingling sensation in arms or legs.
• Aseptic meningitis (inflammation of the meninges or the brain covering that is not of bacterial origin)

Other side effects

Common

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

Uncommon

• Dark urine (due to a metronidazole metabolite)

Rare

• Changes in ECG (heart activity)

Very rare:

• Psychotic disorders, such as confusion, hallucinations,
• Headache, dizziness, somnolence, fever, visual disturbances, and movement disorders, vertigo, speech defects, seizures
• Visual disorders, e.g., double vision, myopia
• Liver function disorders (e.g., elevated serum levels of certain enzymes and bilirubin)
• Skin allergic reactions such as itching, urticaria
• Muscle and joint pain

Unknown:

• Dizziness, nausea, diarrhea, inflammation of the tongue or mouth, belching, and bitter taste, metallic taste, pressure on the stomach, tongue numbness
• Difficulty swallowing
• Loss of appetite (anorexia)
• Depressive mood
• Somnolence or insomnia, muscle spasms,
• Redness and itching of the skin (erythema multiforme)
• Irritation of the venous walls (up to the point of presenting inflamed and thrombosed veins) after intravenous administration, states of weakness, fever

The type and severity of side effects in children are the same as in adults.

Reporting of 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 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 out of the sight and reach of children.

Bags: Store below30°C. Store in the original packaging to protect it from light. Do not freeze or refrigerate.

Since metronidazol is sensitive to light, only remove the overwrap from the bag immediately before administration.

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

Dispose of if any alterations are observed in the packaging or the liquid it contains.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Metronidazol Normon:

The active ingredient is metronidazol.

Each 100 ml of solution contains 500 mg of metronidazol.

The other components are: sodium dihydrogen phosphate, citric acid monohydrate, sodium chloride and water for injectable preparations.

Each 300 ml of solution contains 1.5 g of metronidazol.

The other components are: sodium dihydrogen phosphate, citric acid monohydrate, sodium chloride and water for injectable preparations.

Appearance of the product and contents of the packaging:

Metronidazol Normon contains a transparent, colorless or slightly yellowish solution.

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

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 250 mg tablets

Last review date of the leaflet:June 2021.

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