PATIENT INFORMATION LEAFLET

Read this leaflet carefully before you start using the medicine

Contents of the leaflet:

1. What METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG is and what it is used for
2. Before using METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG
3. How to use METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG
4. Possible side effects
5. Storage of METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG
6. Additional information for healthcare professionals

METRONIDAZOL SERRACLINICS5mg/ml, solution for infusion EFG is presented inflasksthat contain100ml of solution.

METRONIDAZOL SERRACLINICS5mg/ml, solution for infusion EFG, is an antimicrobial medication, belonging to the group of nitroimidazoles, which prevents the growth and development of certain bacteria and parasites.

It is used for thetreatment of infectionsproduced by anaerobic bacteria, especiallyBacteroides fragilisand other species ofBacteroidesand non-Bacteroides,such as fusobacteria, eubacteria,clostridiumand anaerobic streptococci.

The injectable metronidazole has been used successfully in:

• Septicemia, bacteremia. (Blood infection).
• Surgical wound infections.
• Cerebral abscess. (Localized accumulation of pus in the brain)
• Postoperative intra-abdominal infections. (Infections following surgical interventions).
• Pelvic abscess, pelvic cellulitis. (Inflammation of tissues around the uterus)
• Septic thrombophlebitis. (Inflammation of veins caused by an infection)
• Puerperal sepsis. (Infectious state occurring after childbirth)
• Osteomyelitis. (Bone infection)
• Purulent meningitis. (Inflammation of membranes covering the brain and spinal cord with pus production).
• Gas gangrene. (Localized tissue death with gas production)
• Necrotizing pneumonia. (Inflammation of lungs associated with localized tissue death)
• Acute ulcerative gingivitis. (Inflammation of gums with ulcer formation), in infections where one or more anaerobic bacteria from the above-mentioned species have been isolated.

It is also indicated for thepreventionof infections following surgical interventions due to anaerobic bacteria, especially speciesBacteroidesand anaerobic streptococci.

No use METRONIDAZOL SERRACLINICS 5 mg/ml

-In case you are allergic to metronidazole, to medications in the imidazole group, or to any of the other components of METRONIDAZOL SERRACLINICS 5 mg/ml

Tenga especial cuidado con METRONIDAZOL SERRACLINICS 5 mg/ml

• If you have severe liver disorders.
• If your treatment is prolonged. Your doctor may ask you to have regular blood tests, especially to monitor your white blood cell count. You will also be closely monitored for the risk of nervous system disorders such as paresthesia (tingling in the feet or hands), ataxia (loss of coordination), vertigo, and seizures.
• If you have severe acute or chronic disorders of the central or peripheral nervous system, due to the possible risk of worsening.
• If you have severe kidney disorders. In this case, your doctor may reduce your dose when you are not undergoing dialysis or when your blood levels of this medication are not controlled.
• Your urine may darken.

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

If you have Cockayne syndrome, your doctor must closely monitor your liver function while you receive treatment with metronidazole and afterwards.

Inform your doctor immediately and stop taking metronidazole if you experience: stomach pain, loss of appetite, nausea, vomiting, fever, general discomfort, fatigue, jaundice, dark urine, clay-colored stools, or itching.

Embarazo

Consult your doctor or pharmacist before using a medication.

Since metronidazole passes through the placenta and there is not enough data to establish its safety during pregnancy, your doctor will carefully evaluate the convenience of using METRONIDAZOL SERRACLINICS 5 mg/ml during pregnancy.

Lactancia

Consult your doctor or pharmacist before using a medication.

Metronidazole passes into breast milk, so it should be avoided during the lactation period.

Conducción y uso de máquinas:

If you experience any of the following adverse effects after taking METRONIDAZOL SERRACLINICS 5 mg/ml, such as confusion, vertigo, hallucinations, seizures, and transient visual disturbances, you should refrain from driving vehicles or operating machinery.

Información importante sobre alguno de los componentes de METRONIDAZOL SERRACLINICS 5 mg/ml:

This medication contains 326 mg of sodium per 100 ml, which should be taken into account in patients with low-sodium diets.

Uso de otros medicamentos:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

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

The concomitant administration of metronidazole and disulfiram is not recommended, as there have been cases of mental disorders.

Alcoholic beverages and medications containing alcohol should not be consumed during metronidazole treatment until at least one day after treatment, due to the possibility of the Antabus effect, a reaction characterized by flushing, vomiting, and tachycardia.

The concomitant administration of metronidazole and oral anticoagulant medications (such as warfarin) may increase the risk of bleeding. If metronidazole is administered at the same time as these medications, you should be closely monitored by your doctor.

There is a risk of increased blood levels of lithium (a medication for depression) and cyclosporine (a medication that reduces the body's defenses) when these medications are administered concurrently with metronidazole. Therefore, if they are administered concurrently, it should be under strict medical supervision.

Phenytoin and phenobarbital (antiepileptic medications) increase the elimination of metronidazole, thereby reducing its blood levels.

Metronidazole increases the toxicity of fluorouracil.

Your doctor will tell you your daily dose and the duration of your treatment. Do not stop your treatment before. The dosage is individual for you and may be modified by your doctor based on your response to treatment.

1. Treatment:

In adults and children over 12 years: 100 ml (500 mg of metronidazol) by intravenous infusion every 8 hours, being replaced as soon as possible by oral treatment. In no case should the treatment last longer than seven days, unless circumstances advise otherwise.

In children under 12 years: the same as for adults, but at a dose of 20-30 mg/kg/day in two or three intravenous infusions.

1. Prophylaxis: :

The injection of Metronidazol should be administered by intravenous infusion at a rate of 5 ml per minute.

In adults and children over 12 years: 300 ml (1,500 mg of metronidazol) by intravenous infusion immediately before, during or after surgery in a single dose.

In children under 12 years: the same as for adults, but at a dose of 4.5 ml (2.5 mg of metronidazol) per kg of weight, in a single dose.

Use in elderly: No dose adjustment is considered necessary in these patients, unless evidence of renal insufficiency.

Patients with renal insufficiency: It may be recommended to reduce the dose of metronidazol in patients with renal insufficiency, when not undergoing dialysis and monitoring of serum levels of metabolites.

If you estimate that the action of METRONIDAZOL SERRACLINICS 5 mg/ml is too strong or weak, inform your doctor or pharmacist.

If you are administered more METRONIDAZOL SERRACLINICS 5 mg/ml than you should:

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

An accidental overdose could lead to vomiting, movement coordination and mild disorientation.

No specific antidote is known for metronidazol overdose. In cases where a massive ingestion is suspected, treatment will be based on symptoms.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

Like all medicines, METRONIDAZOL SERRACLINICS 5 mg/ml may have adverse effects:

• Gastrointestinal reactions: upper stomach pain, nausea, vomiting, diarrhea, oral mucosa inflammation, taste disturbances, loss of appetite, and exceptionally (<1>

• Allergic reactions: skin rash, itching, fever, urticaria (generalized skin irritation and itching accompanied by inflammation of feet, hands, throat, lips, and respiratory passages (angioedema), and exceptionally (<1>

• Nervous system reactions: peripheral sensory neuropathy, headache, seizures, dizziness, and coordination of movements (ataxia).

• Mental disturbances including confusion and hallucinations.

• Transient vision disturbances such as double vision (diplopia) and myopia.

• Hematological and lymphatic system reactions: very rarely (<1>0.000)cases of agranulocytosis orneutropenia(decrease in a type of white blood cells, granulocytes or neutrophils respectively), and thrombocytopenia (reduction in the number of platelets).

• Hepatobiliary reactions: very rarely (<1>0.000)cases of reversible abnormal liver function test results and cholestatic hepatitis.

A very rare severe adverse reaction is a brain disease (encephalopathy). Symptoms vary, but it may present with fever, neck stiffness, headache, or seeing or hearing things that do not exist. It may also have difficulty using arms and legs or speaking, or feeling confused. Immediately consult your doctor if you notice any of these adverse reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Store at a temperature below 25°C and protected from light.

Keep METRONIDAZOL SERRACLINICS5mg/ml out of the reach and sight of children.

Expiration:

Do not use METRONIDAZOL SERRACLINICS5mg/ml after the expiration date indicated on the packaging.

The active principle is Metronidazole (D.O.E.)

The other components are anhydrous disodium hydrogen phosphate, citric acid monohydrate, sodium chloride, and injection water.

METRONIDAZOL SERRACLINICS 5 mg/ml is a perfusion solution, colorless and transparent.

METRONIDAZOL SERRACLINICS 5 mg/ml, perfusion solution EFG: Container containing a bottle of 100 ml and a leaflet. Clinical container containing 20 unitary containers of 100 ml .

Holder of the marketing authorization

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for manufacturing

INSTITUTO FARMACOLOGICO ESPAÑOL

Ramallosa s/n.

15883 Teo (La Coruña). (Coruña), Spain

Additional information for the healthcare professional.

Preparation before administration

The solution must be transparent and not contain precipitates.

If leaks, particles, or the solution is not clear, discard the container.

WARNING: DO NOT ADD SUPPLEMENTARY MEDICATION

Administration

1. Hang the bottle by the plastic loop existing at the bottom of it.
2. Remove the "Flip-Off" capsule and pierce the rubber stopper with the trocar of the administration equipment.
3. Follow the instructions that appear on the administration equipment container.

Precautions

1. Do not use a Y-connector.
2. Do not connect in series as it may cause gas embolism due to residual air carried from the first container before the administration of the solution from the second container.

This leaflet was revised in July 2017.