METRONIDAZOL SERRACLINICS 5mg/ml SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this 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

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

METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG comes in vials containing 100 ml of solution.

METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG is an anti-infective medicine, belonging to the group of nitroimidazoles, which prevents the growth and development of certain bacteria and parasites.

It is used to treat infections caused by anaerobic bacteria, especially Bacteroides fragilisand other Bacteroidesspecies and non-Bacteroidesspecies, such as fusobacteria, eubacteria, clostridium, and anaerobic streptococci.

Injectable metronidazole has been used successfully in:

• Septicaemia, bacteraemia (infection in the blood).
• Surgical wound infections.
• Brain abscess (localised accumulation of pus in the brain)
• Post-operative intra-abdominal infections (infections following surgical interventions).
• Pelvic abscess, pelvic cellulitis (inflammation of the tissues around the uterus)
• Septic thrombophlebitis (inflammation of the veins caused by an infection)
• Puerperal sepsis (infectious state that occurs after childbirth)
• Osteomyelitis (infection of the bone)
• Purulent meningitis (inflammation of the membranes covering the brain and spinal cord with pus production).
• Gas gangrene (local death of subcutaneous tissue with gas production)
• Necrotizing pneumonia (inflammation of the lungs associated with gangrene or local tissue death)
• Acute ulcerative gingivitis (inflammation of the gums in which ulcers form), in whose infections one or more anaerobic bacteria of the above-mentioned species have been isolated.

It is also indicated for the prevention of post-operative infections due to anaerobic bacteria, especially Bacteroidesspecies and anaerobic streptococci.

2. Before using Metronidazol Serraclinics 5 mg/ml, solution for infusion EFG

Do not use METRONIDAZOL SERRACLINICS 5 mg/ml

• If you are allergic to metronidazole, to medicines of the imidazole group, or to any of the other components of METRONIDAZOL SERRACLINICS 5 mg/ml

Be careful with 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 check your white blood cell count. You will also be closely monitored for the risk of nervous system disorders such as paresthesia (tingling in feet or hands), ataxia (lack of coordination), dizziness, and convulsions.
• if you have acute or chronic severe central or peripheral nervous system diseases, due to the possible risk of worsening.
• if you have severe kidney disorders. In this case, your doctor may reduce the dose when you are not undergoing dialysis or when your blood levels of this medicine are not controlled.
• it may darken the color of your urine.

There have been reports of severe liver toxicity/liver failure, some of which were fatal, 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 being treated with metronidazole and afterwards.

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

Pregnancy

Consult your doctor or pharmacist before using a medicine.

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

Breast-feeding

Consult your doctor or pharmacist before using a medicine.

Metronidazole passes into breast milk, so its administration should be avoided during the breastfeeding period.

Driving and using machines:

If you experience any of the following side effects after taking METRONIDAZOL SERRACLINICS 5 mg/ml, such as confusion, dizziness, hallucinations, convulsions, and transient vision disorders, you should avoid driving vehicles or using machines.

Important information about some of the components of METRONIDAZOL SERRACLINICS 5 mg/ml:

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

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription, homeopathic medicines, herbal remedies, and 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 anti-infectives commonly used. It can be administered simultaneously, although separately (i.e., not in the same container), with other anti-infectives.

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

Drinks and medicines containing alcohol should not be consumed during treatment with metronidazole until at least one day after treatment, due to the possibility of the so-called Antabus effect, a reaction characterized by flushing, vomiting, and tachycardia.

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

There is a risk of increased blood levels of lithium (a medicine for depression) and cyclosporin (a medicine that decreases the body's defenses) when these medicines are administered concomitantly with metronidazole. Therefore, if they are administered concomitantly, it should be under strict medical control.

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

Metronidazole increases the toxicity of fluorouracil.

3. How to use Metronidazol Korhispana 5 mg/ml, solution for infusion EFG

Your doctor will indicate 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 metronidazole) by intravenous infusion every 8 hours, being replaced as soon as possible by oral treatment. In no case should the treatment last more than seven days, unless the 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 metronidazole) by intravenous infusion immediately before, during, or after surgical intervention 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 metronidazole) per kg of body weight, in a single dose.

Use in elderly patients: Dose adjustment is not considered necessary in these patients, unless there is evidence of renal insufficiency.

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

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

If you are given too much METRONIDAZOL SERRACLINICS 5 mg/ml:

Your doctor or nurse will make sure you receive the correct intravenous dose.

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

There is no specific antidote for metronidazole overdose. In cases where a massive ingestion is suspected, treatment will be based on symptoms.

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

4. Possible side effects

Like all medicines, METRONIDAZOL SERRACLINICS 5 mg/ml can have side effects:

• Gastrointestinal reactions: pain in the upper part of the stomach, nausea, vomiting, diarrhea, inflammation of the oral mucosa, taste disorders, loss of appetite, and exceptionally (<1/10,000) and reversible, some cases of pancreatitis (inflammation of the pancreas) have been reported.

• Allergic reactions: skin rash, itching, fever, urticaria (irritation and itching of the skin) generalized and accompanied by swelling of feet, hands, throat, lips, and respiratory tract (angioedema), and exceptionally (<1/10,000) severe allergic reactions such as anaphylactic shock.

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

• Mental disorders including confusion and hallucinations.

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

• Hematological and lymphatic disorders: very rarely (<1/10,000) cases of agranulocytosis or neutropenia (decrease in a type of white blood cell, granulocytes or neutrophils, respectively) and thrombocytopenia (reduction in platelet count) have been reported.

• Hepatobiliary disorders: very rarely (<1/10,000) cases of reversible abnormal liver function tests and cholestatic hepatitis have been reported.

A very rare serious adverse reaction is brain disease (encephalopathy). The symptoms vary, but you may experience fever, neck stiffness, headache, or see or hear things that are not there. You may also have problems using your arms and legs or speaking, or feel confused. Talk to your doctor immediately if you notice any of these side effects.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metronidazol Serraclinics 5 mg/ml, solution for infusion EFG

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

Keep METRONIDAZOL SERRACLINICS 5 mg/ml out of the reach and sight of children

Expiry date:

Do not use METRONIDAZOL SERRACLINICS 5 mg/ml after the expiry date stated on the packaging.

6. Additional information for healthcare professionals

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

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

METRONIDAZOL SERRACLINICS 5 mg/ml is a colorless and translucent solution for infusion.

METRONIDAZOL SERRACLINICS 5 mg/ml, solution for infusion EFG: Packaging containing a 100 ml vial and a leaflet. Clinical packaging containing 20 single-dose units of 100 ml.

Marketing authorisation holder

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

INSTITUTO FARMACOLOGICO ESPAÑOL

Ramallosa s/n.

15883 Teo (La Coruña), Spain

Additional information for healthcare professionals.

Preparation before administration

The solution must be transparent and not contain precipitates.

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

WARNING: DO NOT ADD SUPPLEMENTARY MEDICATION

Administration

1. Hang the vial by the plastic ring on the bottom of the vial.
2. Remove the "Flip-Off" cap and puncture the rubber stopper with the trocar of the solution administration equipment.
3. Follow the instructions on the packaging of the solution administration equipment.

Precautions

1. Do not use air intake.
2. Do not connect in series, as gas embolism may occur due to residual air being dragged from the first container before administration of the solution from the second container.

This leaflet was revised in July 2017.