METRONIDAZOL ALTAN 5 mg/ml SOLUTION FOR INFUSION

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

This medicine contains metronidazole, an antibiotic belonging to a group called nitroimidazoles, which prevents the growth and development of certain bacteria and parasites.

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

It is essential that you follow the instructions regarding dosage, administration, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

It is used in the treatment of the following infections caused by bacteria:

• Sepsis, bacteremia (infection in the blood).
• Infections of surgical wounds.
• Brain abscess (localized accumulation of pus in the brain).
• Post-operative intra-abdominal infections (infections after 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 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 have been isolated.

It is also indicated for the prevention of post-operative infections due to certain bacteria.

2. What you need to know before you use Metronidazole Altan

Do not use Metronidazole Altan:

• If you are allergic to metronidazole, to medicines of the imidazole group, or to any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine:

- if you have severe liver disorders.

• it may darken the color of your urine.

Using Metronidazole Altan with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines, 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 known 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 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 reduces 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 reducing its blood levels.

Metronidazole increases the toxicity of fluorouracil.

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

Using Metronidazole Altan with food and drinks and alcohol

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.

Pregnancy, Breastfeeding, and Fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Since metronidazole passes into the placenta and there is not enough data to establish its safety during pregnancy, your doctor will carefully assess the convenience of using this medicine during pregnancy.

This medicine should not be administered during breastfeeding, as metronidazole passes into breast milk.

Driving and Using Machines:

If you experience any of the following side effects after taking this medicine, such as confusion, dizziness, hallucinations, convulsions, and transient vision disorders, you should refrain from driving vehicles or using machines.

Metronidazole Altan contains sodium

Patients on low-sodium diets should note that this medicine contains 326 mg of sodium per 100 ml.

3. How to use Metronidazole Altan

Follow the instructions for administration of this medicine indicated by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse again.

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 treatment last more 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. Prevention:

Intravenous infusion at a rate of 5 ml per minute.

In adults and children over 12 years: 300 ml (1,500 mg of metronidazole) in 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.

Patients 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 levels of this drug.

If you use more Metronidazole Altan than you should:

Your doctor or nurse will ensure that 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 massive ingestion is suspected, treatment will be based on symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken. It may be necessary to go to a hospital. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to use Metronidazole Altan

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any side effect, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

After taking this medicine, the following side effects have been reported:

The following classification has been used according to the frequency of occurrence:

Very common (at least 1 in 10 people)

Common (less than 1 in 10 people and more than 1 in 100 people)

Uncommon (less than 1 in 100 people and more than 1 in 1,000 people)

Rare (less than 1 in 1,000 people and more than 1 in 10,000 people)

Very rare (less than 1 in 10,000 people).

Not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Very rare: Agranulocytosis, neutropenia, and thrombocytopenia.

Eye disorders

Frequency not known: Transient vision disorders such as diplopia, myopia.

Gastrointestinal disorders

Frequency not known: Epigastric pain, nausea, vomiting, diarrhea; oral mucositis and taste disorders and anorexia.

Very rare: Reversible cases of pancreatitis.

Hepatobiliary disorders

Very rare: Reversible cases of abnormal liver function tests and cholestatic hepatitis.

Immune system disorders

Very rare: Rash, pruritus, urticaria, fever, and angioedema.

Frequency not known: Anaphylactic shock.

Nervous system disorders

Frequency not known: Peripheral sensory neuropathy, headaches, convulsions, dizziness, and ataxia.

Psychiatric disorders

Frequency not known: Confusion and hallucinations.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Metronidazole Altan

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

Store in the original package to protect from light. Store below 30°C.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metronidazole Altan

• The active ingredient is metronidazole.
• The other ingredients are: sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium chloride, and water for injectable preparations.

Appearance of the product and pack contents

This medicine is presented as a solution for infusion, clear and colorless or slightly yellowish.

Each pack contains a poly(vinyl chloride) bag with 100 or 300 ml of solution, containing 0.5 or 1.5 g of metronidazole for use in intravenous infusion.

Marketing authorization holder and manufacturer

Marketing authorization holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1ª planta – Oficina F

Edificio Prisma

28230 Las Rozas. Madrid - Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

Bernedo (Álava)

01118 Spain

Date of the last revision of this leaflet: May 2018

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Intravenous route. Administer by intravenous infusion over 30-60 minutes.

It can be administered alone or simultaneously (but separately) with other appropriate antibacterial agents by parenteral route.

Preparation before administration

1. Remove the external protective overwrap by tearing it from top to bottom from the marked cut and remove the poly(vinyl chloride) bag.

1. Press the bag, inspect for leaks, and examine the solution for particles and turbidity by looking at the bag laterally.

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

WARNING: DO NOT ADD SUPPLEMENTARY MEDICATION

Intravenous administration

1. Hang the bag by the tab at the bottom of the bag,
2. Break the infusion point (twist-off) and pierce the membrane with the trocar of the solution administration equipment.
3. Follow the instructions on the packaging of the administration equipment.

Precautions

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