Metronidazole Altan 5 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metronidazole Altan 5 mg/ml solution for infusion 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet contents

1. What Metronidazol Altan is and what it is used for
2. What you need to know before using Metronidazol Altan
3. How to use Metronidazol Altan
4. Possible side effects
5. Storage of Metronidazol Altan
6. Contents of the pack and other information

1. What Metronidazol Altan is and what it is 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 influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used in the treatment of the following bacterial infections:

• Septicaemia, bacteraemia (infection in the blood)
• Surgical wound infections
• Brain abscess (localized accumulation of pus in the brain)
• Postoperative intra-abdominal infections (infections following surgical procedures)
• Pelvic abscess, pelvic cellulitis (inflammation of tissues around the uterus)
• Septic thrombophlebitis (vein inflammation caused by infection)
• Puerperal sepsis (infectious condition occurring after childbirth)
• Osteomyelitis (bone infection)
• Purulent meningitis (inflammation of the membranes covering the brain and spinal cord with pus formation)
• Gas gangrene (localized death of subcutaneous tissue with gas production)
• Necrotizing pneumonia (lung inflammation associated with gangrene or localized tissue death)
• Acute ulcerative gingivitis (gum inflammation with ulcer formation)

in which one or more of the anaerobic bacteria mentioned above have been isolated.

It is also indicated for the prevention of infections following surgical procedures caused by certain bacteria.

2. What you need to know before using Metronidazole Altan

Do not use Metronidazole Altan:

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

Warnings and precautions

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

- 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 due to the risk of neurological disorders such as paresthesia (tingling in hands or feet), ataxia (lack of coordination), dizziness, and seizures.

• if you have severe acute or chronic diseases 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 blood levels of this medicine are not being monitored.

  • may darken the color of your urine.

Use of Metronidazole Altan with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines—including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products—as it may be necessary to interrupt treatment or adjust the dose of one or more of these medicines.

There is no known therapeutic incompatibility with any of the anti-infective agents commonly used. Metronidazole may be administered simultaneously, although separately (i.e., not in the same container), with other anti-infective agents.

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 must be closely monitored by your doctor.

There is a risk of increased blood levels of lithium (a medicine used for depression) and cyclosporine (a medicine that suppresses the body's immune defenses) when these are administered together with metronidazole. Therefore, if co-administered, they must be used under strict medical supervision.

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

Metronidazole increases the toxicity of fluorouracil.

Concomitant administration of metronidazole and disulfiram is not recommended, as cases of mental disturbances have been reported.

Use of Metronidazole Altan with food, beverages, and alcohol

Beverages and medicines containing alcohol must not be consumed during treatment with metronidazole and for at least one day after completion of treatment, due to the possibility of developing the so-called Antabuse effect—a reaction characterized by flushing, vomiting, and tachycardia.

Pregnancy, lactation and fertility:

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

Since metronidazole crosses the placenta and there are insufficient data to establish its safety during pregnancy, your doctor will carefully assess whether the use of this medicine is advisable during pregnancy.

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

Driving and use of machines:

If you experience any of the following adverse effects after administration of this medicine, such as confusion, dizziness, hallucinations, seizures, or transient visual disturbances, you should refrain from driving vehicles or operating machinery.

Metronidazole Altan contains sodium

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

3. How to use Metronidazol Altan

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

1. Treatment:

In adults and children over 12 years of age: 100 ml (500 mg of metronidazole) by intravenous infusion every 8 hours, to be replaced as soon as possible by oral treatment. Under no circumstances should treatment last longer than seven days, unless circumstances indicate otherwise.

In children under 12 years of age: same as for adults, but at a dose of 20–30 mg/kg/day administered 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 of age: 300 ml (1,500 mg of metronidazole) by intravenous infusion immediately before, during, or after surgical intervention as a single dose.

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

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

Patients with renal impairment: Dose reduction of metronidazole may be recommended in patients with renal impairment who are not undergoing dialysis, and monitoring of serum metabolite levels may be required.

If you use more Metronidazol Altan than you should:

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

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

There is no known 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, stating the name of the medicine and the amount taken. It may be necessary to go to a hospital. It is recommended to bring the medicine container and package leaflet to the healthcare professional.

If you forget to use Metronidazol Altan

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, please inform your doctor, pharmacist, or nurse.

The following adverse effects have been reported as possible after administration of this medicine:

The following frequency-based classification has been used:

Very common (≥ 1 in 10 people)
Common (less than 1 in 10 and more than 1 in 100 people)
Uncommon (less than 1 in 100 and more than 1 in 1,000 people)
Rare (less than 1 in 1,000 and more than 1 in 10,000 people)
Very rare (less than 1 in 10,000 people)
Not known (cannot be estimated from available data)

Blood and lymphatic system disorders

Very rare: Agranulocytosis, neutropenia, and thrombocytopenia.

Eye disorders

Frequency not known: Transient visual disturbances such as diplopia, myopia.

Gastrointestinal disorders

Frequency not known: Epigastric pain, nausea, vomiting, diarrhea; oral mucositis, taste disturbances, 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, headache, seizures, dizziness, and ataxia.

Psychiatric disorders

Frequency not known: Confusion and hallucinations.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 container to protect from light. Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging 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 unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metronidazol Altan

• The active substance is metronidazole.
• The other components are: sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium chloride, and water for injections.

Appearance of the product and contents of the pack

This medicine is presented as a clear, colourless or slightly yellowish infusion solution.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.
C/ Cólquide 6, Portal 2, 1st floor – Office 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 most recent revision of this summary: May 2018

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

This information is intended for healthcare professionals only:

By intravenous route. Administer via intravenous infusion over 30–60 minutes.

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

Preparation prior to administration

1. Remove the outer protective overwrap by tearing it from top to bottom starting at the marked cut, and take out the poly(vinyl chloride) bag.
2. Squeeze the bag, check for leaks, and examine the solution for particles and turbidity by viewing the bag from the side.
   If leaks, particles, or lack of clarity are observed, discard the container.

WARNING: DO NOT ADD SUPPLEMENTARY MEDICATION

Intravenous administration

1. Hang the bag by the eyelet located at the bottom of the bag.
2. Break off the infusion port (twist-off) and pierce the membrane with the administration set spike.
3. Follow the instructions provided on the administration set packaging.

Precautions

1. Do not use air-inlet administration sets.
2. Do not connect in series, as this may result in gas embolism due to residual air carried over from the first container before the solution in the second container is administered.