Leaflet: information for the user

Metronidazol Altan 5 mg/ml solution for infusion EFG

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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

• Sepsis, bacteremia (blood infection).
• Surgical wound infections.
• Cerebral abscess (localized accumulation of pus in the brain).
• Post-operative 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 (local death of subcutaneous tissue with gas production).
• Necrotizing pneumonia (inflammation of lungs associated with local death of tissue).
• Acute ulcerative gingivitis (inflammation of gums with ulcer formation).

infections in which one or more anaerobic bacteria from the above-mentioned list have been isolated.

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

No use Metronidazol Altan:

- If you are allergic to metronidazole, to medications in the imidazole group, or to any of the other components of this medication (listed in section 6)

Advertencias 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 request that you undergo regular blood tests, especially to monitor your white blood cell count. You will also be closely monitored for the risk of neurological disorders such as paresthesia (tingling in the feet or hands), ataxia (loss of coordination), dizziness, 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 not undergoing dialysis or when your blood levels of this medication are not controlled.

• It may darken the color of your urine.

Use of Metronidazol Altan with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, homeopathic, herbal, 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 commonly used antimicrobials. It can be administered simultaneously, although separately (i.e., not in the same package) with other antimicrobials.

The concurrent 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 must 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 control.

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

Metronidazole increases the toxicity of fluorouracil.

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

Use of Metronidazol Altan with foods and beverages and alcohol

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

Pregnancy, lactation, and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this 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 this medication during pregnancy.

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

Driving and operating machinery:

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

Metronidazol Altan contains sodium

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

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

1. Treatment:

For 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 7 days, unless circumstances advise otherwise.

For children under 12 years: the same as for adults, but at a dose of 20-30 mg/kg/day in 2 or 3 intravenous infusions.

1. Prevention::

Intravenous infusion at a rate of 5 ml per minute.

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

For 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 patients: dose adjustment is not considered necessary in these patients, unless evidence of renal insufficiency is present.

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

If you use more Metronidazol Altan than you should:

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

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

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

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

If you forgot to use Metronidazol Altan

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor, pharmacist, or nurse.

After administration of this medicine, the following side effects have been reported as possible:

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

Very common (equal to or more than 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)

Unknown (cannot be estimated from available data)

Blood and lymphatic system disorders

Very rare: Agranulocytosis, neutropenia, and thrombocytopenia.

Eye disorders

Unknown frequency: Transient visual disturbances such as diplopia, myopia.

Gastrointestinal disorders

Unknown frequency:Epigastric pain, nausea, vomiting, diarrhea; oral mucositis and disturbances of taste and anorexia

Very rare: Reversible cases of pancreatitis

Hepatobiliary disorders

Very rare: Reversible abnormal liver function test abnormalities and cholestatic hepatitis.

Immune system disorders

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

Unknown frequency: Anaphylactic shock.

Nervous system disorders

Unknown frequency:Peripheral sensory neuropathy, headaches, convulsions, vertigo, and ataxia

Mental disorders

Unknown frequency: Confusion and hallucinations

Reporting of side effects

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

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

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

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofMetronidazolAltan

- The active ingredient is metronidazol.

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

Aspect of the product and content of the package

This medication is presented in the form of a perfusion solution, clear and colorless or slightly yellowish.

Each package contains a poly(vinyl chloride) bag with 100, or 300 ml of solution, containing 0.5 or 1.5 g of metronidazol for intravenous perfusion use.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st floor – Office F

Edificio Prisma

28230 Las Rozas. Madrid - Spain

Responsible for manufacturing

Altan Pharmaceuticals, S.A.

Industrial Park of Bernedo s/n

Bernedo (Álava)

01118 Spain

Date of the last review of this leaflet: May 2018

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

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This information is intended solely for healthcare professionals:

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

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

Preparation before administration

1.Remove the external protective packaging, tearing it from top to bottom from the marked cut on the same and take out the poly(vinyl chloride) bag.

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

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

WARNING: DO NOT ADD ADDITIONAL MEDICATION

Administration by intravenous route

Precautions

1.Do not use air intake.

2.Do not connect in series as it may cause gas embolism due to residual air carried from the first package before the administration of the solution from the second package is performed.