FLUMAZENIL ALTAN 0.1 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Flumazenil Altan 0.1 mg/ml Solution for Injection EFG

Flumazenil

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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Flumazenil Altan contains the active substance flumazenil, which is an antagonist of a group of drugs called benzodiazepines.

Flumazenil has an opposing action and neutralizes the effect of benzodiazepines (compounds used for their sedative, muscle relaxant, and anticonvulsant properties) and belongs to the group of antidotes. Its action consists of interrupting the nerve conduction produced by benzodiazepines by competing with them for binding to receptors in the nervous system.

This medicine is indicated to neutralize totally or partially the central sedative effect of benzodiazepines. Consequently, it should be used in anesthesia and intensive care for the following indications:

In anesthesia:

• To end anesthesia produced by benzodiazepines in hospitalized patients.
• To end the calming or sedative effect produced by benzodiazepines in patients who have undergone diagnostic tests or short treatments in the hospital or outpatient clinic.

In intensive care:

• To reverse the effect of benzodiazepines on the central nervous system and allow the recovery of spontaneous breathing.

• For the diagnosis or treatment of intoxications or overdoses caused solely or mainly by benzodiazepines.

Flumazenil Altan is also used in children over 1 year of age to wake them up from sedation induced by benzodiazepines.

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

Do not use Flumazenil Altan:

Warnings and precautions:

Talk to your doctor or pharmacist before starting to use Flumazenil Altan. Inform your doctor if:

• The use in children is not recommended for indications other than ending the calming or sedative effect. This is also applicable to children under 1 year of age, in whom flumazenil should not be used unless the potential benefits outweigh the possible risk.
• If the patient does not wake up because it may be due to another cause. If used to end anesthesia after surgery, it should not be administered until the peripheral muscle relaxant effects have disappeared. Since the action of flumazenil is normally shorter than that of benzodiazepines, and the sedative effect may reappear, the patient should be closely monitored, preferably in the intensive care unit, until the effect of flumazenil has disappeared.
• In the case of patients who are at risk, the advantages of sedation with benzodiazepines should be weighed against the disadvantages that would occur if rapid awakening were to occur. In some patients, such as those with heart problems, some degree of sedation may be preferred over complete awakening.
• Rapid injection of high doses (more than 1 mg) of flumazenil should be avoided in patients who are receiving long-term treatment with benzodiazepines, as this could cause withdrawal symptoms.
• The dose of flumazenil should be carefully adjusted in patients who have anxiety before surgery or who have a history of anxiety.
• If you experience pain after surgery.
• If you have been on long-term treatment with high doses of benzodiazepines. In patients with epilepsy treated with benzodiazepines for a long time, sudden neutralization of the effect could cause seizures.
• If you have severe brain injuries, as it may increase intracranial pressure.
• If you have dependence or withdrawal syndrome to benzodiazepines, treatment with flumazenil is not recommended.
• If you have a history of panic disorders.
• Due to the increased frequency of tolerance and dependence on benzodiazepines in patients with alcoholism and dependence on other drugs, flumazenil should be used with caution in this population.
• Patients treated with this medicine to neutralize the effects of benzodiazepines should be monitored at all times as necessary, depending on the duration of the effect of the benzodiazepine used, to prevent the appearance of breathing problems, drowsiness, or any other effect due to the benzodiazepine.
• If you have severe liver problems.
• It should not be administered in anesthesia until it has been verified that the peripheral muscle relaxant effects have disappeared.

Children and adolescents

As a general rule, it is recommended not to use this medicine in children under 1 year of age (see section 3 How to use Flumazenil Altan)

Other medicines and Flumazenil Altan:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

This medicine counteracts the effects of benzodiazepines on the central nervous system; the action of non-benzodiazepine agonists, such as zopiclone (used in the treatment of sleep disorders), triazolopyridazines (non-benzodiazepine anxiolytics), and others, is also counteracted by flumazenil.

After being treated with Flumazenil Altan, consult your doctor before taking any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is not known whether Flumazenil Altan passes into breast milk. If you are breastfeeding, you should not be treated with Flumazenil Altan unless in cases of emergency and by parenteral route. Your doctor will decide what is best for you.

Driving and using machines:

Although after intravenous administration of this medicine, patients may be awake and conscious, during the 24 hours following administration, they should avoid engaging in hazardous activities that require full mental alertness (such as operating hazardous machinery or driving vehicles), as the effects of the previously taken or administered benzodiazepine, such as sedation, may reappear.

Flumazenil Altan contains sodium:

This medicine contains 9 mg of sodium per ml, which is 45 mg per 5 ml ampoule and 90 mg per 10 ml ampoule of solution for injection, so it should be taken into account in patients on a low-sodium diet.

3. How to use Flumazenil Altan

This medicine is presented as a solution for injection in ampoules. Each pack contains 5 ampoules.

Follow these instructions unless your doctor has given you different instructions.

This medicine is recommended for intravenous use only and should be administered by an anesthesiologist or experienced doctor.

Your doctor will indicate your daily dose and the duration of your treatment.

Since the duration of action of some benzodiazepines exceeds that of this medicine, repeated doses may be required if sedation reappears after awakening.

Adults

In anesthesia

The recommended initial dose is 0.2 mg i.v., administered over 15 seconds. If the desired level of consciousness is not achieved within 60 seconds after the first i.v. administration, a new dose of 0.1 mg may be injected, repeating it if necessary at 60-second intervals, up to a total dose of 1 mg. The usual dose is between 0.3 and 0.6 mg, but individual requirements may vary considerably, depending on the dose and duration of the effect of the administered benzodiazepine and the characteristics of the patient.

In intensive care units and in the diagnosis of unconsciousness of unknown origin

The recommended initial dose is 0.3 mg administered intravenously. If after 60 seconds the desired level of consciousness is not achieved, a new dose of 0.1 mg may be injected, repeating it at 60-second intervals, up to a total dose of 2 mg or until the patient awakens.

If drowsiness reappears, it may be useful to administer an intravenous infusion of 0.1-0.4 mg/h. The infusion rate should be adjusted individually to achieve the desired level of consciousness.

If after repeated dosing, no evident effect on consciousness and breathing is observed, it should be considered that the intoxication is not caused by benzodiazepines.

The perfusion should be interrupted every 6 hours to check if the patient is sedated again.

To avoid the appearance of withdrawal in patients treated for a long period with high doses of benzodiazepines in the intensive care unit, the dose of flumazenil should be assessed individually, and the injection should be administered slowly.

If unexpected signs of overstimulation appear, diazepam or midazolam should be administered carefully, titrated by the intravenous route according to the patient's response. In anesthesia, it is recommended to inject 5 mg of the aforementioned active ingredients by the intravenous route.

Use in children and adolescents

Children over 1 year of age:

To eliminate sedation produced by benzodiazepines in children over 1 year of age, the recommended initial dose is 0.01 mg/kg (up to 0.2 mg) administered intravenously over 15 seconds. If consciousness is not recovered after 45 seconds, new injections of 0.01 mg/kg (up to 0.2 mg) may be administered at 60-second intervals (up to a maximum of 4 times) up to a maximum total dose of 0.05 mg/kg or 1 mg (the dose that is lower of the two should be used). The dose should be calculated individually for each patient.

Children under 1 year of age:

Since experience is limited, Flumazenil Altan should be used with caution in the recovery of conscious sedation in children under 1 year of age, for the treatment of intoxication in children, neonatal resuscitation, and to reverse the sedative effects of benzodiazepines used for the induction of general anesthesia in children.

Until sufficient data are available, Flumazenil Altan should not be used in children under 1 year of age, unless the risks to the patient (especially in cases of accidental overdose) have been weighed against the benefits of treatment.

Use in patients over 65 years of age:

It is recommended to use in patients over 65 years of age with due caution, as this population is generally more sensitive to the effects of medicines.

Patients with liver and kidney function disorders:

In patients with liver function disorders, the elimination of flumazenil may be delayed, so it is recommended to reduce the doses when repeated doses are to be administered (not for the initial dose).

No dose adjustments are necessary in patients with kidney problems.

If you use more Flumazenil Altan than you should:

If you think you have been given too much flumazenil, you may not notice any effect; however, it is recommended to consult your doctor or pharmacist as soon as possible.

If you have any further questions on the use of this product, ask your doctor or pharmacist. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone: (91) 562 04 20.

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, Flumazenil Altan can cause side effects, although not everybody gets them.

Flumazenil Altan is well tolerated in children and adults. In adults, it is well tolerated even at doses higher than those recommended.

The frequency of these side effects is classified into the following categories:

• Very common: may affect more than 1 in 10 patients
• Common: may affect up to 1 in 10 patients
• Uncommon: may affect up to 1 in 100 patients
• Rare: may affect up to 1 in 1,000 patients
• Very rare: may affect up to 1 in 10,000 patients
• Frequency not known: frequency cannot be estimated from the available data.

Generally, these reactions disappear quickly without the need for special treatment.

Immune system disorders

• Frequency not known: Hypersensitivity reactions (allergy), including anaphylaxis, may occur.

Psychiatric disorders

• Uncommon: Anxiety and fear after rapid administration of Flumazenil Altan, generally did not require treatment.
• Frequency not known: Withdrawal syndrome, with symptoms such as agitation (excitement, restlessness), anxiety (anxiety, fear), emotional lability (attacks of laughter or crying), confusion, and sensory distortions (illusions, hallucinations).

These symptoms may occur after rapid administration of flumazenil in patients with high doses and/or treated for prolonged periods with benzodiazepines.

Panic attacks (in patients with a history of panic reactions), abnormal crying, agitation, and aggressive reactions.

Generally, the side effects in children are similar to those in adults. When this medicine has been used to wake the child from sedation, abnormal crying, agitation, and aggressive reactions have been reported.

Nervous system disorders

• Frequency not known: Seizures in patients with epilepsy or severe liver problems, especially after long-term treatment with benzodiazepines or in cases of overdose with mixed drugs.

Cardiac disorders

• Uncommon: Palpitations (strong and rapid heartbeats) after rapid administration of flumazenil.

Vascular disorders

• Frequency not known: Temporary increase in blood pressure (upon awakening).

Gastrointestinal disorders

• Common: Postoperative nausea and vomiting, especially if opioids (narcotics) have also been used.

Skin and subcutaneous tissue disorders

• Frequency not known: Flushing.

General disorders and administration site conditions

• Frequency not known: Chills, after rapid administration of flumazenil.

In the case of overdose with mixed drugs, especially with tricyclic antidepressants, toxic effects such as seizures or cardiac arrhythmias may appear, these effects may arise when flumazenil reverses the effect of benzodiazepines.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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: www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flumazenil Altan

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

No special storage conditions are required.

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

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

6. Container Content and Additional Information

Composition of Flumazenil Altan

The active ingredient is Flumazenil.

Each ml contains 0.1 mg of flumazenil.

1 ampoule with 5 ml contains 0.5 mg of flumazenil

1 ampoule with 10 ml contains 1 mg of flumazenil

The other components (excipients) are: sodium edetate, glacial acetic acid, sodium chloride, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Container Content

Packaging of 5 glass ampoules with 0.5 mg of active ingredient in 5 ml of aqueous solution or with 1 mg of active ingredient in 10 ml of aqueous solution.

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide nº 6. Portal 2, 1ª planta,

Edificio Prisma

28230 - Las Rozas. MADRID

Spain

Manufacturer:

Laboratorio Reig Jofré, S.A.

c/ Gran Capitán, nº 10.

08970 Sant Joan Despí. (Barcelona)

Spain

Date of the Last Revision of this Prospectus: April 2025

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

This information is intended only for doctors or healthcare professionals:

Flumazenil Altan is recommended for intravenous use only and should be administered by an anesthesiologist or experienced physician.

Any remaining unused solution should be discarded.

The medication should be visually inspected. It should only be used if the solution is transparent and practically free of particles.

When Flumazenil Altan is to be used in perfusion, it should be diluted before perfusion. Flumazenil should only be diluted with a 9 mg/ml (0.9%) sodium chloride solution, a 50 mg/ml (5%) dextrose solution, or a Ringer Lactate solution. The compatibility between flumazenil and other injectable solutions has not been established.

Solutions for intravenous perfusion or syringes filled with a flumazenil solution should be discarded after 24 hours.

From a microbiological point of view, the product should be used immediately. If it is not used immediately, the time and storage conditions before use are the responsibility of the user and should not normally exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under conditions suitable to prevent contamination.

Flumazenil Altan can also be used in conjunction with other resuscitation measures. Since the duration of action of some benzodiazepines exceeds that of Flumazenil Altan, repeated doses may be required if sedation reappears after awakening.

Rapid injection of Flumazenil Altan should be avoided. In patients who have received high doses and/or prolonged treatment with benzodiazepines in the weeks preceding its administration, rapid injection of a dose equal to or greater than 1 mg may cause withdrawal symptoms, including palpitations, agitation, anxiety, emotional lability, as well as mild confusion and sensory distortions.

Flumazenil Altan is not recommended for the treatment of benzodiazepine dependence or for the control of withdrawal symptoms caused by benzodiazepines.