ALPRAZOLAM TECNIGEN 0.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam TecniGen 0.25 mg EFG Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What is Alprazolam TecniGen and what is it used for
2. What you need to know before taking Alprazolam TecniGen
3. How to take Alprazolam TecniGen
4. Possible side effects
5. Storage of Alprazolam TecniGen
6. Package contents and additional information

1. What is Alprazolam TecniGen and what is it used for

This medication contains the active ingredient alprazolam. Alprazolam belongs to a group of medications called benzodiazepines.

Alprazolam is indicated in adults for the treatment of:

1. Anxiety states (anxiety neurosis):

The symptoms that occur in these patients include anxiety, tension, agitation, insomnia, apprehension, irritability, and/or vegetative hyperactivity, leading to various somatic complaints.

1. Anxiety in patients with depression:

In these patients, simultaneous symptoms of anxiety and depression occur.

1. Anxiety states associated with other situations, such as the chronic phase of alcohol withdrawal syndrome and functional or organic diseases, especially certain gastrointestinal, cardiovascular, or dermatological disorders.

1. Panic disorders:

Alprazolam is indicated for the treatment of panic disorders, with or without phobic avoidance.

Alprazolam is also indicated for blocking or mitigating panic attacks and phobias in patients with agoraphobia and panic attacks.

Alprazolam is only indicated when the disorder is severe, disabling, or subjects the patient to extreme distress.

You should consult a doctor if your symptoms worsen or do not improve.

2. What you need to know before taking Alprazolam TecniGen

Do not take Alprazolam TecniGen

• if you are allergic to alprazolam or other similar benzodiazepine medications or to any of the other components of this medication (listed in section 6).
• if you have a disease called 'myasthenia gravis' in which you suffer from very weak and tired muscles.
• if you have severe chest problems or breathing difficulties (e.g., chronic bronchitis or emphysema).
• if you have severe liver problems.
• if you have "sleep apnea": a condition in which your breathing becomes irregular, even stops for brief periods, while you are asleep.
• if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take alprazolam.

Inform your doctor if you are in one of the following situations:

• You have ever felt so depressed that you thought about taking your own life.
• You have ever suffered from any mental illness that required hospital treatment.
• You have problems with your lungs, kidneys, or liver.
• You have abused drugs or alcohol in the past or find it difficult to stop taking medications, drinking, or using drugs. Your doctor may want to give you special help when you need to stop taking these tablets.
• You have been prescribed medications for severe anxiety in the past, as your body may quickly become accustomed to this type of medication so that it no longer helps.
• You have symptoms of mania (overexcited behavior, feeling of euphoria, hyperirritability) or hypomania (overactive and excited behavior)

The use of benzodiazepines, including alprazolam, may lead to the development of dependence. The risk of dependence increases with the dose and duration of treatment. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients) and should never be advised to others.
• Do not increase the doses prescribed by your doctor, and do not take this medication for longer than your doctor has advised.
• Regularly contact your doctor, as they will decide if you should continue treatment.
• Do not combine multiple benzodiazepines, regardless of their indication.

When interrupting treatment with alprazolam, the symptoms for which it was originally treated may reappear (rebound effect). To avoid this effect, treatment should not be interrupted abruptly. It is recommended to gradually decrease the dose, according to your doctor's instructions.

The concomitant use of alprazolam and opioids may cause sedation, respiratory depression, coma, and death.

Benzodiazepines may cause temporary memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If you notice any of these changes in your behavior while taking this medication, please talk to your doctor, as it will be necessary to discontinue it.

Elderly patients

Benzodiazepines and related products should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness that may cause falls, often with serious consequences in this population.

Children and adolescents

Alprazolam is not recommended for children and adolescents under 18 years of age. The safety and efficacy of alprazolam in children and adolescents under 18 years of age have not been established.

Other medications and Alprazolam TecniGen

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, especially those listed below, as the effect of alprazolam or the other medication may change if taken at the same time:

• Any other medication for treating anxiety or depression or for helping you sleep (e.g., nefazodone, fluvoxamine, fluoxetine).
• Certain potent analgesics (e.g., opioids such as morphine, codeine, or propoxyphene).
• Antipsychotic medications used to treat mental illnesses such as schizophrenia.
• Medications for treating epilepsy (e.g., carbamazepine).
• Antihistamines for relieving allergies.
• Medications for treating fungal infections (e.g., ketoconazole, itraconazole).
• Oral contraceptives ("the pill").
• Certain antibiotics (e.g., erythromycin, clarithromycin, and troleandomycin).
• Cimetidine (for treating stomach ulcers).
• Diltiazem (used for angina pectoris and high blood pressure).
• Digoxin (used for treating various heart conditions).
• Ritonavir or other similar medications used for treating HIV.

If you are going to undergo surgery with general anesthesia, inform your doctor or anesthesiologist that you are taking Alprazolam.

The concomitant use of alprazolam and opioids (potent analgesics, replacement therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes alprazolam along with opioids, you should limit the dose and duration of concomitant treatment. Please inform your doctor about all opioid medications you are taking and follow your doctor's dosing recommendations exactly. It may be helpful to inform your friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Taking Alprazolam TecniGen with food, drinks, and alcohol

It is essential that you do not drink alcohol while taking alprazolam, as alcohol increases the effects of the medication.

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 medication.

The use of benzodiazepines is not recommended during pregnancy and breastfeeding.

If alprazolam is administered during late pregnancy or during labor, effects on the newborn may occur, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence and may experience a withdrawal syndrome in the postnatal period.

Inform your doctor immediately if you become pregnant while taking alprazolam.

Driving and using machines

Alprazolam may affect your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction time. The occurrence of these effects is more likely at the start of treatment or when the dose is increased. It is not recommended to drive vehicles or operate machinery that requires special attention or concentration until you have verified that your ability to perform these activities is not affected.

These effects are enhanced by alcohol.

Alprazolam TecniGen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Alprazolam TecniGen contains lactose monohydrate

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Alprazolam TecniGen contains sodium benzoate

This medication contains 0.15 mg of sodium benzoate per tablet.

3. How to take Alprazolam TecniGen

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Do not take the tablets with an alcoholic beverage.

Treatment should be as short as possible. The total duration of treatment should not exceed 8-12 weeks for the treatment of anxiety disorders and eight months for the treatment of panic disorders, including a period where the dose is gradually decreased.

Treatment should be started with the minimum recommended dose. The maximum recommended dose should not be exceeded.

Adults

Anxiety

The initial recommended dose is 0.25 mg to 0.5 mg of alprazolam three times a day. This gives a total dose of 0.75 mg to 1.5 mg per day. The dose may be gradually increased up to 0.5 mg to 4 mg per day, administered in divided doses.

Panic disorders

The initial recommended dose is 0.5 mg to 1.0 mg of alprazolam at bedtime. The dose should be adjusted based on the patient's response. Adjustments should not exceed an increase of 1 mg every 3 or 4 days. Additional doses may be added to reach a therapeutic regimen of three or four daily doses. Some patients may require the maximum dose of 10 mg/day.

Elderly patients

If you are an elderly patient or have, for example, kidney or liver problems and need a lower dose, you will normally start with a dose of 0.5 mg to 0.75 mg per day, administered in divided doses (0.25 mg two or three times a day). This dose may be gradually increased up to 0.5 mg to 0.75 mg per day, administered in divided doses, if necessary and tolerated.

Children and adolescents

Alprazolam is not recommended for children and adolescents under 18 years of age.

The score line should not be used to divide the tablet.

If you take more Alprazolam TecniGen than you should

It is essential that you do not take more tablets than prescribed. If you accidentally take too many tablets, seek medical attention immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Overdose of benzodiazepines usually manifests with degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in more severe cases, symptoms may include ataxia (incoordination), hypotonia (decreased muscle tone), hypotension (decreased blood pressure), respiratory depression, rarely coma, and very rarely death.

If you forget to take Alprazolam TecniGen

If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Alprazolam TecniGen

Always consult your doctor before stopping the tablets, as the dose should be gradually reduced.

If you stop taking the tablets or reduce the dose suddenly, you may experience withdrawal symptoms (e.g., headache, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, and, in severe cases, depersonalization, derealization, hyperacusis, numbness, tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, and epileptic seizures). If this occurs, you should contact your doctor immediately.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Very common(may affect more than 1 in 10 people)

• Depression
• Drowsiness and sleepiness
• Spasmodic and uncoordinated movements
• Inability to recall fragments of information
• Difficulty speaking
• Dizziness, lightheadedness
• Headaches
• Constipation
• Dry mouth
• Fatigue
• Irritability

Common(may affect up to 1 in 10 people)

• Loss of appetite
• Confusion, disorientation, changes in libido, feeling of anxiety, insomnia, nervousness
• Balance problems, abnormal coordination, abnormally prolonged sleep, deep sleep, tremors
• Blurred vision
• Feeling of discomfort
• Dermatitis
• Erectile dysfunction
• Weight change

Uncommon(may affect up to 1 in 100 people)

• Mania, hallucinations, anger, agitation
• Memory loss
• Muscle weakness
• Incontinence
• Irregular menstruation

Frequency not known(frequency cannot be estimated from available data)

• Hyperprolactinemia
• Hypomania, aggression, hostility, abnormal thoughts, psychomotor hyperactivity, autonomic nervous system imbalance
• Changes in muscle tone
• Gastrointestinal disorders
• Hepatitis (inflammation of the liver), liver function problems, jaundice
• Angioedema, photosensitivity
• Urinary retention
• Peripheral edema
• Increased eye pressure

It is possible to become dependent on medications like alprazolam while taking them, which increases the likelihood of experiencing withdrawal symptoms when treatment is interrupted. Inform your doctor if you start to feel dependent on your treatment. Withdrawal symptoms are more common if treatment is interrupted abruptly, if you have been taking high doses, if you have been taking this medication for a long time, or if you have a history of alcohol or drug abuse. This can cause effects such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, difficulty sleeping, and irritability. In severe cases of withdrawal, you may also experience symptoms such as a feeling of unreality, depersonalization, hyperacusis, numbness and tingling in hands and feet, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Alprazolam TecniGen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. By doing so, you will help protect the environment.

6. Package Contents and Additional Information

Composition of AlprazolamTecniGen

• The active ingredient is alprazolam.

Each tablet contains 0.25 mg of alprazolam.

• The other components are: sodium docusate (85%) + sodium benzoate (15%) (E-211), pregelatinized corn starch, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, quinoline yellow (E-104)

Appearance of the Product and Package Contents:

The tablets are yellow, biconvex, rounded, and scored on one side.

Alprazolam TecniGen is available in packages of 20, 30, and 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Bluepharma – Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the Last Revision of this Prospectus: 07/2021

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