Label: Information for the User

Alprazolam TecniGen 0.5 mg Tablets EFG

Read this label carefully before taking this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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.

2. Anxiety in patients with depression:

In these patients, symptoms of both anxiety and depression are present simultaneously.

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

4. Panic disorders:

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

Alprazolam is also indicated to block or mitigate panic attacks and phobias in patients with agoraphobia and panic attacks.

Alprazolam is only indicated when the disorder is severe, incapacitating, or causes extreme anguish.

You should consult a doctor if it worsens or does not improve.

Do not take Alprazolam TecniGen

- if you are allergic to alprazolam or to other similar benzodiazepine medications or to any of the other components of this medication (listed in section 6).

- if you have a condition called 'myasthenia gravis' in which you suffer from very weak and tired muscles.

- if you have severe chest problems or breathing difficulties (for example, chronic bronchitis or emphysema).

- if you have severe liver problems.

- if you have 'sleep apnea': a condition in which your breathing becomes irregular, even stopping for brief periods, while you are asleep.

- if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant.

Warnings and precautions

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

Inform your doctor if you are in any of the following situations

- You have ever felt so depressed that you thought about taking your own life.

- You have ever had a mental illness that required hospital treatment.

- You have problems with your lungs, kidneys, or liver.

- You have a history of abusing drugs or alcohol or have difficulty stopping medication, drinking, or taking drugs. Your doctor may want to give you special help when you need to stop taking these tablets.

- You have been prescribed medication for severe anxiety in the past, as your body may become accustomed to this type of medication quickly, so it will no longer help you.

- You have symptoms of mania (overexcited behavior, feeling of euphoria, irritability) or hypomania (overactive and excited behavior)

The use of benzodiazepines, including alprazolam, may cause 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 it has worked for other patients) and should never be recommended to others

- Do not increase the prescribed doses and do not take this medication for longer than your doctor has advised.

- Contact your doctor regularly, as they will decide whether you should continue treatment.

- Do not combine several benzodiazepines, regardless of their indication.

When treatment with alprazolam is stopped, the original symptoms may return (rebound effect). To avoid this effect, treatment should not be stopped abruptly. It is recommended to gradually reduce 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 speak with your doctor, as it will be necessary to discontinue it.

Older patients

Benzodiazepines and related products should be used with caution in older patients, due to the risk of sedation and/or muscle 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 old. The safety and efficacy of alprazolam in children and adolescents under 18 years old have not been established.

Other medications and Alprazolam TecniGen

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

- Any other medication for anxiety or depression or to help you sleep (for example, nefazodone, fluvoxamine, fluoxetine).

- Some strong painkillers (for example, opioids such as morphine, codeine, or propoxyphene).

- Medications used to treat mental illnesses such as schizophrenia.

- Medications to treat epilepsy (for example, carbamazepine).

- Antihistamines to relieve allergies.

- Medications to treat fungal infections (for example, ketoconazole, itraconazole).

- Oral contraceptives ("the pill").

- Some antibiotics (for example, erythromycin, clarithromycin, and troleandomycin).

- Cimetidine (for the treatment of stomach ulcers).

- Diltiazem (used to treat angina and high blood pressure).

- Digoxin (used to treat various heart conditions).

- Ritonavir or other similar medications used to treat HIV.

If you are to undergo surgery in which you will be given general anesthesia, inform your doctor or anesthesiologist that you are taking Alprazolam.

The concomitant use of alprazolam and opioids (strong painkillers, medication for substitution therapy, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put your life in danger. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes alprazolam along with opioids, you should limit the dose and duration of concomitant treatment. Please inform your doctor of all the opioid medications you are taking and follow your doctor's dosage recommendations carefully. 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.

Alprazolam TecniGen with food, drinks, and alcohol

It is essential not to 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Benzodiazepines are not recommended during pregnancy and breastfeeding.

If your doctor decides to administer alprazolam during a late stage of pregnancy or during delivery, the newborn may experience effects 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, which may trigger withdrawal syndrome in the postnatal period.

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

Driving and operating machinery

Alprazolam may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive vehicles or operate machinery that requires special attention or concentration until it is confirmed that your ability to perform these activities is not affected.

These effects are potentiated 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 azo dyes (Ponceau 4R and Yellow Orange S)

It may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Alprazolam TecniGen contains sodium benzoate

This medication contains 0.15 mg of sodium benzoate in each tablet.

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

Do not take the tablets with an alcoholic beverage.

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

The treatment should start with the minimum recommended dose. Do not exceed the maximum recommended dose.

Adults

Anxiety

The recommended initial 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 can be increased gradually up to 0.5 mg to 4 mg per day, administered in divided doses.

Panic disorders

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

Older adults

If you are an older adult or have, for example, renal or hepatic problems and need a lower dose, you will usually start with a dose of 0.5 mg to 0.75 mg/day, administered in divided doses (0.25 mg two or three times a day). This dose can be increased gradually 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 old.

The notch should not be used to break the tablet.

If you take more Alprazolam TecniGen than you should

It is essential not to take more tablets than you have been told. 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.

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

If you forgot 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 compensate for the missed 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 abruptly, 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, sound, and physical contact, hallucinations, and seizures). If this occurs, you should contact your doctor immediately.

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

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

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

- Depression

- Drowsiness and drowsiness

- Spasmodic and uncoordinated movements

- Inability to remember fragments of information

- Difficulty speaking

- Dizziness, drowsiness

- 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

Rare(may affect up to 1 in 100 people)

- Mania, hallucinations, anger, agitation

- Memory loss

- Muscle weakness

- Incontinence

- Irregular menstruation

Unknown frequency(frequency cannot be estimated from available data)

- Hyperprolactinemia

- Hypomania, aggression, hostility, abnormal thoughts, hyperactivity, autonomic nervous system imbalance

- Muscle tone changes

- Gastrointestinal disorders

- Hepatitis (liver inflammation), liver function problems, jaundice

- Angioedema, photosensitivity

- Urinary retention

- Peripheral edema

- Increased eye pressure

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

Reporting of adverse effects

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

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. 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 drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alprazolam TecniGen

• The active ingredient is alprazolam.

Each tablet contains 0.5 mg of alprazolam.

• The other components are: sodium docusate (85%) + sodium benzoate (15%) (E-211), pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, ponceau 4 R (E-124), and yellow-orange S (E-110).

Appearance of the product and contents of the packaging:

The tablets are orange, biconvex, rounded, and scored on one face.

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

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Bluepharma – Indústria Farmacêutica, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the last review of this leaflet: 07/2021

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