ALPRAZOLAM TECNIGEN 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam TecniGen 0.5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

This medicine contains the active substance alprazolam. Alprazolam belongs to a group of medicines 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 conditions, 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 it worsens or does not improve.

2. What you need to know before you take Alprazolam TecniGen

Do not take Alprazolam TecniGen

• if you are allergic to alprazolam or other similar benzodiazepine medicines or to any of the other ingredients of this medicine (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 or breathing problems (e.g. chronic bronchitis or emphysema).
• if you have severe liver problems.
• if you have "sleep apnea": this is a condition in which your breathing becomes irregular, even stops for short periods, while you are asleep.
• if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby.

Warnings and precautions

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

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

• You have ever felt so depressed that you have thought of ending your life.
• You have ever suffered from any mental illness that has 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 medicines, drinking, or taking drugs. Your doctor may want to give you special help when you have to stop taking these tablets.
• You have been prescribed other medicines for severe anxiety in the past, because your body may quickly become used to this type of medicine so that it no longer helps you.
• 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. In order to minimize the risk of dependence, the following precautions should be taken into account:

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

When discontinuing treatment with alprazolam, the symptoms for which it was originally treated may reappear (rebound effect). To avoid this effect, treatment should not be stopped 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 medicine, please talk to your doctor, as it will be necessary to stop 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 medicines and Alprazolam TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those listed below, as the effect of alprazolam or the other medicine may change if taken at the same time:

• Any other medicine for treating anxiety or depression or for helping you sleep (e.g. nefazodone, fluvoxamine, fluoxetine).
• Certain powerful painkillers (e.g. opioids such as morphine, codeine, or propoxyphene).
• Antipsychotic medicines used to treat mental illnesses such as schizophrenia.
• Medicines for treating epilepsy (e.g. carbamazepine).
• Antihistamines for relieving allergies.
• Medicines 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 and high blood pressure).
• Digoxin (used for treating various heart conditions).
• Ritonavir or other similar medicines used for treating HIV.

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

The concomitant use of alprazolam and opioids (powerful painkillers, medicines for replacement therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes alprazolam with opioids, you should limit the dose and duration of concomitant treatment. Please inform your doctor of all opioid medicines you are taking and follow your doctor's dosing instructions to the letter. It may be useful to inform your friends or family to be 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 important that you do not drink alcohol while taking alprazolam, as alcohol increases the effects of the medicine.

Pregnancy, breastfeeding, and fertility

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

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

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

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, reduce your attention, or reduce your reaction ability. 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 it is verified that your ability to perform these activities is not affected.

These effects are enhanced by alcohol.

Alprazolam TecniGen contains sodium

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

Alprazolam TecniGen contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Alprazolam TecniGen contains azo colorants (Ponceau 4R and Orange Yellow S)

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

Alprazolam TecniGen contains sodium benzoate

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

3. How to take Alprazolam TecniGen

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

Do not take the tablets with an alcoholic drink.

Treatment should be as short as possible. The total duration of treatment should not exceed 8-12 weeks in the treatment of anxiety disorders and eight months in the treatment of panic disorders, including a period in which 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 according to the patient's response. Adjustments should not exceed an increase of 1 mg every 3 or 4 days. Additional doses may be added up to a therapeutic regimen of three or four daily doses. Some patients may need 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/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 important that you do not take more tablets than you have been 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, telephone 91 562 04 20, indicating the medicine 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 stop taking Alprazolam TecniGen

Always consult your doctor before stopping the tablets of alprazolam, 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 limbs, hypersensitivity to light, noise, and physical contact, hallucinations, and epileptic seizures). If this happens, you should contact your doctor immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Depression
• Drowsiness and somnolence
• Spasmodic and uncoordinated movements
• Inability to remember fragments of information
• Difficulty speaking
• Dizziness, dizziness
• 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 the available data)

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

It is possible to become dependent on medicines like alprazolam while taking them, which increases the likelihood of experiencing withdrawal symptoms when treatment is discontinued. Inform your doctor if you start to feel dependent on your treatment. Withdrawal symptoms are more frequent if treatment is stopped abruptly, if high doses have been taken, if the medicine has been taken for a long time, or if there is 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, the following symptoms may also occur: feeling of unreality, depersonalization, hyperacusis, numbness and tingling in hands and feet, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam TecniGen

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

Do not use this medicine after the expiry date that appears on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

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 corn starch, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, ponceau 4R (E-124), orange yellow S (E-110).

Product Appearance and Packaging Content:

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

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

Only some pack 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 Leaflet: 07/2021

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