ALPRAZOLAM MABO 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam Mabo 1 mg tablets EFG

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

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

Contents of the package leaflet:

1. What is Alprazolam Mabo and what is it used for
2. What you need to know before taking Alprazolam Mabo
3. How to take Alprazolam Mabo
4. Possible side effects

5 Storage of Alprazolam Mabo

1. Package contents and additional information

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

This medicine contains the active substance alprazolam. Alprazolam Mabo belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

This medicine is used in adults for the treatment of anxiety symptoms that are severe, disabling, or cause significant distress to the patient. This medicine is for short-term use only.

2. What you need to know before taking Alprazolam Mabo

Do not take Alprazolam Mabo

• If you are allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• If you have breathing difficulties related to or not related to sleep (sleep apnea).
• If you have a disease called myasthenia gravis, characterized by muscle weakness.
• If you have severe liver disorders.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Before starting treatment, make sure your doctor knows if you:

• Have any lung, liver, or kidney disorder.
• Have felt or feel so depressed that you have had thoughts or ideas of suicide.
• Have a history of drug and alcohol abuse.
• There is a risk of developing addiction/dependence when using alprazolam.

• If during treatment you notice symptoms of mania (state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (state of excitement and excessive activity).
• After continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.

Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, you should stop treatment and consult your doctor.

When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment with alprazolam (rebound effect) may appear. To avoid this, it is recommended not to interrupt treatment abruptly, but to gradually reduce the dose, according to the doctor's instructions (see section 3 "If you stop taking Alprazolam Mabo").

Taking alprazolam with medicines of the opioid type may cause deep sedation, respiratory depression, coma, and death.

Risk of dependence

Treatment with benzodiazepines, including alprazolam, may cause dependence (see section 3 "If you stop taking Alprazolam Mabo"). This occurs mainly after uninterrupted use of the medicine for a long time. To minimize the risk, the following precautions should be taken into account:

• the use of benzodiazepines will only be done under medical prescription (never because it has worked for other patients) and should never be advised to other people.
• do not increase the prescribed doses by the doctor, nor prolong treatment for longer than recommended (generally, it is a treatment of limited duration).
• consult your doctor regularly to decide if treatment should continue.
• do not combine several benzodiazepines, regardless of their indication.

Follow your doctor's recommendations strictly regarding the dose and duration of treatment.

Taking Alprazolam Mabo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Therefore, you should not take other medicines at the same time as alprazolam unless your doctor is informed and approves it beforehand.

Alprazolam may interact with other medicines. Inform your doctor or pharmacist if you are taking any of the following medicines:

Central nervous system depressants, as they may potentiate the sedative effect of alprazolam:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medicines used to treat depression.
• Medicines for the treatment of epilepsy (antiepileptics).
• Narcotic analgesics (morphine derivatives), as they may increase the feeling of euphoria, which can lead to increased psychological dependence.
• Medicines used for the treatment of anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medicines for treating allergies).
• The concomitant use of alprazolam and opioids (potent analgesics, medicines for substitution therapy (treatment of opioid addiction), and some cough medicines) increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes alprazolam with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and follow your doctor's dose recommendation closely. It may be useful to inform friends or family members so they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

There are groups of medicines that, due to their action in the body (cytochrome P450 inhibitors), may interact with alprazolam and, in some cases, increase its activity. Some of the medicines that interact with alprazolam are:

• Medicines used for the treatment of fungal infections, such as ketoconazole, itraconazole, posaconazole, or voriconazole. It is not recommended to take them at the same time as alprazolam.
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectors, such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (antihypertensive).
• Macrolide antibiotics, such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medicines used for the treatment of AIDS, such as ritonavir, etc.
• Digoxin (medicine used to suppress or prevent heart rhythm disorders).

Taking Alprazolam Mabo with food and drinks

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, which can affect your ability to drive or operate machinery (see section 2 "Driving and using machines"). If you need additional information on this point, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Alprazolam is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefit outweighs the risk to the child.

If alprazolam is administered during late pregnancy or during childbirth, 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, which can trigger a withdrawal syndrome in the postnatal period.

Use in children and adolescents (under 18 years)

Alprazolam is not recommended for children and adolescents under 18 years. Benzodiazepines should not be administered to children unless strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam in children under 18 years have not been established.

Use in elderly patients (over 65 years)

This medicine may affect this group of patients more than younger patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow their instructions carefully (see section "How to take Alprazolam Mabo").

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

Special patient groups

If your liver or kidneys do not function properly, consult your doctor, who may advise you to use a lower dose of alprazolam.

If you have respiratory disorders, inform your doctor.

Driving and using machines

Alprazolam may alter your ability to drive or operate machinery, as it can cause somnolence, decrease your attention, or decrease your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects. These effects can be potentiated if you consume alcohol at the same time.

Alprazolam Mabo 1 mg tablets contain lactose

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

Alprazolam Mabo 1 mg tablets contain sodium benzoate

This medicine contains sodium benzoate: benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Alprazolam Mabo 1 mg tablets contain sodium

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

Alprazolam Mabo 1 mg tablets contain orange yellow

This medicine may cause allergic reactions because it contains "Orange Yellow". It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Alprazolam Mabo

Follow your doctor's instructions for taking Alprazolam Mabo exactly. If in doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or its part should be swallowed without chewing, with the help of a little liquid. Your doctor will prescribe the most suitable presentation of alprazolam for you, according to the dose you need.

The usual doses are as follows:

• The initial dose is 1 mg of alprazolam per day, divided into one or two doses.
• The usual dose ranges from 0.5 mg to 4 mg per day, divided into one or two doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney disorders, the recommended initial dose is 0.5 mg to 1 mg of alprazolam per day, divided into one or two doses, which may be increased by your doctor if necessary and well tolerated.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor explicitly indicates it.

Duration and suppression of treatment

The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If your doctor considers it necessary to prolong treatment in your case, it will be for limited periods, and they will closely monitor your situation.

Never stop treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and explain how to gradually reduce the dose until the end of treatment.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Alprazolam Mabo than you should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the doctor or the Emergency Department of the nearest hospital and/or consult the Toxicology Information Service (telephone: 91 562 04 20), indicating the medicine and the amount taken. Bring this package leaflet with you.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, ranging from somnolence to coma. Symptoms include somnolence (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged sleep), decreased muscle tone (hypotonia), decreased blood pressure, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medicines or alcohol.

If you forget to take Alprazolam Mabo

Do not take a double dose to make up for forgotten doses. If the forgotten dose is recent, take your dose immediately, and if not, wait for the next dose, without taking a double dose to make up for it.

If you stop taking Alprazolam Mabo

Treatment with alprazolam may produce dependence, so when stopping this medicine abruptly, withdrawal symptoms may appear.

The withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, intolerance to light, sounds, and physical contact, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. If this occurs, you should consult your doctor immediately.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

The adverse effects that may appear during treatment with this medication occur predominantly at the beginning of treatment and generally disappear with continued administration or after a reduction in dosage.

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Depression.
• Sedation, somnolence, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common Adverse Effects (may affect up to 1 in 10 people):

• Feeling of confusion, disorientation, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleepiness (hypersomnia), state of deep and prolonged drowsiness (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• Mental and behavioral disorders (mania), hallucinations, anger reactions, agitation, dependence.
• Memory loss (amnesia).
• Muscle weakness.
• Inability to retain urine in the bladder (urinary incontinence).
• Irregular menstruation.
• Withdrawal symptoms.

Frequency Not Known (cannot be estimated from available data):

• Increased prolactin levels in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggressiveness, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function alteration, yellowing of the skin and whites of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

Somnolence, lack of reaction to emotional stimuli (emotional blunting), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision. These phenomena occur predominantly at the beginning of treatment and generally disappear with continued administration. Gastrointestinal alterations, changes in sexual desire, or skin reactions may occasionally occur.

A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.

The use of benzodiazepines may unmask a pre-existing depression.

When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral alterations may appear. These reactions can be severe and occur more frequently in children and the elderly.

Administration of the product (even at usual doses) may lead to the development of physical dependence. Interruption of treatment may lead to the development of withdrawal or rebound phenomena. Psychic dependence may occur. Cases of abuse have been reported.

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 it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

.

5. Conservation of Alprazolam Mabo

Keep this medication out of sight and reach of children.

Do not store at a temperature above 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.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alprazolam Mabo 1 mg EFG Tablets

• The active ingredient is alprazolam. Each tablet contains 1 mg of alprazolam.

• The other components are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch type A (derived from potatoes), cornstarch, povidone, magnesium stearate, anhydrous colloidal silica, sodium docusate, sodium benzoate (E-211), hydrated aluminum oxide, and indigo carmine.

Appearance of the Product and Package Contents

Alprazolam Mabo 1 mg EFG tablets are presented in the form of cylindrical, biconvex tablets of light blue color, with a notch on one of the faces, in packages of 30 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados Street, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10-Industrial Area Areta.

31620 Huarte – Pamplona (Navarra). Spain.

This prospectus was approved in June 2021

Date of the last revision of this prospectus: July 2022

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