Alprazolam Mabo 0.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Alprazolam Mabo 0.5 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Alprazolam Mabo

3. How to take Alprazolam Mabo

4. Possible side effects

5. How to store Alprazolam Mabo

6. Contents of the pack and other information

1. What Alprazolam Mabo is and what it is 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 severe, disabling, or extremely distressing anxiety symptoms. This medicine is intended only for short-term use.

2. What you need to know before starting to take Alprazolam Mabo

Do not take Alprazolam Mabo

• If you are allergic to alprazolam, to benzodiazepines, or to any of the other components of this medicine (listed in section 6).
• If you suffer from respiratory difficulties, with or without sleep-related breathing problems (sleep apnea).
• If you have a disease called myasthenia gravis, which is characterized by muscle weakness.
• If you have severe liver problems.

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 disorders.

• Have felt or currently feel so depressed that you have had thoughts or ideas about suicide.

• Have a history of drug or alcohol abuse.

• With prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.

• There is a risk of developing addiction/dependence when using alprazolam.

• If during treatment you notice symptoms of mania (a state of overexcitement, feelings of euphoria or hyperirritability) or hypomania (a state of exaggerated excitement and activity).

Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, you must stop treatment and consult your doctor.

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

The use of alprazolam together with opioid-type medicines may cause deep sedation, respiratory depression, coma, and death.

Risk of dependence

Treatment with benzodiazepines, including alprazolam, may lead to dependence (see section 3 “If you stop taking Alprazolam Mabo”). This mainly occurs after long-term, uninterrupted use. To minimize the risk as much as possible, the following precautions should be observed:

• Benzodiazepines should only be taken on a doctor's prescription (never because they worked for someone else), and you should never recommend them to others.
• Do not increase the dose prescribed by your doctor or extend treatment beyond the recommended duration (in general, treatment should be short-term).
• Consult your doctor regularly so they can decide whether treatment should continue.
• Do not combine multiple benzodiazepines, regardless of their indication.

Strictly follow your doctor's instructions regarding dosage and duration of treatment.

Taking Alprazolam Mabo with other medicines

This is particularly important because taking more than one medicine at the same time may increase or decrease its effect.

Therefore, do not take other medicines simultaneously with alprazolam unless your doctor is aware and has approved it beforehand.

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

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

• Major tranquilizers (antipsychotics).
• Sleep-inducing medicines (hypnotics).
• Medicines used to treat depression.
• Medicines used to treat epilepsy (antiepileptics).
• Narcotic analgesics (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.
• Medicines used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medicines used to treat allergies).
• The concomitant use of alprazolam and opioids (strong analgesics, medicines for substitution therapy (treatment of opioid addiction), and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.
• However, if your doctor prescribes alprazolam together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
• Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

Certain groups of medicines that affect the body (cytochrome P450 inhibitors) may interact with alprazolam and, in some cases, increase its activity. Some of the medicines that interact with alprazolam include:

• Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Concurrent use with alprazolam is not recommended.
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectants such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (antihypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medicines used to treat HIV/AIDS such as ritonavir, etc.
• Digoxin (a medicine used to suppress or prevent heart rhythm disturbances).

Taking Alprazolam Mabo with food and drinks

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which may affect your ability to drive or operate machinery (see section 2 “Driving and use of machines”). If you need further 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.

The use of alprazolam is not recommended during pregnancy or breastfeeding, unless, in the doctor’s judgment, the benefit outweighs the risk to the child.

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

Infants born to mothers who chronically take benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a postnatal withdrawal syndrome.

Benzodiazepines are excreted in breast milk; therefore, you should consult your doctor about whether it is advisable to take alprazolam while breastfeeding.

Use in children and adolescents (under 18 years of age)

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

Use in elderly patients (over 65 years of age)

This medicine may affect elderly patients more than younger ones. If you belong to this group, your doctor may reduce your dose and monitor 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 may lead to falls—often with serious consequences in this population.

Special patient groups

If your liver or kidneys are not functioning 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 use of machines

Alprazolam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or decreased reaction ability. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects. These effects may be intensified if alcohol is consumed simultaneously.

Alprazolam Mabo 0.5 mg

Tablets contain lactose

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

Alprazolam Mabo 0.5 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 0.5 mg Tablets contain sodium

This medicine contains sodium: this medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free.”

Alprazolam Mabo 0.5 mg Tablets contain orange yellow

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

3. How to take Alprazolam Mabo

Follow exactly the instructions for using Alprazolam Mabo as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosing:

The tablet or its portion should be swallowed whole, with a little liquid. Your doctor will prescribe the most suitable alprazolam formulation according to the dose you require.

The usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg three times daily.
• The usual dose ranges from 0.5 mg up to a maximum of 4 mg per day, divided into 2–3 doses.

In elderly patients, those with chronic respiratory insufficiency, or with liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam two or three times daily, resulting in a total daily alprazolam intake of 0.5 mg to 0.75 mg in divided doses. This dose may be gradually increased if necessary and well tolerated.

No individual dose should exceed the limits indicated, nor should the total daily dose, unless your doctor specifically instructs otherwise.

Duration and discontinuation 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 extend treatment in your case, it will be done only for limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the progression of your illness and will explain how you should gradually reduce the dose until treatment is completed.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Mabo than you should

If you have taken more alprazolam than you should, contact your doctor or pharmacist immediately or go immediately to your doctor or the nearest hospital's Emergency Department and/or contact the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount ingested. Take this leaflet with you.

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

If you forget to take Alprazolam Mabo

Do not take a double dose to make up for forgotten doses. If the missed dose is recent, take it immediately; otherwise, wait until the next scheduled dose, without taking a double dose to compensate.

If you stop treatment with Alprazolam Mabo

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping administration of this medicine may cause withdrawal symptoms.

Withdrawal symptoms that may occur include: 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, tremor, depersonalization, hallucinations, and seizures. If this occurs, you should consult your doctor immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects that may occur during treatment with this medicine usually appear at the beginning of treatment and generally disappear with continued administration or after a dose reduction.

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

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

Common adverse effects (may affect up to 1 in 10 people):

• Confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), prolonged and profound 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 behavioural disorders (mania), hallucinations, anger reactions, agitation, dependence.
• Memory loss (amnesia).
• Loss of muscle strength.
• Inability to retain urine in the bladder (urinary incontinence).
• Irregular menstruation.
• Withdrawal symptoms.

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

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

With the use of benzodiazepines, the following may occur:

Drowsiness, reduced response to emotional stimuli (emotional blunting), decreased 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 disturbances, changes in sexual desire, or skin reactions may occasionally occur.

Memory loss (amnesia) may develop, which may be associated with inappropriate behaviour.

The use of benzodiazepines may unmask an existing depression.

When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other behavioural disturbances may occur. These reactions can be severe and occur more frequently in children and elderly patients.

Administration of the product (even at usual doses) may lead to the development of physical dependence. Discontinuation of treatment may lead to withdrawal or rebound phenomena. Psychological 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Mabo

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Alprazolam Mabo 0.5 mg tablets EFG

• The active substance is alprazolam. Each tablet contains 0.5 mg of alprazolam.

• The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), corn starch, povidone, magnesium stearate, colloidal anhydrous silica, sodium docusate, sodium benzoate (E-211), hydrated aluminium oxide, and sunset yellow FCF (E-110).

Appearance of the product and contents of the package

Alprazolam Mabo 0.5 mg tablets EFG are presented as orange, cylindrical, biconvex, scored tablets, in packs containing 30 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

LABORATORIOS CINFA, S.A.

C/Olaz-Chipi, 10-Polígono Industrial Areta.

31620 Huarte – Pamplona (Navarra). Spain.

This summary of product characteristics was approved in June 2021

Date of the most recent review of this summary: July 2022

Detailed and up-to-date 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/)