ALPRAZOLAM MABO 0.5 mg TABLETS

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 components of this medication (listed in section 6).
• If you have respiratory 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 impairment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Before starting treatment, ensure that your doctor knows if you:

• have any lung, liver, or kidney disorders
• have felt or feel depressed, with thoughts or ideas of suicide
• have a history of drug and alcohol use.

• After continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.
• 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).

Benzodiazepines may cause memory loss and reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, you should discontinue 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 medications 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 medication 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 recommended to other people.
• do not increase the prescribed doses by your 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 medications

This is especially important because the simultaneous use of more than one medication can increase or decrease its effect.

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

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

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

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications 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.
• Medications used for the treatment of anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medications for treating allergies).
• The concomitant use of alprazolam and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction), and some medications for cough) 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.
• Inform your doctor about all opioid medications you are taking and closely follow your doctor's dose recommendation. It may be helpful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

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

• Medications used to treat 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.
• Medications used to treat AIDS, such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm disturbances)

Taking Alprazolam Mabo with food and beverages

During treatment, avoid alcoholic beverages. The effect of alcohol can 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 medication.

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.

Benzodiazepines are excreted in breast milk; therefore, you should consult your doctor about the convenience of taking alprazolam while breastfeeding your child.

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 it is strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam have not been established in children under 18 years.

Use in elderly patients (over 65 years)

This medication may affect this group of patients more than younger patients. If you belong to this group, your doctor may reduce the 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 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.

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Driving and using machines

Alprazolam may alter your ability to drive or operate machinery, as it can cause drowsiness, 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 simultaneously...

Alprazolam Mabo 0.5 mg

tablets contain lactose

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

Alprazolam Mabo 0.5 mg tablets contain sodium benzoate

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

Alprazolam Mabo 0.5 mg tablets contain orange yellow

This medication 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 you have any doubts, consult your doctor or pharmacist again.

Dosage:

The tablet or part of it 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 0.25 mg to 0.5 mg three times a day.
• The usual dose ranges from 0.5 mg to a maximum of 4 mg per day, divided into 2-3 doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam two or three times a day, with a total daily dose of 0.5 mg to 0.75 mg in divided doses, which can be gradually increased 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 otherwise.

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 medication 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, consult your doctor or pharmacist immediately or go to the doctor or the Emergency Service of the nearest hospital and/or consult the Toxicology Information Service (telephone: 91 562 04 20), indicating the medication 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 drowsiness to coma. Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged drowsiness), 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 medications 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; therefore, when stopping this medication 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 medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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, alteration of liver function, 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. Discontinuation 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 medicine.

5. Conservation of Alprazolam Mabo

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Alprazolam Mabo 0.5 mg EFG Tablets

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

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

Appearance of the Product and Package Contents

Alprazolam Mabo 0.5 mg EFG tablets are presented in the form of cylindrical, biconvex, orange-colored tablets, scored, in packages containing 30 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

LABORATORIOS CINFA, S.A.

C/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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/

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