Package Leaflet: Information for the User

Alprazolam Mabo 1 mg Tablets EFG

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

2.What you need to know before you start taking Alprazolam Mabo

3.How to take Alprazolam Mabo

4.Possible side effects

5Storage of Alprazolam Mabo

6.Contents of the pack and other information

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

This medication is used in adults for the treatment of severe, debilitating, or highly distressing anxiety symptoms. This medication is only for short-term use.

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 breathing difficulties related or unrelated to sleep (sleep apnea).
• If you have a condition called myasthenia gravis, characterized by muscle weakness.
• If you have severe liver dysfunction.

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 so depressed that you have had thoughts or ideas of suicide.
• Have a history of drug and alcohol consumption.
• There is a risk of developing addiction/dependence when using alprazolam.

• If during treatment you notice symptoms of mania (a state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (a state of excitement and excessive activity).
• After prolonged use of alprazolam, there may be a certain loss of effectiveness (tolerance).

Benzodiazepines can cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, discontinue treatment and consult your doctor.

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

The use of alprazolam with opioid-type medications can cause deep sedation, respiratory depression, coma, and death.

Risk of dependence

Treatment with benzodiazepines, including alprazolam, can cause dependence (see section 3 “If you stop taking Alprazolam Mabo”). This occurs mainly after taking the medication continuously for a long time. To minimize the risk, 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 or prolong treatment beyond the recommended duration (usually a limited duration treatment).
• Consult your doctor regularly to decide whether to continue treatment.
• Do not combine multiple benzodiazepines regardless of their indication.

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

Alprazolam Mabo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Therefore, do not take other medications at the same time as alprazolam unless your doctor is informed and approves it in advance.

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 used to treat epilepsy (antiepileptics).
• Opioid analgesics (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Medications used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (allergy medications).
• The concomitant use of alprazolam and opioids (powerful analgesics, medication for opioid addiction treatment, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, 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 follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

There are some groups of medications that, due to their action in the body (inhibitors of cytochrome P450), may interact with alprazolam and, in some cases, increase its activity. Some of the 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.
• Protective gastric medications such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (anti-hypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat HIV/AIDS such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm alterations).

Alprazolam Mabo with food and beverages

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be 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 benefits outweigh the risks for the baby.

If, by the doctor's decision, alprazolam is administered during a late stage of pregnancy or during delivery, there may be effects on the newborn such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Newborns of mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which may trigger 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 it is 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 medication may affect this group of patients more than young patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow your doctor's 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 muscle weakness that may cause falls, often with serious consequences in this population.

Special groups of patients

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

If you have respiratory disorders, inform your doctor.

Driving and operating machines

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 or operate machines if you experience any of these effects. These effects may be potentiated if you consume alcohol simultaneously.

Alprazolam Mabo 1 mg tablets contain lactose

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

Alprazolam Mabo 1 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 old).

Alprazolam Mabo 1 mg tablets contain sodium

This medication contains less than 1 mmol of sodium (23 mg) in each unit; it is essentially “sodium-free”

Alprazolam Mabo 1 mg tablets contain yellow-orange

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

Follow exactly the administration instructions for Alprazolam Mabo as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

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

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 impairment, 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 indicates 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 that in your case it is necessary to prolong the treatment, they will do so for limited periods and will follow up on your situation frequently.

You should never interrupt treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to gradually reduce the dose until you finish your treatment.

If you estimate that the action 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 nearest hospital emergency room and/or contact the Toxicology Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested. Bring this leaflet with you.

Benzodiazepine overdose generally manifests by different degrees of depression of the central nervous system, ranging from drowsiness to coma. Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (prolonged and deep sleep), muscle tone decrease (hypotonia), blood pressure drop, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medications or alcohol.

If you forgot to take Alprazolam Mabo

Do not take a double dose to compensate for the missed doses. If the missed dose is recent, take your dose immediately, and if not, wait for the next dose, without taking a double dose to compensate.

If you interrupt treatment with Alprazolam Mabo

Alprazolam treatment can cause dependence, so when stopping the administration of this medication abruptly, withdrawal symptoms may appear.

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

Common side 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 sleep (hypersomnia), deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Rare side effects (may affect up to 1 in 100 people):

• Mental and behavioral 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.
• Abstinence symptoms.

Unknown frequency (cannot be estimated from available data):

• Increased levels of prolactin in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggression, 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 white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's surface).
• Phototoxicity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

Drowsiness, lack of reaction to emotional stimuli (emotional numbing), reduced state of 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. Occasionally, gastrointestinal alterations, changes in sexual desire, or skin reactions may occur.

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

The use of benzodiazepines may unmask an existing depression.

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

The 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. It may produce psychological dependence. Cases of abuse have been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alprazolam Mabo 1 mg tablets EFG

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

• The other components are: lactose monohydrate, microcrystalline cellulose, carboxymethylstarch sodium type A (from potato), cornstarch, povidone, magnesium stearate, anhydrous colloidal silica, sodium docusate, sodium benzoate (E-211), hydrated aluminum oxide, and indigotin.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada. Madrid

Spain

Responsible for manufacturing

LABORATORIOS CINFA, S.A.

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

31620 Huarte – Pamplona (Navarra). Spain.

This leaflet was approved in June 2021

Last review date of this leaflet: July 2022

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