Package Insert: Information for the User

Alprazolam Aristo 2 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Alprazolam Aristo contains the active ingredient alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

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

Do not take Alprazolam Aristo

• if you are allergic to alprazolam, benzodiazepines, or any of the other ingredients in 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 damage

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Aristo.

• If you have any lung, kidney, or liver problems
• If you have felt or feel so depressed that you have had thoughts or ideas of suicide.
• After prolonged use of alprazolam, certain loss of effectiveness (tolerance) may be detected.
• There is a risk of developing addiction/dependence when using Alprazolam Aristo.
• If during treatment you notice symptoms of mania (a state of overexcitement, feeling of euphoria, or irritability) or hypomania (a state of excessive excitement and activity).
• The treatment with benzodiazepines, including alprazolam, may cause dependence, mainly after taking the medication continuously for a long time.

To minimize this risk of dependence, the following precautions should be taken:

• When stopping treatment with alprazolam, symptoms similar to those that led to starting treatment with Alprazolam Aristo may appear (rebound effect). To avoid this, it is recommended not to stop treatment abruptly, but to gradually reduce the dose, as instructed by your doctor (see section “If you stop taking Alprazolam Aristo”).
• The use of alprazolam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines may 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.
• It is very important to inform your doctor if you have a history of drug and alcohol consumption.

Taking Alprazolam Aristo with other medications

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

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 Aristo:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications used to treat epilepsy (antiepileptics).
• Opioid analgesics and narcotics (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 Aristo and opioids (powerful analgesics, addiction treatment medications, and some cough medications) increases the risk of drowsiness, breathing difficulty (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 Aristo 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 dosage recommendation. 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 (cytochrome P450 inhibitors), may interact with Alprazolam Aristo and, in some cases, increase its activity. Some of the medications that may interact with Alprazolam Aristo are:

Taking Alprazolam Aristo with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your alertness (see section “Driving and operating machines”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Alprazolam Aristo 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 Aristo is administered during a late stage of pregnancy or during delivery, certain effects may appear in the newborn, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Newborns born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, and a withdrawal syndrome may occur 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 have not been established in children under 18 years.

Use in elderly patients (over 65 years)

Alprazolam Aristo 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 Aristo”).

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 patient groups

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

If you have respiratory problems, inform your doctor.

Driving and operating machines

Alprazolam Aristo may impair 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 at the same time.

Alprazolam Aristo contains lactose

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

Alprazolam Aristo contains sodium benzoate

This medication contains 0.224 mg of sodium benzoate (E-211) in each 2 mg tablet.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

Dosage:

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

Usual doses are as follows:

- The initial dose is 0.25 mg to 0.5 mg of alprazolam three times a day.

- The usual dose ranges from 0.5 mg to a maximum of 4 mg per day, divided into 2 or 3 doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the amount of alprazolam ingested per day ranging from 0.5 mg to 0.75 mg in divided doses, which can be gradually increased as needed 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 it necessary to prolong treatment in your case, they will do so for limited periods and will frequently monitor your situation.

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

If you estimate that the action of alprazolam is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Aristo than you should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the nearest hospital with this leaflet.

Benzodiazepine overdose generally manifests itself 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 (a state of deep and prolonged somnolence), 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.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alprazolam Aristo

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 Aristo

Alprazolam treatment can cause dependence, so when discontinuing alprazolam administration abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (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, consult your doctor or pharmacist.

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

The side effects that may occur during treatment with Alprazolam Aristo predominantly occur 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.
• Sedation, 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.
• Withdrawal 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).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Somnolence, lack of reaction to emotional stimuli (emotional numbing), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena predominantly occur 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.
• Using benzodiazepines or similar compounds may cause reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations. 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. Stopping treatment may lead to the development of withdrawal or rebound phenomena. Psychological dependence may occur. Cases of abuse have been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed 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.

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

Store in the original packaging to protect it from light.

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 Aristo 2 mg tablets

• The active ingredient is 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.

Appearance of the product and content of the packaging

Cylindrical, biconvex tablets, white in color, and scored in a cross on one of their faces.

Each package contains 30 or 50 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 Industrial Estate Areta.

31620 Huarte. Pamplona (Navarra). Spain

or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Last review date of this leaflet: July 2022

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