ALPRAZOLAM ARISTO 2 mg TABLETS

2. What you need to know before you take Alprazolam Aristo

Do not take Alprazolam Aristo

• if you are allergic to alprazolam, benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
• if you have breathing problems related or not 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

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 continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.
• There is a risk of developing addiction/dependence when using Alprazolam Aristo.
• If during treatment you notice symptoms of mania (state of overexcitement, feeling of euphoria or hyperirritability) or hypomania (state of excitement and excessive activity).
• Treatment with benzodiazepines, including alprazolam, may cause dependence, mainly after uninterrupted use of the medicine for a long time.

To minimize this risk of dependence, the following precautions must 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 the treatment for a longer time than recommended.
• Regularly consult your doctor so that he decides if the treatment should be continued.
• Do not combine several benzodiazepines regardless of their indication.

• When stopping treatment with alprazolam, symptoms similar to those that led to starting treatment with Alprazolam Aristo (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 "If you stop taking Alprazolam Aristo").
• The use of alprazolam together with opioid-type medications can cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines can 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 happens, you should stop treatment and consult your doctor.
• It is very important that you inform your doctor if you have a history of drug and alcohol use.

Taking Alprazolam Aristo with other medicines

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

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

• Central nervous system depressants, as they may enhance the sedative effect of Alprazolam Aristo:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medicines used to treat depression.
• Medicines for the treatment of epilepsy (antiepileptics).
• Narcotic analgesics and opioids (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 Aristo and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction) and some medications for cough) increases the risk of suffering from drowsiness, 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 Aristo together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medications you are taking, and follow your doctor's dose recommendation. It may be helpful to inform friends or family members so that 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 on the body (cytochrome P450 inhibitors), may interact with Alprazolam Aristo and, in some cases, increase its activity. Some of the medicines that may interact with Alprazolam Aristo are:

• Medicines 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 Aristo.
• 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 to treat AIDS such as ritonavir, etc.
• Digoxin (medicine used to suppress or prevent heart rhythm disorders).

Taking Alprazolam Aristo with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol can enhance sedation, and this can affect your alertness (see section "Driving and using machines").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Alprazolam Aristo is not recommended during pregnancy or breastfeeding unless, in the doctor's opinion, the benefits outweigh the risks to the baby.

If, by medical decision, Alprazolam Aristo 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 appear.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, and a withdrawal syndrome may be triggered in the postnatal period.

Use in children and adolescents (under 18 years)

Alprazolam is not recommended in children and adolescents under 18 years. Benzodiazepines should not be given 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)

Alprazolam Aristo 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 the 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 musculoskeletal weakness that can cause falls, often with serious consequences in this population.

Special groups of patients

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

If you have respiratory disorders, inform your doctor.

Driving and using machines

Alprazolam Aristo may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce 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 enhanced if you consume alcohol at the same time.

Alprazolam Aristo contains lactose

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

Alprazolam Aristo contains sodium benzoate

This medicine contains 0.224 mg of sodium benzoate (E-211) per 2 mg tablet.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; that is, it is essentially "sodium-free".

3. How to take Alprazolam Aristo

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

Dosage:

The tablet or its part will be swallowed without chewing, with the help of a little liquid. Your doctor will prescribe the presentation of Alprazolam Aristo most suitable 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 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 disorders, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, being the amount of alprazolam ingested per day 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 so.

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 that, in your case, it is necessary to prolong the treatment, it will be done for limited periods and will frequently monitor your situation.

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

If you think the effect of alprazolam is too strong or too weak, tell 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.

Overdose with benzodiazepines is usually manifested by different degrees of central nervous system depression, which can range from drowsiness to coma. Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, disorientation, fatigue, headache, dizziness, weakness, ataxia, or double vision. These phenomena occur predominantly at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal disorders, changes in sexual desire, or skin reactions may occur.

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

If you forget to take Alprazolam Aristo

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 Aristo

Treatment with alprazolam can produce dependence, so when stopping the administration of alprazolam 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 happens, 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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 disorder, difficulty concentrating, excessive sleepiness (hypersomnia), state of deep and prolonged drowsiness (letargia), tremors.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

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

• Mental and behavioral disorders (mania), hallucinations, fits of rage, 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 the available data):

• Increased prolactin levels 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 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:

• Drowsiness, lack of reaction to emotional stimuli (emotional bluntness), 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. Occasionally, gastrointestinal disorders, 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 a pre-existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior may appear. 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Aristo

Keep this medication out of sight and reach of children.

Store in the original package to protect it from light.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alprazolam Aristo 2 mg tablets

• The active ingredient is alprazolam.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), corn starch, povidone, magnesium stearate, anhydrous colloidal silica, sodium docusate, sodium benzoate (E-211), hydrated aluminum oxide.

Appearance of the Product and Package Contents

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

Each package contains 30 or 50 tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 Polígono Industrial Areta.

31620 Huarte. Pamplona (Navarra), Spain

or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Date of the Last Revision of this Leaflet: July 2022

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