ALPRAZOLAM SANDOZ 0.50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alprazolam Sandoz 0.25 mg tablets EFG

Alprazolam Sandoz 0.50 mg tablets EFG

Alprazolam Sandoz 1 mg tablets EFG

Alprazolam Sandoz 2 mg tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Alprazolam Sandoz is and what it is used for
2. What you need to know before taking Alprazolam Sandoz
3. How to take Alprazolam Sandoz
4. Possible side effects
5. Storage of Alprazolam Sandoz
6. Contents of the pack and further information

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

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

Alprazolam is used in adults to treat symptoms of anxiety that are severe, disabling, or cause significant distress to the patient. This medicine is for short-term use only.

2. What you need to know before taking Alprazolam Sandoz

Do not take Alprazolam Sandoz

• if you are allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6),
• if you have breathing 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 disorders.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alprazolam Sandoz:

• 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 or 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),
• treatment with benzodiazepines, including alprazolam, may cause dependence, mainly after uninterrupted use of the medicine for a long time.

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

• the use of benzodiazepines will only be under medical prescription (never because they have worked for other patients) and will never be recommended to other people,
• do not increase the prescribed doses by your doctor, nor prolong the treatment for longer than recommended,
• consult your doctor regularly so that he decides if you should continue with the treatment,
• do not combine several benzodiazepines regardless of their indication,

• 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, in accordance with the doctor's instructions (see section "If you stop taking Alprazolam Sandoz"),
• the use of alprazolam along with opioid medications can cause deep sedation, respiratory depression, coma, and death.
• benzodiazepines can cause memory loss and reactions such as: restlessness, agitation, irritability, aggressiveness, 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.

Children and adolescents (under 18 years old)

Alprazolam is not recommended for children and adolescents under 18 years old. 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 old have not been established.

Older adults (over 65 years old)

Alprazolam 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 section "How to take Alprazolam Sandoz").

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 populations

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

If you have respiratory disorders, inform your doctor.

Other medicines and Alprazolam Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Alprazolam may interact with other medicines. Inform 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:
• major tranquilizers (antipsychotics),
• sleep inducers (hypnotics),
• medicines used to treat depression,
• medicines used to treat 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 to treat anxiety (anxiolytics/sedatives),
• anesthetics,
• sedating antihistamines (medicines for treating allergies),
• concomitant use of alprazolam and opioids (potent analgesics, substitution treatment (treatment of opioid addiction), and some cough medicines) increases the risk of 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 along 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 closely. It may be helpful to inform friends or family members so 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 in the body (cytochrome P450 inhibitors), may interact with alprazolam and, in some cases, increase its activity. Some of the medicines that interact with alprazolam 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,

• 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 Sandoz 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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, and a withdrawal syndrome may occur in the postnatal period.

Driving and using machines

Alprazolam may affect your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction time. 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 Sandoz 0.25 mg, Alprazolam Sandoz 0.5 mg, Alprazolam Sandoz 1 mg, and Alprazolam Sandoz 2 mg contain sodium

These medicines contain less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Alprazolam Sandoz 0.25 mg tablets and Alprazolam Sandoz 2 mg tablets contain lactose

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

Alprazolam Sandoz 0.50 mg tablets contain lactose and orange yellow S (E110)

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

It can cause allergic reactions.

Alprazolam Sandoz 1 mg tablets contain lactose and amaranth (E123).

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

It can cause allergic reactions.

3. How to take Alprazolam Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or its part should be swallowed without chewing, with the help of a little liquid. The score line is only for breaking the tablet if you find it difficult to swallow it whole. Your doctor will prescribe the most suitable presentation of Alprazolam Sandoz, 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, with the amount of alprazolam ingested per day being 0.5 mg to 0.75 mg in divided doses, and may 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 discontinuation of treatment:

The maximum duration of treatment should not exceed 2 to 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 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 will explain how to gradually reduce the dose until the end of treatment.

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

If you take more Alprazolam Sandoz than you should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, taking this leaflet with you. Overdose with benzodiazepines is generally characterized 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 medicines or alcohol.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alprazolam Sandoz

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.

If you stop taking Alprazolam Sandoz

Treatment with alprazolam can produce dependence, so when stopping 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 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 alprazolam occur predominantly at the beginning of treatment and generally disappear with continued administration or after a reduction in dosage.

Very frequent 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.

Frequent 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.

Infrequent 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, yellowish discoloration 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 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. Gastrointestinal alterations, changes in sexual desire, or skin reactions may occasionally occur.
• A loss of memory (amnesia) may develop, which can 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 medicine (even at usual doses) may lead to the development of physical dependence. Interruption 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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Alprazolam Sandoz

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

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 in the SIGRE Point of 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 Sandoz 0.25 mg tablets

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato), and magnesium stearate.

Composition of Alprazolam Sandoz 0.50 mg tablets

• The active ingredient is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, orange-yellow S (E110), and quinoline yellow (E104).

Composition of Alprazolam Sandoz 1 mg tablets

• The active ingredient is alprazolam. Each tablet contains 1 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, patent blue V (E131), and amaranth (E123).

Composition of Alprazolam Sandoz 2 mg tablets

• The active ingredient is alprazolam. Each tablet contains 2 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato), and magnesium stearate.

Appearance of the Product and Package Contents

Alprazolam Sandoz 0.25 mg are round, flat, scored tablets, white in color.

Alprazolam Sandoz 0.50 mg are round, flat, scored tablets, salmon-colored.

Alprazolam Sandoz 1 mg are round, flat, scored tablets, light blue in color.

Alprazolam Sandoz 2 mg are round, flat, cross-scored tablets, white in color.

Alprazolam Sandoz 0.25 mg is available in blisters containing 30 tablets.

Alprazolam Sandoz 0.50 mg is available in blisters containing 30 tablets.

Alprazolam Sandoz 1 mg is available in blisters containing 30 tablets.

Alprazolam Sandoz 2 mg is available in blisters containing 30 or 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LACER, S.A.

C/ Boters nº 5; Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès, Barcelona

Spain

Date of the Last Revision of this Prospectus: March 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/.