Alprazolam Sandoz 1 mg tablets EFG

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Alprazolam Sandoz
6. Contents of the pack and other 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 for the treatment of anxiety symptoms that are severe, disabling, or causing significant distress to the patient. This medicine is intended 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, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6),
• if you have breathing difficulties, with or without sleep-related apnea (sleep apnea),
• if you have a disease called myasthenia gravis, which is characterized by muscle weakness,
• if you have severe liver problems.

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 currently feel so depressed that you have had thoughts or ideas of suicide,
• with prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur,
• there is a risk of developing addiction or dependence when using alprazolam,
• if during treatment you experience symptoms of mania (a state of overexcitement, feelings of euphoria or hyperirritability) or hypomania (a state of exaggerated excitement and activity),
• treatment with benzodiazepines, including alprazolam, may lead to dependence, particularly after long-term continuous use.

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

• benzodiazepines should only be taken on prescription (never because they worked for other patients) and should never be recommended to others,

• do not increase the dose prescribed by your doctor in any way, nor extend treatment beyond the recommended duration,

• consult your doctor regularly so they can decide whether you should continue treatment,

• do not combine multiple benzodiazepines regardless of their indication,

• when stopping treatment with alprazolam, symptoms similar to those that led to starting alprazolam treatment may occur (rebound effect). To avoid this, it is recommended not to stop treatment abruptly, but to gradually reduce the dose according to your doctor's instructions (see section “If you stop taking Alprazolam Sandoz”),

• using alprazolam together with opioid medicines may cause deep sedation, respiratory depression, coma, and death.

• benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, you should stop treatment and consult your doctor,

• it is very important that you inform your doctor if you have a history of drug or alcohol use.

Children and adolescents (under 18 years of age)

Alprazolam is not recommended for children and adolescents under 18 years of age. Benzodiazepines should not be given to children unless strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam have not been established in individuals under 18 years of age.

Elderly (over 65 years of age)

Alprazolam may affect this group of patients more than younger patients. If you belong to this group, your doctor may reduce your dose and monitor 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, which may lead to falls, often with serious consequences in this population.

Special populations

If your liver or kidneys are not functioning properly, consult your doctor, who may advise you to use a lower dose of alprazolam.

If you suffer from respiratory disorders, inform your doctor.

Other medicines and Alprazolam Sandoz

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

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-inducing medicines (hypnotics),

• medicines used to treat depression,

• medicines used to treat epilepsy (antiepileptics),

• narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence,

• medicines used to treat anxiety (anxiolytics/sedatives),

• anesthetics,

• sedating antihistamines (medicines used to treat allergies),

• the concomitant use of alprazolam and opioids (strong analgesics, opioid substitution treatment medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are available,

• however, if your doctor prescribes alprazolam together with opioids, the dose and duration of concomitant treatment must be limited by your doctor,

• inform your doctor about all opioid medicines you are taking and closely follow their dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned 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 include:

• antifungal medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole. Concomitant use with alprazolam is not recommended,

• the following antidepressants: nefazodone, fluvoxamine, and fluoxetine,

• gastric protectants such as cimetidine,

• dextropropoxyphene (a narcotic analgesic),

• oral contraceptives,

• diltiazem (an antihypertensive),

• macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin,

• medicines used to treat HIV/AIDS such as ritonavir, etc.,

• digoxin (a medicine used to suppress or prevent heart rhythm disturbances).

Taking Alprazolam Sandoz with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which can affect your alertness (see section “Driving and using machines”).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of alprazolam is not recommended during pregnancy or breastfeeding unless, in the doctor’s judgment, the benefit outweighs the risk to the child.

If, on the doctor’s decision, alprazolam is administered during late pregnancy or during childbirth, effects in the newborn such as reduced body temperature (hypothermia), reduced muscle tone (hypotonia), and moderate respiratory depression may occur.

Infants born to mothers who chronically take benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a postnatal withdrawal syndrome.

Driving and using machines

Alprazolam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or slow reaction times. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects. These effects may be intensified if alcohol is consumed simultaneously.

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, i.e., essentially “sodium-free”.

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

If your doctor has informed 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 sunset yellow FCF (E110)

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

May cause allergic-type reactions.

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

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

May cause allergic-type reactions.

3. How to take Alprazolam Sandoz

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

Dosing:

The tablet or part thereof should be swallowed whole, with a little liquid. The score line is intended solely for dividing the tablet if you find it difficult to swallow it whole. Your doctor will prescribe the most appropriate Alprazolam Sandoz presentation according to the dose you require.

The usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg of alprazolam three times daily.

• 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, or those with chronic respiratory insufficiency, or with liver or kidney impairment, the initially recommended dose is 0.25 mg of alprazolam, 2 or 3 times daily, resulting in a total daily alprazolam intake of 0.5 mg to 0.75 mg in divided doses. This dose may be gradually increased if necessary and well tolerated. Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless expressly instructed otherwise by your doctor.

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 it necessary to extend treatment in your case, it will be done only for limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the course of your illness and will explain how you should gradually reduce the dose until treatment is discontinued.

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

If you take more Alprazolam Sandoz than you should

If you have taken more alprazolam than you should, contact your doctor or pharmacist immediately or go to the nearest hospital, taking this leaflet with you. Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (sedation), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (state of prolonged and deep drowsiness), decreased muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious outcomes are uncommon unless alprazolam is taken together with other medications or alcohol.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Alprazolam Sandoz

Do not take a double dose to make up for a missed dose. If the missed dose is recent, take it immediately; otherwise, wait until the next scheduled dose, without taking a double dose to compensate.

If you stop treatment with Alprazolam Sandoz

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping alprazolam may cause withdrawal symptoms.

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, sensitivity to light, sound, and physical touch, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremor, depersonalization, hallucinations, and seizures. If this occurs, you should contact your doctor immediately.

If you have any further 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 everyone experiences them.

Adverse effects that may occur during treatment with alprazolam predominantly appear at the beginning of treatment and usually disappear with continued administration or after a dose reduction.

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

• Depression.
• Sedation, drowsiness, coordination disorder (ataxia), memory impairment, difficulty speaking (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common adverse effects (may affect up to 1 in 10 people)

• Confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), 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 behavioural 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.

Frequency not known (cannot be estimated from available data)

• Increased levels of prolactin in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioural disorders (hypomania), aggression, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function abnormalities, 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.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, reduced responsiveness 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 usually disappear with continued administration. Gastrointestinal disturbances, changes in sexual desire, or skin reactions may occasionally occur.
• Memory loss (amnesia) may develop, which may be associated with inappropriate behaviour.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other behavioural disturbances may occur. These reactions can be severe and occur more frequently in children and elderly patients.
• Administration of the medicine (even at usual doses) may lead to physical dependence. Discontinuation of treatment may lead to withdrawal or rebound phenomena. Psychological dependence may also 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

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

5. Storage of Alprazolam Sandoz

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Alprazolam Sandoz 0.25 mg tablets

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

Composition of Alprazolam Sandoz 0.50 mg tablets

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

Composition of Alprazolam Sandoz 1 mg tablets

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

Composition of Alprazolam Sandoz 2 mg tablets

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

Appearance of the product and contents of the container

Alprazolam Sandoz 0.25 mg are round, flat tablets, scored on one side, white in colour.

Alprazolam Sandoz 0.50 mg are round, flat tablets, scored on one side, salmon-coloured.

Alprazolam Sandoz 1 mg are round, flat tablets, scored on one side, light blue in colour.

Alprazolam Sandoz 2 mg are round, flat tablets, cross-scored on one side, white in colour.

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.

Parque Norte Business Centre

Roble Building

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 most recent review of this leaflet: March 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.