ALPRAZOLAM AUROVITAS 0.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam Aurovitas 0.25 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get 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 pack

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

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

The active substance is alprazolam. It belongs to a group of medicines called benzodiazepines. Alprazolam acts on the central nervous system, reducing anxiety. It also has a sedative, sleep-inducing, and muscle-relaxing effect.

Alprazolam Aurovitas tablets are used for:

• the symptomatic treatment of anxiety in adults.
• Alprazolam is only indicated if it is a severe, disabling, or distressing disorder for the patient.

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

Do not takeAlprazolamAurovitas:

• If you are allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• If you have a disease called "myasthenia gravis" characterized by muscle weakness and fatigue.
• If you have severe chest problems or breathing difficulties (such as chronic bronchitis or emphysema).
• If you have "sleep apnea" - a disease in which your breathing is irregular, even interrupted for short periods while you are sleeping.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Alprazolam Aurovitas if:

• You notice that the effect of the tablets weakens after taking them for several weeks (tolerance).
• You are concerned about physical and mental dependence caused by alprazolam. If you do not want to stop treatment, you may become mentally dependent on this medicine. If there is physical dependence, stopping treatment is accompanied by withdrawal symptoms (see section 3, If you stop taking Alprazolam Aurovitas). The risk of dependence is greater with increasing dose and treatment duration in patients with a history of alcohol or drug abuse, or if several benzodiazepines are combined. For this reason, treatment should be as short as possible.
• Benzodiazepines and similar medicines should be used with caution in elderly patients due to the risk of drowsiness and/or musculoskeletal weakness that can cause falls, often with serious consequences in this population.
• You have a history of alcohol, drug, or narcotic abuse.
• You have had memory disorders. Memory loss usually occurs several hours after taking the medicine. To reduce this risk, make sure you sleep uninterrupted for 7-8 hours after taking the medicine.
• You have unexpected reactions, such as restlessness, agitation, irritability, aggression, disillusionment, fits of anger, nightmares, hallucinations, psychosis, inappropriate behavior, delirium, or other behavioral disorders. These unexpected reactions occur more frequently in children and elderly patients.
• You have a chronic lung disease.
• You are taking alcohol and sedatives at the same time.
• You have severe depression (suicide risk). You have depression and during treatment, you notice symptoms of mania (state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (state of excitement and excessive activity).
• You have been diagnosed with kidney or liver failure.
• You have been diagnosed with a psychiatric illness.
• You have a certain type of glaucoma.

If you are going to have an operation

Tell your doctor that you are taking alprazolam.

Children and adolescents:Alprazolam is not recommended in children and adolescents under 18 years of age.

Other medicines andAlprazolam Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as the effect of alprazolam may be stronger when taken at the same time.

Some medicines may produce side effects if taken at the same time as alprazolam. If you are taking certain medicines at the same time, this may affect the effectiveness of the treatment. In this case, your doctor may adjust your medication or administration instructions.

These medicines are:

Medicines that increase the sedative effect of alprazolam:

• sleeping pills and sedatives,
• antipsychotics and antidepressants,
• antiepileptics,
• anesthetics,
• strong painkillers that act on the central nervous system,
• sedating antihistamines.

Medicines that increase the effect of alprazolam due to reduced metabolism in the liver:

• nefazodone, fluvoxamine, fluoxetine, sertraline (medicines for severe depression),
• cimetidine (used to treat stomach problems),
• medicines used to treat HIV,
• dextropropoxyphene,
• oral contraceptives,
• diltiazem (medicine for blood pressure and heart),
• certain antibiotics (such as erythromycin, clarithromycin, telithromycin, and troleandomycin) and certain medicines for treating fungal infections (such as itraconazole, ketoconazole, posaconazole, voriconazole).

Medicines that decrease the effect of alprazolam due to increased metabolism in the liver:

• carbamazepine or phenytoin (antiepileptics, also used for other treatments),
• St. John's Wort (Hypericum perforatum, a medicinal plant),
• rifampicin (antitubercular medicine),
• concomitant use of alprazolam and HIV protease inhibitors (e.g., ritonavir) requires dose adjustment or discontinuation of alprazolam.

Alprazolam may increase the effect of the following medicines:

• digoxin (heart medicine),
• muscle relaxants,
• imipramine and desipramine (medicines for severe depression),
• clozapine (medicine for psychosis). There is a greater risk of cardiac and/or respiratory arrest.

Alcohol enhances the sedative effect of alprazolam.

Concomitant use of alprazolam and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, causes breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes alprazolam with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medicines you are taking and follow your doctor's recommended dose carefully. It may be useful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

The next time you visit your doctor, do not forget to tell them that you are taking alprazolam tablets.

Taking Alprazolam Aurovitaswith food, drinks, and alcohol

Swallow the tablet with a glass of water or other liquid.

Alcohol

Do not drink alcoholic beverages during treatment with alprazolam tablets.

Pregnancy and breastfeeding

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

Alprazolam is not recommended during pregnancy unless your doctor considers it absolutely necessary for the treatment of the mother.

There is no adequate experience of the use of alprazolam in pregnant women. Do not take alprazolam if you are pregnant or planning to become pregnant, unless your doctor considers it strictly indicated. Human experience suggests that alprazolam may be harmful to the fetus (increases the risk of malformations (cleft palate)). If you are pregnant or planning to become pregnant, consult your doctor about the possibility of stopping treatment. If you are taking alprazolam until birth, inform your doctor, as your baby may experience some withdrawal symptoms at birth. A high dose at the end of pregnancy or during delivery may also cause a drop in body temperature, respiratory depression, decreased muscle tone, and poor feeding (hypotonic infant syndrome).

Alprazolam is not recommended during breastfeeding. There is a risk that it may affect the baby.

Driving and using machines

Due to its sedative, muscle-relaxing, and sleep-inducing effects, alprazolam can impair driving and other tasks that require special attention, especially at the beginning of treatment and if you do not sleep enough. For this reason, do not drive or operate machinery during treatment with alprazolam.

Alprazolam Aurovitascontains lactose monohydrate

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

Alprazolam Aurovitas contains sodium

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

3. How to take Alprazolam Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will tell you how many tablets to take and when to take them.

Do not take your tablets with an alcoholic drink.

Treatment should start with the minimum recommended dose. Do not exceed the maximum recommended dose.

Adults

Normally, you will start by taking a 0.25 mg or 0.5 mg tablet three times a day. This corresponds to a total dose of 0.75 mg to 1.5 mg per day.

This dose may be gradually increased to a total of 4 mg per day in divided doses throughout the day.

If a higher dose is needed, it is usual to first increase the evening dose before the daytime dose, to ensure that you maintain a higher state of alertness during the day. If you start to experience side effects, your doctor may reduce the dose.

Elderly patients

If you are an elderly patient or have, for example, liver or kidney problems, you need a lower dose. Normally, you will start by taking a 0.25 mg dose two or three times a day. This dose may be gradually increased if necessary and if you do not experience side effects.

Use in children and adolescents

Alprazolam is not recommended in children and adolescents under 18 years of age.

The tablets can be divided into equal doses.

Duration of treatment

The risk of dependence and abuse may increase with the dose and duration of treatment. Therefore, your doctor will prescribe the effective dose and the shortest possible treatment duration and will frequently reassess the need to continue treatment (see section 2 - Warnings and precautions).

The maximum treatment duration should not exceed 2-4 weeks. Long-term treatment is not recommended. A decrease in the effect of the medicine may develop if used for more than a few weeks.

If you take moreAlprazolam Aurovitasthan you should

If you or someone else (e.g., a child) takes a too high dose of this medicine, contact your doctor or hospital immediately. If the patient is conscious, they should be given activated charcoal as emergency medication.

Take the pack of this medicine with you if you seek medical help.

An overdose of alprazolam causes extreme fatigue, ataxia (lack of coordination), and reduces the level of consciousness. It may also cause a drop in blood pressure, unconsciousness, and respiratory depression. Alcohol and other central nervous system depressants increase the adverse effects of alprazolam.

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

If you forget to takeAlprazolam Aurovitas

If you forget to take a dose, take the next dose as soon as you remember, unless it is time for the next dose. Do not take a double dose to make up for forgotten doses.

If you stop takingAlprazolam Aurovitas

Alprazolam may produce physical and mental dependence. This risk is greater with high doses and long treatments, in patients with a history of alcohol or drug abuse, or if several benzodiazepines are combined.

Sudden interruption of treatment causes withdrawal symptoms (such as headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability, and insomnia, and in severe cases, depersonalization, loss of sense of reality, hyperacusis, vomiting, sweating, numbness, and tingling in the limbs, intolerance to light, sound, and physical contact, hallucinations, and epileptic seizures). Withdrawal symptoms may appear several days after stopping treatment.

For this reason, treatment with alprazolam should not be stopped suddenly; the dose should be gradually reduced following your doctor's instructions.

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 all people suffer from them.

The most frequent adverse effect is fatigue, which may be associated with ataxia (lack of coordination), abnormal muscle coordination, and confusion. Fatigue may occur especially in elderly patients. Fatigue and related symptoms are stronger at the start of treatment. They will become milder or disappear when the dose is reduced or treatment is continued.

Adverse effects associated with treatment with alprazolam in patients participating in controlled clinical trials and post-marketing experience were the following:

Very Common Adverse Effects:may affect more than 1 in 10 people

• sedation, somnolence,
• depression,
• difficulty controlling movements (ataxia),
• memory impairment,
• difficulty speaking,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common Adverse Effects(may affect up to 1 in 10 people):

• loss of appetite,

• confusion, disorientation, motor agitation (akathisia),
• changes in sexual desire (decreased libido, increased libido),
• insomnia (inability to sleep or disturbed sleep),
• nervousness or feeling anxious or agitated,
• balance disorders, coordination disorders,
• attention impairment,
• excessive abnormal sleepiness (hypersomnia),
• pronounced state of weakening (lethargy),
• tremors or tremors,
• difficulty concentrating,
• blurred vision,
• tachycardia (rapid heartbeat), palpitations,
• nasal congestion,
• nausea,
• allergic rash,
• skin inflammation (dermatitis),
• sexual dysfunction,
• weakness (asthenia),
• weight loss, weight gain.

Uncommon Adverse Effects:may affect up to 1 in 100 people

• loss of appetite (anorexia),
• mania (exaggerated activity and abnormal state of excitement),
• hallucinations, anger, agitation,
• drug dependence,
• stimulation,
• amnesia (memory loss)

• double vision,

• vomiting,
• itching,
• muscle weakness,
• urinary incontinence, menstrual disorders, withdrawal syndrome.

Rare Adverse Effects:may affect up to 1 in 1,000 people

• decrease in blood pressure,
• agranulocytosis (absence of certain white blood cells in the blood),

• skin alterations,
• appetite stimulation,
• numbness sensation, decreased attention,
• cholestasis (decrease in bile flow),
• sporadic anomalies in ovulation and breast enlargement.

Frequency Not Known:cannot be estimated from available data

• liver inflammation (hepatitis),
• hyperprolactinemia (abnormally high levels of prolactin in the blood),
• hypomania,
• peripheral edema (swelling of the ankles, feet, or fingers),
• aggressive or hostile behavior,
• abnormal thinking,
• psychomotor stimulation,
• drug abuse,
• autonomic nervous system imbalance,
• muscle tone alterations (dystonia),
• gastrointestinal disorders (increased salivation, difficulty swallowing, diarrhea),
• jaundice, abnormal liver function,
• swelling under the skin surface (angioedema),
• exaggerated response to light (photosensitivity),
• urinary retention in the bladder,
• increased intraocular pressure.

Alprazolam may produce physical and psychological dependence. See section "Take special care with Alprazolam Aurovitas".

Sudden interruption of treatment with alprazolam may produce withdrawal symptoms such as anxiety, insomnia, and convulsions (See "If you stop taking Alprazolam Aurovitas tablets").

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. Storage of Alprazolam Aurovitas

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiration date that appears on the label and carton 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 at the SIGRE Point in 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 Aurovitas

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.

• The other components are: microcrystalline cellulose, lactose monohydrate, corn starch, sodium docusate, sodium benzoate (E211), anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Alprazolam Aurovitas 0.25mg tablets:

Uncoated tablets, white, oval, scored on one side, marked with "5" and "0" on either side of the score and "Z" on the other side.

Alprazolam Aurovitas tablets are available in blisters and high-density polyethylene (HDPE) bottles.

Package sizes:

Blister packs: 20, 30, 50, and 60 tablets.

Bottles (HDPE): 30, 250, and 1,000 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Alprazolam AB 0.25 mg tablets

Spain: Alprazolam Aurovitas 0.25 mg tablets EFG

Netherlands: Alprazolam Aurobindo 0.25 mg, tablets

Poland: Alprazolam Aurovitas

Portugal: Alprazolam Aurovitas

Czech Republic: Alprazolam Aurovitas 0.25 mg tablets

Date of the Last Revision of this Prospectus:October 2023

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