Alprazolam Aurovitas 0.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprazolam Aurovitas 0.25 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance is alprazolam. It belongs to a group of medicines called benzodiazepines. Alprazolam works through the central nervous system, reducing anxiety. It also has sedative, sleep-inducing, and muscle relaxant effects.

Alprazolam Aurovitas tablets are used for:

• the symptomatic treatment of anxiety in adults.
• Alprazolam is indicated only if the disorder is severe, disabling, or causing significant distress to the patient.

2. What you need to know before taking Alprazolam Aurovitas

Do not take Alprazolam Aurovitas:

• 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 a disease called "myasthenia gravis," which is characterized by muscle weakness and fatigue.
• If you have serious chest problems or breathing difficulties (such as chronic bronchitis or emphysema).
• If you have "sleep apnea" – a condition in which your breathing is irregular or stops briefly during sleep.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alprazolam Aurovitas if:

• You notice that the effect of the tablets diminishes after taking them for several weeks (tolerance).
• You are concerned about physical and mental dependence caused by alprazolam. If you do not wish to stop treatment, you may be mentally dependent on this medicine. If physical dependence has occurred, stopping treatment may lead to withdrawal symptoms (see section 3, If you stop taking Alprazolam Aurovitas). The risk of dependence increases with higher doses and longer treatment duration, especially in patients with a history of alcohol or drug abuse, or when multiple benzodiazepines are used together. Therefore, 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, which may lead to falls, often with serious consequences in this population.
• You have a history of alcohol, drug, or narcotic abuse.
• You have experienced memory disorders. Memory loss may occur several hours after taking the medicine. To reduce this risk, ensure you sleep uninterrupted for 7–8 hours after taking the medicine.
• You experience unexpected reactions such as restlessness, agitation, irritability, aggressiveness, confusion, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, delirium, or other behavioral disturbances. These unexpected reactions occur more frequently in children and elderly patients.
• You have a chronic lung disease.
• You are consuming alcohol or sedatives at the same time.
• You suffer from severe depression (risk of suicide). If you have depression and notice symptoms of mania (a state of overexcitement, feelings of euphoria, or hyperirritability) or hypomania (a state of exaggerated excitement and activity) during treatment, inform your doctor.
• You have been diagnosed with kidney or liver impairment.
• You have been diagnosed with a psychiatric disorder.
• You have a certain type of glaucoma.

If you are undergoing surgery

Inform your doctor that you are taking alprazolam.

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

Other medicines and Alprazolam Aurovitas

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

Some medicines may cause adverse effects when taken together with alprazolam. Taking certain medicines simultaneously may affect the effectiveness of treatment. In such cases, your doctor may adjust your medication or dosing instructions.

These medicines include:

Medicines that increase the sedative effect of alprazolam:

• Sleeping pills and sedatives,
• Antipsychotics and antidepressants,
• Antiepileptics,
• Anesthetics,
• Strong analgesics acting on the central nervous system,
• Sedating antihistamines.

Medicines that increase the effect of alprazolam by reducing its 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 (a medicine for blood pressure and heart conditions),
• Certain antibiotics (such as erythromycin, clarithromycin, telithromycin, and troleandomycin) and certain antifungal medicines (such as itraconazole, ketoconazole, posaconazole, voriconazole).

Medicines that decrease the effect of alprazolam by increasing its metabolism in the liver:

• Carbamazepine or phenytoin (antiepileptics, also used for other treatments),
• St. John’s wort (Hypericum perforatum, a herbal remedy),
• Rifampicin (an antituberculosis 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 (a heart medicine),
• Muscle relaxants,
• Imipramine and desipramine (medicines for severe depression),
• Clozapine (a medicine for psychosis). There is an increased risk of cardiac arrest and/or respiratory failure.

Alcohol enhances the sedative effect of alprazolam.

Concomitant use of alprazolam and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, 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 strictly follow the recommended dose. It may be advisable 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.

Next time you visit your doctor, do not forget to mention that you are taking alprazolam tablets.

Taking Alprazolam Aurovitas with food, drinks, and alcohol

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

Alcohol

Do not consume alcoholic beverages during treatment with alprazolam tablets.

Pregnancy and breastfeeding

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

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

There is insufficient experience with the use of alprazolam in pregnant women. Do not take alprazolam if you are pregnant or planning to become pregnant, unless your doctor strictly indicates it. Human experience suggests that alprazolam may harm the fetus (increasing the risk of malformations such as cleft palate). If you are pregnant or planning to become pregnant, discuss with your doctor the possibility of stopping treatment. If you take alprazolam until delivery, inform your doctor, as your baby may experience withdrawal symptoms at birth. High doses near the end of pregnancy or during delivery may also cause low body temperature, respiratory depression, reduced muscle tone, and poor feeding (floppy 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 may impair your ability to drive or perform tasks requiring special attention, especially at the beginning of treatment or if you do not get enough sleep. For this reason, do not drive or operate machinery while being treated with alprazolam.

Alprazolam Aurovitas contains lactose monohydrate

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Alprazolam Aurovitas contains sodium

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

3. How to take Alprazolam Aurovitas

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. 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 lowest recommended dose. The maximum recommended dose must not be exceeded.

Adults

You will usually start by taking one 0.25 mg tablet or one 0.5 mg tablet three times a day. This corresponds to a total daily dose of 0.75 mg to 1.5 mg.

This dose may be gradually increased up to a total of 4 mg per day, divided into doses taken throughout the day.

If a higher dose is needed, it is usual to first increase the evening dose rather than the daytime dose, to ensure you remain more alert during the day. If you start experiencing adverse effects, your doctor may reduce your dose.

Elderly patients

If you are an elderly patient or have, for example, liver or kidney problems, you will require a lower dose. You will usually start taking a dose of 0.25 mg two or three times a day. This dose may be slowly increased if necessary and if no adverse effects occur.

Use in children and adolescents

Alprazolam is not recommended for 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 dose and duration of treatment. Therefore, the doctor will prescribe the lowest effective dose and the shortest possible treatment duration, and will frequently re-evaluate the need to continue treatment (see section 2 - Warnings and precautions).

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

If you take more Alprazolam Aurovitas than you should

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

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

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

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

If you forget to take Alprazolam Aurovitas

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

If you stop taking Alprazolam Aurovitas

Alprazolam may cause physical and psychological dependence. This risk is higher with high doses and long-term treatment, in patients with a history of alcohol or drug abuse, or when multiple benzodiazepines are combined.

Abruptly stopping treatment causes withdrawal symptoms (such as headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability, and insomnia; in severe cases, depersonalization, loss of sense of reality, hyperacusis, vomiting, sweating, numbness and tingling sensations in the extremities, 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 must not be stopped abruptly; the dose should be gradually reduced according to 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 everyone will experience them.

The most common 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 strongest at the beginning of treatment. They will become milder or disappear when the dose is reduced or treatment is continued.

The adverse effects associated with alprazolam treatment observed 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, drowsiness,
• depression,
• difficulty controlling movements (ataxia),
• memory impairment,
• difficulty speaking,
• dizziness,
• headache,
• constipation,
• dry mouth,
• tiredness,
• 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 disturbance,

• abnormal excessive sleepiness (hypersomnia),

• pronounced state of weakness (lethargy),

• tremors or shaking,

• 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

• drop in blood pressure,

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

• skin disorders,

• increased appetite,

• numbness sensation, decreased attention,

• cholestasis (reduced bile flow),

• sporadic abnormalities in ovulation and breast enlargement.

Frequency not known: cannot be estimated from the available data

• liver inflammation (hepatitis),
• hyperprolactinemia (abnormally high levels of prolactin in the blood),
• hypomania,
• peripheral edema (swelling of ankles, feet, or fingers),
• aggressive or hostile behavior,
• abnormal thinking,
• psychomotor stimulation,
• drug abuse,
• autonomic nervous system imbalance,
• muscle tone disorders (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 cause physical and psychological dependence. See section “Take special care with Alprazolam Aurovitas”.

Abrupt discontinuation of alprazolam treatment may cause withdrawal symptoms such as anxiety, insomnia, and seizures (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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Aurovitas

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

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

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

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

6. Contents of the pack and other information

Composition of Alprazolam Aurovitas

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

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

Appearance of the product and contents of the pack

Alprazolam Aurovitas 0.25 mg tablets:

Uncoated tablets, white in colour, oval-shaped, scored on one side, marked with “5” and “0” on either side of the score line and “Z” on the other side.

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

Pack sizes:

Blisters: 20, 30, 50 and 60 tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Belgium: Alprazolam AB 0.25 mg tabletten

Spain: Alprazolam Aurovitas 0.25 mg tablets EFG

Netherlands: Alprazolam Aurobindo 0.25 mg, tabletten

Poland: Alprazolam Aurovitas

Portugal: Alprazolam Aurovitas

Czech Republic: Alprazolam Aurovitas 0.25 mg tablety

Date of the most recent revision of this leaflet: October 2023

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