Package Insert: Information for the User

Alprazolam Aurovitas 0.25 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What isAlprazolam Aurovitasand for what it is used

2. What you need to know before starting to takeAlprazolam Aurovitas

3. How to takeAlprazolam Aurovitas

4. Possible adverse effects

5. Storage ofAlprazolam Aurovitas

6. Contents of the package and additional information

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

Alprazolam Aurovitas tablets are used for:

• symptomatic treatment of anxiety in adults.
• Alprazolam is only indicated if it is a severe, incapacitating, or highly distressing disorder.

Do not takeAlprazolam Aurovitas:

• If you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6).
• If you have a condition 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 condition in which your breathing is irregular, even stopping for short periods while you are sleeping.
• If you have severe liver problems.

Warnings and precautions

Consult 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 be mentally dependent on this medication. If there is physical dependence, stopping treatment is accompanied by withdrawal symptoms (see section 3, If you interrupt treatment with Alprazolam Aurovitas). The risk of dependence is higher with increased dose and duration of treatment in patients with a history of alcohol or drug abuse, or if several benzodiazepines are combined. Therefore, treatment should be as short as possible.
• Benzodiazepines and similar medications should be used with caution in elderly patients due to the risk of drowsiness and/or muscle 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 medication. To reduce this risk, make sure you sleep uninterrupted for 7-8 hours after taking the medication.
• You have unexpected reactions, such as restlessness, agitation, irritability, aggression, disappointment, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, delirium, or other conduct disorders. These unexpected reactions occur more frequently in children and elderly patients.
• You have 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 (a state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (a state of excitement and excessive activity).
• You have been diagnosed with kidney or liver insufficiency.
• You have been diagnosed with any psychiatric disorder.
• You have a certain type of glaucoma.

If you are to undergo surgery

Inform your doctor that you are taking alprazolam.

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

Other medications and Alprazolam Aurovitas

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

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

These medications are:

Medications that increase the sedative effect of alprazolam:

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

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

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

Medications that reduce 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 medication),
• The concomitant use of alprazolam and HIV protease inhibitors (e.g., ritonavir) requires dose adjustment or suspension of alprazolam.

Alprazolam may increase the effect of the following medications:

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

The alcohol potentiates the sedative effect of alprazolam.

The concomitant use of alprazolam and opioids (strong analgesics, medication for substitution therapy, and some medications for cough) increases the risk of drowsiness, causes breathing difficulties (respiratory depression), coma, and may put life in danger. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all the opioid medications you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Do not forget to tell your doctor that you are taking alprazolam tablets when you visit them next.

Alprazolam Aurovitas intake with food, drinks, and alcohol

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

Alcohol

Do not take alcoholic beverages during treatment with alprazolam tablets.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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

There is no adequate experience with the use of alprazolam in pregnant women. Do not take alprazolam if you are pregnant or intend 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 intend to become pregnant, consult your doctor about the possibility of interrupting 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, muscle weakness, and poor feeding (hypotonic syndrome).

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

Driving and operating machines

Due to its sedative, muscle relaxant, and sleep-inducing effects, alprazolam may impair driving and other tasks that require special attention, especially at the beginning of treatment and if you do not sleep enough. Therefore, do not drive or operate machines during treatment with alprazolam.

Alprazolam Aurovitas contains lactose monohydrate

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

Alprazolam Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 beverage.

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

Adults

Normally, you will start taking one tablet of 0.25 mg or one tablet of 0.5 mg three times a day. This represents a total daily dose of 0.75 mg to 1.5 mg.

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 usually increased first at night before the day dose, to ensure that you maintain a higher level of alertness during the day. If you start to experience adverse effects, your doctor may reduce your dose.

Older patients

If you are an older patient or have, for example, liver or kidney problems, you will need a lower dose. Normally, you will start taking a dose of 0.25 mg two or three times a day. This dose may be increased slowly if necessary, and if it does not cause adverse effects.

Use in children and adolescents

Xanax is not recommended for children and adolescents under 18 years old.

Tablets can be divided into equal doses.

Treatment duration

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 reevaluate 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 decrease in the effect of the medication may occur if used for more than a few weeks.

If you take moreAlprazolam Aurovitasthan you should

If you or someone else (for example, a child) takes too much of this medication, contact your doctor or hospital immediately. If the patient is conscious, give them activated charcoal as emergency medication.

Bring the box of this medication with you if you seek medical help.

A overdose of alprazolam produces extreme fatigue, ataxia (lack of coordination), and reduces the level of consciousness. It may also produce a decrease 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot 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 compensate for the missed doses.

If you interrupt treatment withAlprazolam Aurovitas

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

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

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Very common side effects:may affect more than 1 in 10 people

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

Common side 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 alteration,
• excessive abnormal sleep (hypersomnia),
• pronounced debilitation (lethargy),
• tremors or shakiness,
• difficulty concentrating,
• blurred vision,
• rapid heartbeat, palpitations,
• nasal congestion,
• nausea,
• allergic eruption,
• skin inflammation (dermatitis),
• sexual dysfunction,
• weakness (asthenia),
• weight loss, weight gain.

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

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

• double vision,

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

Rare side effects:may affect up to 1 in 1,000 people

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

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

Frequency not known:cannot be estimated from available data

• inflammation of the liver (hepatitis),
• hyperprolactinemia (abnormally high levels of prolactin in the blood),
• hypomania,
• peripheral edema(swelling of the ankles, feet, or toes),
• 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 beneath the skin surface (angioedema),
• exaggerated response to light (photophobia),
• urinary retention in the bladder,
• increased intraocular pressure.

Alprazolam may cause physical and psychological dependence. See the section“Be especially careful with Alprazolam Aurovitas”.

Stopping treatment abruptly with alprazolam may cause withdrawal symptoms such as anxiety, insomnia, and seizures (See “If you stop taking Alprazolam Aurovitas tablets”).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Medications should not be disposed of through drains or trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

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, cornstarch, sodium docusate, sodium benzoate (E 211), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Alprazolam Aurovitas 0.25 mg tablets:

Uncoated tablets, white in color, oval in shape, 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 in high-density polyethylene (HDPE) bottles.

Packaging sizes:

Blisters: 20, 30, 50, and 60 tablets.

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

Some packaging sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 with the following names:

Belgium: Alprazolam AB 0.25 mg tabletten

Spain: Alprazolam Aurovitas 0.25 mg comprimidos EFG

Netherlands: Alprazolam Aurobindo 0.25 mg, tabletten

Poland: Alprazolam Aurovitas

Portugal: Alprazolam Aurovitas

Czech Republic: Alprazolam Aurovitas 0.25 mg tablety

Last review date of this leaflet: October 2023

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