Package Leaflet: Information for the User

Alprazolam Neuraxpharm 0.25 mg Tablets EFG

Alprazolam

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Alprazolam Neuraxpharm

3.How to take Alprazolam Neuraxpharm

4.Possible side effects

5.Storage of Alprazolam Neuraxpharm

6.Contents of the pack and additional information

Alprazolam Neuraxpharm is a tranquilizer that contains the active substance alprazolam. Alprazolam belongs to a group of medicines called benzodiazepines.

Alprazolam Neuraxpharm tabletsare only usedin adultsto treat severe anxiety and severe anxiety associated with depression. Alprazolam Neuraxpharm is not recommended for the treatment of depression.

Benzodiazepines are only indicated when the disorder is severe, incapacitating or subjects the individual to extreme stress.

Do not takeAlprazolam Neuraxpharm:

• if you are allergic to alprazolam, other benzodiazepine medications, or any of the other components of this medication (listed in section 6).
• if you have a condition called "myasthenia gravis" where you have very weak and tired muscles.
• if you have severe chest problems or difficulty breathing (for example, emphysema or chronic bronchitis).
• if you have "sleep apnea": this is a condition where your breathing becomes irregular, even stops for short periods, while you are asleep.
• if you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication

• be aware that the effect of the tablets will be reduced after using them for several weeks (tolerance)
• are concerned about physical and mental dependence caused by alprazolam. If you do not want to stop treatment, you may have mental dependence on this medication. If there is physical dependence, stopping treatment is accompanied by withdrawal symptoms (see section 3, If you interrupt treatment with Alprazolam Neuraxpharm). The risk of dependence is higher as the dose and duration of treatment increase in patients with a history of alcohol or drug abuse or if several benzodiazepines are combined. Therefore, treatment should be as short as possible.
• are pregnant, think you may be, intend to become pregnant, or are breastfeeding (also see the sections on "Pregnancy" and "Breastfeeding" for more information).
• benzodiazepines and related products should be used with caution in elderly patients, due to the risk of sedation and/or muscle weakness that can cause falls, often with serious consequences in this population.
• have a history of alcohol, drug, or narcotic abuse
• have had memory disorders. Memory loss usually occurs several hours after ingestion of the product. To reduce the risk, ensure you can have uninterrupted sleep of 7-8 hours after taking the medication.
• have unexpected reactions, for example, restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, delirium, and other behavioral disorders. These unexpected reactions occur more frequently in children and elderly patients.
• have chronic lung disease
• are using alcohol and sedative medications concurrently
• have severe depression (suicide risk)
• have been diagnosed with liver or kidney problems
• have been diagnosed with any psychiatric disorder
• have a certain type of glaucoma.

If you are to undergo surgery

Inform your doctor that you are taking this medication.

Children and adolescents:Do not recommend the use of alprazolam in children and adolescents under 18 years old.

Other medications and Alprazolam Neuraxpharm

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

Some medications may cause unwanted effects if taken at the same time as alprazolam. If you are taking other medications at the same time, this may affect the effectiveness of the treatment. In this case, your doctor may adjust your medication or dosage instructions.

These medications include:

- medications to treat fungal infections (for example, ketoconazole, itraconazole, posaconazole, voriconazole)

- sleeping pills, antipsychotics, or anesthetics

- painkillers (for example, dextropropoxyphene or opioids)

- medications used to treat depression (for example, St. John's Wort, fluoxetine, fluvoxamine, sertraline, nefazodone, imipramine, and desipramine)

- anxiolytics (used to treat anxiety)

- medications to treat schizophrenia (for example, clozapine)

- medications to treat epilepsy (for example, carbamazepine, phenytoin)

- sedating antihistamines (used to treat allergies and sedation as a side effect)

- oral contraceptives based on hormones (the "pill")

- antibiotics (for example, erythromycin, troleandomycin, rifampicin, clarithromycin, telithromycin)

- medications used to treat heart disease (for example, digoxin)

- medications that lower blood pressure (for example, diltiazem)

- muscle relaxants

- medications used to treat HIV

- cimetidine (medication to combat stomach acid)

Alcohol potentiates the sedative effect of alprazolam.

Next time you visit your doctor, remember to tell them that you are taking this medication.

Alprazolam Neuraxpharm with food, drink, and alcohol

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

Alcohol

Do not drink alcohol while taking Alprazolam Neuraxpharm.

Alcohol potentiates the sedative effect of alprazolam.

Pregnancy and breastfeeding

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

Alprazolam should not be used during pregnancy unless your doctor considers it absolutely necessary for the treatment of the mother.

No adequate experiences are available on 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 observations have indicated that the active substance alprazolam may be harmful to the fetus (greater risk of malformations (cleft palate). If you are pregnant or planning to be, consult your doctor about the possibility of interrupting treatment. If you are taking alprazolam until birth, inform your doctor, as your newborn may have some withdrawal symptoms when born. High-dose use at the end of pregnancy or during delivery may cause the newborn to have low body temperature, cause respiratory depression, muscle tone decrease, and poor feeding (floppy baby syndrome).

Do not breastfeed while taking alprazolam. There is a risk that it may affect the baby.

Driving and operating machinery

Due to its sedative, muscle relaxant, and sleep-inducing effects, alprazolam may affect your performance in traffic and other tasks that require special alertness, especially at the beginning of treatment and if sleep is insufficient. Therefore, do not drive or operate machinery during treatment with Alprazolam Neuraxpharm.

Alprazolam Neuraxpharm contains lactose monohydrate

This medication contains lactose monohydrate. If your doctor has told you that you have intolerance to some sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, that is, it is essentially "sodium-free".

This medication contains 0.15 mg of sodium benzoate in each tablet.

It may cause allergic reactions.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. Your doctor will tell you how many tablets to take and when.

Do not take your tablets with alcoholic beverages.

* If adverse reactions occur, the dose should be reduced.

Patients with renal and hepatic insufficiency

Care should be taken when establishing the initial dose in patients with renal and hepatic insufficiency. In patients with severe hepatic insufficiency, treatment with alprazolam, like other benzodiazepines, is contraindicated (see section 4.3) due to the associated risk of encephalopathy.

Patients with respiratory insufficiency

It is recommended to administer lower doses to patients with chronic respiratory insufficiency due to the risk of respiratory depression.

Use in children and adolescents

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

The notch is only for breaking and swallowing and not for dividing into equal doses.

If you take more Alprazolam Neuraxpharm than you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. Activated charcoal should be administered as an emergency medication if the patient is conscious.

Carry this box with you if you seek medical help.

A alprazolam overdose causes intense fatigue, ataxia (lack of coordination), and decreased level of consciousness. It is also possible to have decreased blood pressure, loss of consciousness, and respiratory depression. Alcohol and other central nervous system depressants increase the undesirable effects of alprazolam.

If you forgot to take Alprazolam Neuraxpharm

If you forgot to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to compensate for a missed dose.

Treatment duration

Alprazolam Neuraxpharm tablets are only used for short-term treatments (not more than 12 weeks). Normally, you will not be given a prescription for more than 4 weeks, and your doctor will check on you periodically during this time.

If you interrupt treatment with Alprazolam Neuraxpharm

Alprazolam can cause physical and psychological dependence. The risk is higher with high doses and prolonged treatment periods, in patients with a history of alcohol or drug abuse, or if several benzodiazepines are combined.

Abruptly stopping treatment causes withdrawal symptoms (e.g., headache, muscle pain, intense anxiety, tension, restlessness, confusion, irritability, and in severe cases, depersonalization, derealization, hyperacusis, numbness, tingling in the extremities, hypersensitivity to light, sound, and touch, hallucinations, and seizures). Withdrawal symptoms may appear several days after treatment ends.

For this reason,Alprazolam Neuraxpharm treatment should not be stopped abruptly; the dose should be reduced gradually according to your doctor's instructions.

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

Like all medications, this medication may cause side effects, although not everyone experiences them.

The most common side effect is fatigue, which may be associated with ataxia (loss of coordination), muscle coordination impairment, and confusion. Fatigue may occur particularly in elderly patients. Fatigue and related symptoms are stronger at the beginning of treatment. They will decrease or disappear with dose reduction or continued treatment.

Very common(may affect more than 1 in 10 patients):

• Depression, sedation, drowsiness, ataxia, memory impairment, dysarthria, dizziness, headache
• Constipation, dry mouth
• Fatigue, irritability

Common(may affect up to 1 in 10 patients):

• Decreased appetite,
• Confusion, disorientation, decreased libido, anxiety, insomnia, nervousness, increased libido
• Balance disorder, abnormal coordination, attention impairment, hypersomnia, lethargy, tremor, blurred vision
• Blurred vision
• Nausea
• Dermatitis
• Sexual dysfunction
• Weight loss, weight gain

Rare(may affect up to 1 in 100 patients):

• Mania, hallucinations, anger, agitation
• Amnesia
• Musculoskeletal weakness
• Incontinence
• Irregular menstruation

Unknown(frequency cannot be estimated from available data):

• Hypoprolactinemia,hypomania, aggression, hostility, abnormal thinking, hyperactivity
• Autonomic nervous system imbalance, dystonia
• Gastrointestinal disorder
• Hepatitis, abnormal liver function, jaundice
• Angioedema, photosensitivity reaction
• Urinary retention
• Peripheral edema
• Increased intraocular pressure

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

Stopping alprazolam treatment abruptly may cause withdrawal symptoms such as anxiety, insomnia, and seizures (see "If you interrupt treatment with Alprazolam Neuraxpharm").

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the label or the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alprazolam Neuraxpharm

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

The other components are: docusate sodium (85/15) (V): docusate sodium and sodium benzoate; pregelatinized cornstarch, lactose monohydrate, cellulose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, yellow colorant PB-22877: lactose monohydrate, quinoline aluminum yellow lake (E104).

Appearance of Alprazolam Neuraxpharm and content of the container

Tablet.

The Alprazolam Neuraxpharm 0.25 mg tablets are round, biconvex, yellow, and scored on one side.

The Alprazolam Neuraxpharm tablets are available in PVC/ALU blisters.

Container sizes: 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Responsible for manufacturing

Bluepharma Indústria Farmaceutica, S.A.

S. Martinho do Bispo

3045-016 Coimbra

Portugal

Last review date of this leaflet: July 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /