ALPRAZOLAM NEURAXPHARM 0.25 mg TABLETS

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

Do not take Alprazolam Neuraxpharm:

• if you are allergic to alprazolam, other benzodiazepine medicines, or any of the other ingredients of this medicine (listed in section 6).
• if you have a disease called "myasthenia gravis" in which you have very weak and tired muscles.
• if you have severe chest problems or breathing difficulties (e.g. emphysema or chronic bronchitis).
• if you have "sleep apnea": this is a condition in which your breathing becomes irregular, even stops for short periods, while you sleep.
• if you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

• note that the effect of the tablets will be reduced after they have been used 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 medicine. If there is physical dependence, stopping treatment is accompanied by withdrawal symptoms (see section 3, If you stop taking Alprazolam Neuraxpharm). The risk of dependence is greater as the dose and duration of treatment increase in patients with a history of alcohol or drug abuse or if several benzodiazepines are combined. That's why treatment should be as short as possible.
• are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding (see also the sections on "Pregnancy" and "Breast-feeding" for more information).
• benzodiazepines and related products should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness that can cause falls, often with serious consequences in this population.
• a history of alcohol, drug, or narcotic abuse
• have had memory disorders. Memory loss usually occurs several hours after taking the product. To reduce the risk, make sure you can have uninterrupted sleep for 7-8 hours after taking the medicine.
• have unexpected reactions, such as 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.
• chronic lung disease
• are using alcohol and sedative medications concomitantly
• have severe depression (suicide risk)
• have been diagnosed with liver or kidney problems
• have been diagnosed with any psychiatric illness
• have a certain type of glaucoma.

If you are going to have surgery

Tell your doctor that you are taking this medicine.

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

Other medicines and Alprazolam Neuraxpharm

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

Some medicines may cause unwanted effects if taken at the same time as alprazolam. If you are taking other medicines 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 medicines include:

• medicines for treating fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole)
• sleeping pills, antipsychotic medicines, or anesthetics
• analgesics (e.g. dextropropoxyphene or opioids)
• medicines used to treat depression (e.g. St. John's Wort, fluoxetine, fluvoxamine, sertraline, nefazodone, imipramine, and desipramine)
• anxiolytics (used to treat anxiety)
• medicines for treating schizophrenia (e.g. clozapine)
• medicines for treating epilepsy (e.g. carbamazepine, phenytoin)
• sedating antihistamines (used to treat allergies with sedation as a side effect)
• hormonal oral contraceptives (the "pill")
• antibiotics (e.g. erythromycin, troleandomycin, rifampicin, clarithromycin, telithromycin)
• medicines used to treat heart conditions (e.g. digoxin)
• medicines that lower blood pressure (e.g. diltiazem)
• muscle relaxants
• medicines used to treat HIV
• cimetidine (a medicine to combat stomach acid)

Alcohol increases the sedative effect of alprazolam.

The next time you visit your doctor, remember to tell him that you are taking this medicine.

Alprazolam Neuraxpharm with food, drink, and alcohol

Take the tablet with a glass of water or some other liquid.

Alcohol

Do not drink alcohol while taking Alprazolam Neuraxpharm.

Alcohol increases the sedative effect of alprazolam.

Pregnancy and breast-feeding

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

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

There is no sufficient experience with the use of alprazolam in pregnant women. Do not take Alprazolam if you are pregnant or plan to become pregnant, unless your doctor considers it strictly indicated. Observations in humans have indicated that the active substance alprazolam may be harmful to the fetus (increased risk of malformations (cleft palate). If you are pregnant or plan to become pregnant, consult your doctor about the possibility of stopping treatment. If you are taking alprazolam until birth, inform your doctor, as your newborn may have some withdrawal symptoms when born. The use of a high dose at the end of pregnancy or during delivery may cause the newborn to also have low body temperature, respiratory depression, decreased muscle tone, and poor feeding (floppy baby syndrome).

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

Driving and using machines

Due to its sedative effect, muscle relaxation, and sleep-inducing effect, alprazolam may affect performance in traffic and other tasks that require a special state of alertness, especially at the beginning of treatment and if sleep is insufficient. For this reason, do not drive or use machines during treatment with Alprazolam Neuraxpharm.

Alprazolam Neuraxpharm contains lactose monohydrate

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

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

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

It can cause allergic reactions.

3. How to take Alprazolam Neuraxpharm

Follow exactly the administration instructions of this medicine 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 appear, the dose should be reduced.

Patient with renal and hepatic insufficiency

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

Patient with respiratory insufficiency

Lower doses are recommended for 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 of age.

The score line is only to facilitate breaking and swallowing and not to divide into equal doses.

If you take more Alprazolam Neuraxpharm than you should

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

Take this box with you if you seek medical help.

An overdose of alprazolam 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 forget to take Alprazolam Neuraxpharm

If you forget 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 make up for a forgotten dose.

Duration of treatment

Alprazolam Neuraxpharm tablets are only used for short-term treatments (no more than 12 weeks). Normally, you will not be given a prescription for more than 4 weeks and your doctor will review you regularly during this time.

If you stop taking Alprazolam Neuraxpharm

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

Sudden interruption of treatment causes withdrawal symptoms (e.g. headache, muscle pain, intense anxiety, tension, restlessness, confusion, irritability, and in severe cases, depersonalization, derealization, hyperacusis, numbness, tingling sensation in the limbs, hypersensitivity to light, noise, and touch, hallucinations, and epileptic seizures). Withdrawal symptoms may appear several days after the end of treatment.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effect is fatigue, which may be associated with ataxia (lack of coordination), altered muscular coordination, and confusion. Fatigue may occur in elderly patients in particular. Fatigue and fatigue-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 people):

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

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

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

Uncommon(may affect up to 1 in 100 people):

• Mania, hallucinations, rage, agitation
• amnesia
• Musculoskeletal weakness
• Incontinence
• Irregular menstruation

Rare(cannot be estimated from the available data):

• Hyperprolactinemia,hypomania, aggression, hostility, abnormal thinking, psychomotor 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 mental dependence. See the section "Be careful with Alprazolam Neuraxpharm".

Sudden interruption of treatment with alprazolam may cause withdrawal symptoms such as anxiety, insomnia, and convulsions (see "If you stop taking Alprazolam Neuraxpharm").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Neuraxpharm

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the label or 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. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Alprazolam Neuraxpharm

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

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

Appearance of Alprazolam Neuraxpharm and pack contents

Tablet.

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

Alprazolam Neuraxpharm tablets are available in PVC/ALU blisters.

Package sizes: 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Bluepharma Indústria Farmaceutica, S.A.

• Martinho do Bispo

3045-016 Coimbra

Portugal

Date of last revision of this leaflet: July 2021

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