Package Insert: Information for the User

Alprazolam Stada 1 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 should not be given 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.

Alprazolam belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Alprazolam is used in adults for the treatment of severe, incapacitating, or extremely distressing anxiety symptoms. This medicine is only for short-term use.

Do not take Alprazolam Stada:

• If you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6)
• If you have respiratory difficulties related or unrelated to sleep (sleep apnea)
• If you have a disease called myasthenia gravis characterized by muscle weakness
• If you have severe liver damage

Warnings and precautions

Consult your doctor or pharmacist before starting to take alprazolam.

• If you have any lung, kidney, or liver problems.
• If you have felt or feel so depressed that you have had thoughts or ideas of suicide.
• If you notice that the effect of the tablets weakens after taking them for several weeks (tolerance).
• If 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).
• If 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 Stada). 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.
• If you have a history of alcohol, drug, or narcotic abuse.
• If 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.
• If 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.
• If you have chronic lung disease.
• If you are taking alcohol and sedatives at the same time.
• If you have been diagnosed with any psychiatric disease.
• If you have a certain type of glaucoma.

To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines should only be under medical prescription (never because they have worked in other patients) and should never be recommended to others.
• Do not increase the doses prescribed by your doctor, nor prolong the treatment longer than recommended.
• Consult your doctor regularly so that they can decide if you should continue with the treatment.
• Do not combine several benzodiazepines regardless of their indication.
• When stopping treatment with alprazolam, withdrawal symptoms similar to those that led you to start treatment with alprazolam may appear (rebound effect). To avoid this, it is recommended not to stop treatment abruptly, but to gradually reduce the dose, according to your doctor's instructions (see section "If you interrupt treatment with Alprazolam STADA").
• 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.

Use of Alprazolam Stada with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Alprazolam may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

Medications that increase the sedative effect of alprazolam:

• Sleeping pills and sedatives
• Antipsychotics and antidepressants
• Antiepileptics
• Anesthetics
• Potent 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 disease)
• 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).

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 depression.

The concomitant use of alprazolam and opioids (potent analgesics, medication for substitution therapy, and some medications for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes alprazolam along 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 dosing closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Use of Alprazolam Stada with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol can potentiate sedation, and this can affect your alertness (see section "Driving and operating machines").

During treatment with alprazolam tablets, do not take alcoholic beverages.

Pregnancy, breastfeeding, and fertility

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

Alprazolam is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefits outweigh the risks for the baby.

If, by the doctor's decision, alprazolam is administered during a late stage of pregnancy or during delivery

or during delivery, withdrawal symptoms may appear in the newborn, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Newborns of mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which can trigger withdrawal syndrome in the postnatal period.

Use in children and adolescents (under 18 years)

Alprazolam is not recommended for children and adolescents under 18 years old. Benzodiazepines should not be administered to children unless it is strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam have not been established in children under 18 years old.

Use in elderly patients (over 65 years)

Alprazolam may affect this group of patients more than young patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow your doctor's instructions carefully (see section "How to take Alprazolam STADA").

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.

Special patient groups

If your liver or kidneys do not function well, consult your doctor, who may advise you to use a lower dose of alprazolam.

If you have respiratory disorders, inform your doctor.

Driving and operating machines

Alprazolam may affect your ability to drive or operate machines, as it can cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machines if you experience any of these effects. These effects may be potentiated if you consume alcohol at the same time.

Alprazolam Stada contains lactose

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

Alprazolam Stada contains sodium

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

Alprazolam Stada contains the colorant amaranto (E123)

This medication maycause allergic reactions because it contains amaranto colorant (E123). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or its part should be ingested without chewing, with the help of a little liquid. Your doctor will prescribe the most suitable presentation of alprazolam for you, according to the dose you need.

Usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg of alprazolam three times a day.
• The usual dose ranges from 0.5 mg to a maximum of 4 mg per day, divided into 2 or 3 doses.

In elderly patients with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with a daily dose of 0.5 mg to 0.75 mg in divided doses, which can be gradually increased as needed and well tolerated.

No individual dose should exceed the indicated limits, and the total daily dose should not either, unless your doctor instructs you otherwise.

Durationandwithdrawalof treatment:

The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If your doctor considers it necessary to prolong treatment in your case, they will do so for limited periods and will frequently monitor your condition.

Never discontinue treatment abruptly. Your doctor will indicate the duration of treatment based on the evolution of your disease and will explain how to gradually reduce the dose until you complete your treatment.

If you estimate that the action of alprazolam is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Stada than you should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the nearest hospital with this leaflet.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (prolonged and deep sleep), decreased muscle tone (hypotonia), decreased blood pressure, and respiratory depression, rarely coma and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medications or alcohol.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you forgot to take Alprazolam Stada

Do not take a double dose to compensate for the missed doses.

If the missed dose is recent, take your dose immediately, and if not, wait for the next dose without taking a double dose to compensate.

If you interrupt treatment with Alprazolam Stada

Alprazolam treatment can cause dependence, so when discontinuing alprazolam administration abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures. In case of this occurring, you should consult your doctor immediately.

If you have any other doubts 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 side effects that may occur during treatment with alprazolam predominantly occur at the beginning of treatment and generally disappear with continued administration or after a reduction in dose.

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

• Depression.
• Drowsiness, drowsiness, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

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

• Feeling of confusion, disorientation, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleep (hypersomnia), deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Rare side effects(may affect up to 1 in 100 people):

• Memory loss (amnesia).
• Mental and behavioral disorders (mania), hallucinations, anger reactions, agitation, dependence.
• Loss of muscle strength.
• Inability to retain urine in the bladder (urinary incontinence).
• Irregular menstruation.
• Withdrawal symptoms

Unknown frequency(cannot be estimated from available data):

• Increased levels of prolactin in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggression, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function alteration, yellowing of the skin and white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, lack of reaction to emotional stimuli (emotional numbing), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal alterations, changes in sexual desire, or skin reactions may occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask an existing depression.
• Using benzodiazepines or similar compounds may cause reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations. These reactions can be severe and occur more frequently in children and elderly patients.
• The administration of the product (even at usual doses) may lead to the development of physical dependence. Stopping treatment may lead to the development of withdrawal or rebound phenomena. Psychic dependence may occur. Cases of abuse have been reported.

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 prospectus. 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alprazolam Stada

• The active ingredient is alprazolam. Each tablet contains 1 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch (gluten-free), talc, sodium glycolate starch, magnesium stearate, patent blue V (E131) colorant, and amaranth (E123) colorant.

Appearance of the product and content of the packaging

Alprazolam Stada 1 mg are blue sky-colored, round, and scored tablets on one side.

The tablet can be divided into equal doses.

Alprazolam Stada 1 mg tablets are presented in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

LACER, S.A.

C/. Boters, 5 –Parc Tecnològic del Vallès-

08290 Cerdanyola del Vallès (Barcelona)

Spain

Other presentations

Alprazolam Stada 0.25 mg tablets EFG: packs of 30 tablets.

Alprazolam Stada 0.5 mg tablets EFG: packs of 30 or 500 (clinical pack) tablets.

Alprazolam Stada 2 mg tablets EFG: packs of 30 or 50 tablets.

Last review date of this prospectus: February 2022

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