ALPRAZOLAM STADA 0.5 mg TABLETS

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

Do not take Alprazolam Stada:

• If you are allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6)
• If you have breathing difficulties related to or not related to sleep (sleep apnea)
• If you have a disease called myasthenia gravis, which is characterized by muscle weakness
• If you have severe liver disorders

Warnings and precautions

Consult your doctor or pharmacist before starting to take alprazolam.

• You have any lung, kidney, or liver problems.
• You have felt or feel so depressed that you have had thoughts or ideas of suicide.
• Note that the effect of the tablets weakens after taking them for several weeks (tolerance).
• If during treatment you notice symptoms of mania (state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (state of excitement and excessive activity).
• You are concerned about physical and mental dependence caused by alprazolam. If you do not want to stop treatment, you may become mentally dependent on this medicine. If there is physical dependence, stopping treatment is accompanied by withdrawal symptoms (see section 3, If you stop taking Alprazolam Stada). The risk of dependence is greater when increasing the dose and duration of treatment in patients with a history of alcohol or drug abuse, or if several benzodiazepines are combined. For this reason, treatment should be as short as possible.
• You have a history of alcohol, drug, or narcotic abuse.
• You have had memory disorders. Memory loss usually occurs several hours after taking the medicine. To reduce this risk, make sure you sleep uninterrupted for 7-8 hours after taking the medicine.
• You have unexpected reactions, such as restlessness, agitation, irritability, aggression, disillusion, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, delirium, or other behavioral disorders. These unexpected reactions occur more frequently in children and elderly patients.
• You have a chronic lung disease.
• You are taking alcohol and sedatives at the same time.
• You have been diagnosed with a psychiatric illness.
• You have a certain type of glaucoma.

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

• Benzodiazepines will only be taken under medical prescription (never because they have worked for other patients) and will never be recommended to other people.
• Do not increase the prescribed doses by your doctor, nor prolong treatment longer than recommended.
• Consult your doctor regularly so that he can decide if you should continue treatment.
• Do not combine several benzodiazepines regardless of their indication.
• When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment with alprazolam (rebound effect) may appear. To avoid this, it is recommended not to interrupt treatment abruptly, but to gradually reduce the dose, according to the doctor's instructions (see section "If you stop taking Alprazolam Stada").
• Benzodiazepines and similar medicines should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness.

Using Alprazolam Stada with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

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

Medicines that increase the sedative effect of alprazolam:

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

Medicines that increase the effect of alprazolam due to reduced 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 (medicine for blood pressure and heart)
• certain antibiotics (such as erythromycin, clarithromycin, telithromycin, and troleandomycin) and certain medicines for treating fungal infections (such as itraconazole, ketoconazole, posaconazole, voriconazole).

Medicines that decrease the effect of alprazolam due to increased metabolism in the liver:

• carbamazepine or phenytoin (antiepileptics, which are also used for other treatments)
• St. John's Wort (Hypericum perforatum, a medicinal plant)
• rifampicin (antitubercular medicine).

Alprazolam may increase the effect of the following medicines:

• digoxin (heart medicine)
• muscle relaxants
• imipramine and desipramine (medicines for severe depression)
• clozapine (medicine for psychosis). There is a greater risk of cardiac and/or respiratory arrest.

The concomitant use of alprazolam and opioids (potent painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, 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.

Tell your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendations. It may be useful to inform friends or relatives so that they are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Using Alprazolam Stada with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

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

Alprazolam is not recommended during pregnancy or breastfeeding unless, in the doctor's opinion, the benefit outweighs the risk to the child.

If alprazolam is administered during late pregnancy or during childbirth, effects on the newborn such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression may occur.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, and a withdrawal syndrome may be triggered in the postnatal period.

Use in children and adolescents (under 18 years)

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

Use in elderly patients (over 65 years)

Alprazolam may affect this group of patients more than younger patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow their instructions carefully (see the 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, which can cause falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys do not work 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 using machines

Alprazolam Stada may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects. These effects can be enhanced if you consume alcohol at the same time.

Alprazolam Stada contains lactose

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

Alprazolam Stada contains sodium

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

Alprazolam Stada contains the yellow-orange colorant E-110

This medicine may cause allergic reactions because it contains the yellow-orange colorant E-110. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Alprazolam Stada

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

Dosage:

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

The 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 disorders, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the total daily dose of alprazolam being 0.5 mg to 0.75 mg in divided doses, which can be gradually increased if necessary and well tolerated.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor explicitly indicates so.

Duration and suppression of treatment:

The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If your doctor considers that, in your case, it is necessary to prolong treatment, it will be for limited periods, and you will be frequently monitored.

Never stop treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to gradually decrease the dose until the end of treatment.

If you think the effect of alprazolam is too strong or too weak, tell 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, taking this leaflet with you.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, which can range from drowsiness to coma. Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged drowsiness), 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 medicines or alcohol.

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

If you forget to take Alprazolam Stada

Do not take a double dose to make up for forgotten doses.

If the forgotten dose is recent, take your dose immediately, and if not, wait for the next dose without taking a double dose to make up for it.

If you stop taking Alprazolam Stada

Treatment with alprazolam may produce dependence, so when stopping alprazolam abruptly, withdrawal symptoms may appear.

The withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, intolerance to light, sounds, and physical contact, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. If this happens, you should consult your doctor immediately.

If you have any other 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 all people suffer from them.

The adverse effects that may appear during treatment with alprazolam occur predominantly at the beginning of treatment and usually disappear with continued administration or after a reduction in dosage.

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

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

Common adverse 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 sleepiness (hypersomnia), state of deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

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

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

Frequency not known (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), aggressiveness, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, alteration of liver function, yellowing of the skin and whites of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

• Somnolence, lack of reaction to emotional stimuli (emotional blunting), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision. These phenomena occur predominantly at the beginning of treatment and usually disappear with continued administration. Gastrointestinal alterations, changes in sexual desire, or skin reactions may occasionally occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral alterations may appear. These reactions may be severe and occur more frequently in children and elderly patients.
• Administration of the product (even at usual doses) may lead to the development of physical dependence. Interruption of treatment may lead to the development of withdrawal or rebound phenomena. Psychic dependence may occur. Cases of abuse have been reported.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Alprazolam Stada

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging, after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. - Packaging Contents and Additional Information

Composition of Alprazolam Stada

• The active ingredient is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, corn starch (gluten-free), talc, sodium glycolate starch, magnesium stearate, orange-yellow colorant (E-110), and quinoline yellow colorant.

Appearance of the Product and Packaging Contents

Alprazolam Stada 0.5 mg are orange, round, and scored tablets on one side.

The tablet can be divided into equal doses.

Alprazolam Stada 0.5 mg tablets are available in packages of 30 or 500 (clinical packaging) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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: packages of 30 tablets.

Alprazolam Stada 1 mg tablets EFG: packages of 30 tablets.

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

Date of the Last Revision of this Prospectus: February 2022

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