ALPRAZOLAM TARBIS 0.5 mg TABLETS

2. What you need to know before taking Alprazolam Tarbis

Do not take Alprazolam

• If you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6)

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.
• After continued use of alprazolam, some loss of efficacy (tolerance) may be detected.
• There is a risk of developing addiction/dependence when using this medication.
• If during treatment you notice symptoms of mania (state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (state of excitement and excessive activity).
• Treatment with benzodiazepines, including alprazolam, may cause dependence, mainly after uninterrupted use of the medication for a long time.

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

• • The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and will never be advised to other people.
  • Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
  • Regularly consult your doctor so that they 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 this medication (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").
• The use of alprazolam along with opioid medications can cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines can cause memory loss and reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, you should stop treatment and consult your doctor.
• It is very important that you inform your doctor if you have a history of drug and alcohol use.

Taking Alprazolam with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use another medication.

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

• Central nervous system depressants, as they may potentiate the sedative effect of Alprazolam Tarbis:

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications for the treatment of epilepsy (antiepileptics).
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, which can lead to increased psychological dependence.
• Medications used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medications for treating allergies).
• The concomitant use of Alprazolam Tarbis and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction), and some medications for cough) 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 Tarbis along with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
• Tell your doctor about all opioid medications you are taking and closely follow your doctor's dose recommendation. It may be helpful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

• There are groups of medications that, due to their action in the body (cytochrome P450 inhibitors), may interact with Alprazolam Tarbis and, in some cases, increase its activity. Some of the medications that may interact with Alprazolam Tarbis are:

• Medications used to treat fungal infections, such as ketoconazole, itraconazole, posaconazole, or voriconazole. It is not recommended to take them at the same time as Alprazolam Tarbis.
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectors, such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (antihypertensive).
• Macrolide antibiotics, such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat AIDS, such as ritonavir, etc.

Digoxin (medication used to suppress or prevent heart rhythm disorders).

Alprazolam 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 using machines").

Pregnancy, breastfeeding, and fertility

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

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

If, by medical decision, this medication 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 appear.

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 in children and adolescents under 18 years. Benzodiazepines should not be administered to children unless it is 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 Tarbis 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 Tarbis").

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 properly, consult your doctor, who may advise you to use a lower dose of Alprazolam Tarbis.

If you have respiratory disorders, inform your doctor.

Driving and using machines

Alprazolam may alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease 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 potentiated if you consume alcohol at the same time.

Alprazolam contains lactose

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

Alprazolam contains sodium benzoate

This medication contains 0.12 mg of sodium benzoate (E-211) per 0.25 mg tablet.

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

3. How to take Alprazolam Tarbis

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or part of it should be swallowed 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.

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 amount of alprazolam ingested per day being 0.5 mg to 0.75 mg in divided doses, and may 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 otherwise.

Duration and discontinuation of 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 closely monitor your situation.

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

If you think the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam than you should

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

Overdose with benzodiazepines is usually 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, 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 the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Alprazolam

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

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 extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and convulsions. If this occurs, you should consult your doctor immediately.

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

4. Possible side effects

Like all medications, Alprazolam Tarbis can have side effects, although not everyone will experience them.

The side effects that may occur during treatment with alprazolam occur predominantly at the start of treatment and usually disappear with continued administration or after a dose reduction.

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

• Depression.
• Sedation, drowsiness, coordination disorder (ataxia), memory impairment, 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, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance disorder, difficulty concentrating, excessive sleepiness (hypersomnia), state of deep and prolonged drowsiness (lethargy), tremors.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

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

• Mental and behavioral disorders (mania), hallucinations, fits of rage, agitation, dependence.
• Memory loss (amnesia).
• 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 prolactin levels 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, altered 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.
• Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

• Drowsiness, 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 start of treatment and usually disappear with continued administration. Occasionally, gastrointestinal disorders, 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 a pre-existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disorders may appear. These reactions can be severe and occur more frequently in children and the elderly.

Administration of the product (even at usual doses) may lead to the development of physical dependence. Discontinuation of treatment may lead to the development of withdrawal or rebound phenomena. Psychological dependence may occur. Cases of abuse have been reported.Reporting of side effects

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

5. Storage of Alprazolam Tarbis

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

Do not store above 25 ºC.

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

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 disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Alprazolam Tarbis 0.5 mg EFG tablets

• The active ingredient is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other ingredients (excipients) are: sodium docusate, sodium benzoate (E-211), pregelatinized potato starch, microcrystalline cellulose (E-460), lactose monohydrate, magnesium stearate (E-572), anhydrous colloidal silica, and erythrosine lake (E-127).

Appearance of the Product and Package Contents

It is presented in scored, pink, oblong tablets, engraved with "APZM 0.50" on one side. Each package (blister) contains 30 tablets.

Other Presentations:

Alprazolam Tarbis 0.25 mg EFG tablets, package with 30 tablets.

Alprazolam Tarbis 1 mg EFG tablets, package with 30 tablets.

Alprazolam Tarbis 2 mg EFG tablets, package with 30 and 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94,

08028 Barcelona

Manufacturer

Dragenopharm Apotheker Püschl GmbH Co. KG

Göllstrasse 1, 84529 Tittmoning

Germany

The last revision of this prospectus was inJanuary 2023

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