ALPRAZOLAM TARBIS 0.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam Tarbis 0.25 mg Tablets EFG

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What Alprazolam Tarbis is and what it is used for.
2. What you need to know before taking Alprazolam Tarbis.
3. How to take Alprazolam Tarbis.
4. Possible side effects.
5. Storage of Alprazolam Tarbis.
6. Package Contents and Additional Information

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

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

This medicine is used in adults for the treatment of symptoms of anxiety that are severe, disabling, or cause significant distress to the patient. This medicine is for short-term use only.

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 medicine (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 continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.
• There is a risk of developing addiction/dependence when using this medicine.
• 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 medicine 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 medicine (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-type 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 medicines

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

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

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

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medicines used to treat depression.
• Medicines 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.
• Medicines used for the treatment of anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (medicines for treating allergies).
• The concomitant use of Alprazolam Tarbis and opioids (potent analgesics, medications for substitution therapy (treatment of opioid addiction), and some cough medications) 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 should be limited by your doctor.
• Tell your doctor about all opioid medications you are taking and closely follow the dosage recommendation of your doctor. 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 medicines 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 medicines that may interact with Alprazolam Tarbis are:

• Medicines 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.
• Medicines used to treat AIDS, such as ritonavir, etc.

Digoxin (medicine 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 medicine.

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

If, by medical decision, this medicine is administered during late pregnancy or during labor, 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 for 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, which 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, 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 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 them before taking this medicine.

Alprazolam contains sodium benzoate

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

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

3. How to take Alprazolam Tarbis

Follow your doctor's instructions for taking this medicine exactly. In case of 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 daily amount of alprazolam being 0.5 mg to 0.75 mg in divided doses, and it 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 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, it will be for limited periods, and they 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 explain how to gradually reduce the dose until the end of treatment.

If you think the effect of this medicine 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, taking this package leaflet with you.

Overdose with benzodiazepines is generally characterized by various degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (drowsiness), speech disorders (dysarthria), coordination disorders, confusion, lethargy (state of deep and prolonged sleep), 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 medicine 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 compensate.

If you stop taking Alprazolam

Treatment with alprazolam can 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 generally 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 sleep (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 bluntness), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the start of treatment and generally disappear with continued administration. Gastrointestinal disorders, 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 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.

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. 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 Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 expiry date stated on the packaging after Exp. The expiry 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 pharmacy's SIGRE Point. 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 0.25 mg EFG tablets

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components (excipients) are: sodium docusate, sodium benzoate (E-211), pregelatinized starch (from potato), microcrystalline cellulose (E-460), lactose monohydrate, magnesium stearate (E-572), and anhydrous colloidal silica.

Appearance of the Product and Package Contents

It is presented in scored white tablets, oblong, engraved with "APZM 0.25" on one side. Each package (blister) contains 30 tablets.

Other Presentations:

Alprazolam Tarbis 0.5 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 on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/