Alprazolam Tarbis 2 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alprazolam Tarbis 2 mg Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, 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 effects not listed in this leaflet.

Leaflet Contents:

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. How to store Alprazolam Tarbis.
6. Contents of the pack and other 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 anxiety symptoms that are severe, disabling, or causing significant distress to the patient. This medicine is intended only for short-term use.

2. What you need to know before taking Alprazolam Tarbis

Do not take Alprazolam

• If you are allergic to alprazolam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6)
• if you have breathing difficulties, with or without sleep-related breathing disorders (sleep apnea)
• if you have a disease called myasthenia gravis, characterized by muscle weakness
• if you have severe liver impairment

Warnings and precautions

• Consult your doctor or pharmacist before starting to take alprazolam if:
  • You have any lung, kidney, or liver problems.
  • You have felt or currently feel so depressed that you have had thoughts or ideas about suicide.
  • After prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.
  • There is a risk of developing addiction/dependence when using this medicine.
  • If during treatment you experience symptoms of mania (a state of overexcitement, feelings of euphoria, or hyperirritability) or hypomania (a state of exaggerated excitement and activity).
  • Treatment with benzodiazepines, including alprazolam, may lead to dependence, particularly after long-term, uninterrupted use.

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

• • Benzodiazepines should only be taken under medical prescription (never because they worked for other patients), and you should never recommend them to others.
  • Do not increase the doses prescribed by your doctor or extend the treatment beyond the recommended duration.
  • Consult your doctor regularly so they can decide whether you should continue treatment.
  • Do not combine different benzodiazepines, regardless of their indication.
• When stopping treatment with alprazolam, symptoms similar to those that led to starting the treatment (rebound effects) may occur. 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 stop taking Alprazolam”).
• The use of alprazolam together with opioid-type medications may cause profound sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, you must stop treatment and consult your doctor.
• It is very important that you inform your doctor if you have a history of drug or alcohol use.

Taking Alprazolam with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other 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 enhance the sedative effect of Alprazolam Tarbis:

• Major tranquilizers (antipsychotics).

• Sleep-inducing agents (hypnotics).

• Medicines used to treat depression.

• Medicines used for epilepsy treatment (antiepileptics).

• Narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence.

• Medicines used for anxiety treatment (anxiolytics/sedatives).

• Anesthetics.

• Sedating antihistamines (medicines used to treat allergies).

• The concomitant use of Alprazolam Tarbis and opioids (strong analgesics, medications for substitution therapy (opioid addiction treatment), and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.

• However, if your doctor prescribes Alprazolam Tarbis together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.

• Inform your doctor about all opioid medications you are taking and closely follow your doctor’s dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

• Certain groups of medicines that affect 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 include:

• Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Concurrent use with Alprazolam Tarbis is not recommended.

• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.

• Gastric protectants such as cimetidine.

• Dextropropoxyphene (narcotic analgesic).

• Oral contraceptives.

• Diltiazem (antihypertensive).

• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.

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

Digoxin (a medicine used to suppress or prevent heart rhythm disturbances).

Alprazolam with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which can affect your level of alertness (see section “Driving and use of machines”).

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.

This medicine is not recommended during pregnancy or breastfeeding, unless, in the doctor’s judgment, the benefit outweighs the risk to the child.

If, on the doctor’s advice, this medicine is administered during late pregnancy or during childbirth, effects on the newborn such as lowered body temperature (hypothermia), reduced muscle tone (hypotonia), and moderate respiratory depression may occur.

Infants born to mothers who chronically take benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a postnatal withdrawal syndrome.

Use in children and adolescents (under 18 years of age)

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

Use in elderly patients (over 65 years of age)

Alprazolam Tarbis may have a stronger effect in this group of patients than in younger patients. If you belong to this group, your doctor may reduce your dose and monitor your response to treatment. Please follow their instructions carefully (see 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 may lead to falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys are not functioning 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 use of machines

Alprazolam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or impair your reaction capacity. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects. These effects may be intensified if alcohol is consumed simultaneously.

Alprazolam contains lactose

If your doctor has informed 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) in each 0.25 mg tablet.

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

3. How to take Alprazolam Tarbis

Follow exactly the dosing instructions for this medicine as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosing:

The tablet or its portion should be swallowed whole, with a little liquid. Your doctor will prescribe the most suitable alprazolam formulation according to your required dose.

The usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg of alprazolam three times daily.
• 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, or those with chronic respiratory insufficiency, or with liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times daily, resulting in a total daily alprazolam intake of 0.5 mg to 0.75 mg in divided doses. This dose may be gradually increased if necessary and well tolerated.

Each individual dose must not exceed the recommended limits, nor should the total daily dose, unless specifically instructed otherwise by your doctor.

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 extend the treatment in your case, it will be done for limited periods, and your condition will be monitored frequently.

You must never stop treatment abruptly. Your doctor will determine the treatment duration based on your condition's progression and will explain how to gradually reduce the dose until treatment is discontinued.

If you feel that 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 prescribed, contact your doctor or pharmacist immediately, or go to the nearest hospital, taking this leaflet with you.

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (sedation), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of prolonged and deep drowsiness), decreased muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death. Serious outcomes are uncommon unless alprazolam is taken together with other drugs or alcohol.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 a missed dose. If you remember the missed dose soon after the scheduled time, take it immediately. Otherwise, wait until your next scheduled dose and do not take a double dose to compensate.

If you stop Alprazolam treatment

Treatment with alprazolam may lead to dependence; therefore, abruptly stopping alprazolam may cause withdrawal symptoms.

Possible withdrawal symptoms include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general discomfort (dysphoria), insomnia, intolerance to light, sound, and physical contact, tingling and cramps in the limbs and abdomen, vomiting, sweating, tremor, depersonalization, hallucinations, and seizures. If this occurs, you should consult your doctor immediately.

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

4. Possible adverse effects

Like all medicines, Alprazolam Tarbis can have adverse effects, although not everyone experiences them.

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

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

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

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

• Confusion, disorientation, altered sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, impaired balance, difficulty concentrating, excessive sleepiness (hypersomnia), state of prolonged and profound drowsiness (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

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

• Mental and behavioural disorders (mania), hallucinations, anger reactions, agitation, dependence.
• Memory loss (amnesia).
• Loss of muscle strength.
• 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 behavioural 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 oedema.
• Angioedema (swelling under the skin).
• 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 response 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 disturbances, changes in sexual desire, or skin reactions may occasionally occur.
• Memory loss (amnesia) may develop, which may be associated with inappropriate behaviours.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other behavioural disturbances may occur. These reactions can be severe and occur more frequently in children and elderly patients.

Administration of the product (even at usual doses) may lead to physical dependence. Discontinuation of treatment may lead to withdrawal or rebound phenomena. Psychological 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Tarbis

Keep this medicine out of sight and reach of children.

Do not store above 25 °C.

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

Do not use this medicine after the expiry date stated on the container after Exp. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Alprazolam Tarbis 2 mg tablets EFG

• The active substance is alprazolam. Each tablet contains 2 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 colloidal anhydrous silica.

Appearance of the product and contents of the container

It is presented as white, oval, scored tablets, marked with “APZM 2” on one side. Each pack (blister) contains 30 or 50 tablets.

Other presentations:

Alprazolam Tarbis 0.25 mg tablets EFG, pack containing 30 tablets.

Alprazolam Tarbis 0.5 mg tablets EFG, pack containing 30 tablets.

Alprazolam Tarbis 1 mg tablets EFG, pack containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94,

08028 Barcelona, Spain

Manufacturer

Dragenopharm Apotheker Püschl GmbH Co. KG

Göllstrasse 1, 84529 Tittmoning

Germany

The last revision of this leaflet was in January 2023

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