Alprazolam Pensa 0.50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprazolam pensa 0.50 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Alprazolam pensa is and what it is used for
2. What you need to know before taking Alprazolam pensa
3. How to take Alprazolam pensa
4. Possible side effects
5. How to store Alprazolam pensa
6. Contents of the pack and other information

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

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

Alprazolam pensa is used in adults to treat severe, disabling, or extremely distressing anxiety symptoms.

This medicine is intended for short-term use only.

2. What you need to know before taking Alprazolam pensa

Do not take Alprazolam pensa

• if you are allergic to the active substance, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from breathing difficulties, with or without sleep-related breathing disorders (sleep apnea)

if you have a disease called myasthenia gravis, which is characterized by muscle weakness

• if you have severe liver impairment

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam pensa

• If you have any lung, liver, or kidney problems.
• If you have felt or currently feel so depressed that you have had thoughts or ideas of suicide.
• With prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.
• There is a risk of developing addiction/dependence when using alprazolam.
• If during treatment you notice 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, mainly 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 someone else) and should never be recommended to others.
  • Do not increase the dose prescribed by your doctor, nor extend the treatment beyond the recommended duration.
  • Consult your doctor regularly so they can decide whether you should continue treatment.
  • Do not combine multiple benzodiazepines regardless of their indication.
• When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment with alprazolam may appear (rebound effect). To avoid this, it is recommended not to abruptly interrupt treatment, but to gradually reduce the dose according to your doctor's instructions (see section “If you stop taking Alprazolam pensa”).
• The use of alprazolam together with opioid-type medicines may cause profound sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggressiveness, delusions, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. 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 or alcohol use.

Other medicines and Alprazolam pensa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is extremely important because taking more than one medicine at the same time may increase or decrease their effects.

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

Central nervous system depressants, as they may enhance the sedative effect of alprazolam:

• major tranquilizers (antipsychotics)
• sleep-inducing agents (hypnotics)
• medicines used to treat depression
• medicines for the treatment of epilepsy (antiepileptics)
• narcotic analgesics and opioids (morphine derivatives), as they may increase feelings of euphoria, potentially increasing psychological dependence
• medicines used for the treatment of anxiety (anxiolytics/sedatives)
• anesthetics
• sedating antihistamines (medicines used to treat allergies)
• the concomitant use of alprazolam and opioids (strong analgesics, medicines for substitution therapy (treatment of opioid addiction), 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 together with opioids, the dose and duration of concomitant treatment must be limited by your doctor
• inform your doctor about all opioid medicines 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 mentioned above. Contact your doctor if you experience any of these symptoms.

Certain groups of medicines that act on the body (cytochrome P450 inhibitors) may interact with alprazolam and in some cases increase its activity. Some of the medicines that interact with alprazolam include:

• 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
• 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).

Taking Alprazolam pensa with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of alprazolam is not recommended during pregnancy or breastfeeding unless, in the doctor's judgment, the benefit outweighs the risk to the child.

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

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 administered 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 may affect this group of patients more than younger patients. If you belong to this group, your doctor may reduce the dose and monitor your response to treatment. Please follow their instructions carefully (see section “How to take Alprazolam pensa”).

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 do not function properly, consult your doctor, who may advise you to use a lower dose of alprazolam.

If you suffer from respiratory disorders, inform your doctor.

Driving and use of machines

Alprazolam pensa may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or decreased reaction ability. 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 enhanced if alcohol is consumed simultaneously.

Alprazolam pensa contains lactose, sodium, and yellow FDC No. 6 lake (E-110)

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

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

This medicine may cause allergic reactions as it contains yellow FDC No. 6 lake (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Alprazolam pensa

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

Dosage

The tablet or its fraction should be swallowed whole, without chewing, with a little liquid. Your doctor will prescribe the most suitable alprazolam formulation according to the dose you require.

The recommended 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 liver or kidney impairment, the initially recommended 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.

No individual dose should exceed the limits indicated, nor should the total daily dose, unless expressly instructed otherwise by your doctor.

Duration and discontinuation of treatment

The maximum treatment duration should not exceed 2–4 weeks. Long-term treatment is not recommended. If your doctor considers it necessary to extend treatment in your case, it will be done for limited periods, with frequent monitoring of your condition.

You must never stop treatment abruptly. Your doctor will determine the duration of treatment depending on the progression of your illness and will explain how you should gradually reduce the dose until treatment is completed.

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

If you take more Alprazolam pensa than you should

If you have taken more alprazolam than you should, 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 (drowsiness), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of prolonged and deep drowsiness), decreased muscle tone (hypotonia), lowered blood pressure, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare unless alprazolam is taken together with other drugs or alcohol.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at Tel. 91 562 04 20, indicating the product and the amount ingested.

If you forget to take Alprazolam pensa

Do not take a double dose to make up for missed doses. If the missed dose was recent, take it immediately; otherwise, wait until the next scheduled dose, without taking a double dose to compensate.

If you stop taking Alprazolam pensa

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

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of 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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The 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 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), 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):

• Memory loss (amnesia)
• Mental and behavioural disorders (mania), hallucinations, angry reactions, agitation, dependence
• 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 (a 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, 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
• 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, aggressiveness, 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 the elderly.
• Administration of the product (even at usual doses) may lead to the development of 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam pensa

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

Do not store above 30°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the mentioned month.

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

6. Contents of the pack and other information

Composition of Alprazolam pensa

• The active substance is alprazolam. Each tablet contains 0.50 mg of alprazolam.
• The other components (excipients) are lactose, microcrystalline cellulose (E-460i), sodium docusate, sodium benzoate, colloidal silicon dioxide (E-551), corn starch, magnesium stearate (E-572), FDC Yellow No. 6 lake (E-110).

Appearance of the product and contents of the pack

Alprazolam pensa 0.50 mg tablets are orange, scored tablets supplied in packs containing 30 tablets.

Other presentations

Alprazolam pensa 0.25 mg tablets: Pack containing 30 tablets.

Alprazolam pensa 1 mg tablets: Pack containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Date of the most recent revision of this leaflet: November 2022

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/