ALPRAZOLAM PENSA 0.50 mg TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Alprazolam pensa and what is it used for
2. What you need to know before you take Alprazolam pensa
3. How to take Alprazolam pensa
4. Possible side effects
5. Storage of Alprazolam pensa
6. Pack contents and further information

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

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

Alprazolam pensa is used in adults for the treatment of symptoms of anxiety that are severe, disabling or causing the patient great distress.

This medicine is for short-term use only.

2. What you need to know before you take 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 have breathing difficulties related or not to sleep (sleep apnea)

if you have a disease called myasthenia gravischaracterized by muscle weakness

• if you have severe liver disorders

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 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 alprazolam.
• 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
• • Benzodiazepines will only be taken under medical prescription (never because they have worked for 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
  • 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 pensa").
• Taking alprazolam with medicines of the opioid type 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 happens, 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.

Other medicines and Alprazolam pensa

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

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

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

• 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 to treat anxiety (anxiolytics/sedatives)
• anesthetics
• sedating antihistamines (medicines for treating allergies)
• concomitant use of alprazolam and opioids (potent analgesics, substitution therapy medicines (treatment of opioid addiction) 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 with opioids, the dose and duration of concomitant treatment must be limited by your doctor
• tell your doctor about all opioid medicines 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 medicines that, due to their action in the body (cytochrome P450 inhibitors), may interact with alprazolam and in some cases increase its activity. Some of the medicines that interact with alprazolam 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
• 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).

Taking Alprazolam pensa 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Alprazolam is not recommended during pregnancy or breastfeeding unless, in the doctor's opinion, the benefits outweigh the risks to the baby.

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.

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 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 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 pensa").

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 groups of patients

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 pensa 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 alcohol is consumed at the same time

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

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

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

This medicine may cause allergic reactions because it contains yellow FDC color no. 6 lake (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Alprazolam pensa

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 recommended 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, being the amount of alprazolam ingested per day 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 discontinuation 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 will closely monitor your situation.

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 reduce 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 pensa than you should

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

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 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 medicines or alcohol.

In case of overdose or accidental ingestion, consult the Toxicology Information Service 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 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 pensa

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 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that may appear 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, alteration of 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):

• Memory loss (amnesia)
• Mental and behavioral disorders (mania), hallucinations, fits of rage, agitation, dependence
• Muscle weakness
• Urinary incontinence
• Irregular menstruation
• Withdrawal symptoms

Frequency not known (cannot be estimated from the 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, liver function alteration, 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 that may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask a pre-existing depression.
• The use of benzodiazepines or similar compounds may cause reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disorders. 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam pensa

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date shown 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 medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Alprazolam pensa

• The active ingredient 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), and yellow FDC No. 6 lake (E-110)

Appearance of the product and package contents

Alprazolam pensa 0.50 mg tablets are presented in the form of orange, scored tablets in packages containing 30 tablets.

Other presentations

Alprazolam pensa 0.25 mg tablets: Package containing 30 tablets.

Alprazolam pensa 1 mg tablets: Package 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 last revision of this prospectus:November 2022

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