ALPRAZOLAM ALTER 0.50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alprazolam Alter 0.50 mg tablets EFG

Alprazolam

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Alprazolam Alter contains the active substance alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Alprazolam Alter 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 Alter

Do not take Alprazolam Alter

• if you are allergic to alprazolam, to benzodiazepines in general, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe respiratory failure or lung disease.
• if you have severe liver damage.
• if you have myasthenia gravis (a form of muscle weakness).
• if you have nocturnal awakenings due to interruption of breathing (sleep apnea syndrome).
• if you have glaucoma (increased eye pressure that can cause blindness).

Warnings and precautions

Talk to your doctor or pharmacist before taking Alprazolam Alter.

• if you have or have had any liver or kidney disease, or if you have chronic respiratory failure, inform your doctor.
• if you have depression or anxiety associated with depression, as alprazolam may increase any suicidal feelings you may have.
• if during treatment you notice symptoms of mania (state of overexcitement, feeling of euphoria, or hyperirritability) or hypomania (state of excitement and excessive activity).
• after continuous use of alprazolam, some loss of efficacy (tolerance) may be detected.
• if you notice any change in your personality, as alprazolam, and benzodiazepines in general, have been associated with rare reactions such as restlessness, agitation, irritability, aggression, confusion, rage, nightmares, hallucinations, psychosis, and inappropriate behavior. If this happens, you should consult your doctor immediately.

• When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment with Alprazolam Alter (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 the section "If you stop taking Alprazolam Alter").
• Taking alprazolam 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, rage, nightmares, hallucinations, psychosis, and inappropriate 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.

• There is a risk of developing addiction/dependence when using Alprazolam Alter.

The use of this medicine, and that of all benzodiazepines in general, can lead to dependence. This occurs mainly after uninterrupted use of the medicine for a prolonged period or when increasing the dose. To minimize these risks, you should take into account the following:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and never advise such use to other people.
• Never increase the dose prescribed by your doctor, nor prolong treatment for longer than recommended.
• Consult your doctor regularly so that he can decide whether to continue treatment.
• Using abusive drugs or alcohol can increase the risk of dependence.

Since you should never stop taking this medicine abruptly, but rather gradually, follow your doctor's instructions strictly for the end of treatment.

Children and adolescents (under 18 years old)

The efficacy and safety of use in children have not been established. Therefore, the use of Alprazolam Alter is not recommended in children and adolescents (under 18 years old).

Use in elderly patients (over 65 years old)

Alprazolam Alter 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 Alter").

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 work well, consult your doctor, who may advise you to use a lower dose of Alprazolam Alter.

If you have respiratory disorders, inform your doctor.

Taking Alprazolam Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Central nervous system depressants, as they may enhance the sedative effect of Alprazolam Alter

Alter:

• major tranquilizers (antipsychotics)
• sleep inducers (hypnotics)
• medicines used to treat depression
• medicines for the treatment of epilepsy (antiepileptics)
• narcotic analgesics and opioids (morphine derivatives) because they can increase the feeling of euphoria, which can lead to increased psychological dependence
• medicines for the treatment of anxiety (anxiolytics/sedatives)
• anesthetics
• sedating antihistamines (medicines for treating allergies)
• however, if your doctor prescribes Alprazolam Alter 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 follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members so they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

• There are groups of drugs that, due to their action in the body (cytochrome P450 inhibitors), can increase the activity of Alprazolam Alter, such as:
• medicines for treating fungal infections, such as ketoconazole, itraconazole, posaconazole, or voriconazole
• 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
• protease inhibitors for treating HIV infections, such as ritonavir
• digoxin (medicine used to suppress or prevent heart rhythm disorders).

If you need to undergo surgery that requires general anesthesia, inform your doctor that you are taking Alprazolam Alter.

Taking Alprazolam Alter with food, drinks, and alcohol

During treatment, avoid taking alcoholic beverages. The effect of alcohol can enhance sedation, and this can affect your alertness (see also the 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 Alter is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefit outweighs the risk to the child.

If you take alprazolam regularly during the last 3 months of pregnancy, your baby may develop dependence on alprazolam and be at risk of experiencing withdrawal symptoms after birth.

If, by medical decision, alprazolam is administered at the end of pregnancy or during delivery, effects on the newborn may appear, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Benzodiazepines pass into breast milk, so their use is not recommended in women during breastfeeding.

Driving and using machines

This medicine can cause drowsiness, sedation, difficulty concentrating, and decreased reflexes, which can be enhanced if you consume alcohol at the same time. Therefore, do not drive or use potentially hazardous machinery until you have checked how you tolerate the medicine.

Alprazolam Alter contains orange yellow S (E110)

This medicine can cause allergic reactions because it contains orange yellow S. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Alprazolam Alter contains lactose

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

Alprazolam Alter sodium

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

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

3. How to take Alprazolam Alter

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dosage

Alprazolam Alter tablets should be swallowed without chewing, with the help of a sufficient amount of liquid (e.g., a glass of water). The score line on the tablet can help you break it if you find it difficult to swallow whole. If they are to be taken once a day, it is preferable to take the dose in the morning.

Your doctor will prescribe the most suitable presentation of Alprazolam Alter, 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 failure, liver or kidney damage, 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, which can be gradually increased if necessary and well tolerated.

Each individual dose should not exceed the indicated limits, nor should the total daily dose, unless your doctor explicitly indicates otherwise.

Duration and suppression 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 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 Alter than you should

If you have taken more alprazolam than you should, talk to 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 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 medicine and the amount ingested.

If you forget to take Alprazolam Alter

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 Alter

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Alprazolam Alter can cause adverse effects, although not all people suffer from them.

The following are the adverse effects produced during treatment with

alprazolam:

• Very frequent adverse effects (may affect more than 1 in 10 patients)
  • Depression.
  • Sedation, somnolence, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
  • Constipation, dry mouth.
  • Fatigue, irritability

• Frequent adverse effects (may affect between 1 and 10 in 100 patients)
  • Feeling of confusion, disorientation, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
  • Abnormal coordination, balance alteration, difficulty concentrating, excessive sleepiness (hypersomnia), state of deep and prolonged drowsiness (lethargy), tremor.
  • Nausea, decreased appetite.
  • Blurred vision.
  • Dermatitis.
  • Sexual dysfunction.
  • Weight changes.

• Infrequent adverse effects (may affect between 1 and 10 in 1,000 patients)
  • Mental and behavioral disorders (mania), hallucinations, anger reactions, agitation, dependence.
  • Memory loss (amnesia).
  • Muscle weakness.
  • Inability to retain urine in the bladder (urinary incontinence).
  • Irregular menstruation.
  • Withdrawal symptoms.

• Unknown frequency (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), aggressiveness, 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 in the bladder.
  • Elevated intraocular pressure.

With the use of benzodiazepines, the following may appear:

• Somnolence, 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 beginning of treatment and usually disappear with continued administration. Gastrointestinal alterations, 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, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral alterations 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. Interruption of treatment may lead to the development of withdrawal or rebound phenomena. Psychic 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 an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Alprazolam Alter

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Alprazolam Alter 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 thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Alprazolam Alter 0.50 mg tablets

The active ingredient is alprazolam. Each tablet contains 0.50 mg of alprazolam.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (Type A), magnesium stearate, quinoline yellow (E104), and orange yellow S (E110).

Appearance of the Product and Package Contents

Round, scored, and orange-colored tablets. The score line is to facilitate breaking and swallowing, but not to divide into exactly equal doses. Packaging with 30 tablets.

Marketing Authorization Holder and Manufacturer

Holder

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036- Madrid

Spain

Manufacturer

LACER, S.A.

C/. Boters, 5 -Parc Tecnològic del Vallès-

08290 Cerdanyola del Vallès (Barcelona, Spain)

This prospectus was approved in June 2022

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