Alprazolam Alter 0.50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprazolam Alter 0.50 mg tablets EFG

Alprazolam

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 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, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Alprazolam Alter is and what it is 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 anxiety symptoms that are severe, disabling, or causing significant distress to the patient. This medicine is intended 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 insufficiency or lung diseases.
• if you have severe liver disorders.
• if you have myasthenia gravis (a form of muscle weakness).
• if you experience nighttime awakenings due to interrupted breathing (sleep apnea syndrome).
• if you have glaucoma (increased intraocular pressure that may lead to blindness).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Alter.

• if you have or have had liver or kidney disease, or suffer from chronic respiratory insufficiency, inform your doctor.

• if you have depression or anxiety associated with depression, as alprazolam may increase any suicidal thoughts you may have.

• 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).

• after prolonged use of alprazolam, a certain loss of effectiveness (tolerance) may occur.

• if you notice any changes in your personality, as alprazolam and benzodiazepines in general have been associated with rare reactions such as restlessness, agitation, irritability, aggressiveness, confusion, rage attacks, nightmares, hallucinations, psychosis, and inappropriate behavior. If this occurs, you must consult your doctor immediately.

• When stopping treatment with alprazolam, symptoms similar to those that led you to start treatment with Alprazolam Alter may appear (rebound effect). To avoid this, it is recommended not to interrupt treatment abruptly, but to gradually reduce the dose according to your doctor's instructions (see section “If you stop taking Alprazolam Alter”).

• The use of alprazolam together with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.

• Benzodiazepines may cause memory loss and reactions such as: anxiety, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, treatment should be discontinued and you should consult your doctor.

• It is very important that you inform your doctor if you have a history of drug or alcohol use.

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

The use of this medicine, and of benzodiazepines in general, may lead to dependence. This occurs mainly after uninterrupted use of the medicine for a prolonged period or when the dose is increased. To minimize these risks, consider the following:

• Benzodiazepines should only be taken under medical prescription (never because they worked for other patients), and you should never recommend them to others.
• You must never increase the dose prescribed by your doctor or extend treatment beyond the recommended duration.
• You should consult your doctor regularly so they can decide whether treatment should continue.
• The use of drugs of abuse or alcohol may increase the risk of dependence.

Since administration of this medicine should never be stopped abruptly but gradually tapered, strictly follow your doctor's instructions for ending treatment.

Children and adolescents (under 18 years of age)

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 of age).

Use in elderly patients (over 65 years of age)

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 monitor your response to treatment. Please follow their instructions carefully (see 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, 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 Alter.

If you suffer from respiratory disorders, inform your doctor.

Taking Alprazolam Alter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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:

  • 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 for the treatment of anxiety (anxiolytics/sedatives)
  • anesthetics
  • sedating antihistamines (medicines for treating allergies)
  • however, if your doctor prescribes Alprazolam Alter 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 the 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.

• There are groups of drugs that, due to their action in the body (cytochrome P450 inhibitors), may increase the activity of Alprazolam Alter, such as:

  • antifungal medicines for 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 (a medicine used to suppress or prevent heart rhythm disturbances).

If you are scheduled for surgery requiring general anesthesia, inform your doctor that you are taking Alprazolam Alter.

Taking Alprazolam Alter with food, drinks, and alcohol

During treatment, avoid consuming alcoholic beverages. The effect of alcohol may enhance sedation, which could affect your level of alertness (see also the 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.

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

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

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

Benzodiazepines pass into breast milk; therefore, their use is not recommended in women who are breastfeeding.

Driving and use of machines

This medicine may cause drowsiness, sedation, difficulty concentrating, and reduced reflexes, which may be intensified if alcohol is consumed at the same time. Therefore, do not drive or operate potentially dangerous machinery until you know how you react to this medicine.

Alprazolam Alter contains sunset yellow FCF (E110)

This medicine may cause allergic reactions because it contains sunset yellow FCF. It may 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 certain sugars, consult with them before taking this medicine.

Alprazolam Alter sodium content

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

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

3. How to take Alprazolam Alter

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

Dosing

Alprazolam Alter tablets should be swallowed whole with sufficient liquid (for example, a glass of water). The tablet score may help you break the tablet if you find it difficult to swallow whole. If a single daily dose is prescribed, it is preferable to take the dose in the morning.

Your doctor will prescribe the most appropriate Alprazolam Alter formulation based on the dose you require.

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 and the total daily dose should not exceed the limits indicated, unless your doctor specifically instructs 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 extend treatment in your case, it will be done in 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 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 Alter 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 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 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 telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Alprazolam Alter

Do not take a double dose to make up for a missed dose. If you remember the missed dose soon after, take it immediately; otherwise, wait until your next scheduled dose, without taking a double dose to compensate.

If you stop taking Alprazolam Alter

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

Withdrawal symptoms may include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, sensitivity to light, sound, and physical touch, tingling sensations 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 Alter can produce adverse effects, although not everyone will experience them.

The adverse effects observed during treatment with alprazolam are listed below:

• Very common adverse effects (may affect more than 1 in 10 patients)

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

• Common adverse effects (may affect between 1 and 10 in 100 patients)

  • 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 between 1 and 10 in 1,000 patients)

  • Mental and behavioral 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 unknown (cannot be estimated from available data)

  • Increased levels of prolactin 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 abnormalities, yellowing of the skin and whites of the eyes (jaundice).
  • Peripheral edema.
  • Angioedema (swelling beneath 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, reduced responsiveness 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 behaviors.
• The use of benzodiazepines may unmask an underlying depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disturbances may occur. These reactions can be severe and are more frequent 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 also 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 they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alprazolam Alter

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

No special storage conditions are required.

Do not use Alprazolam Alter after the expiry date stated on the container following “Exp”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprazolam Alter 0.50 mg tablets

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

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, corn starch, talc, sodium carboxymethyl starch (Type A), magnesium stearate, quinoline yellow (E104) and sunset yellow FCF (E110).

Appearance of the product and contents of the pack

Orange, circular, scored tablets. The score line is intended to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses. Pack containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 leaflet was approved in June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/