Alprazolam Viatris 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alprazolam Viatris 2 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

Alprazolam Viatris is used in adults for the treatment of severe, disabling, or distressing anxiety symptoms. This medicine is intended only for short-term use.

2. What you need to know before taking Alprazolam Viatris

Do not take Alprazolam Viatris:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Alprazolam Viatris.

• If you have any lung, kidney, or liver problems.
• If 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 alprazolam.
  • 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 someone else), and you should never recommend them to others.

• Do not increase the dose 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 multiple benzodiazepines, regardless of their intended use.

• 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 Viatris”).

• The use of alprazolam together with opioid medicines may cause profound sedation, respiratory depression, coma, and death.

• Benzodiazepines may cause memory loss and reactions such as: restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If any of these occur, 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 Viatris

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

Alprazolam may interact with other medicines. Inform your doctor or pharmacist 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 medicines (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 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. Because of this, 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 should 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 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 and, in some cases, increase its activity. Some of the medicines that may interact with alprazolam include:

• Medicines used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. Taking them together with alprazolam is not recommended.

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

• Gastric protectants such as cimetidine.

• Dextropropoxyphene (a narcotic analgesic).

• Oral contraceptives.

• Diltiazem (an 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 Viatris with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 have chronically taken benzodiazepines during the last stage of pregnancy may develop physical dependence, potentially leading to a withdrawal syndrome in the postnatal period.

Children and adolescents

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 may have a greater 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 Viatris”).

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.

If you have respiratory disorders, inform your doctor.

Driving and using machines

Alprazolam 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 at the same time.

Alprazolam Viatris contains lactose and sodium

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

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

3. How to take Alprazolam Viatris

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosing:

The tablet or part thereof should be swallowed whole with a little liquid. Your doctor will prescribe the most appropriate formulation of Alprazolam Viatris according to 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 3 or 4 doses.

In elderly patients, or those with chronic respiratory insufficiency, or with 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.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless expressly 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 treatment in your case, it will be done only for limited periods, with frequent monitoring of your condition.

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

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

If you take more Alprazolam Viatris 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 disturbances (dysarthria), coordination disturbances, confusion, lethargy (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 name of the medicine and the amount ingested.

If you forget to take Alprazolam Viatris

Do not take a double dose to make up for a missed dose. If you remember the missed dose soon after it was due, take it immediately. Otherwise, wait until the next scheduled dose and do not take a double dose to compensate.

If you stop taking Alprazolam Viatris

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

Withdrawal symptoms that may occur include: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discomfort (dysphoria), insomnia, sensitivity to light, sound, and physical contact, tingling sensations and cramps in the limbs and abdomen, vomiting, sweating, tremor, depersonalization, hallucinations, and seizures. If this occurs, you should contact 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, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects that may occur during treatment with alprazolam occur predominantly 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, alteration of 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, angry 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 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, 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 behaviour.
• 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 may be severe and occur more frequently in children and elderly individuals.
• 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 Viatris

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to 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 you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alprazolam Viatris

• The active substance is alprazolam. Each tablet contains 2 mg of alprazolam.
• The other components are: monohydrate lactose, microcrystalline cellulose (E-460), corn starch, talc (E-553b), sodium carboxymethylstarch (potato starch), magnesium stearate (E-470b).

Appearance of the product and contents of the pack

Alprazolam Viatris is presented as tablets. The tablets are white, circular, and cross-scored.

The score line is provided only to facilitate breaking the tablet if you have difficulty swallowing it whole.

It is available in blisters of 30 and 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

LACER, S.A.

C/ Boters, 5, Parc Tecnològic del Vallès

08290 - Cerdanyola del Vallès (Barcelona)

Spain

Date of the most recent review of this leaflet: March 2022

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