Label: information for theuser

Alprazolam Viatris 2 mg tablets EFG

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6.Contents of the package and additionalinformation

Alprazolam Viatriscontains the active ingredient alprazolam.It belongsto agroupof medicines called benzodiazepines (anxiolytic medicines).

Alprazolam Viatrisis usedinadults forthe treatment ofthe symptoms ofanxietythat are severe, debilitating or cause greatanxietyto the patient. This medicine is only for short-term use.

Do not take Alprazolam Viatris:

• If you are allergic to alprazolam, benzodiazepines, or any of the other components of this medication (listed in section 6).
• If you have respiratory difficulties related or unrelated to sleep (sleep apnea).
• If you have a condition called myasthenia gravis, characterized by muscle weakness.
• If you have severe liver damage.

Warnings and precautions

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

- If you have any lung, kidney, or liver problems.

- If you have felt, or feel, so depressed that you have had thoughts or ideas of suicide.

To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines may cause memory loss and reactions, such as: restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, discontinue treatment and consult your doctor.

• It is very important to inform your doctor if you have a history of drug and alcohol consumption.

Other medications and Alprazolam Viatris

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

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

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

• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Depression medications.
• Antiepileptic medications.
• Narcotic analgesics and opioids (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Anxiety medications (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (allergy medications).
• The concomitant use of alprazolam and opioids [potent analgesics, addiction treatment medications (opioid substitution therapy), and some cough medications] increases the risk of sedation, respiratory depression, coma, and may be potentially fatal. Therefore, 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 should be limited by your doctor.

Inform your doctor about all opioid medications you are taking and follow your doctor's dosage recommendation closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• There are some groups of medications that, due to their action in the body (inhibitors of cytochrome P450), may interact with alprazolam and, in some cases, increase its activity. Some of the medications that may interact with alprazolam are:

• Medications 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 (anti-hypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat HIV/AIDS such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm alterations).

Alprazolam Viatris with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your alertness (see section “Driving and operating machines”).

Pregnancy,breastfeeding,and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

If, by the doctor's decision, alprazolam is administered during a late stage of pregnancy or during delivery, the following effects may occur in the newborn: decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which may trigger withdrawal syndrome in the postnatal period.

Children and adolescents

Alprazolam is not recommended for children and adolescents under 18 years old. Benzodiazepines should not be administered to children, unless strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam in children under 18 years old have not been established.

Use in elderly patients (65 years and older)

Alprazolam may affect this group of patients more than young patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow your doctor's 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 muscle weakness, which may cause falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys do not function well, consult your doctor, who may advise you to use a lower dose of alprazolam.

If you have respiratory problems, inform your doctor.

Driving and operating machines

Alprazolam may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when increasing the dose. Do not drive or operate machines if you experience any of these effects.These effects may be potentiated if you consume alcohol 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 them before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

The tablet or its part will be ingested without chewing, with the help of a little liquid.Your doctor will prescribe the Alprazolam Viatris presentation most suitable for you, according to the dose you need.

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 3 or 4 doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with a daily alprazolam intake of 0.5 mg to 0.75 mg in divided doses, which can be gradually increased as needed and well tolerated.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor indicates otherwise.

Duration and discontinuation of treatment:

The maximum duration of treatment should not exceed 2-4 weeks.No long-term treatment is recommended. If your doctor considers it necessary to prolong the treatment in your case, they will do so for limited periods and will frequently monitor your situation.

Never interrupt 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 you finish treatment.

If you estimate that alprazolam's action 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 you should, consult your doctor or pharmacist immediately or go to the nearest hospital with this leaflet.

Benzodiazepine overdose typically manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (prolonged and deep sleep), muscle tone decrease (hypotonia), blood pressure drop, 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Alprazolam Viatris

Do not take a double dose to compensate for the missed doses.If the missed dose is recent, take your dose immediately, and if not, wait for the next dose without taking a double dose to compensate.

If you interrupt treatment with Alprazolam Viatris

Alprazolam treatment can cause dependence, so when interrupting alprazolam administration abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discontent (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures.Immediately consult your doctor if this occurs.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur during treatment with alprazolam predominantly occur at the beginning 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.
• Drowsiness, drowsiness, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

Common side effects (may affect up to 1 in 10 people):

• Sensation of confusion, disorientation, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleep (hypersomnia), deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

Rare side effects (may affect up to 1 in 100 people):

• 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.

Unknown frequency (cannot be estimated from available data):

• Increased levels of prolactin in 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 white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's surface).
• Phototoxicity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Drowsiness, lack of reaction to emotional stimuli (emotional numbing), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal alterations, changes in sexual desire, or skin reactions may occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations may occur. 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAlprazolamViatris

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

Appearance of the product and contents of the packaging

AlprazolamViatris is presented in the form of tablets.The tablets are white, circular, scored in a cross.

The score is only for breaking the tablet if it is difficult to swallow whole.

It is available in blisters of 30 and 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for Manufacturing

LACER, S.A.

C/ Boters, 5, Parc Tecnològic del Vallès

08290 - Cerdanyola del Vallès (Barcelona)

Spain

Last review date of this leaflet:March 2022

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