ALPRAZOLAM VIATRIS 0.5 mg TABLETS

Introduction

Package Leaflet: Information for thepatient

Alprazolam Viatris 0.5 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The tablets contain alprazolam, which belongs to a group of medicines called benzodiazepines.

It is believed that alprazolam may increase the action of a natural substance called GABA in the brain. Alprazolam is used for the short-term treatment of severe anxiety disorder.

Alprazolam should only be used for a short period, as it can cause dependence.

2. What you need to know before you take Alprazolam Viatris

Do not takeAlprazolam Viatris:

• If you are allergic to alprazolam or any of the other ingredients of this medicine (listed in section 6).
• If you have a disease called myasthenia gravis, which is characterized by muscle weakness.
• If you have severe breathing difficulties or lung disease.
• If you have sleep apnea (irregular breathing while sleeping).
• If you have severe liver disorders.
• If you have a history of alcohol or drug abuse.
• If you are taking other medicines that have a known effect on the central nervous system (such as benzodiazepines, neuroleptics).
• If you have glaucoma.

Warnings and precautions

Consult your doctor or pharmacist before taking Alprazolam Viatris:

• If you have long-term lung problems, mild or moderate liver or kidney problems.
• If you have depression or anxiety associated with depression, as alprazolam may increase any suicidal feelings you may have.
• If you are taking any other medicine for anxiety or insomnia.
• If you have a history of alcohol or drug abuse, or if you find it difficult to stop taking medicines, drinking, or using drugs. Your doctor can help you stop taking this medicine.
• If you have personality disorders.
• If you are an elderly patient, as alprazolam may cause drowsiness or muscle weakness, which can lead to falls, often with serious consequences in this population.

You may experience temporary memory loss while taking this medicine. To reduce the risk, you should try to sleep for a full night (7-8 hours) while taking this medicine.

Alprazolam has been associated with rare reactions such as restlessness, agitation, irritability, aggression, confusion, rage, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (loss of contact with reality), and inappropriate behavior. If you notice any of these changes in your behavior while taking this medicine, please contact your doctor, as you should stop treatment.

Children and adolescents

Alprazolam is not recommended for children and adolescents under 18 years of age.

Other medicines and Alprazolam Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. It is especially important that you tell your doctor if you are taking any of the following medicines:

• Antipsychotics (medicines used to treat mental problems) such as haloperidol and chlorpromazine, hypnotics (medicines used to induce sleep) such as phenobarbital and zolpidem, sedatives (medicines used to treat anxiety) such as diazepam and lorazepam, narcotic analgesics (pain relief medicines) such as propoxyphene, antitussives (cough medicines) such as dextromethorphan and codeine, medicines such as methadone (which may be used for pain relief or as an aid to opioid addiction), anesthetics (medicines used in anesthesia) such as halothane and bupivacaine, or some antidepressants, as these may also increase the effects of alprazolam.
• Clozapine (a medicine used to treat mental illnesses such as schizophrenia). This medicine may increase the amount of alprazolam in the blood.
• Medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs), used to treat depression (such as fluoxetine and sertraline).
• Medicines for treating epilepsy (such as phenytoin and carbamazepine).
• Medicines for allergies (antihistamines such as cetirizine and cyclizine).
• Medicines for treating fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, and other azole derivatives).
• Cimetidine (for treating stomach ulcers), nefazodone (for treating depression), or fluvoxamine (for treating Obsessive-Compulsive Disorder, OCD), as your dose of alprazolam may need to be adjusted.
• Imipramine or desipramine, medicines known as tricyclic antidepressants (TCAs), used to treat depression, as the dose of these medicines may need to be adjusted.
• Oral contraceptives (the "pill").
• Diltiazem (used to treat angina and high blood pressure).
• Certain antibiotics (such as erythromycin, clarithromycin, telithromycin, troleandomycin, and rifampicin).
• Medicines known as Protease Inhibitors used to treat HIV (such as ritonavir).
• Digoxin (a medicine used to treat heart conditions). You may be at risk of digoxin toxicity (signs of toxicity are: irregular heartbeats, confusion, delirium, vision disturbances, headache, abdominal pain, nausea, and vomiting) while taking digoxin with this medicine.

Taking this medicine with opioids (strong pain relief medicines, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Deaths have been reported. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Alprazolam Viatris tablets with opioids, the doctor should limit the dose and duration of concomitant treatment.

Tell your doctor about all opioids you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform your friends or family to be aware of the signs and symptoms described above. Contact your doctor if you experience these symptoms.

If you are going to have an operation where you will be given general anesthesia, tell your doctor that you are taking alprazolam.

TakingAlprazolam Viatriswith drinks and alcohol

Do not drink alcohol while taking alprazolam, as alcohol increases the effects of this medicine and should be avoided. Do not drink excessively large amounts of grapefruit juice while taking this medicine, as it may increase the amount of alprazolam in the blood.

Pregnancy and breastfeeding

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. Do not takealprazolam if you are pregnant unless you and your doctor have evaluated the risks and benefits involved.

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 your doctor decides that you should take this medicine at the end of pregnancy or during childbirth, your baby may experience a drop in body temperature, flaccidity, breathing difficulties, and feeding difficulties, tremors, increased excitability, and agitation.

Do not take alprazolam if you are breastfeeding, as the medicine may pass into breast milk.

Driving and using machines

Do not drive or operate machinery after taking alprazolam, as you may lose concentration or muscular control, experience memory loss, have vertigo, feel drowsy, or dizzy.

Alprazolam Viatris contains lactose

Alprazolam Viatris contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking alprazolam.

Alprazolam Viatris contains sodium

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

Alprazolam Viatris contains sodium benzoate

This medicine contains 0.1 mg of sodium benzoate in each tablet.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Alprazolam Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults (over 18 years)

The recommended dose is between 0.25 mg and 0.5 mg three times a day.

If necessary, your doctor may decide to increase your dose up to a maximum of 3 mg per day. Consult your doctor or pharmacist if you have any doubts. The dose increase should be done with caution and the nighttime dose should be increased before the daytime dose.

If you have never taken this type of medicine before or have a history of alcoholism, a lower dose may be necessary.

Elderly patients

The recommended dose in elderly patients is 0.25 mg two or three times a day. If you are physically well and it is necessary, your doctor may decide to increase the dose to 0.5 mg every 3 days up to a maximum of 1.5 mg per day. Weak elderly patients should not take more than 0.75 mg per day.

Alprazolam Viatris tablets should be taken orally. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Patient with liver or kidney problems

If you have liver or kidney problems, your doctor may recommend taking a lower dose than usual. The maximum recommended dose for patients with liver or kidney problems is 0.75 mg to 1.5 mg per day.

Duration of treatment

Alprazolam Viatris should not be taken for longer than prescribed by your doctor and should not exceed 8-12 weeks. This is because taking alprazolam for too long and at too high a dose can lead to physical and mental dependence on this substance.

If you take more Alprazolam Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional. The symptoms of an overdose include drowsiness, confusion, lack of coordination or involuntary movements, breathing difficulties, low blood pressure, fatigue, loss of consciousness, and very rarely death.

If you forget to take Alprazolam Viatris

Do not take a double dose to make up for forgotten doses, wait for the next dose.

If you stop taking Alprazolam Viatris

It is generally recommended not to stop the medication abruptly, but to gradually reduce the dose, always according to the doctor's instructions.

When stopping the administration, side effects such as anxiety, restlessness, convulsions, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and sleep problems may appear. In extreme cases, this can also include symptoms such as loss of self-awareness, loss of contact with reality, increased sensitivity to light, sound, and physical contact, feeling of numbness or tingling in the limbs, seeing or hearing things that are not real, convulsions, stomach spasms, muscle cramps, vomiting, sweating, and agitation.

Consult your doctor immediately if you experience any of these symptoms or changes in mood.

If you have any further questions on 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 all people suffer from them.

Harmful or hostile behavior has been detected in people with a history of violence, borderline personality disorder, history of alcoholism, and in people who have taken medications that affect the Central Nervous System. If you suffer from post-traumatic stress disorder, stopping treatment with alprazolam could cause you irritability, hostility, and unpleasant ideas and thoughts.

Some of the most common adverse effects are observed at the start of treatment. Generally, these adverse effects disappear during treatment.

Inform your doctor immediatelyif you experience any of the following adverse effects that may be serious:

Uncommon(may affect up to 1 in 100 people)

• Seizures or convulsions.
• Brain attacks that can affect muscle activity, one of the senses, bodily functions, or the way of thinking, feeling, or experiencing things.
• Memory loss (amnesia).
• An unusual reaction to this medicine may include one or more of the following symptoms: restlessness, agitation, irritability, aggression, irrational thoughts (delirium), anger, nightmares, seeing or hearing things that do not exist (hallucinations), loss of contact with reality (psychosis), or unusual behavior.
• Withdrawal symptoms

Frequency not known(cannot be estimated from the available data)

• Increased number of infections that you may experience in the form of fever, intense chills, mouth ulcers, or sore throat. These symptoms could be indicative of low white blood cell counts.
• Obstruction of the airways that causes difficulty breathing.
• Liver inflammation (hepatitis), which can cause nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellowing of the skin or the whites of the eyes, light-colored stools, dark-colored urine.
• Signs of a severe allergic reaction, including symptoms such as itching, skin rash, swelling of the eyelids, face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing.
• Difficulty urinating, little or no urination, with possible pain.
• Drug abuse

You will have to interrupt treatment with this medicine. Your doctor will indicate how to perform the treatment interruption.

Other possible adverse effects could be:

Very common(may affect more than 1 in 10 people)

• Sleepiness or drowsiness.
• Difficulty sleeping.
• Dizziness, difficulty controlling movements (ataxia).
• Headaches.
• Difficulty speaking.
• Severe constipation, dry mouth.
• Fatigue.
• Weight gain or loss.
• Depression.
• Difficulty remembering.

Common(may affect up to 1 in 10 people)

• Increased or decreased appetite.
• Blurred vision.
• Feeling disconnected or separated from one's own body (dissociation).
• Seeing other people and the environment as a dream or unreal (derealization).
• Fear, nervousness, or anxiety, confusion, disorientation.
• Numbness, uncontrollable spasms, tremors, or convulsions, abnormal coordination, tremors, or convulsions, balance problems.
• Difficulty concentrating, lack of energy.
• Rapid heartbeats that are perceived as stabbing in the chest (palpitations).
• Hot flashes.
• Nasal congestion, sore throat, or productive cough. These symptoms could be indicative of an infection.
• Rapid breathing.
• Increased or decreased sexual desire.
• Inability to fall asleep (insomnia).
• Excessive sleepiness.
• Sexual dysfunction.
• Increased saliva production.
• Discomfort (vomiting), stomach upset, diarrhea, nausea, stomach pain.
• Excessive sweating.
• Skin rash, itching.
• Muscle spasms or cramps, back pain, muscle pain, joint pain.
• Chest pain.
• Unusual weakness.
• Swelling due to excess fluid in the body (edema).
• Ringing in the ears.
• Risk of traffic accidents.

Uncommon(may affect up to 1 in 100 people)

• Greater tendency to develop bruises.
• Sleep disturbances.
• Talkativeness (talking too much), impulsivity, slowed thoughts.
• Muscle weakness.
• Reduced mobility.
• Double vision, other vision problems.
• Euphoria or feeling overexcited, inability to enjoy normal pleasurable activities.
• Persistent inability to achieve orgasm.
• Mood changes.
• Panic attacks.
• Fainting.
• Clumsiness.
• Taste problems.
• State of near-unconsciousness (stupor).
• Joint stiffness, pain in the limbs.
• Involuntary loss of urine (incontinence) or frequent urination, abnormal urination during the day.
• Ejaculation problems, inability to achieve or maintain an erection.
• Irregular menstrual period in women.
• Abnormal sensation.
• Change in gait, feeling of drunkenness, feeling of nervousness or tension, feeling of relaxation, feeling of hangover.
• Flu-like symptoms, lethargy.
• Thirst.
• Increased bilirubin levels that can be observed through blood tests.
• Falls, injuries to the limbs.
• Overdose.
• Drug addiction

Frequency not known(cannot be estimated from the available data)

• High prolactin levels in the blood that can be observed through a blood test (hyperprolactinemia).
• Hostile behavior.
• Inability to remain seated or still, hyperactivity.
• Abnormal thinking.
• Learning and problem-solving difficulties.
• Vascular problems.
• Swelling of hands and feet (peripheral edema).
• State of excessive alertness.
• Increased sensitivity to light.
• Rapid heart rate (tachycardia).
• Low blood pressure.
• Decreased salivation.
• Abnormal liver function that can be detected through blood tests.
• Muscle tone problems.
• Feeling of heat.
• Increased eye pressure.
• Drug abuse

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 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. Storage of Alprazolam Viatris

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging after CAD or EXP. 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 that 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 that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofAlprazolam Viatris

• The active ingredient is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other components are lactose monohydrate (see section 2, "Alprazolam Viatris contains lactose"), microcrystalline cellulose, cornstarch, sodium benzoate (E-211), sodium docusate, povidone, anhydrous colloidal silica, sodium starch glycolate (potato starch), magnesium stearate, carmine indigo color (E-132), and erythrosine (E-127).

Appearance of the Product and Package Contents

The 0.5 mg tablets are pink, oval, marked with "AL" and a score line "0.5" on one side and "G" on the reverse.

Alprazolam Viatris is available in plastic bottles of 20, 28, 30, 50, 56, 60, 84, and 100 tablets, and in transparent or green/aluminum PVC blisters of 20, 28, 30, 40, 50, 56, 60, 84, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan B.V.

Krijgsman 20

1186 DM Amstelveen

Netherlands

or

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark: Alprazolam Mylan 0.5 mg

Spain: Alprazolam Viatris 0.5 mg EFG tablets

Netherlands: Alprazolam Mylan 0.5 mg Tablets

Date of the last revision of this prospectus: September 2020

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