Patient Information Leaflet: Package Insert

Alprazolam Viatris 1 mg Tablets EFG

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

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAlprazolam Viatrisand what is it used for

2. What you need to know before starting to takeAlprazolam Viatris

3. How to takeAlprazolam Viatris

4. Possible side effects

5. Storage ofAlprazolam Viatris

6. Contents of the pack and additional information

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 may cause dependence.

Do not takeAlprazolam Viatris:

• If you are allergic to alprazolam or any of the other ingredients of this medication (listed in section 6).
• If you have a condition called myasthenia gravis, which is characterized by muscle weakness.
• If you have severe breathing difficulties or lung diseases.
• If you have sleep apnea (irregular breathing while sleeping).
• If you have severe liver damage.
• If you have alcoholism or drug addiction.
• If you are taking another medication that affects the central nervous system (such as benzodiazepines, neuroleptics).
• If you have glaucoma.

Warnings and precautions

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

• If you have long-term lung problems, mild or moderate liver problems, 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 medication for anxiety or insomnia.
• If you have a history of alcoholism, drug addiction, or find it difficult to stop taking medications, drinking, or using drugs. Your doctor may help you stop taking this medication.
• If you have personality disorders.
• If you are an elderly patient, as alprazolam may cause drowsiness or muscle weakness that may lead to falls, often with serious consequences in this population.

You may experience temporary memory loss while taking this medication. To reduce the risk, try to sleep for the entire night (7-8 hours) while taking this medication.

Alprazolam has been associated with rare reactions such as restlessness, agitation, irritability, aggression, confusion, anger attacks, 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 medication, please contact your doctor, as you should stop treatment.

Children and adolescents

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

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, even those purchased without a prescription. It is especially important to inform your doctor if you are taking any of the following medications:

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

The concomitant use of this medication and opioids (strong pain relievers, medication for substitution therapy, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Deaths have been reported. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

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

If you are to undergo surgery where you will be given general anesthesia, inform your doctor that you are taking alprazolam.

Alprazolam Viatris with beverages and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.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 has decided that you should take this medication at the end of pregnancy or during delivery, 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 medication may pass into breast milk.

Driving and operating machinery

Do not drive or operate machinery after taking alprazolam, as you may lose concentration or muscle control, memory loss, experience dizziness, feel drowsy, or feel nauseous.

Alprazolam Viatris contains lactose

Alprazolam Viatris contains lactose. If your doctor has diagnosed you with lactose intolerance, consult your doctor before taking alprazolam.

Alprazolam Viatris contains sodium

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

Alprazolam Viatris contains sodium benzoate

This medication contains 0.1 mg of sodium benzoate per tablet.

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

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

Adults (18 years and older)

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 doubts. Theincrease in dose should be done with caution and the dose should be increased at night before the day dose.

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

Older adults

Therecommendeddosein older adults 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 by 0.5 mg every 3 days up to a maximum of 1.5 mg per day. Weak older adults should not take more than 0.75 mg per day.

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

Patients with liver or kidney problems

If you have liver or kidney problems, your doctor may recommend 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.

Treatment duration

Alprazolam Viatris should not be taken for longer than established by your doctor and generally 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. Phone 91 562 04 20 indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional. Symptoms of an overdose include drowsiness, confusion, lack of coordination or involuntary movements, difficulty breathing, decreased blood pressure, fatigue, loss of consciousness, and rarely death.

If you forgot to take Alprazolam Viatris

Do not take a double dose to compensate for the missed doses, wait for the next dose.

If you interrupt treatment with Alprazolam Viatris

It is generally recommended not to interrupt the medication abruptly, but to gradually reduce the dose, always in accordance with the doctor's instructions.

When stopping administration, withdrawal symptoms such as anxiety,restlessness, convulsions, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and difficulty sleeping may appear. In extreme cases, this may also include symptoms such as loss of self-awareness,disconnection from reality,increased sensitivity to light,sound, andphysical contact, numbness or tingling in the extremities, seeing or hearing things that are not real, convulsions,abdominal cramps,muscle spasms,nausea, sweating, and agitation.

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Aggressive or hostile behavior has been detected in people with a history of violence, borderline personality disorder, a 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 alprazolam treatment may cause irritability, hostility, and unpleasant thoughts and ideas.

Some of the most common side effects are observed at the beginning of treatment. These side effects usually disappear during treatment.

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

Rare(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 you think, feel, or experience things.
• Memory loss (amnesia).
• An unusual reaction to this medication may include one or more of the following symptoms: restlessness, agitation, irritability, aggressiveness, irrational thoughts (delirium), rage, 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 available data)

• Increased susceptibility to infections in the form of fever, intense chills, mouth ulcers, or sore throat. These symptoms may indicate low white blood cell levels.
• Obstruction of the airways that causes difficulty breathing.
• Liver inflammation (hepatitis), which may cause nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellowing of the skin or eyes, pale stools, dark 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 may cause difficulty swallowing or breathing.
• Difficulty urinating, urinating little or not at all, with possible pain.
• Drug abuse

You will have to interrupt treatment with this medication. Your doctor will instruct you on how to interrupt treatment.

Other possible side effects may be:

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

• Drowsiness or sleepiness.
• Difficulty sleeping.
• Dizziness, difficulty controlling movements (ataxia).
• Headaches.
• Difficulty speaking.
• Constipation, dry mouth.
• Restlessness.
• Weight gain or loss.
• Depression.
• Difficulty remembering.

Common(may affect up to 1 in 10 people)

• Increased or decreased appetite.
• Blurred vision.
• Sensation of being disconnected or separated from one's own body (derealization).
• Seeing other people and the environment as a dream or unreal (depersonalization).
• Fear, nervousness, or anxiety, confusion, disorientation.
• Tingling, uncontrollable spasms, tremors, or convulsions, abnormal coordination, tremors, or convulsions, balance problems.
• Difficulty concentrating, lack of energy.
• Palpitations, rapid heartbeats that feel like stabbing in the chest.
• Hot flashes.
• Congestion, sore throat, or productive cough. These symptoms may indicate an infection.
• Fast breathing.
• Increased or decreased libido.
• Inability to fall asleep (insomnia).
• Excessive sleep.
• Sexual dysfunction.
• Excessive salivation.
• Discomfort (vomiting), stomach discomfort, diarrhea, nausea, stomach pain.
• Excessive sweating.
• Skin rash, itching skin.
• Muscle spasms or cramps, back pain, muscle pain, joint pain.
• Chest pain.
• Unusual weakness.
• Swelling due to excess fluid in the body (edema).
• Tinnitus.
• Risk of traffic accidents.

Rare(may affect up to 1 in 100 people)

• Increased tendency to develop petechiae.
• Sleep disturbances.
• Loquacity (talking too much), impulsivity, slowed thoughts.
• Muscle weakness.
• Reduced mobility.
• Diplopia, other vision problems.
• Euphoria or feeling overexcited, inability to enjoy normal pleasurable activities.
• Inability to achieve orgasm persistently.
• Mood changes.
• Panic attacks.
• Fainting.
• Clumsiness.
• Taste problems.
• State of near unconsciousness (stupor).
• Joint stiffness, limb pain.
• Involuntary loss of urine (incontinence) or frequent, abnormal daytime urination.
• Sexual dysfunction, inability to achieve or maintain an erection.
• Irregular menstrual periods in women.
• Abnormal sensation.
• Change in gait, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of hangover.
• Symptoms similar to the flu, 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 available data)

• High levels of prolactin in the blood that can be observed through blood tests (hyperprolactinemia).
• Hostile behavior.
• Inability to remain seated or still, hyperactivity.
• Abnormal thinking.
• Learning and problem-solving difficulties.
• Problems with blood vessels.
• Swelling of hands and legs (peripheral edema).
• Excessive alertness.
• Increased sensitivity to light.
• Rapid heartbeats (tachycardia).
• Low blood pressure.
• Decreased salivation.
• Abnormal liver function that can be detectable through blood tests.
• Problems with muscle tone.
• Sensation of heat.
• Increased intraocular pressure.
• Drug abuse

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 the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 medication after the expiration date that appears on the packaging after 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 ofAlprazolam Viatris

• The active ingredient is alprazolam. Each tablet contains 1 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, potato starch glycolate sodium (potato starch), magnesium stearate, and indigo carmine colorant (E-132).

Appearance of the product and contents of the package

The 1 mg tablets are blue, oval-shaped, marked with “AL” notch “1.0” 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 PVC transparent or green/Aluminum blisters of 20, 28, 30, 40, 50, 56, 60, 84, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 with the following names:

Denmark:Alprazolam Mylan 1.0 mg

Spain:Alprazolam Viatris 1 mg tablets EFG

Last review date of this leaflet: September 2020

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