Alprazolam Viatris 0.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alprazolam Viatris 0.5 mg tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 Viatis is and what it is used for

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

Alprazolam is thought to 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 lead to dependence.

2. What you need to know before taking Alprazolam Viatris

Do not take Alprazolam Viatris:

• If you are allergic to alprazolam or to 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 diseases.
• If you have sleep apnea (irregular breathing while sleeping).
• If you have severe liver problems.
• If you suffer from alcoholism or drug addiction.
• If you are taking other medications known to act on the central nervous system (e.g., benzodiazepines, neuroleptics).
• If you have glaucoma.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alprazolam Viatris:

• If you have long-term lung problems, mild or moderate liver or kidney problems.
• If you suffer from depression or anxiety associated with depression, as alprazolam may increase any suicidal thoughts you may have.
• If you are taking any other medicine for anxiety or insomnia.
• If you have a history of alcoholism, drug abuse, or difficulty stopping medications, drinking, or drug use. Your doctor can help you discontinue this medicine.
• If you have personality disorders.
• If you are an elderly patient, as alprazolam may cause drowsiness or muscle weakness, which could lead to falls—often with serious consequences in this population.

You may experience temporary memory loss while taking this medicine. To reduce this risk, ensure you get a full night’s sleep (7–8 hours) while on this medication.

Alprazolam has been associated with uncommon reactions such as restlessness, agitation, irritability, aggression, confusion, rage attacks, nightmares, hallucinations (seeing or hearing things that are not real), psychosis (loss of contact with reality), and inappropriate behavior. If you notice any of these behavioral changes while taking this medicine, please contact your doctor immediately, as treatment must be stopped.

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 need to take any other medicines, including those obtained without a prescription. It is especially important to inform your doctor if you are taking any of the following medicines:

• Antipsychotics (medicines used to treat mental disorders) 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 (medicines used to treat pain) such as propoxyphene, antitussives (medicines used to treat cough) such as dextromethorphan and codeine, medicines like methadone (which may be used for pain relief or as aid in opioid addiction), anesthetics (medicines used in anesthesia) such as halothane and bupivacaine, or certain antidepressants, as these may increase the effects of alprazolam.
• Clozapine (a medicine used to treat mental illnesses such as schizophrenia). This medicine may increase the level of alprazolam in the blood.
• Medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs), used to treat depression (e.g., fluoxetine and sertraline).
• Medicines used to treat epilepsy (e.g., phenytoin and carbamazepine).
• Medicines for allergies (antihistamines such as cetirizine and cyclizine).
• Medicines used to treat fungal infections (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, and other azole derivatives).
• Cimetidine (used to treat stomach ulcers), nefazodone (used to treat depression), or fluvoxamine (used to treat Obsessive-Compulsive Disorder, OCD), as your alprazolam dose may need to be adjusted.
• Imipramine or desipramine, medicines known as tricyclic antidepressants (TCAs), used to treat depression, as your dose of these medicines may need to be adjusted.
• Oral contraceptives ("the pill").
• Diltiazem (used to treat angina and high blood pressure).
• Certain antibiotics (e.g., erythromycin, clarithromycin, telithromycin, troleandomycin, and rifampicin).
• Medicines known as protease inhibitors used to treat HIV (e.g., ritonavir).
• Digoxin (a medicine used to treat heart conditions). You may become poisoned by digoxin (signs of poisoning include: irregular heartbeat, confusion, delirium, vision disturbances, headache, abdominal pain, nausea, and vomiting) while taking digoxin with this medicine.

The concomitant use of this medicine with opioids (strong painkillers, medications for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Deaths have been reported. Because of this, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all opioids you are taking and follow your doctor’s dosing recommendations carefully. It may be helpful to inform your friends or family members so they are aware of the symptoms described above. Contact your doctor if you experience any of these symptoms.

If you are undergoing surgery requiring general anesthesia, inform your doctor that you are taking alprazolam.

Taking Alprazolam Viatris with food and alcohol

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

Pregnancy and breastfeeding

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. Do not take alprazolam during pregnancy unless you and your doctor have evaluated the risks and benefits involved.

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

If your doctor has decided you should take this medicine towards the end of pregnancy or during delivery, your baby may experience low body temperature, floppiness, breathing and feeding difficulties, tremors, increased excitability, and agitation.

You should not take alprazolam while breastfeeding, as the medicine may pass into breast milk.

Driving and using machines

Do not drive or operate machinery after taking alprazolam, as it may impair concentration or muscle control, cause memory loss, dizziness, drowsiness, or lightheadedness.

Alprazolam Viatris contains lactose

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

Alprazolam Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

Alprazolam Viatris contains sodium benzoate

This medicine 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 of age).

3. How to take Alprazolam Viatris

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

Adults (over 18 years of age)

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

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. Dose increases should be made cautiously, and the evening dose should be increased before the daytime dose.

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

Elderly patients

The recommended dose for elderly patients is 0.25 mg two or three times daily. If physically well and if necessary, your doctor may decide to increase the dose by 0.5 mg every 3 days, up to a maximum of 1.5 mg daily. Frail elderly patients should not take more than 0.75 mg daily.

Alprazolam Viatris tablets should be taken orally. The score line is intended only for dividing the tablet if you have difficulty swallowing it whole.

Patients with liver or kidney problems

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

Duration of treatment

Alprazolam Viatris should not be taken for longer than prescribed 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 may lead to physical and psychological 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional. Symptoms of 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 until your next scheduled dose.

If you stop taking Alprazolam Viatris

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

When stopping treatment, adverse effects such as anxiety, restlessness, seizures, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and sleep disturbances may occur. In extreme cases, this may also include symptoms such as depersonalization, loss of contact with reality, increased sensitivity to light, sound, and physical touch, numbness or tingling sensations in the limbs, seeing or hearing things that are not real, seizures, 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 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 will experience them.

Harmful or hostile behaviour has been observed in people with a history of violence, borderline personality disorder, alcoholism, or those who have taken medicines affecting the Central Nervous System. If you suffer from post-traumatic stress disorder, stopping treatment with alprazolam may cause irritability, hostility, and unpleasant thoughts or ideation.

Some of the more common adverse effects occur at the beginning of treatment. These adverse effects usually disappear during treatment.

Contact your doctor immediately if you experience any of the following adverse effects, which may be serious:

Uncommon (may affect up to 1 in 100 people)

• Seizures or fits.
• Strokes that may 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 medicine may include one or more of the following symptoms: restlessness, agitation, irritability, aggression, irrational thoughts (delirium), rage, nightmares, seeing or hearing things that are not there (hallucinations), loss of contact with reality (psychosis), or strange behaviour.
• Withdrawal symptoms.

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

• Increased frequency of infections, which may present as fever, severe chills, mouth ulcers, or sore throat. These symptoms could indicate low levels of white blood cells.
• Airway obstruction causing breathing difficulties.
• Inflammation of the liver (hepatitis), which may cause nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin or whites of the eyes, pale stools, or 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, which may cause difficulty swallowing or breathing.
• Difficulty urinating, passing small amounts, or inability to urinate, possibly accompanied by pain.
• Drug abuse.

You will need to discontinue treatment with this medicine. Your doctor will advise you on how to stop the treatment.

Other possible adverse effects may include:

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

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

Common (may affect up to 1 in 10 people)

• Increased or decreased appetite.
• Blurred vision.
• Feeling detached or separated from oneself (depersonalization).
• Perceiving other people and the environment as dream-like or unreal (derealization).
• Fear, nervousness, or anxiety, confusion, disorientation.
• Tingling, uncontrollable spasms, jerking, or twisting movements, abnormal coordination, tremors, or seizures, balance problems.
• Difficulty concentrating, lack of energy.
• Fast heartbeats felt as pounding in the chest (palpitations).
• Hot flushes.
• Nasal congestion, sore throat, or productive cough. These symptoms could indicate an infection.
• Rapid breathing.
• Increased or decreased sex drive.
• Inability to fall asleep (insomnia).
• Excessive sleepiness.
• Sexual dysfunction.
• Increased saliva production.
• Nausea (vomiting), stomach discomfort, diarrhoea, feeling sick (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 (oedema).
• Ringing in the ears.
• Risk of traffic accidents.

Uncommon (may affect up to 1 in 100 people)

• Increased tendency to bruise.
• Sleep disturbances.
• Talkativeness (excessive talking), impulsiveness, slowed thinking.
• Muscle weakness.
• Reduced mobility.
• Double vision, other vision problems.
• Euphoria or feeling overexcited, inability to enjoy normal pleasurable activities.
• Persistent inability to reach orgasm.
• Mood changes.
• Panic attacks.
• Fainting.
• Clumsiness.
• Problems with taste.
• A state close to unconsciousness (stupor).
• Joint stiffness, limb pain.
• Involuntary loss of urine (incontinence) or frequent urination, abnormal urination during the day.
• Ejaculation problems, inability to achieve or maintain an erection.
• Irregular menstrual periods in women.
• Abnormal sensation.
• Changes in walking pattern, feeling of drunkenness, feeling of nervousness or tension, feeling of relaxation, hangover-like feeling.
• Flu-like symptoms, lethargy.
• Thirst.
• Increased levels of bilirubin detectable by blood test.
• Falls, limb injuries.
• Overdose.
• Drug dependence.

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

• High levels of prolactin in the blood detectable by blood test (hyperprolactinaemia).
• Hostile behaviour.
• Inability to sit still or remain motionless, hyperactivity.
• Abnormal thinking.
• Difficulties with learning and problem-solving.
• Problems with blood vessels.
• Swelling of hands and feet (peripheral oedema).
• Excessive alertness.
• Increased sensitivity to light.
• Fast heart rate (tachycardia).
• Low blood pressure.
• Decreased saliva production.
• Abnormal liver function detectable in blood tests.
• Problems with muscle tone.
• Feeling of warmth.
• Increased eye pressure.
• Drug abuse.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 the sight and reach of children.

Do not store above 25°C. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after CAD or 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 unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 0.5 mg of alprazolam.
• The other components are monohydrate lactose (see section 2, “Alprazolam Viatris contains lactose”), microcrystalline cellulose, corn starch, sodium benzoate (E-211), sodium docusate, povidone, anhydrous colloidal silica, sodium starch glycolate from potato (potato starch), magnesium stearate, carmine indigo dye (E-132) and erythrosine (E-127).

Appearance of the product and contents of the pack

The 0.5 mg tablets are pink, oval-shaped, marked with “AL” and scored with “0.5” on one side and “G” on the reverse.

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

Only certain pack 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
The Netherlands

or

Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Alprazolam Mylan 0.5 mg
Spain: Alprazolam Viatris 0.5 mg tablets EFG
The Netherlands: Alprazolam Mylan 0.5 mg Tabletten

Date of the most recent review of this leaflet: September 2020

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