PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Alpragen (Alprazolam Viatris 0.25 mg tablets EFG)
0.25 mg, tablets
Alprazolamum
Alpragen and Alprazolam Viatris 0.25 mg comprimidos EFG are different brand names of the
same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Alpragen is and what it is used for
Important information before taking Alpragen
How to take Alpragen
Possible side effects
How to store Alpragen
Contents of the pack and other information

1. What Alpragen is and what it is used for

Alpragen contains the active substance alprazolam, which belongs to a group of medicines called
benzodiazepines.
Alpragen is indicated for the treatment of symptoms of anxiety disorders in adults, but only in
situations where symptoms are severe, impair normal functioning, or cause significant distress to the patient. This medicine is intended for short-term use only.

2. Important information before using Alpragen

When not to use Alpragen:

if the patient is allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
if the patient has muscle weakness ( myasthenia gravis );
if the patient has severe breathing difficulties or lung disease;
if the patient has been diagnosed with sleep apnoea syndrome (irregular breathing during sleep);
if the patient has severe liver failure;
if the patient has acute alcohol intoxication or other substances acting on the central nervous system, e.g. narcotics;
if the patient has been diagnosed with glaucoma.

Warnings and precautions
Before starting treatment with Alpragen, consult your doctor or pharmacist if:

the patient has chronic lung problems, mild to moderate liver or kidney impairment;
the patient has depression or anxiety disorders associated with depression, as alprazolam may cause suicidal thoughts (if present) to become more frequent;
the patient is taking other medicines for anxiety disorders or insomnia;
the patient is taking medicines acting on the central nervous system (e.g. benzodiazepines, neuroleptics);
the patient has previously abused narcotics or alcohol, or has difficulties discontinuing drug use, alcohol consumption, or narcotics. The doctor may recommend special assistance when discontinuing this medicine;
the patient has personality disorders;
the patient is elderly, as this medicine may cause drowsiness or muscle weakness, which may lead to falls, often with serious consequences.

During treatment, the patient may experience anterograde amnesia. To reduce this risk,
the patient should ensure uninterrupted sleep of 7–8 hours while taking the medicine.
Use of alprazolam has been associated with unusual reactions such as:
agitation, particularly motor agitation, stimulation, irritability, aggression, hallucinations,
rage attacks, nightmares,
illusions (seeing or hearing things that do not exist), psychosis (loss of contact with
reality), and bizarre behaviour. If such symptoms occur, contact a doctor immediately,
as treatment must be discontinued.
Children and adolescents
Alpragen is not recommended for use in children and adolescents under 18 years of age.
Alpragen and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used,
as well as any medicines the patient plans to use, including those available without a prescription.
It is particularly important to inform the doctor about the use of the following medicines:

antipsychotics (medicines used to treat psychiatric disorders) such as haloperidol and chlorpromazine, hypnotics (medicines used to induce sleep) such as phenobarbital and zolpidem, anxiolytics (medicines used to treat anxiety) such as diazepam and lorazepam, opioid analgesics (a type of painkiller) such as propoxyphene, antitussives (medicines used to treat cough) such as dextromethorphan and codeine, medicines such as methadone (which may be used to relieve pain or assist people addicted to opioids), anaesthetics (medicines used for anaesthesia) such as halothane and bupivacaine, or antidepressants, as they may enhance the effect of alprazolam;
clozapine (a medicine used to treat psychiatric disorders such as schizophrenia). This medicine may increase the level of alprazolam in the blood;
medicines belonging to the group of selective serotonin re-uptake inhibitors (SSRIs), used to treat depression (e.g. fluoxetine or sertraline);
medicines used to treat epilepsy (e.g. phenytoin and carbamazepine);
antihistamines (antiallergic medicines) such as cetirizine, cyclizine;
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole or other azole derivatives);
cimetidine (used to treat stomach ulcers), nefazodone (used to treat depression), or fluvoxamine (used to treat obsessive-compulsive disorder), as the dose of alprazolam may need to be adjusted during concomitant use;
imipramine or desipramine – tricyclic antidepressants (TCA), used to treat depression, as dose adjustment may be necessary;
oral contraceptives;
diltiazem (used to treat angina and hypertension);
certain antibiotics, e.g. erythromycin, clarithromycin, telithromycin, troleandomycin, and rifampicin;
medicines used to treat HIV infection, known as protease inhibitors (e.g. ritonavir);
digoxin (a medicine used to treat heart conditions). The patient may experience symptoms of digoxin toxicity (symptoms include irregular heartbeat, confusion, delirium, visual disturbances, headache, abdominal pain, nausea, and vomiting) when digoxin is used concomitantly with Alpragen. Concomitant use of Alpragen with opioids (strong analgesics, medicines used in substitution therapy for drug addiction, some antitussives) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Fatal cases have been reported. For this reason, concomitant use should only be considered when other treatment options are not possible.

Nevertheless, if the doctor prescribes Alpragen together with opioids,
the dosage and duration of treatment should be strictly limited by the treating physician.
Inform the doctor about all opioid medicines being taken and strictly follow
the dosage recommended by the doctor. It may be helpful to inform friends or family
about the above symptoms. If such symptoms occur, contact a doctor.
If surgery under general anaesthesia is planned, inform the doctor about alprazolam use.
Alpragen, alcohol consumption, and alcohol
Do not drink alcohol while taking Alpragen; alcohol enhances the effect of Alpragen.
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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine. Do not use
Alpragen during pregnancy without discussing the potential risks and benefits
with a doctor.
If alprazolam is used regularly during the third trimester of pregnancy, the newborn may
develop dependence on alprazolam and withdrawal symptoms.
If the doctor decides to use alprazolam in late pregnancy or during delivery,
the newborn may experience symptoms such as low body temperature, floppiness,
breathing difficulties, feeding problems, tremors, increased irritability, and agitation.
Do not use Alpragen during breastfeeding, as this medicine may pass into breast milk.
Driving and operating machinery
Do not drive or operate machinery after taking alprazolam, as symptoms such as:
loss of concentration, loss of muscle control, memory loss, dizziness, drowsiness, or dizziness may occur.
Alpragen contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars,
the patient should consult a doctor before taking Alpragen.
Alpragen contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Alpragen contains sodium benzoate
The medicine contains 0.1 mg of sodium benzoate per tablet.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age), although this medicine is not recommended for use in patients under 18 years of age.

3. How to use Alpragen

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Alpragen is available in the following strengths: 0.25 mg, 0.5 mg, 1 mg.
Adults (over 18 years of age)
The recommended dose is 0.25 mg to 0.5 mg three times daily.
If necessary, the doctor may decide to increase the dose up to the maximum dose of 4 mg per
day. If in doubt, consult your doctor or pharmacist again.
Caution should be exercised when increasing the dose. First increase the evening dose, and only then the daytime dose.
In patients who have not previously taken this type of medication and in patients with a history of alcohol dependence, a lower dose should be used.
Elderly patients
The recommended dose for elderly patients is 0.25 mg two to three times daily. In physically healthy elderly patients, the doctor may, if necessary, increase the dose by 0.5 mg every third day, up to a maximum dose of 1.5 mg per day. In frail elderly patients, the dose should not exceed 0.75 mg per day.
Alpragen tablets should be taken orally. The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.
Patients with hepatic or renal impairment
In cases of liver or kidney impairment, the doctor may recommend using a lower than usual dose. The maximum recommended dose in patients with hepatic or renal impairment is 0.75 mg to 1.5 mg per day.
Duration of treatment
Alpragen should not be used for longer than prescribed by the doctor. The total treatment duration should not exceed 2–4 weeks. Taking alprazolam for too long and at too high a dose may lead to the development of psychological and physical dependence. Do not discontinue treatment prematurely.
Taking more Alpragen than recommended
If you have taken more than the recommended dose, seek immediate medical advice from a doctor or go to the nearest hospital emergency department. Take the medicine packaging and any remaining tablets with you. Symptoms of overdose include: drowsiness, confusion, lack of coordination or unsteady movements, breathing difficulties, low blood pressure, fatigue, loss of consciousness, and in rare cases, death.
If you forget to take Alpragen
Do not take a double dose to make up for a missed dose. Simply take the next dose at the scheduled time.
Stopping Alpragen
Do not stop taking this medicine without consulting your doctor. Before stopping treatment, the dose should be gradually reduced. Your doctor will advise you how to do this. If treatment with Alpragen is stopped or discontinued too early, symptoms such as anxiety, restlessness especially motor agitation, seizures, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and difficulty falling asleep may occur.
In extreme cases, symptoms may also include loss of awareness, detachment from reality, increased sensitivity to light, sound, and touch, feelings of numbness or tingling in the limbs, seeing or hearing things that are not real, seizures, abdominal and muscle cramps, vomiting, sweating, and tremors.
Contact your doctor immediately if any of these symptoms or mood changes occur.
If you have any further questions about the use of this medicine, consult 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 behaviours have been observed in patients with a history of violence, borderline personality disorder, alcohol abuse, and in patients taking medicines affecting the central nervous system. In patients with post-traumatic stress, discontinuation of Alpragen treatment may lead to irritability, hostility, and unpleasant thoughts and reflections.
Common adverse effects are observed at the beginning of Alpragen treatment. These symptoms usually resolve during continued treatment.
You should contact your doctor immediately if any of the following adverse effects occur, as they may be serious:
Uncommon (may affect up to 1 in 100 patients)

seizures;
epileptic seizures in the brain, which may affect muscle activity, senses, vital functions, or changes in the way the patient thinks, feels and experiences things;
memory loss (amnesia);
an unusual reaction to the medicine, which may include one or more of the following symptoms: anxiety, especially motor restlessness, excitement, irritability, aggression, delusions, outbursts of anger, nightmares, seeing or hearing things that do not exist (hallucinations), loss of contact with reality (psychosis), and strange behaviour;
withdrawal syndrome.

Adverse effects with unknown frequency (frequency cannot be estimated from the available data)

increased number of infections, which may present as fever, severe chills, mouth ulcers, or sore throat. These may be symptoms of low white blood cell count;
airway obstruction causing difficulty in breathing;
hepatitis, which may cause nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin or whites of the eyes, pale stools, dark urine;
symptoms of a severe allergic reaction, which may include itchy rash, swelling of the eyelids, face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing;
passing small amounts of urine or inability to pass urine;
medicine abuse.

You should stop taking the medicine. Your doctor will advise you how to do this.
Other adverse effects:
Very common (may affect more than 1 in 10 patients)

drowsiness or sedation, sleep problems;
dizziness, difficulty controlling movements (ataxia);
headache;
speech difficulties;
severe constipation, dry mouth;
fatigue;
weight gain or weight loss;
depression;
memory problems.

Common (may affect up to 1 in 10 patients)

increased or decreased appetite;
blurred vision;
feeling detached from the body (depersonalization);
perceiving other people and the surrounding world as unreal, dream-like (derealization);
fear, nervousness or anxiety, confusion, disorientation;
tingling, uncontrolled muscle spasms, coordination disturbances, chills or tremors, balance problems;
difficulty concentrating, lack of energy;
rapid heartbeat, which may be felt as fluttering in the chest (palpitations);
hot flushes;
stuffy nose, sore throat or choking cough. These may be symptoms of infection;
rapid breathing;
increased or decreased sexual drive;
inability to sleep (insomnia);
excessive sleepiness;
sexual dysfunction;
increased salivation;
vomiting, feeling of discomfort in the stomach, diarrhoea, nausea, abdominal pain;
excessive sweating;
skin rash, skin itching;
muscle cramps or spasms, back pain, muscle pain, joint pain;
chest pain;
unusual weakness;
swelling due to fluid accumulation in the body (oedema);
ringing in the ears;
risk of causing road traffic accidents.

Uncommon (may affect up to 1 in 100 patients)

increased tendency to bruise;
restless sleep;
talkativeness, impulsiveness, slowed thinking;
muscle weakness;
restricted movement;
double vision, other vision problems;
euphoria or feeling of excitement, inability to feel pleasure from enjoyable activities;
persistent inability to achieve orgasm;
mood changes;
panic attacks;
fainting;
clumsiness;
taste disturbances;
a state close to unconsciousness (stupor);
joint stiffness, limb pain;
uncontrolled urination (urinary incontinence) or frequent urination during the day;
problems with ejaculation, inability to achieve or maintain erection;
irregular menstruation in women;
malaise;
change in walking pattern, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of being high;
flu-like symptoms, drowsiness;
thirst;
increased bilirubin levels, which may be detected in blood tests;
falls, limb injuries;
overdose;
medicine dependence.

Adverse effects with unknown frequency (frequency cannot be estimated from the available data)

high levels of prolactin in the blood, which may be detected in blood tests (hyperprolactinaemia);
hostile behaviour;
inability to sit or stand still, hyperactivity;
disturbances in thinking;
problems with learning and problem-solving;
vascular problems;
swelling of hands and feet (peripheral oedema);
excessive alertness;
increased sensitivity to light;
rapid heartbeat (tachycardia);
low blood pressure;
decreased salivation;
liver function disturbances, which may be detected in blood tests;
problems with muscle tone;
feeling of warmth;
increased intraocular pressure.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, tel: 22 49 21 301, fax: 22 49 21 309, Website:
https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Alpragen

Keep this medicine out of sight and reach of children.
Do not store above 25℃. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Alpragen contains

The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
The other ingredients are: lactose monohydrate (see section 2 “Alpragen contains lactose monohydrate”), microcrystalline cellulose, maize starch, sodium benzoate, sodium lauryl sulfate, povidone, colloidal anhydrous silica, sodium carboxymethyl starch, magnesium stearate.

What Alpragen looks like and contents of the pack
0.25 mg tablets: white, oval tablets marked with “AL” and a score line “0.25” on one side and “G” on the other side.
Alpragen is available in packs containing 30 tablets in blisters.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
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
Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
The Netherlands
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Spain, country of export: 665224.4
Parallel Import Licence number: 245/20