Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Alpragen (Alprazolam Viatris 0,5 mg comprimidos EFG)
0,5 mg, tablets
Alprazolamum
Alpragen and Alprazolam Viatris 0,5 mg comprimidos EFG are different trade names for the same
medicine.
Please read this leaflet carefully before taking the medicine, as it contains important information for
the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, interfere with normal functioning, or are highly distressing to
the patient. This medicine is intended for short-term use only.

2. Important information before taking Alpragen

When not to take Alpragen

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

Warnings and precautions
Before starting treatment with Alpragen, discuss this with your doctor or pharmacist.

if you have chronic lung problems, mild to moderate liver or kidney dysfunction;
if you have depression or anxiety disorders associated with depression, because alprazolam may increase the frequency of suicidal thoughts (if present);
if you are taking other medicines for anxiety disorders or insomnia;
if you are taking medicines that act on the central nervous system (e.g. benzodiazepines, neuroleptics);
if you have previously abused narcotics or alcohol, or if you have difficulty stopping the use of drugs, drinking alcohol, or taking narcotics. Your doctor may recommend special support when discontinuing this medicine;
if you have personality disorders;
if you are elderly, 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 the 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: anxiety, especially motor
restlessness, agitation, irritability, aggression, rage attacks, nightmares, hallucinations (seeing or
hearing things that do not exist), psychosis (loss of contact with reality), and strange behaviour. If
such symptoms occur, you must consult a doctor, as treatment must be discontinued.
Children and adolescents
The use of Alpragen is not recommended in children and adolescents under 18 years of age.
Alpragen and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
including those obtained without a prescription, and any medicines you plan to take. It is especially
important to inform your doctor about the use 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, 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 help 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 mental illnesses such as schizophrenia). This medicine may increase the amount of alprazolam in the blood;
medicines from the group of selective serotonin reuptake 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). The dose of alprazolam should be appropriately adjusted when taking these medicines;
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 infections, called protease inhibitors (e.g. ritonavir);
digoxin (a medicine used to treat heart conditions). You may experience symptoms of digoxin toxicity (symptoms include irregular heartbeat, confusion, delirium, visual disturbances, headache, abdominal pain, nausea, and vomiting) when digoxin is taken concomitantly with Alpragen.

Concomitant use of Alpragen with opioids (strong painkillers, medicines used in opioid substitution
therapy, 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 your doctor prescribes Alpragen together with opioids, the dosage and duration of
treatment should be strictly limited by the prescribing physician.
Inform your doctor about all opioid medicines you are taking and strictly follow the dosage
recommended by your doctor. It may be helpful to inform friends or family about the above symptoms.
If such symptoms occur, contact your doctor.
If you are scheduled for surgery under general anaesthesia, inform your doctor that you are taking
alprazolam.
Alpragen and alcohol consumption
Do not drink alcohol while taking Alpragen; alcohol enhances the effect of Alpragen.
Do not drink 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, breastfeeding, think you may be pregnant, or are planning to have a child, you
should consult your doctor or pharmacist before taking this medicine. Do not
take Alpragen if you are pregnant without discussing the possible risks and benefits with your doctor.
If alprazolam is used regularly during the last trimester of pregnancy, the newborn may develop
dependence on alprazolam and withdrawal symptoms.
If your 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 take Alpragen while 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 you have been previously diagnosed with intolerance to certain sugars, you should contact your
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 in each 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 exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Alpragen is available in doses of: 0.25 mg, 0.5 mg, and 1 mg.
Adults (over 18 years of age)
The recommended dose is 0.25 mg to 0.5 mg three times daily.
If necessary, your doctor may decide to increase the dose up to the maximum daily dose of 4 mg.
If in doubt, contact your doctor or pharmacist again.
Exercise caution when increasing the dose. First increase the evening dose, then the daytime dose.
In patients who have not previously taken this type of medicine, 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 daily dose of 1.5 mg. In frail elderly patients, the daily dose should not exceed 0.75 mg.
Alpragen tablets should be taken orally. The score line on the tablet is only intended to facilitate
breaking the tablet for easier swallowing.
Patients with hepatic or renal impairment
In cases of hepatic or renal impairment, the doctor may recommend a lower than usual dose. The
maximum recommended daily dose for patients with hepatic or renal impairment is 0.75 mg to 1.5 mg.
Duration of treatment
Alpragen should not be used for longer than prescribed by your doctor. The total duration of treatment
should not exceed 2–4 weeks. Prolonged use of alprazolam 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 take more Alpragen than recommended, seek immediate medical advice or go to the
nearest hospital emergency department. Bring 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.
Missed dose of Alpragen
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
Stopping Alpragen treatment
Do not stop taking this medicine on your own. The dose should be gradually reduced before treatment
is discontinued. Your doctor will advise you how to do this. If Alpragen treatment is stopped or
discontinued too early, symptoms such as anxiety, restlessness (especially motor restlessness),
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, tingling or numbness in the limbs, seeing or hearing things that
are not real, seizures, abdominal and muscle cramps, vomiting, sweating, and tremor.
Contact your doctor if any of these symptoms or mood changes occur.
If you have any further doubts about using 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 disorders, 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.
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)

convulsions
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)
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 (psychoses), and strange behaviour
withdrawal syndrome.

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

increased frequency 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 breathing difficulties
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 severe allergic reaction, which may include itchy rash, swelling of the eyelids, face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing
passing small amounts of urine or inability to pass urine
misuse of the medicine.

Discontinue use of 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 sleepiness, sleep problems
dizziness, difficulty controlling movements (ataxia)
headaches
speech difficulties
severe constipation, dry mouth
fatigue
increased or decreased body weight
depression
difficulty remembering.

Common (may affect up to 1 in 10 patients)

increased or decreased appetite
blurred vision
feeling detached from one's body (depersonalization)
perceiving other people and the surrounding world in an unreal way, as if in a dream (derealization)
fear, nervousness or anxiety, confusion, disorientation
tingling, uncontrolled muscle spasms, coordination problems, 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
increased breathing rate
increased or decreased sexual drive
inability to sleep (insomnia)
excessive sleepiness
disturbances in sexual function
increased salivation
vomiting, feeling of discomfort in the stomach, diarrhoea, nausea, abdominal pain
excessive sweating
skin rash, itchy skin
muscle cramps or twitching, back pain, muscle pain, joint pain
chest pain
unusual weakness
swelling due to fluid retention 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
reduced mobility
double vision, other vision problems
euphoria or feeling of excitement, inability to experience 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 passing of urine (urinary incontinence) or frequent urination during the day
problems with ejaculation, inability to achieve or maintain an erection
irregular menstruation in women
malaise
change in the way of walking, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of intoxication
influenza-like symptoms, drowsiness
thirst
increased bilirubin levels, which may be seen in blood tests
falls, limb injuries
overdose
drug dependence.

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

high levels of prolactin in the blood, which may be seen 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)
increased alertness
increased sensitivity to light
rapid heartbeat (tachycardia)
low blood pressure
reduced salivation
liver function disturbances, which may be seen 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, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Alpragen

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

6. Contents of the pack and other information

What Alpragen contains

The active substance is alprazolam. Each tablet contains 0.5 mg of alprazolam.
The other ingredients are: monohydrate lactose (see section 2 "Alpragen contains monohydrate lactose"), microcrystalline cellulose, corn starch, sodium benzoate, sodium lauryl sulfate, povidone, anhydrous colloidal silicon dioxide, sodium carboxymethyl starch, magnesium stearate, indigotine (E 132) and erythrosine (E 127).

What Alpragen looks like and contents of the pack
Pink, oval tablets marked with "AL", a division line and "0.5" on one side and "G" on the other side.
Alpragen is available in packs of 30 or 60 tablets in blister packs.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturers:
Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary
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
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Spain, the country of export: 665216.9
Parallel Import Licence Number: 181/23