Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Alpragen (Alprazolam Viatris 1 mg comprimidos EFG), 1 mg, tablets
(Alprazolamum)
Alpragen and Alprazolam Viatris 1 mg comprimidos EFG are different trade names of the same
medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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 a specific individual. Do not pass it on 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.

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, 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 intoxication with 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, discuss this with your doctor or pharmacist:

if the patient has chronic lung problems, mild to moderate liver or kidney impairment,
if the patient has depression or anxiety disorders associated with depression, because alprazolam may increase the frequency of suicidal thoughts (if present),
if the patient is taking other medicines for anxiety disorders or insomnia,
if the patient is taking medicines that act on the central nervous system (e.g. benzodiazepines, neuroleptics),
if the patient has previously abused narcotics or alcohol, or has difficulties stopping the use of medicines, drinking alcohol, or taking narcotics. The doctor may recommend special assistance when discontinuing this medicine.
if the patient has personality disorders,
if the patient is 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.
The use of alprazolam has been associated with unusual reactions such as: restlessness,
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, the patient should contact 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 the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take. It is especially important to inform the doctor about the use of medicines such as:

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 painkillers) 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 mental disorders 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), as the dose of alprazolam may need to be adjusted appropriately during concomitant use of 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, known as protease inhibitors (e.g. ritonavir),
digoxin (a medicine used to treat heart diseases). 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. Therefore, concomitant use should only be considered when other treatment options are not feasible.
Nevertheless, if the 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 surgery under general anaesthesia is planned, inform the doctor about 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 the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Do not
use Alpragen during pregnancy without discussing the possible risks and benefits associated with its use with a doctor.
If alprazolam is used regularly during the last 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 excitability 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
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Alpragen contains sodium benzoate
This 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); however, 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 physician or pharmacist. In case of doubt,
consult a physician 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 physician may decide to increase the dose up to the maximum daily dose of 4 mg.
If in doubt, contact your physician 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 physician 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 case of hepatic or renal impairment, the physician may recommend using 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 the physician. 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 prescribed
If more medicine has been taken than prescribed, 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. Simply take the next dose at the scheduled
time.
Stopping Alpragen treatment
Do not stop taking this medicine without consulting your physician. Before stopping treatment, the
dose should be gradually reduced. Your physician will advise you how to do this. If Alpragen is
discontinued or stopped 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, tingling or
numbness in the limbs, seeing or hearing things that are not real, seizures, abdominal and muscle
spasms, vomiting, sweating, and tremor.
Contact your physician if any of these symptoms or mood changes occur.
If you have any further questions about the use of this medicine, consult your physician 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 individuals with a history of violence, borderline personality disorder, alcohol abuse, and in those taking medicines affecting the central nervous system.
If a patient has experienced post-traumatic stress, discontinuation of treatment with Alpragen may lead to irritability, hostility, and unpleasant thoughts and reflections.
Common adverse effects are observed at the beginning of Alpragen treatment. These symptoms usually subside during continued treatment.
Immediately contact your doctor 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 with 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 determined from 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 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, possibly causing difficulty swallowing or breathing
passing small amounts of urine or inability to pass urine
medicine misuse.

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
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 (depersonalisation)
perceiving other people and the surrounding world as unreal, dream-like (derealisation)
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
blocked 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
sexual dysfunction
increased salivation
vomiting, feeling of discomfort in the stomach, diarrhoea, nausea, stomach 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 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
restricted movements
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
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 erection
irregular menstruation in women
malaise
change in walking pattern, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of being drunk
flu-like symptoms, drowsiness
thirst
increased bilirubin levels, which may be observed in blood tests
falls, limb injuries
overdose
medicine dependence.

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

high levels of prolactin in the blood, which may be observed in blood tests (hyperprolactinaemia)
hostile behaviour
inability to sit or stand still, hyperactivity
thinking disturbances
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 observed in blood tests
muscle tone problems
feeling of heat
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 Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Alpragen

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 1 mg of alprazolam.
The other ingredients are: monohydrate lactose (see section 2 "Alpragen contains monohydrate lactose"), microcrystalline cellulose, maize starch, sodium benzoate, sodium lauryl sulfate, povidone, colloidal anhydrous silica, sodium carboxymethyl starch, magnesium stearate, indigotine (E 132).

What Alpragen looks like and contents of the pack
1 mg tablets: light blue, oval tablets marked with "AL" and a score line "1.0" 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
trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin, Ireland
Mylan Hungary Kft.
2900 Komárom
Mylan utca 1.
Hungary

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, country of export: 665208.4
Parallel Import Licence Number: 356/19