Package leaflet: Information for the patient

Warning! Keep the 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 brand names of the same
medicinal product.
Please read the entire leaflet carefully before using 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, consult 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 appear identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the 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 taking 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 long-term lung problems, mild to moderate liver or kidney impairment
the patient has depression or anxiety disorders associated with depression, because alprazolam may increase the frequency of suicidal thoughts (if present)
the patient is taking other medicines for anxiety disorders or insomnia
the patient is taking medicines that act on the central nervous system (e.g. benzodiazepines, neuroleptics)
the patient has previously abused narcotics or alcohol, or has difficulties discontinuing the use of medicines, alcohol consumption, or narcotic use. The doctor may recommend special support during withdrawal from 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 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:
anxiety, particularly motor restlessness, stimulation, irritability, aggression, delusions,
rage attacks, nightmares, hallucinations (seeing or hearing things that do not exist),
psychoses (loss of contact with reality), and strange behaviour. If such symptoms occur,
seek medical advice 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, 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 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 for pain relief or to help people addicted to opioids), anaesthetics (medicines used for anaesthesia) such as halothane and bupivacaine, or antidepressants, as these may enhance 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
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 gastric ulcers), nefazodone (used to treat depression), or fluvoxamine (used to treat obsessive-compulsive disorder). The dose of alprazolam should be adjusted appropriately 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 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 taken 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.
However, if the doctor prescribes Alpragen together with opioids, the dosage and duration of treatment should be strictly limited by the treating physician.
Inform your doctor about all opioid medicines being taken and strictly follow the dosage prescribed by the doctor. It may be helpful to inform friends or family about the above symptoms. If such symptoms occur, contact your doctor immediately.
If surgery under general anaesthesia is planned, inform the doctor about taking alprazolam.
Alpragen and alcohol
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 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 baby, she should consult her doctor or pharmacist before taking this medicine. Do not
take Alpragen if the patient is pregnant without discussing the potential risks and benefits with the 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 during 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 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 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 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 doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Alpragen is available in the following doses: 0.25 mg, 0.5 mg, 1 mg.
Adults (over 18 years)
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 the doctor or pharmacist again.
Exercise caution 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 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 dose of 1.5 mg per day. In frail elderly patients, the daily dose should not exceed 0.75 mg.
Alpragen tablets should be taken orally. The break line on the tablet is intended only to facilitate crushing 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 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 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 more medicine has been taken than recommended, seek immediate medical advice or go to the emergency department of the nearest hospital. 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.
If you miss a 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 doctor. Before ending 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, the patient may experience symptoms such as: anxiety, restlessness (especially motor restlessness), seizures, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and difficulty falling asleep. 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 there, seizures, abdominal and muscle cramps, vomiting, sweating, and tremors.
Contact your doctor 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 reactions

Like all medicines, this medicine can cause adverse reactions, 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 that affect 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 reactions occur at the beginning of Alpragen treatment. These symptoms usually resolve during continued treatment.
Immediately consult a doctor if any of the following adverse reactions 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)
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 reactions 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 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 severe allergic reaction, such as 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
drug abuse.

Treatment should be discontinued. The doctor will advise the patient how to do this.
Other adverse reactions
Very common (may affect more than 1 in 10 patients)

drowsiness or somnolence, sleep problems
dizziness, difficulty controlling movements (ataxia)
headache
speech difficulties
severe constipation, dry mouth
fatigue
increased or decreased body weight
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 disorders, chills or tremor, 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, discomfort in the stomach, diarrhoea, nausea, abdominal pain
excessive sweating
skin rash, itching
muscle cramps or twitching, back pain, muscle pain, joint pain
chest pain
unusual weakness
fluid retention causing swelling (oedema)
ringing in the ears
risk of 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 experience pleasure from pleasurable activities (anhedonia)
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 intoxication
flu-like symptoms, drowsiness
thirst
increased bilirubin levels, which may be visible in blood tests
falls, limb injuries
overdose
drug dependence.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 reactions helps to provide more information on the safety of this medicine.

5. How to store Alpragen medicine

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. Following this advice helps protect the environment.

6. Contents of the packaging and other information

What Alpragen contains

The active substance is alprazolam. Each tablet contains 1 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, indigo carmine (E 132).

What Alpragen looks like and contents of the pack
Alpragen 1 mg are light blue oval tablets marked with "AL", a division line and "1.0" on one side and "G" on the other side.
Alpragen is available in packs containing 30 or 60 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, Dublín 15
Dublin, Ireland
Manufacturer:
Mylan Hungary Kft.
Mylan utca 1.
2900 Komárom
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, country of export: 665208.4
Parallel import authorisation number: 19/21