Package leaflet: Information for the patient

Warning!
Keep this leaflet. Information on the immediate packaging in a foreign language.
Alpragen (Alprazolam Mylan), 1 mg, tablets
Alprazolamum
Alpragen and Alprazolam Mylan are different brand names of the same medicine.
Please read the entire leaflet carefully before using 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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, significantly impair normal functioning, or are extremely
distressing 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 dysfunction,
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 that act on the central nervous system (e.g. benzodiazepines, neuroleptics),
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 support during discontinuation of 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.
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, as well as any medicines the patient plans to take, including those available without a prescription. It is especially 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 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,
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),
antiallergic medicines (antihistamines 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 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 infections, known as protease inhibitors (e.g. ritonavir),
digoxin (a medicine used to treat heart conditions). The patient may experience 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 opioid addiction substitution therapy, 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 treating physician.
Inform your 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 a surgical procedure under general anaesthesia is planned, inform the doctor about taking alprazolam.

Alpragen, drinking and alcohol
Do not drink alcohol while taking Alpragen; alcohol enhances the effect of Alpragen.
Do not drink excessive 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 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 possible risks and benefits 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 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 contact the doctor before taking Alpragen.

Alpragen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

Alpragen contains sodium benzoate
This 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), 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 exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Alpragen is available in the following strengths: 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, your doctor may decide to increase the dose up to the maximum dose of 4 mg per
day. If in doubt, you should contact your doctor or pharmacist again.
Exercise caution when increasing the dose. First increase the evening dose, and only then the
daytime dose.
A lower dose should be used in patients who have not previously taken this type of medicine and
in patients with a history of alcohol dependence.
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 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 score line on the tablet is only intended to facilitate
breaking the tablet for easier swallowing.
Patients with liver or kidney impairment
In cases of liver or kidney impairment, your doctor may recommend a lower than usual dose. The
maximum recommended dose in patients with liver or kidney impairment is 0.75 mg to 1.5 mg per
day.
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 than the recommended dose, you should contact your doctor immediately or go
to the nearest hospital emergency department. You should 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.
Missing a dose of Alpragen
Do not take a double dose to make up for a missed dose. Simply take the next dose at the correct
time.
Stopping Alpragen treatment
Do not stop taking this medicine on your own. Before stopping treatment, the dose should be
gradually reduced. Your doctor will inform you how to do this. If treatment with Alpragen 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, hallucinations (seeing or hearing things that are not real), seizures, abdominal and muscle
cramps, vomiting, sweating, and tremors.
You should 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Harmful or hostile behaviour has 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.
If a patient suffers from post-traumatic stress, discontinuation of treatment with Alpragen may lead to irritability, hostility, and unpleasant thoughts and reflections.
Common adverse symptoms occur at the beginning of Alpragen treatment. These symptoms usually subside 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)
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 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 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, 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 abuse

Treatment should be discontinued. Your doctor will advise you how to do this.

Other adverse effects
Very common (may affect more than 1 in 10 patients)

drowsiness or somnolence, sleep problems
dizziness, difficulty controlling movements (ataxia)
headaches
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 in an unreal, dream-like way (derealization)
fear, nervousness, or anxiety, confusion, disorientation
tingling, uncontrolled muscle spasms, coordination disorders, 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 abdomen, 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 road traffic accidents

Uncommon (may affect up to 1 in 100 patients)

increased tendency to bruising
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 visible 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 visible 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
reduced salivation
liver function disorders, which may be visible 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, you should 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
Reporting adverse effects helps provide more information on the safety of the medicine.

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 container. 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. Such measures help protect the environment.

6. Contents of the package 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, corn starch, sodium benzoate, sodium docucinate, 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", a break 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 Portugal, country of export:
Towa Pharmaceutical, S.A.
Avenida do Forte, 3, Edifício Suécia IV, Piso 0
2794-093 Carnaxide, Portugal
Manufacturer:
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97
08107 Martorelles, Barcelona
Spain
Mylan Hungary Kft
Mylan utca 1
Komarom H-2900
Hungary
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Portugal, country of export: 2584480
Parallel Import Authorisation Number: 267/21