ALPRAGEN 0.5 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: patient information
3. Alpragen, 0.25 mg, tablets
4. Alpragen, 0.5 mg, tablets
5. Alpragen, 1.0 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
   3. What is Alpragen and what is it used for
6. Important information before taking Alpragen
   1. When not to take Alpragen:
   2. Warnings and precautions
   3. Children and adolescents
   4. Alpragen and other medicines
   5. Alpragen and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Alpragen contains lactose monohydrate.
   9. Alpragen contains sodium
   10. Alpragen contains sodium benzoate
7. How to take Alpragen
   1. Adults (over 18 years of age)
   2. Elderly patients
   3. Patients with liver or kidney failure
   4. Duration of treatment
   5. Taking a higher dose of Alpragen than recommended
   6. Missing a dose of Alpragen
   7. Stopping treatment with Alpragen
   8. Consult a doctor if any of these symptoms or mood changes occur.
8. Possible side effects
   1. Reporting side effects
9. How to store Alpragen
   1. Do not take this medicine after the expiry date stated on the carton and blister after
10. Contents of the packaging and other information
    1. What Alpragen contains
    2. What Alpragen looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Viatris Healthcare Sp. z o.o.
    5. Date of last revision of the leaflet:

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Alpragen, 0.25 mg, tablets

Alpragen, 0.5 mg, tablets

Alpragen, 1.0 mg, tablets

Alprazolam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Alpragen and what is it used for
• 2. Important information before taking Alpragen
• 3. How to take Alpragen
• 4. Possible side effects
• 5. How to store Alpragen
• 6. Contents of the packaging and other information

1.

What is Alpragen and what is it 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 the symptoms are severe, interfere with normal functioning, or are very troublesome for the patient. This medicine is intended for short-term use only.

2. Important information before taking Alpragen

When not to take 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 apnea syndrome (irregular breathing during sleep)
• if the patient has severe liver failure
• if the patient has acute alcohol poisoning or other substances affecting the central nervous system, such as narcotics
• if the patient has been diagnosed with glaucoma

Warnings and precautions

Before starting to take Alpragen, discuss it with your doctor or pharmacist

• -if the patient has long-term lung problems, mild to moderate liver or kidney disorders
• -if the patient has depression or anxiety disorders associated with depression, as alprazolam may cause suicidal thoughts (if they occur) to become more frequent
• -if the patient is taking other medicines for anxiety disorders or insomnia
• if the patient is taking medicines that affect the central nervous system (e.g., benzodiazepines, neuroleptics)
• -if the patient has a history of substance abuse or alcoholism, or if they have difficulty stopping the use of medicines, drinking alcohol, or taking substances. The doctor may recommend special help when stopping this medicine
• -if the patient has personality disorders
• -if the patient is elderly, this medicine may cause drowsiness or muscle weakness, which can lead to falls, often with serious consequences

During treatment with Alpragen, the patient may experience anterograde amnesia. To reduce the risk, the patient should have uninterrupted sleep for 7-8 hours during treatment.
Alprazolam use has been associated with unusual reactions, such as: anxiety, especially motor, agitation, irritability, aggression, delusions, fits of anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (loss of contact with reality), and strange behavior. If such symptoms occur , you should consult a doctor, as it may be necessary to
stop taking the medicine.

Children and adolescents

Alpragen is not recommended for children and adolescents under 18 years of age.

Alpragen and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription. It is especially important to inform your doctor about taking medicines such as:

• antipsychotic medicines (used to treat mental disorders) such as haloperidol and chlorpromazine, sleeping medicines (used to induce sleep) such as phenobarbital and zolpidem, sedatives (used to treat anxiety) such as diazepam and lorazepam, opioid painkillers (a type of painkiller) such as propoxyphene, cough 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 opiates), anesthetics (used for anesthesia) 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 reuptake inhibitors (SSRIs, used to treat depression, e.g., fluoxetine or sertraline)
• medicines used to treat epilepsy (e.g., phenytoin and carbamazepine)
• antihistamines (e.g., 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, also known as anxiety disorder). When taking these medicines, the dose of alprazolam should be adjusted accordingly
• imipramine or desipramine - tricyclic antidepressants (TCA), used to treat depression, as the dose may need to be changed
• oral contraceptives
• diltiazem (used to treat angina and high blood pressure)
• certain antibiotics, such as erythromycin, clarithromycin, telithromycin, 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 symptoms of digoxin toxicity (symptoms include irregular heartbeat, confusion, hallucinations, vision disturbances, headaches, abdominal pain, nausea, and vomiting) when taking digoxin with Alpragen

Taking Alpragen with opioids (strong painkillers, medicines used in substitution therapy for drug addiction, some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening.
Deaths have been reported. For this reason, concurrent use should only be considered when other treatment methods are not possible.
However, if the doctor prescribes Alpragen with opioids, the dosage and duration of such treatment should be limited by the attending physician.
The patient should inform the 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. In case of such symptoms, the patient should contact their doctor.
In case of planned surgery under general anesthesia, the patient should 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 too much 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Do not
take Alpragen if the patient is pregnant without discussing the possible risks and benefits of taking this medicine with their doctor.
If alprazolam is taken regularly in the last trimester of pregnancy, the baby may experience withdrawal symptoms after birth, such as low body temperature, limpness, breathing difficulties, and feeding problems, tremors, increased irritability, and agitation.
If the doctor decides to take alprazolam in late pregnancy or during childbirth, the baby may experience symptoms such as low body temperature, limpness, breathing difficulties, and feeding problems, tremors, increased irritability, and agitation.
Do not take Alpragen while breastfeeding, as the medicine may pass into breast milk.

Driving and using machines

Do not drive or operate machinery after taking alprazolam, as it may cause symptoms such as: loss of concentration, loss of muscle control, memory loss, dizziness, drowsiness, or fainting.

Alpragen contains lactose monohydrate.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Alpragen.

Alpragen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means 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), but this medicine is not recommended for patients under 18 years of age.

3. How to take Alpragen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Adults (over 18 years of age)

The recommended dose is 0.25 mg to 0.5 mg three times a day.
If necessary, the doctor may decide to increase the dose to a maximum of 4 mg per day. In case of doubts, consult your doctor or pharmacist again. Be careful when increasing the dose. First, increase the evening dose, and then the daily dose.
For patients who have not taken this type of medicine before and for patients with a history of alcoholism, a lower dose should be used.

Elderly patients

The recommended dose for elderly patients is 0.25 mg two to three times a day. For elderly patients in good physical condition, the doctor may increase the dose by 0.5 mg every third day, up to a maximum dose of 1.5 mg per day. For frail elderly patients, the dose should not exceed 0.75 mg per day.
Alpragen should be taken orally. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Patients with liver or kidney failure

In case of liver or kidney failure, the doctor may recommend a lower dose than usual. The maximum recommended dose for patients with liver or kidney failure is 0.75 mg to 1.5 mg per day.

Duration of treatment

Alpragen should not be taken for longer than prescribed by your doctor. The total treatment duration should not exceed 2-4 weeks. Taking alprazolam for too long and in too high a dose may lead to the development of psychological and physical dependence. Do not stop treatment prematurely.

Taking a higher dose of Alpragen than recommended

In case of taking a higher dose than recommended , consult a doctor or go to the emergency department of the nearest hospital. Take the packaging of the medicine 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, just take the next dose at the right time.

Stopping treatment with Alpragen

Do not stop taking the medicine on your own. Before stopping treatment, the doses of the medicine should be gradually reduced. The doctor will inform the patient how to do this. If treatment with Alpragen is stopped too early, the patient may experience symptoms such as: anxiety, restlessness, especially motor, seizures, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and difficulty sleeping.
In severe cases, symptoms may also include loss of consciousness, loss of contact with reality, increased sensitivity to light, sound, and touch, feeling of numbness or tingling in the limbs, seeing or hearing things that do not exist, seizures, abdominal cramps, and muscle spasms, vomiting, sweating, and shivering.

Consult a doctor if any of these symptoms or mood changes occur.

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Alpragen can cause side effects, although not everybody gets them.
In people with a history of violence, borderline personality disorders, alcohol abuse, and those taking medicines that affect the central nervous system, hostile or aggressive behavior has been observed. If the patient has post-traumatic stress disorder, stopping treatment with Alpragen may cause irritability, hostility, and unpleasant thoughts and reflections.
Common side effects are usually observed at the beginning of treatment with Alpragen. These symptoms usually disappear during further treatment.
Consult a doctor immediatelyif any of the following side effects occur, as they may be serious:
Uncommon(may affect up to 1 in 100 people)

• 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: restlessness, especially motor, agitation, irritability, aggression, delusions, fits of anger, nightmares, hallucinations (seeing or hearing things that do not exist), loss of contact with reality (psychosis), and strange behavior
• withdrawal syndrome.

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

• increased risk of infections, which may be manifested by fever, severe chills, mouth ulcers, or throat pain. These may be symptoms of a low white blood cell count
• respiratory tract obstruction causing breathing difficulties
• liver inflammation, 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 symptoms such as itching 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
• medicine abuse

Stop taking the medicine. The doctor will inform the patient how to do this.
Other side effects
Very common(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

• increased or decreased appetite
• blurred vision
• feeling of detachment from the body (depersonalization)
• perceiving others and the surrounding world in an unrealistic way, as if in a dream (derealization)
• fear, nervousness, or anxiety, confusion, disorientation
• tingling, uncontrolled muscle contractions, coordination disorders, shivering, or trembling, balance problems
• difficulty concentrating, lack of energy
• rapid heartbeat, which may be felt as palpitations in the chest
• hot flashes
• stuffy nose, sore throat, or choking cough. These may be symptoms of an infection
• rapid breathing
• increased or decreased sexual desire
• insomnia
• excessive drowsiness
• sexual function disorders
• increased salivation
• vomiting, feeling of discomfort in the stomach, diarrhea, nausea (nausea), abdominal pain
• excessive sweating
• skin rash, itching
• muscle spasms or convulsions, back pain, muscle pain, joint pain
• chest pain
• unusual weakness
• swelling due to excess fluid in the body (peripheral edema)
• ringing in the ears
• risk of causing road accidents

Uncommon(may affect up to 1 in 100 people)

• greater tendency to bruise
• restless sleep
• talkativeness, impulsiveness, slowed thinking
• muscle weakness
• restricted movement
• double vision, other vision problems
• euphoria or excitement, inability to feel pleasure from pleasurable activities
• permanent inability to achieve orgasm
• mood changes
• panic attacks
• fainting
• clumsiness
• taste disorders
• state of near-unconsciousness (stupor)
• joint stiffness, limb pain
• involuntary urination (incontinence) or frequent urination during the day
• problems with ejaculation, inability to achieve or maintain an erection
• irregular menstrual periods in women
• general malaise
• change in gait, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of drunkenness
• flu-like symptoms, lethargy
• thirst
• increased bilirubin levels, which may be visible in blood tests
• falls, limb injuries
• overdose
• addiction to the medicine

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

• high prolactin levels in the blood, which may be visible in blood tests (hyperprolactinemia)
• hostile behavior
• inability to sit or stand still, hyperactivity
• thinking disorders
• learning and problem-solving difficulties
• vessel problems
• swelling of the hands and feet (peripheral edema)
• increased 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 disorders
• feeling of heat
• increased eye pressure

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, phone: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Alpragen

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.

Do not take this medicine after the expiry date stated on the carton and blister after

“EXP”.The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Alpragen contains

• The active substance of Alpragen is alprazolam. Each tablet contains 0.25 mg, 0.5 mg, or 1 mg of alprazolam
• Other ingredients are: lactose monohydrate (see section 2 "Alpragen contains lactose monohydrate"), microcrystalline cellulose, cornstarch, sodium benzoate, dioctyl sodium sulfosuccinate, povidone, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate
• The coating of the 0.5 mg tablets contains indigo carmine (E 132) and erythrosine aluminum lake (E 127)
• The coating of the 1.0 mg tablets contains indigo carmine (E 132)

What Alpragen looks like and contents of the pack

0.25 mg tablets: white, oval tablets with the inscription "AL" and a score line "0.25" on one side and "G" on the other side.
0.5 mg tablets: pink, oval tablets with the inscription "AL" and a score line "0.5" on one side and "G" on the other side.
1 mg tablets: light blue, oval tablets with the inscription "AL" and a score line "1.0" on one side and "G" on the other side.
Alpragen is available in packs containing 30 or 60 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Ltd., trading as Gerard Laboratories Ltd.
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
To obtain more detailed information, please contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

phone: +48 22 54 66 400

Date of last revision of the leaflet: