Alpragen

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Alpragen(Alprazolam Viatris 0.5 mg tablets EFG)

0.5 mg, tablets

Alprazolamum
Alpragen and Alprazolam Viatris 0.5 mg tablets EFG are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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.
It is thought that alprazolam increases the activity of GABA receptors in the brain.
Alprazolam is used for a short period in the treatment of severe anxiety disorders.
Treatment with alprazolam should be short-term, as it may lead to dependence.

2. Important information before taking Alpragen

When not to take Alpragen:

Warnings and precautions

Before starting treatment with Alpragen, you should 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 (such as 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
• -if the patient has personality disorders
• -if the patient is elderly, as 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.
Treatment with alprazolam has been associated with the occurrence of atypical reactions, such as:
restlessness, especially motor, excitement, irritability, aggression, delusions, outbursts 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 discontinue the medicine.

Children and adolescents

Treatment with Alpragen is not recommended for children and adolescents under the age of 18.

Alpragen and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking, or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.
It is especially important to inform your doctor about the use of medicines such as:

• antipsychotic medicines (medicines used to treat mental disorders) such as haloperidol and chlorpromazine, sleeping medicines (medicines used to induce sleep) such as phenobarbital and zolpidem, sedatives (medicines used to treat anxiety) such as diazepam and lorazepam, opioid painkillers (a type of painkiller) such as propoxyphene, cough medicines (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), anesthetics (medicines 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) (medicines used to treat depression, such as fluoxetine or sertraline)
• medicines used to treat epilepsy (such as phenytoin and carbamazepine)
• antihistamines (such as cetirizine, cyclizine)
• medicines used to treat fungal infections (such as 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 (TCAs) 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, troleandomycin, and rifampicin
• medicines used to treat HIV infections, known as protease inhibitors (such as 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

Concomitant use of Alpragen with opioids (strong painkillers, medicines used in substitution therapy for opioid 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, concomitant 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.
You should inform your doctor about all opioid medicines you are taking and strictly follow the dosage prescribed by your doctor. It may be helpful to inform friends or family about the above symptoms. If such symptoms occur, you should contact your doctor.
In case of planned surgery under general anesthesia, you should inform your doctor about taking alprazolam.

Alpragen and alcohol

You should not drink alcohol while taking Alpragen; alcohol enhances the effect of Alpragen.
You should 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 you are pregnant without discussing the possible risks and benefits of taking this medicine with your doctor.
If alprazolam is taken regularly in the last trimester of pregnancy, the baby may experience dependence on alprazolam and withdrawal symptoms after birth.
If the doctor decides to use alprazolam in late pregnancy or during childbirth, the baby may experience symptoms such as low body temperature, hypotonia, breathing difficulties, and feeding difficulties, tremors, increased excitability, and agitation.
You should not take Alpragen while breastfeeding, as the medicine may pass into breast milk.

Driving and operating machinery

You should 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 that 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 use in patients under 18 years of age.

3. How to take Alpragen

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.

Adults (over 18 years old)

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, you should consult your doctor or pharmacist again.
Caution should be exercised when increasing the dose. You should first increase the evening dose, and then the daily 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 a day. In 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. In 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 period should not be longer than 8-12 weeks, including the period of dose reduction. Taking alprazolam for too long and in too high a dose may lead to the development of psychological and physical dependence.

Taking a higher dose of Alpragen than recommended

In case of taking a higher dose than recommended , you should immediately consult a doctor or go to the emergency department of the nearest hospital. You should take the packaging of the medicine and any remaining tablets with you.
Symptoms of overdose include: drowsiness, confusion, lack of coordination or unsteady gait, breathing difficulties, low blood pressure, fatigue, loss of consciousness, and in rare cases, death.

Missing a dose of Alpragen

You should not take a double dose to make up for a missed dose, you should only take the next dose at the right time.

Stopping treatment with Alpragen

You should not stop taking the medicine on your own. Before stopping treatment, the doses of the medicine should be gradually reduced. Your doctor will inform you how to do this.
In case of stopping or discontinuing treatment with Alpragen 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 tremors.

You should consult your doctor if you experience any of these symptoms or mood changes.

If you have any further doubts about taking this medicine, you should consult your 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 people taking medicines that affect the central nervous system, hostile or aggressive behavior has been observed.
If the patient has post-traumatic stress disorder, discontinuation of 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 continued treatment.
You should immediately inform your doctorif you experience any of the following side effects, as they may be serious:
Uncommon(may affect up to 1 in 100 people)

• seizures
• epileptic seizures in the brain, which can affect muscle activity, senses, vital functions, or changes in the way the patient thinks, feels, and experiences things
• memory loss (amnesia)
• atypical reaction to the medicine, which may include one or more of the following symptoms: restlessness, especially motor, excitement, irritability, aggression, delusions, outbursts 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 the available data)

• increased risk of infections, which may be manifested by fever, chills, mouth ulcers, or sore throat. 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 can cause difficulty swallowing or breathing
• passing small amounts of urine or inability to pass urine
• medicine abuse

You should stop taking the medicine. Your doctor will inform you 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
• difficulty speaking
• severe constipation, dry mouth
• fatigue
• weight gain or loss
• depression
• difficulty remembering.

Common(may affect up to 1 in 10 people)

• increased or decreased appetite
• blurred vision
• feeling of detachment from the body (depersonalization)
• perceiving other people 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 tremors, balance problems
• difficulty concentrating, lack of energy
• rapid heartbeat, which can 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 of the hands and feet (peripheral edema)
• ringing in the ears
• risk of causing road accidents

Uncommon(may affect up to 1 in 100 people)

• 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 enjoyable activities
• permanent inability to achieve orgasm
• mood changes
• panic attacks
• fainting
• clumsiness
• taste disorders
• state of near-unconsciousness (stupor)
• stiffness of the joints, limb pain
• involuntary urination (incontinence) or frequent urination during the day
• problems with ejaculation, inability to achieve or maintain an erection
• irregular menstrual cycles 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 can be seen in blood tests
• falls, limb injuries
• overdose
• dependence on the medicine

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

• high levels of prolactin in the blood, which can be seen 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 can be seen in blood tests
• muscle tone disorders
• feeling of heat
• increased eye pressure

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, tel: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Alpragen

The medicine should be stored in a place that is out of sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.

Do not take this medicine after the expiry date stated on the packaging after "EXP" or "CAD".

The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should 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 the medicine is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other ingredients are: lactose monohydrate (see section 2 "Alpragen contains lactose monohydrate"), microcrystalline cellulose, corn starch, sodium benzoate, sodium docusate, povidone, colloidal silica, sodium carboxymethylcellulose, magnesium stearate, indigo carmine (E 132), erythrosine (E 127).

What Alpragen looks like and contents of the pack

0.5 mg tablets: pink, oval tablets with the inscription "AL" line break "0.5" on one side and "G" on the other side.
Alpragen is available in packs containing 30 tablets in blisters.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Ltd.
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland
Mylan B.V.
Krijgsman 20
Amstelveen, 1186DM
Netherlands
Mylan Hungary Kft
Mylan utca 1
Komárom, H-2900
Hungary

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 665216.9
Parallel import authorization number: 246/20

Date of leaflet approval: 27.09.2023

[Information about the trademark]