Alpragen

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Alpragen (Alprazolam Viatris)

0.5 mg, tablets

Alprazolam
Alpragen and Alprazolam Viatris are different trade names for the same medicine.

You should read 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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; Page 1 9

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, 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

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

Alpragen and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about 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 pills (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, antitussives (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 (used for anesthesia) such as halothane and bupivacaine, or antidepressants, as they may enhance the effects 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, troleandomycin, and rifampicin
• medicines used to treat HIV infections, called protease inhibitors (e.g., ritonavir)

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• 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 drug addiction, some antitussives) 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 options 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 with alcohol and drinking

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 a doctor or pharmacist before taking this medicine. Alpragen should not be taken
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 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.
Alpragen should not be taken during breastfeeding, as the medicine may pass into breast milk.

Driving and using machines

You should not drive or operate machinery after taking alprazolam, as symptoms such as loss of concentration, loss of muscle control, memory loss, dizziness, drowsiness, or confusion may occur.

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.
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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

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Alpragen is available in doses of 0.25 mg, 0.5 mg, and 1 mg.

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. If you are unsure, you should consult your doctor or pharmacist again.
Caution should be exercised when increasing the dose. The evening dose should be increased first, and then the daily dose.
In patients who have not taken this type of medicine before, 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 dose reduction period. 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 movements, 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.
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Stopping treatment with Alpragen

You should not stop taking Alpragen on your own. Before stopping treatment, the dose of the medicine should be gradually reduced. Your doctor will inform you how to do this. If you stop taking Alpragen or discontinue treatment too early, you 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 trembling.

You should consult a 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 further 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)
• unusual 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, severe chills, mouth ulcers, or throat pain. These may be symptoms of a low white blood cell count
• respiratory distress 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 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
• abuse of the medicine.

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 disturbances
• dizziness, difficulty controlling movements (ataxia)
• headaches
• speech difficulties
• 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 trembling, balance problems
• difficulty concentrating, lack of energy
• rapid heartbeat, which may be felt as palpitations in the chest (palpitations)
• hot flashes
• stuffy nose, sore throat, or suffocating cough. These may be symptoms of an infection
• rapid breathing
• increased or decreased sexual desire
• insomnia
• excessive drowsiness
• sexual dysfunction
• 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 caused by excess fluid in the body (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
• limited mobility
• double vision, other vision problems
• euphoria or feeling of 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)
• 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
• feeling unwell
• change in gait, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of drunkenness
• flu-like symptoms, lethargy
• increased bilirubin levels, which may be visible 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 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 tension problems
• 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Alpragen

The medicine should be stored out of sight and reach of children.
Protect from moisture.
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Do not take Alpragen after the expiry date stated on the packaging.

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 of the medicine are: lactose monohydrate (see section 2 "Alpragen contains lactose monohydrate"), microcrystalline cellulose, cornstarch, sodium benzoate, sodium docusate, povidone, anhydrous colloidal silica, sodium carboxymethylcellulose, magnesium stearate, aluminum lake of indigo carmine (E 132), and aluminum lake of erythrosine (E 127).

What Alpragen looks like and contents of the pack

Pink, oval tablets with the marking "AL", a score line, and "0.5" 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, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Viatris Santé
1 Rue de Turin
69007 Lyon
France

Manufacturer:

McDermott Laboratories LTD
trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin, Ireland
Viatris Santé
360 Avenue Henri Schneider
69330 Meyzieu
France
Europeenne de Pharmacotechnie - Europhartec
Rue Henri Matisse
63370 Lempdes
France
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary

Parallel importer:

Delfarma Sp. z o.o.
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ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in France, the country of export:
348 325-2
34009 348 325 2 9
561 820-7
34009 561 820 7 7

Parallel import authorization number: 120/18 Date of leaflet approval: 28.03.2023

[Information about the trademark]
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