Alpragen

Leaflet accompanying 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 EFG)

0.5 mg, tablets

Alprazolam
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.
• 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.
Alpragen is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, prevent 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

Warnings and precautions

Before starting to take 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;

During treatment with Alpragen, the patient may experience subsequent amnesia. To reduce the risk, the patient should have uninterrupted sleep for 7-8 hours during treatment.
Taking alprazolam has been associated with the occurrence of atypical reactions, such as: anxiety, especially motor, agitation, 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 will be necessary to stop taking the medicine.

Children and adolescents

Taking 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 taking now or have taken recently, as well as the medicines you plan to take, including those that are available without a prescription. It is especially important to inform your doctor about taking 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 opiates), 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) (e.g., fluoxetine or sertraline), used to treat depression
• 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 (TLPD), 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 (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 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, 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.
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 consumption

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 she may be pregnant, or plans to have a child, she should consult a 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 take alprazolam in late pregnancy or during childbirth, the baby may experience symptoms such as low body temperature, limpness, breathing difficulties, and feeding difficulties, tremors, increased excitability, and agitation.
Do not take Alpragen while breastfeeding, as this medicine may pass into breast milk.

Driving and operating machinery

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

Alpragen contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some 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, which means 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), 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 according to the doctor's or pharmacist's instructions. If you have any doubts, you should consult a doctor or pharmacist.
Alpragen is available in doses of 0.25 mg, 0.5 mg, and 1 mg.

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. If you have any doubts, 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 addiction, 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 dividing line on the tablet is only to facilitate breaking it into smaller pieces for easier swallowing.

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 the 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 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.

Stopping treatment with Alpragen

You should not stop taking Alpragen on your own. Before ending treatment, the doses of the medicine should be gradually reduced. The doctor will inform you how to do this. If you stop taking Alpragen 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 extreme 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.

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 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 people taking medicines that affect the central nervous system, harmful or hostile behavior has been observed. If the patient has post-traumatic stress, 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.
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, agitation, 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 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
• 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 can 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. The 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
• 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 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 can be felt as palpitations in the chest (palpitations)
• 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), stomach 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)

• increased tendency to bruise
• restless sleep
• talkativeness, impulsiveness, slowed thinking
• muscle weakness
• restricted movements
• double vision, other vision problems
• euphoria or feeling of excitement, inability to feel 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
• uncontrolled urination (incontinence) or frequent urination during the day
• problems with ejaculation, inability to achieve or maintain an erection
• irregular menstrual periods 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
• thirst
• increased bilirubin levels, which can be seen in blood tests
• falls, limb injuries
• overdose
• addiction to the medicine.

Side effects with unknown frequency(frequency cannot be estimated from 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, 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 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 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, colloidal anhydrous silica, sodium carboxymethylcellulose, magnesium stearate, indigo carmine (E 132), and erythrosine (E 127).

What Alpragen looks like and what the packaging contains

Pink, oval tablets with the marking "AL", a dividing line, and "0.5" on one side and "G" on the other side.
Alpragen is available in packaging containing 30 or 60 tablets in blisters.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublín 15, Dublin, Ireland

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o., 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
Spanish marketing authorization number, country of export: 665216.9

Parallel import authorization number: 181/23

Date of leaflet approval: 01.03.2024

[Information about the trademark]