Alpragen

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Alpragen (Alprazolam Viatris 1 mg tablets EFG)

1 mg, tablets

Alprazolam
Alpragen and Alprazolam Viatris 1 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 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, 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, the patient should discuss it with their doctor or pharmacist

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, the patient should consult their 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

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

• antipsychotic medicines (used to treat mental disorders) such as haloperidol and chlorpromazine, sleep-inducing 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 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 (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 (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.

Concomitant use of 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, 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.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage prescribed by their 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 their doctor about taking alprazolam.

Alpragen and drinking alcohol

The patient should not drink alcohol while taking Alpragen; alcohol enhances the effects of Alpragen.
The patient 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. The patient should not take Alpragen if they are 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, limpness, breathing difficulties, and feeding problems, tremors, increased excitability, and excitement.
The patient should not take Alpragen while breastfeeding, as the medicine may pass into breast milk.

Driving and operating machinery

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

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

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Alpragen is available in the following doses: 0.25 mg, 0.5 mg, 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. In case of doubts, the patient should consult their doctor or pharmacist again.
Care should be taken when increasing the dose. The patient should first increase the evening dose, 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 the doctor. The total treatment duration should not be longer than 2-4 weeks. Taking alprazolam for too long and in too high a dose may lead to the development of psychological and physical dependence. The patient should not stop treatment prematurely.

Taking a higher dose of Alpragen than recommended

In case of taking a higher dose than recommended, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. The patient should take the packaging of the medicine and any remaining tablets with them. Symptoms of overdose include drowsiness, confusion, lack of coordination or uncertain movements, breathing difficulties, low blood pressure, fatigue, loss of consciousness, and in rare cases, death.

Missing a dose of Alpragen

The patient should not take a double dose to make up for a missed dose; they should only take the next dose at the right time.

Stopping treatment with Alpragen

The patient should not stop taking Alpragen on their own. Before stopping treatment, the dose of the medicine should be gradually reduced. The doctor will inform the patient how to do this. If the patient stops taking Alpragen too early, they 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.

The patient should contact their doctor if they experience any of these symptoms or mood changes.

If the patient has any further doubts about taking this medicine, they should consult their 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, 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.
The patient should immediately inform their doctorif they experience any of the following side effects, as they may be serious:

• 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 determined 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 failure 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.

The patient should 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 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 saliva production
• 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 (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 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)
• joint stiffness, limb pain
• uncontrolled 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 determined 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
• problems with learning and problem-solving
• vascular problems
• swelling of the hands and feet (peripheral edema)
• increased alertness
• increased sensitivity to light
• rapid heartbeat (tachycardia)
• low blood pressure
• decreased saliva production
• liver function disorders, which can be seen in blood tests
• muscle tension problems
• feeling of heat
• increased eye pressure.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Alpragen

The medicine should be stored out of 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 packaging.The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 1 mg of alprazolam.
• The other ingredients are: lactose monohydrate (see section 2 "Alpragen contains lactose monohydrate"), microcrystalline cellulose, cornstarch, sodium benzoate, sodium docusate, povidone, colloidal silica, sodium carboxymethylcellulose, magnesium stearate, indigo carmine (E 132).

What Alpragen looks like and contents of the pack

Alpragen, 1 mg, are light blue oval tablets with "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.
For more detailed information, the patient 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:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Spain, the country of export:665208.4
Parallel import authorization number:19/21

Date of leaflet approval: 22.12.2023