Alpragen

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

Alpragen (Alprazolam Mylan 1 mg EFG tablets), 1 mg, tablets

(Alprazolam)
Alpragen Alprazolam Mylan 1 mg EFGare 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.
It is believed 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 can lead to dependence.

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 abuses alcohol or drugs
• if the patient has been diagnosed with glaucoma

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
• 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 has a history of drug or alcohol abuse, or if they have difficulty stopping the use of medicines, drinking alcohol, or taking drugs. The doctor may recommend special help when stopping this medicine
• 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 subsequent memory loss. 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: anxiety, especially motor, excitement, 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 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 any 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) (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 obsessive-compulsive neurosis). 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, and 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.
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 recommended by your doctor. It may be helpful to inform friends or family about the above symptoms. In case of such symptoms, you should contact your doctor.
In case of planned surgery under general anesthesia, you should inform your doctor about taking alprazolam.

Alpragen and drinking 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. You should 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 become dependent on alprazolam and experience 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 problems, tremors, increased excitability, and excitement.
You should not take Alpragen while breastfeeding, as the 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, they should consult their doctor before taking Alpragen.

Alpragen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free”

Alpragen contains sodium benzoate (E 211)

This 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).

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 your 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. 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, then the daytime 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 recommended by the doctor. The total treatment duration should not exceed 8-12 weeks, including the period of dose reduction.

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 or stop 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 extreme cases, symptoms may also include loss of consciousness, loss of contact with reality, increased sensitivity to light, sound, and touch, a 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 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 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.
You should immediately inform your doctorif you 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)
• atypical reaction to the medicine, which may include one or more of the following symptoms: restlessness, especially motor, excitement, 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

Side effects with unknown frequency(the frequency cannot be determined 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 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

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)
• 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
• 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 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 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 movements
• 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)
• 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

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

• high prolactin levels 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 tension 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
Side effects can also be reported to the marketing authorization holder.
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.
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 specified month.
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 Alpragen is alprazolam. Each tablet contains 1 mg of alprazolam.
• Other ingredients are: lactose monohydrate (see section 2 "Alpragen contains lactose monohydrate"), microcrystalline cellulose, cornstarch, sodium benzoate (E 211), sodium docusate, povidone, anhydrous colloidal silica, sodium carboxymethylcellulose, magnesium stearate, indigo carmine (E 132).

What Alpragen looks like and what the packaging contains

Light blue, oval tablets with the marking "AL" and a dividing line "1.0" on one side and "G" on the other side.
Alpragen is available in packages containing 30 or 60 tablets in PVC/Al blisters in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Mylan Pharmaceuticals, S.L., C/ Plom, 2-4, 5ª planta, 08038 – Barcelona, Spain

Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan ut. 1, Komárom, 2900, Hungary

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
Marketing authorization number in Spain, the country of export:665208.4

Parallel import authorization number: 103/22 Date of approval of the leaflet: 23.02.2022