ALPRAGEN

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information in a foreign language.
Alpragen (Alprazolam Viatris 0,25 mg tablets EFG), 0.25 mg, tablets
Alprazolam
Alpragen and Alprazolam Viatris 0.25 mg tablets EFG are different brand names of the same
medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains important information
for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Alpragen is and what it is 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 pack and other information

1. What Alpragen is and what it is 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, but only in
situations where symptoms are severe, impair normal functioning, or cause significant distress to the patient. This medicine is intended for short-term use only.

2. Important information before using Alpragen

When not to use 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 apnoea syndrome (irregular breathing during sleep),
• if the patient has severe liver failure,
• if the patient has acute alcohol intoxication or intoxication with other substances acting on the central nervous system, e.g. narcotics,
• if the patient has been diagnosed with glaucoma.

Warnings and precautions
Before starting treatment with Alpragen, discuss this with your doctor or pharmacist if:

• the patient has chronic lung problems, mild to moderate liver or kidney dysfunction,
• the patient has depression or anxiety disorders associated with depression, because alprazolam may cause suicidal thoughts (if present) to become more frequent,
• the patient is taking other medicines for anxiety disorders or insomnia,
• the patient is taking medicines acting on the central nervous system (e.g. benzodiazepines, neuroleptics),
• the patient has previously abused narcotics or alcohol, or has difficulties stopping the use of medicines, drinking alcohol, or taking narcotics. The doctor may recommend special support when discontinuing this medicine.
• the patient has personality disorders,
• the patient is elderly; this medicine may cause drowsiness or muscle weakness, which may lead to falls, often with serious consequences.

During treatment, the patient may experience anterograde amnesia. To reduce the risk,
the patient should ensure uninterrupted sleep of 7–8 hours while taking the medicine.
Use of alprazolam has been associated with unusual reactions such as: anxiety,
particularly motor restlessness, agitation, irritability, aggression, hallucinations, rage attacks,
nightmares, illusions (seeing or hearing things that do not exist), psychosis (loss of contact with
reality), and strange behaviour. If such symptoms occur, contact a doctor immediately,
as treatment must be discontinued.
Children and adolescents
Alpragen is not recommended for use in children and adolescents under 18 years of age.
Alpragen and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. It is particularly important to inform the doctor about the use of medicines such as:

• antipsychotics (medicines used to treat mental disorders) such as haloperidol and chlorpromazine, hypnotics (medicines used to induce sleep) such as phenobarbital and zolpidem, anxiolytics (medicines used to treat anxiety) such as diazepam and lorazepam, opioid analgesics (a type of painkiller) such as propoxyphene, antitussives (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), anaesthetics (medicines used for anaesthesia) 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 re-uptake inhibitors (SSRIs), used to treat depression (e.g. fluoxetine or sertraline),
• medicines used to treat epilepsy (e.g. phenytoin and carbamazepine),
• antiallergic medicines (antihistamines such as 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), as the dose of alprazolam may need to be adjusted,
• imipramine or desipramine – tricyclic antidepressants (TCA), used to treat depression, as dose adjustment may be necessary,
• oral contraceptives,
• diltiazem (used to treat angina and hypertension),
• certain antibiotics, e.g. erythromycin, clarithromycin, telithromycin, troleandomycin and rifampicin,
• medicines used to treat HIV infection, called protease inhibitors (e.g. ritonavir),
• digoxin (a medicine used to treat heart conditions). The patient may experience digoxin toxicity symptoms (symptoms include irregular heartbeat, confusion, delirium, visual disturbances, headache, abdominal pain, nausea and vomiting) when digoxin is taken concomitantly with Alpragen.

Concomitant use of Alpragen with opioids (strong analgesics, medicines used in substitution therapy for drug addiction, some antitussives) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
Cases of fatal outcomes have been reported. Therefore, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor prescribes Alpragen together with opioids, the dosage and duration of treatment should be strictly limited by the treating physician.
Inform the doctor about all opioid medicines being taken and strictly follow the dosage recommended by the doctor. It may be helpful to inform friends or family about the above symptoms. If such symptoms occur, contact the doctor immediately.
If surgery under general anaesthesia is planned, inform the doctor about taking alprazolam.

Alpragen, food and alcohol
Do not drink alcohol while taking Alpragen; alcohol enhances the effect of Alpragen.
Do not drink large amounts of 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Do not
use Alpragen during pregnancy without discussing with the doctor the possible risks and benefits associated with using this medicine.
If alprazolam is used regularly during the last trimester of pregnancy, the newborn may develop dependence on alprazolam and withdrawal symptoms.
If the doctor decides to use alprazolam in late pregnancy or during delivery, the newborn may experience symptoms such as low body temperature, floppiness, breathing difficulties, feeding problems, tremors, increased excitability and agitation.
Do not use Alpragen during breastfeeding, as this medicine may pass into breast milk.

Driving and operating machinery
Do not drive or operate machinery after taking alprazolam, as symptoms such as: loss of concentration, loss of muscle control, memory loss, dizziness, drowsiness or dizziness may occur.

Alpragen contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Alpragen.

Alpragen contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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), however, this medicine is not recommended for use in patients under 18 years of age.

3. How to use Alpragen

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Alpragen is available in the following strengths: 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 daily.
If necessary, your doctor may decide to increase the dose up to the maximum dose of 4 mg per
day. If you have any doubts, please contact your doctor or pharmacist again.
Exercise caution when increasing the dose. First increase the evening dose, and only then the daytime dose.
In patients who have not previously taken this type of medicine, as well as 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 daily. In physically healthy elderly patients, the doctor may, if necessary, 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 daily dose should not exceed 0.75 mg.
Alpragen tablets should be taken orally. The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
Patients with hepatic or renal impairment
In cases of liver or kidney impairment, your doctor may recommend a lower than usual dose. The maximum recommended dose in patients with hepatic or renal impairment is 0.75 mg to 1.5 mg per day.
Duration of treatment
Alpragen should not be used for longer than prescribed by your doctor. The total duration of treatment should not exceed 2–4 weeks. Prolonged use of alprazolam at too high a dose may lead to the development of psychological and physical dependence. Do not discontinue treatment prematurely.
Taking more Alpragen than recommended
If you have taken more than the recommended dose, you should contact your doctor immediately or go to the nearest hospital emergency department. You should bring the medicine packaging 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
Do not take a double dose to make up for a missed dose. Simply take the next dose at the correct time.
Stopping Alpragen treatment
Do not stop taking this medicine on your own. Before stopping treatment, the dose should be gradually reduced. Your doctor will inform you how to do this. If treatment with Alpragen is stopped or discontinued too early, the patient may experience symptoms such as: anxiety, restlessness especially motor agitation, seizures, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and difficulty falling asleep. In extreme cases, symptoms may also include loss of awareness, detachment from reality, increased sensitivity to light, sound, and touch, tingling or numbness in the limbs, seeing or hearing things that are not real, seizures, abdominal and muscle cramps, vomiting, sweating, and tremors.
You should contact your doctor if any of these symptoms or mood changes occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Harmful or hostile behaviour has been observed in patients with a history of violence, borderline personality disorder, alcohol abuse, and in patients taking medicines affecting the central nervous system. In patients with post-traumatic stress, discontinuation of Alpragen treatment may cause irritability, hostility, and unpleasant thoughts and reflections.

Common adverse effects are observed at the beginning of Alpragen treatment. These symptoms usually resolve during continued treatment.

Immediately inform your doctor if any of the following adverse effects occur, as they may be serious:

Uncommon (may affect up to 1 in 100 patients)

• seizures
• epileptic seizures in the brain, which may 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: anxiety, especially motor restlessness, agitation, irritability, aggression, delusions, outbursts of anger, nightmares, seeing or hearing things that do not exist (hallucinations), loss of contact with reality (psychosis), and strange behaviour
• withdrawal syndrome.

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

• increased number of infections, which may present as fever, severe chills, mouth ulcers, or sore throat. These may be symptoms of low white blood cell count
• airway 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 (jaundice), pale stools, dark urine
• symptoms of severe allergic reaction, which may include itchy rash, swelling of the eyelids, face, lips, mouth, tongue, or throat, possibly causing difficulty in swallowing or breathing
• passing small amounts of urine or inability to pass urine
• medicine misuse.

Discontinue use of the medicine. Your doctor will advise you how to do this.

Other adverse effects

Very common (may affect more than 1 in 10 patients)

• drowsiness or sleepiness, sleep problems
• dizziness, difficulty controlling movements (ataxia)
• headache
• speech difficulties
• severe constipation, dry mouth
• fatigue
• increased or decreased body weight
• depression
• memory problems.

Common (may affect up to 1 in 10 patients)

• increased or decreased appetite
• blurred vision
• feeling detached from the body (depersonalization)
• perceiving other people and the surrounding world as unreal, dream-like (derealization)
• fear, nervousness, or anxiety, confusion, disorientation
• tingling, uncontrolled muscle spasms, coordination problems, chills, or tremors, balance problems
• difficulty concentrating, lack of energy
• rapid heartbeat, which may be felt as fluttering in the chest (palpitations)
• hot flushes
• stuffy nose, sore throat, or choking cough. These may be symptoms of infection
• rapid breathing
• increased or decreased sexual drive
• inability to sleep (insomnia)
• excessive sleepiness
• sexual dysfunction
• increased salivation
• vomiting, feeling of discomfort in the stomach, diarrhoea, nausea, stomach pain
• excessive sweating
• skin rash, itchy skin
• muscle cramps or spasms, back pain, muscle pain, joint pain
• chest pain
• unusual weakness
• swelling due to fluid accumulation in the body (oedema)
• ringing in the ears
• risk of causing road traffic accidents.

Uncommon (may affect up to 1 in 100 patients)

• 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 feel pleasure from enjoyable activities
• persistent inability to achieve orgasm
• mood changes
• panic attacks
• fainting
• clumsiness
• taste disturbances
• a state close to unconsciousness (stupor)
• joint stiffness, limb pain
• uncontrolled passing of urine (urinary incontinence) or frequent urination during the day
• problems with ejaculation, inability to achieve or maintain erection
• irregular menstruation in women
• malaise
• change in walking pattern, feeling of intoxication, feeling nervous or tense, feeling of relaxation, feeling of intoxication
• flu-like symptoms, drowsiness
• thirst
• increased bilirubin levels, which may be seen in blood tests
• falls, limb injuries
• overdose
• medicine dependence.

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

• high blood prolactin levels, which may be seen in blood tests (hyperprolactinaemia)
• hostile behaviour
• inability to sit or stand still, hyperactivity
• thinking disturbances
• problems with learning and problem-solving
• vascular problems
• swelling of hands and feet (peripheral oedema)
• excessive alertness
• increased sensitivity to light
• rapid heartbeat (tachycardia)
• low blood pressure
• reduced salivation
• liver function disturbances, which may be seen in blood tests
• muscle tone problems
• feeling of heat
• increased intraocular pressure.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 adverse effects helps provide more information on the safety of this medicine.

5. How to store Alpragen

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Alpragen contains

• The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other ingredients are: monohydrate lactose (see section 2 "Alpragen contains monohydrate lactose"), microcrystalline cellulose, maize starch, sodium benzoate (E 211), sodium lauryl sulfate, povidone, colloidal anhydrous silica, sodium carboxymethyl starch, magnesium stearate.

What Alpragen looks like and contents of the pack
White, oval tablets marked with "AL", a score line "0.25" on one side and "G" on the other side.
Alpragen is available in packs containing 30 tablets in blisters.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer:
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
The Netherlands
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Spain, the country of export: 665224.4
Parallel import licence number: 322/20