Alpragen

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Alpragen (Alprazolam Viatris)
0.5 mg, tablets
Alprazolamum
Alpragen and Alprazolam Viatris are different trade names for the same medicine.
Please read the entire leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any 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.
Alprazolam is believed to enhance the activity of GABA receptors in the brain.
Alprazolam is used short-term in the treatment of severe anxiety disorders.
Treatment with alprazolam should be short-term because it may lead to dependence.

2. Important information before taking Alpragen

When not to take Alpragen

• if you are allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have muscle weakness (myasthenia gravis);
• if you have severe breathing difficulties or lung disease;
• if you have been diagnosed with sleep apnoea syndrome (irregular breathing during sleep);
• if you have severe liver impairment;
• if you have acute alcohol intoxication or intoxication with other substances acting on the central nervous system, e.g. narcotics;
• if you have been diagnosed with glaucoma.

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

• you have chronic lung problems, or mild to moderate liver or kidney dysfunction; Page 1 of 9
• you have depression or anxiety disorders associated with depression, because alprazolam may increase the frequency of suicidal thoughts (if present);
• you are taking other medicines for anxiety disorders or insomnia;
• you are taking medicines acting on the central nervous system (e.g. benzodiazepines, neuroleptics);
• you have previously abused narcotics or alcohol, or have difficulty stopping the use of medicines, alcohol, or narcotics. Your doctor may recommend special support when discontinuing this medicine;
• you have personality disorders;
• you are elderly, as this medicine may cause drowsiness or muscle weakness, which may lead to falls, often with serious consequences.

During treatment, anterograde amnesia (memory loss for events after taking the medicine) may occur. To reduce this risk, ensure uninterrupted sleep of 7–8 hours while taking the medicine.
Use of alprazolam has been associated with unusual reactions such as: restlessness, especially motor agitation, excitement, irritability, aggression, hallucinations, rage attacks, nightmares, illusions (seeing or hearing things that do not exist), psychoses (loss of contact with reality), and strange behaviour. If such symptoms occur, you must consult your doctor, as treatment must be discontinued.

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

Alpragen with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• 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 (cough medicines) such as dextromethorphan and codeine, medicines such as methadone (which may be used for pain relief or to help people addicted to opioids), anaesthetics such as halothane and bupivacaine, or antidepressants, as these may enhance the effect of alprazolam;
• clozapine (a medicine used to treat mental illnesses such as schizophrenia). This medicine may increase the level 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 (antiallergic medicines) such as cetirizine, cyclizine;
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole, or other azole derivatives);
• cimetidine (used to treat gastric ulcers), nefazodone (used to treat depression), or fluvoxamine (used to treat obsessive-compulsive disorder). The dose of alprazolam may need to be adjusted when taking these medicines;
• 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, known as protease inhibitors (e.g. ritonavir).

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• digoxin (a medicine used to treat heart conditions). You may experience symptoms of digoxin toxicity (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. Fatal cases have been reported. Therefore, concomitant use should only be considered when other treatment options are not feasible.
Nevertheless, if your doctor prescribes Alpragen with opioids, the dosage and duration of treatment should be strictly limited by the prescribing physician.
Inform your doctor about all opioid medicines you are taking and strictly follow the prescribed dosage. It may be helpful to inform family members or friends about these symptoms. If such symptoms occur, contact your doctor immediately.
If you are scheduled for surgery under general anaesthesia, inform your doctor that you are taking alprazolam.

Alpragen, alcohol, and grapefruit juice
Do not drink alcohol while taking Alpragen; alcohol enhances the effect of Alpragen.
Do not consume large amounts of grapefruit juice while taking this medicine, as it may increase the level of alprazolam in the blood.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Do not take Alpragen during pregnancy unless you have discussed the potential risks and benefits with your doctor.
If alprazolam is used regularly during the third trimester of pregnancy, the newborn may become dependent on alprazolam and experience withdrawal symptoms.
If your 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 irritability, and excitability.
Do not take Alpragen while breastfeeding, as it 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 you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking Alpragen.

Alpragen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

Alpragen contains sodium benzoate
Each tablet contains 0.1 mg of sodium benzoate.
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.

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3. How to use Alpragen

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, 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 daily.
If necessary, your doctor may decide to increase the dose up to the maximum of 4 mg per day.
If in doubt, 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, 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 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 dose should not exceed 0.75 mg per day.
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, the 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 the doctor. The total duration of treatment should not exceed 8–12 weeks, including the tapering-off period. Prolonged use of alprazolam at high doses may lead to the development of psychological and physical dependence.
Taking more Alpragen than prescribed
If you have taken more than the prescribed dose, you should contact your doctor immediately or go to the emergency department of the nearest hospital. 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 scheduled time.
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Stopping Alpragen treatment
Do not stop taking this medicine on your own. Before stopping treatment, the dose should be gradually reduced. Your doctor will advise you on how to do this. If Alpragen is stopped or treatment is discontinued too early, symptoms such as anxiety, restlessness (especially motor restlessness), seizures, headaches, muscle pain, tension, confusion, irritability, involuntary movements, and difficulty sleeping may occur.
In extreme cases, symptoms may also include loss of awareness, detachment from reality, increased sensitivity to light, sound, and touch, feelings of numbness or tingling in the limbs, seeing or hearing things that are not there, seizures, abdominal and muscle cramps, vomiting, sweating, and tremors.
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 individuals with a history of violence, borderline personality disorder, alcohol abuse, or those taking medicines affecting the central nervous system.
In patients with post-traumatic stress, discontinuation of Alpragen treatment may lead to 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.
You should contact your doctor immediately if any of the following adverse effects occur, as they may be serious:
Uncommon (may affect up to 1 in 100 patients)

• seizures
• epileptic fits 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, excitement, 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 the 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, 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. Page 5 of 9

You should stop taking 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)
• headaches
• 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 (depersonalisation)
• perceiving other people and the surrounding world as unreal, dream-like (derealisation)
• fear, nervousness or anxiety, confusion, disorientation
• tingling, uncontrolled muscle spasms, lack of coordination, chills or tremors, balance problems
• difficulty concentrating, lack of energy
• rapid heartbeat, which may be felt as fluttering in the chest (palpitations)
• hot flushes
• blocked nose, sore throat or choking cough. These may be symptoms of infection
• increased breathing rate
• increased or decreased sex drive
• inability to sleep (insomnia)
• excessive sleepiness
• sexual dysfunction
• increased salivation
• vomiting, abdominal discomfort, diarrhoea, nausea, stomach ache
• excessive sweating
• skin rash, skin itching
• muscle cramps or twitching, back pain, muscle pain, joint pain
• chest pain
• unusual weakness
• swelling due to fluid retention in the body (oedema)
• ringing in the ears
• risk of causing road 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 experience pleasure from enjoyable activities
• persistent inability to achieve orgasm
• mood changes Page 6 of 9
• panic attacks
• fainting
• clumsiness
• taste disturbances
• 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 an erection
• irregular menstruation in women
• malaise
• change in walking pattern, feeling of intoxication, feeling of nervousness or tension, 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 the available data)

• high levels of prolactin in the blood, which may be seen in blood tests (hyperprolactinaemia)
• hostile behaviour
• inability to sit or stand still, hyperactivity
• disturbances in thinking
• 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
• problems with muscle tone
• 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 the medicine out of the sight and reach of children.
Protect from moisture.
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Do not use Alpragen 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Alpragen contains

• The active substance is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other ingredients are: lactose monohydrate (see section 2, "Alpragen contains lactose monohydrate"), microcrystalline cellulose, maize starch, sodium benzoate, sodium lauryl sulfate, povidone, colloidal anhydrous silica, sodium carboxymethyl starch, magnesium stearate, indigo carmine aluminium lake (E 132) and erythrosine aluminium lake (E 127).

What Alpragen looks like and contents of the pack
Pink, oval tablets marked with "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 blister packs.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation 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 Authorisation Number: 120/18
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