Alpragen

Package leaflet: Information for the user

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.
Alpragen (Alprazolam Mylan 0,25 mg tablets EFG), 0.25 mg, tablets
(Alprazolamum)
Alpragen and Alprazolam Mylan 0,25 mg comprimidos EFG are different brand names of the
same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains important
information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 or pharmacist. 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 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 abuses alcohol or narcotic drugs
• 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
• if the patient has depression or anxiety disorders associated with depression, because

alprazolam may cause suicidal thoughts (if present) to become more frequent

• if the patient is taking other medicines for anxiety disorders or insomnia
• if the patient has previously abused narcotic drugs or alcohol, or if the patient has difficulty stopping the use of medicines, drinking alcohol, or taking narcotic drugs. The doctor may recommend special assistance when discontinuing this medicine
• if the patient has personality disorders
• if 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: restlessness, especially motor agitation, excitement, 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 with the medicine 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 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 especially 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, because they may enhance the effects of alprazolam
• clozapine (a medicine used to treat mental illnesses such as schizophrenia). This medicine may increase the blood levels of alprazolam
• medicines belonging to the group of 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), during treatment with these medicines, the dose of alprazolam should be appropriately adjusted
• imipramine or desipramine – tricyclic antidepressants (TCA), used to treat depression, because 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)
• digoxin (a medicine used to treat heart diseases). The patient 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.
For this reason, concomitant use should only be considered when other treatment options are not feasible.
Nevertheless, if a doctor prescribes Alpragen together with opioids, the dosage and duration of treatment should be strictly limited by the treating physician.
Inform your 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 a doctor.
If a surgical procedure 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 effects of Alpragen. Avoid drinking large amounts of grapefruit juice during treatment with this medicine, as it may increase the blood levels of alprazolam.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Do not use Alpragen during pregnancy without discussing the possible risks and benefits with a doctor.
If alprazolam is used regularly during the last trimester of pregnancy, the newborn may develop dependence on alprazolam and experience 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 irritability and excitability.
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, contact a doctor before taking Alpragen.
Alpragen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".
Alpragen contains sodium benzoate (E 211)
This 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 life).

3. How to use Alpragen

This medicine should always be used according to the instructions given by your doctor or pharmacist.
If in doubt, 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 a day.
If necessary, your doctor may decide to increase the dose up to the maximum daily dose of 4 mg.
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 a day. In physically healthy elderly patients, the doctor may, if necessary, increase the dose by 0.5 mg every third day, up to a maximum daily dose of 1.5 mg. In frail elderly patients, the daily dose should not exceed 0.75 mg.
Alpragen tablets should be taken orally. The break 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 dysfunction, 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.
Taking more Alpragen than recommended
If you have taken more Alpragen than recommended, seek immediate medical advice from your doctor or go to the nearest hospital emergency department. Take 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.
If you forget to take Alpragen
Do not take a double dose to make up for a missed dose. Simply take the next dose at the scheduled time.
Stopping Alpragen treatment
Do not stop taking this medicine on your own. Before ending treatment, the dose should be gradually reduced. Your doctor will advise you how to do this. If treatment with Alpragen is stopped too early or discontinued prematurely, 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, disconnection from reality, increased sensitivity to light, sound, and touch, tingling or numbness in the limbs, hallucinations (seeing or hearing things that are not real), seizures, abdominal and muscle cramps, vomiting, sweating, and tremors.
Contact your doctor immediately 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.
If a patient suffers from post-traumatic stress, discontinuation of treatment with Alpragen 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.
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)

• convulsions
• 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, 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

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, which may cause difficulty in swallowing or breathing
• passing small amounts of urine or inability to pass urine. 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 in controlling movements (ataxia)
• headaches
• difficulty in speaking
• severe constipation, dry mouth
• fatigue
• increase or decrease in body weight
• depression
• difficulty in remembering.

Common (may affect up to 1 in 10 patients)

• increased or decreased appetite
• blurred vision
• feeling detached from the body (depersonalization)
• fear, nervousness or anxiety, confusion, disorientation
• tingling, uncontrolled muscle spasms, coordination disorders, 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 sex drive
• inability to sleep (insomnia)
• excessive sleepiness
• sexual dysfunction
• increased salivation
• vomiting, feeling of discomfort in the stomach, diarrhoea, nausea, abdominal pain
• excessive sweating
• skin rash, itchy skin
• 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 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 experience pleasure from enjoyable activities
• persistent inability to achieve orgasm
• mood changes
• panic attacks
• fainting
• clumsiness
• taste disturbances
• state close to unconsciousness (stupor)
• joint stiffness, limb pain
• involuntary urination (urinary incontinence) or frequent urination during the day
• problems with ejaculation, inability to achieve or maintain erection
• irregular menstruation in women
• malaise
• change in the way of walking, feeling of intoxication, feeling of nervousness or tension, feeling of relaxation, feeling of being high
• flu-like symptoms, drowsiness
• thirst
• increased bilirubin levels, which may be visible in blood tests
• falls, limb injuries
• overdose

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

• high levels of prolactin in the blood, which may be visible 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
• decreased salivation
• liver function disorders, which may be visible in blood tests
• problems with muscle tone
• feeling of warmth
• increased intraocular pressure

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the 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 pack 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, corn starch, sodium benzoate (E 211), sodium doxycycline, povidone, colloidal anhydrous silica, sodium carboxymethyl starch, magnesium stearate.

What Alpragen looks like and contents of the pack
White, oval tablets marked with "AL" and a score line "0.25" on one side and "G" on the other side.
Alpragen is available in packs containing 30 or 60 tablets in PVC/Al blisters within a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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 B.V., Dieselweg 25, 3752 LB Bunschoten, Netherlands
Parallel Importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
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 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Marketing Authorisation Number in Spain, the country of export: 665224.4
Parallel Import Licence Number: 108/22