ALPRAZOLAM 0.25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Alprazolam Aurovitas, 0.25 mg, tablets
3. Alprazolam Aurovitas, 0.5 mg, tablets
4. Alprazolam Aurovitas, 1 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
5. What is Alprazolam Aurovitas and what is it used for
6. Important information before taking Alprazolam Aurovitas
   1. Do not take Alprazolam Aurovitas:
   2. Warnings and precautions
   3. Children and adolescents
   4. Alprazolam Aurovitas and other medicines
   5. Using Alprazolam Aurovitas with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Alprazolam Aurovitas contains lactose monohydrate and orange yellow S (E 110) (only 0.5 mg)
   9. Alprazolam Aurovitas contains sodium
7. How to take Alprazolam Aurovitas
   1. Adults
   2. Elderly
   3. Use in children and adolescents
   4. Duration of treatment
   5. Taking a higher dose of Alprazolam Aurovitas than recommended
   6. Missing a dose of Alprazolam Aurovitas
   7. Stopping Alprazolam Aurovitas
8. Possible side effects
9. How to store Alprazolam Aurovitas
10. Contents of the package and other information
    1. What Alprazolam Aurovitas contains
    2. What Alprazolam Aurovitas looks like and contents of the pack
    3. Marketing authorization holder and manufacturer/importer
    4. Marketing authorization holder:
    5. Manufacturer/Importer:
    6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the package leaflet: 10/2023

Package Leaflet: Information for the User

Alprazolam Aurovitas, 0.25 mg, tablets

Alprazolam Aurovitas, 0.5 mg, tablets

Alprazolam Aurovitas, 1 mg, tablets

Alprazolam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Alprazolam Aurovitas and what is it used for
• 2. Important information before taking Alprazolam Aurovitas
• 3. How to take Alprazolam Aurovitas
• 4. Possible side effects
• 5. How to store Alprazolam Aurovitas
• 6. Contents of the package and other information

1. What is Alprazolam Aurovitas and what is it used for

The active substance of the medicine is alprazolam. It belongs to a group of medicines called benzodiazepines.
Alprazolam acts on the central nervous system, reducing anxiety. It also has a calming effect, causing drowsiness and muscle relaxation.
Alprazolam Aurovitas is used for:

• Short-term symptomatic treatment of anxiety in adults.

Alprazolam Aurovitas is indicated only in situations where the symptoms are severe, disrupt normal functioning, or are very troublesome for the patient.

2. Important information before taking Alprazolam Aurovitas

Do not take Alprazolam Aurovitas:

• if you are allergic to alprazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• if you have a disease called "myasthenia", characterized by very weak and quickly fatigued muscles.
• if you have significant respiratory or breathing difficulties (e.g., chronic bronchitis or pulmonary emphysema).
• if you have sleep apnea - a condition in which breathing becomes irregular, even stopping for a short period, during sleep.
• if you have severe liver function disorders.

Warnings and precautions

Before starting treatment with Alprazolam Aurovitas, discuss it with your doctor or pharmacist.
The patient should consider that the effect of the tablets will weaken after taking them for a period of several weeks (development of tolerance to the medicine).
If the patient is concerned that alprazolam may cause physical and mental dependence.
If the patient does not want to stop treatment, it may indicate psychological dependence on taking this medicine. If physical dependence has occurred, withdrawal of treatment may be accompanied by withdrawal symptoms (see section 3, Stopping Alprazolam Aurovitas). The risk of dependence increases with increasing dose and duration of treatment in patients who have previously been dependent on alcohol or drugs or if several benzodiazepines are used together. Therefore, treatment should last as short as possible.
Benzodiazepines and related products should be used with caution in the elderly, due to the risk of drowsiness and (or) skeletal muscle weakness, which may contribute to falls, often with serious consequences in this population.
If the patient has a history of alcohol, drug, or medication dependence.
If the patient has memory disorders. Memory loss usually occurs a few hours after taking the medicine. To reduce the risk, make sure the patient will have uninterrupted sleep for 7-8 hours after taking the medicine.
Occurrence of unexpected reactions in the patient: e.g., restlessness, excitement, irritability, aggression, delusions, outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior, confusion, and other behavioral disorders. These unexpected reactions occur frequently in children and the elderly.
Chronic lung disease in the patient.
If the patient is also using alcohol and sedatives.
Occurrence of severe depression in the patient (risk of suicide).
If the patient has depression and during treatment, symptoms of mania (state of excessive excitement, feeling of euphoria, or excessive irritability) or hypomania (state of excitement and excessive activity) occur.
Recognized kidney or liver function disorders in the patient.
Recognized mental illness in the patient.
Occurrence of a certain type of glaucoma in the patient.
If the patient is scheduled for surgery
The patient should inform the doctor about taking Alprazolam Aurovitas.

Children and adolescents

Alprazolam Aurovitas should not be used in children and adolescents under 18 years of age.

Alprazolam Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as medicines you plan to take, as the effect of Alprazolam Aurovitas may be stronger when used at the same time.
Some medicines may cause side effects if taken with alprazolam.
If you are taking certain other medicines, the effectiveness of treatment may change.
In this case, your doctor may adjust the treatment or dosage.
Such medicines include:

• Sedatives, sleeping pills;
• Antipsychotic, antidepressant medicines;
• Anticonvulsant medicines;
• Anesthetics;
• Strong painkillers acting on the central nervous system;
• Sedating antihistamines.

Medicines that increase the effect of alprazolam because they slow down its metabolism in the liver:

• Nefazodone, fluvoxamine, fluoxetine, sertraline (used to treat severe depression);
• Cimetidine (used to treat stomach problems);
• Medicines used to treat HIV;
• Dextropropoxyphene;
• Oral contraceptives;
• Diltiazem (used to treat high blood pressure and heart disorders);
• Certain antibiotics (e.g., erythromycin, clarithromycin, telithromycin, and troleandomycin) and certain antifungal medicines (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole).

Medicines that weaken the effect of alprazolam because they increase its metabolism in the liver:

• Carbamazepine or phenytoin (used to treat epilepsy and other diseases);
• St. John's Wort (Hypericum perforatum, herbal product);
• Rifampicin (used to treat tuberculosis);
• Concomitant use of alprazolam and HIV protease inhibitors (e.g., ritonavir) requires dose adjustment or discontinuation of alprazolam.

Alprazolam may enhance the effect of medicines such as:

• Digoxin (used to treat heart disorders);
• Muscle relaxants;
• Imipramine and desipramine (used to treat severe depression);
• Clozapine (used to treat psychosis). The risk of respiratory depression and (or) cardiac arrest increases.

Alcohol enhances the sedative effect of alprazolam.
Concomitant use of Alprazolam Aurovitas and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Alprazolam Aurovitas with opioids, they should limit the dose and duration of concomitant treatment.
You should tell your doctor about all opioid medicines you are taking and strictly follow the prescribed dose. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, you should contact your doctor.
During the next visit, remember to tell your doctor about taking Alprazolam Aurovitas.

Using Alprazolam Aurovitas with food, drinks, and alcohol

Tablets should be taken with a glass of water or other liquid.
Alcohol
Do not drink alcohol while taking Alprazolam Aurovitas.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Alprazolam Aurovitas should not be used during pregnancy, unless your doctor considers it absolutely necessary for the mother.
There are no sufficient data on the use of alprazolam in pregnant women. Alprazolam Aurovitas should not be used during pregnancy, suspected pregnancy, or planning pregnancy, unless your doctor considers it absolutely necessary. Observations in humans indicate that the use of alprazolam may be harmful to the fetus (increased risk of developmental abnormalities (cleft palate)). If you are pregnant or planning to become pregnant, you should discuss with your doctor the possibility of stopping treatment. However, if you are taking Alprazolam Aurovitas until the day of delivery, you should inform your doctor, as the newborn may experience some withdrawal symptoms. The use of high doses in late pregnancy or during delivery may cause the newborn to have low body temperature, respiratory depression, decreased muscle tone, and weak sucking reflex (floppy infant syndrome).
Alprazolam Aurovitas should not be used during breastfeeding. There is a risk of harmful effects on the baby.

Driving and using machines

Due to the sedative, muscle relaxant, and sleep-inducing effects, alprazolam may impair performance and other tasks requiring special attention, especially at the beginning of treatment and in case of insufficient sleep. Therefore, you should not drive vehicles or operate machines while taking Alprazolam Aurovitas.

Alprazolam Aurovitas contains lactose monohydrate and orange yellow S (E 110) (only 0.5 mg)

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
Alprazolam Aurovitas also contains a coloring agent called orange yellow S (E 110), which may cause allergic reactions.

Alprazolam Aurovitas contains sodium

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

3. How to take Alprazolam Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you how many tablets to take and when.
Do not take the tablet with an alcoholic drink.
Treatment should be started with the minimum recommended dose. Do not exceed the maximum recommended dose.

Adults

Usually start with one 0.25 mg tablet or one 0.5 mg tablet three times a day. This gives a total dose of 0.75 mg to 1.5 mg per day.
This may be gradually increased to a total of 4 mg per day in divided doses throughout the day.
If the dose needs to be increased, it is usually the nocturnal dose that is increased first, before the daytime dose, to ensure that patients are more alert during the day. If side effects occur, your doctor may reduce the dose.

Elderly

In elderly patients and (or) with impaired renal or hepatic function, when a lower dose is required, treatment may be started with a dose of 0.25 mg twice or three times a day.
This dose may be slowly increased if necessary and if no side effects occur.

Use in children and adolescents

Alprazolam Aurovitas should not be used in children and adolescents under 18 years of age.
The tablet can be divided into equal doses.

Duration of treatment

The risk of dependence and abuse may increase with dose and duration of treatment.
Therefore, your doctor will prescribe the lowest effective dose and recommend the appropriate treatment duration, as well as reassess the need for continued treatment (see section 2 - Warnings and precautions).
The maximum treatment duration should not exceed 2-4 weeks. Long-term treatment is not recommended. If the medicine is used for more than a few weeks, the effect of the medicine may weaken.
In the event of withdrawal of the medicine, the dose should be gradually reduced, according to the doctor's instructions.

Taking a higher dose of Alprazolam Aurovitas than recommended

If you or anyone else (e.g., a child) has taken too much of this medicine, you should immediately contact a doctor or go to the hospital. If you are conscious, you should quickly take activated charcoal.
When going to the doctor or hospital, take the medicine packaging with you.
Taking too much alprazolam can cause excessive drowsiness, muscle weakness (coordination disorders), and decreased level of consciousness. It is also possible to have decreased blood pressure, loss of consciousness, and respiratory depression. Alcohol and other factors that depress the central nervous system enhance the adverse effects of alprazolam.

Missing a dose of Alprazolam Aurovitas

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.

Stopping Alprazolam Aurovitas

Alprazolam may cause physical and psychological dependence. The risk of dependence is highest during treatment with high doses and long treatment periods in patients who have previously abused alcohol, drugs, or when treatment is combined with other benzodiazepines.
Stopping treatment suddenly can cause withdrawal symptoms (e.g., headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability, and insomnia, and in severe cases depersonalization, derealization, increased sensitivity to sound, vomiting, sweating, loss of sensation, feeling of tingling in the limbs, increased sensitivity to light, sounds, and touch, hallucinations, seizures).
Withdrawal symptoms may occur a few days after stopping treatment.
Therefore, do not stop taking Alprazolam Aurovitas suddenly; the dose should be gradually reduced, according to your doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alprazolam Aurovitas can cause side effects, although not everybody gets them.
The most common side effect is drowsiness, which may be associated with ataxia (lack of coordination) and muscle relaxation. Drowsiness may occur especially in elderly patients. The greatest intensity of drowsiness occurs at the beginning of treatment. It will decrease or disappear after reducing the dose or during further treatment.
Side effects related to alprazolam treatment in patients participating in controlled clinical trials and post-marketing experience were:

• Sedation, drowsiness,
• Depression,
• Difficulty in controlling movements (ataxia),
• Memory disorders,
• Slurred speech,
• Dizziness,
• Headache,
• Constipation,
• Dry mouth,
• Fatigue,
• Irritability.

Common(occurring in less than 1 in 10 patients):

• Decreased appetite
• Confusion, disorientation, restlessness (akathisia),
• Changes in sexual desire (decreased libido, increased libido),
• Insomnia (inability to sleep or sleep disorders),
• Nervousness or feeling of anxiety or agitation,
• Balance disorders, coordination disorders,
• Attention disorders,
• Abnormal sleep (hypersomnia),
• Obvious weakness (lethargy),
• Tremors or shakiness,
• Difficulty concentrating,
• Blurred vision,
• Tachycardia (rapid heart rate), palpitations,
• Nasal congestion,
• Nausea,
• Allergic rash,
• Skin inflammation (dermatitis),
• Sexual function disorders,
• Weakness (asthenia),
• Weight loss, weight gain.

Uncommon(occurring in less than 1 in 100 patients):

• Lack of appetite (anorexia),
• Mania (excessive activity and abnormal excitement),
• Hallucinations, outbursts of anger, agitation,
• Dependence on the medicine,
• Excitement,
• Amnesia (memory loss),
• Double vision,
• Vomiting,
• Itching,
• Muscle weakness,
• Urinary incontinence, menstrual disorders,
• Medicine withdrawal syndrome.

Rare(occurring in less than 1 in 1,000 patients):

• Low blood pressure,
• Agranulocytosis (lack of certain white blood cells in the blood),
• Skin reactions,
• Increased appetite,
• Feeling of numbness, decreased sensitivity,
• Cholestasis (decreased bile flow),
• Occasional ovulation disorders and breast enlargement.

Frequency not known(cannot be estimated from the available data):

• Hepatitis (inflammation of the liver),
• Hyperprolactinemia (abnormally high prolactin levels in the blood),
• Hypomania,
• Peripheral edema (swelling of the ankles, feet, or fingers),
• Aggressive or hostile behavior,
• Abnormal thinking,
• Psychomotor stimulation,
• Addiction,
• Autonomic nervous system imbalance,
• Muscle tone disorders (dystonia),
• Gastrointestinal disorders (increased salivation, difficulty swallowing, diarrhea),
• Jaundice, liver function disorders,
• Angioedema (swelling under the skin),
• Excessive sensitivity to light,
• Urinary retention,
• Increased intraocular pressure.

Alprazolam may cause physical and psychological dependence. See section "Warnings and precautions”.
Sudden discontinuation of Alprazolam Aurovitas may cause withdrawal symptoms, such as anxiety, insomnia, and seizures (see also "Stopping Alprazolam Aurovitas").
Reporting suspected adverse reactions
If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Drug Safety Monitoring, 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alprazolam Aurovitas

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture.
HDPE bottle containing 1000 tablets:
Shelf life after first opening the HDPE bottle: 6 months.
Do not use this medicine after the expiry date stated on the blister, label, and carton after EXP. The expiry date refers to the last day of the month.
Medicines should 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 package and other information

What Alprazolam Aurovitas contains

• The active substance is alprazolam. Each tablet contains 0.25 mg or 0.5 mg or 1 mg of alprazolam.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch, sodium benzoate (E 211), colloidal anhydrous silica, magnesium stearate, orange yellow S (E 110), lake (only for 0.5 mg), indigo carmine (E 132), lake (only for 1 mg), erythrosine (E 127), lake (only for 1 mg).

What Alprazolam Aurovitas looks like and contents of the pack

Tablet
Alprazolam Aurovitas, 0.25 mg, tablets
White, oval, uncoated tablets with a dividing line on one side, with the inscription "5" and "0" on either side of the dividing line and "Z" on the other side.
Alprazolam Aurovitas, 0.5 mg, tablets
Oval, uncoated tablets in peach color, with a dividing line on one side, with the inscription "5" and "1" on either side of the dividing line and "Z" on the other side.
Alprazolam Aurovitas, 1 mg, tablets
Oval, uncoated tablets in lavender color, with a dividing line on one side, with the inscription "5" and "2" on either side of the dividing line and "Z" on the other side.
Alprazolam Aurovitas tablets are available in blisters and HDPE bottles in cardboard boxes.
Pack sizes:
Blister: 20, 30, 50, and 60 tablets.
HDPE bottle: 30 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Tel: +48 22 311 20 00

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Alprazolam AB 0.25 mg/0.5 mg/1 mg tablets
Czech Republic:
Alprazolam Aurovitas 0.25 mg/1 mg tablets
Netherlands:
Alprazolam Aurobindo 0.25 mg/0.5 mg tablets
Poland:
Alprazolam Aurovitas
Portugal:
Alprazolam Aurovitas
Spain:
Alprazolam Aurovitas 0.25 mg/0.5 mg/1 mg tablets EFG

Date of last revision of the package leaflet: 10/2023