Alprazolam aurovitas

Package leaflet: Information for the user

Alprazolam Aurovitas, 0.25 mg, tablets
Alprazolam Aurovitas, 0.5 mg, tablets
Alprazolam Aurovitas, 1 mg, tablets
Alprazolamum
Read the entire leaflet carefully before taking this medicine because 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 share it with others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

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

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

• Short-term symptomatic treatment of anxiety in adults.

Alprazolam Aurovitas is indicated only in cases where symptoms are severe, interfere with normal functioning, or cause significant distress to the patient.

2. Important information before using Alprazolam Aurovitas

Do not use Alprazolam Aurovitas:

• if the patient is allergic to alprazolam, other benzodiazepine-containing medicines, or any of the other ingredients of this medicine (listed in section 6.).
• if the patient has a condition called "myasthenia gravis", characterized by very weak muscles that tire easily.
• if the patient has significant chest problems or breathing difficulties (e.g. chronic bronchitis or pulmonary emphysema).
• if the patient has sleep apnoea – a condition in which breathing becomes irregular or even stops briefly during sleep.
• if the patient has severe liver function disorders.

Warnings and precautions
Before starting treatment with Alprazolam Aurovitas, discuss this with your doctor or
pharmacist.
The patient should be aware that the effect of the tablets may decrease after several weeks of use (development of tolerance to the medicine).
If the patient is concerned that alprazolam may cause physical and psychological dependence.
If the patient does not wish to discontinue treatment, this may indicate psychological dependence on the medicine. If physical dependence has occurred, withdrawal symptoms may occur upon stopping treatment (see section 3., Discontinuing Alprazolam Aurovitas). The risk of dependence increases with higher doses and longer treatment duration, particularly in patients with a history of alcohol or drug dependence, or when multiple benzodiazepines are used concurrently. Therefore, treatment should be as short as possible.
Benzodiazepines and related substances should be used with caution in elderly patients due to the risk of drowsiness and/or muscle weakness, which may lead to falls, often with serious consequences in this population.
If the patient has a history of alcohol, medication, or drug dependence.
If the patient has memory disturbances. Memory loss usually occurs several hours after taking the medicine. To reduce this risk, ensure the patient can have uninterrupted sleep for 7–8 hours after taking the medicine.
Occurrence of unexpected reactions in the patient: e.g. motor restlessness, agitation, irritability, aggression, hallucinations, anger outbursts, nightmares, illusions, psychoses, inappropriate behaviour, confusion, and other behavioural disturbances. These unexpected reactions occur more frequently in children and elderly patients.
Chronic lung disease in the patient.
If the patient is concurrently using alcohol and sedative medicines.
Presence of severe depression in the patient (suicidal risk).
If the patient has depression and develops symptoms of mania (a state of excessive excitement, feelings of euphoria or excessive irritability) or hypomania (a state of excitement and excessive activity) during treatment.
Diagnosed kidney or liver function disorders in the patient.
Diagnosed psychiatric illness in the patient.
Presence 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
The use of Alprazolam Aurovitas is not recommended in children and adolescents under 18 years of age.

Alprazolam Aurovitas 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, because the effect of Alprazolam Aurovitas may be stronger when taken simultaneously.
Some medicines may cause adverse effects when taken together with alprazolam.
If the patient takes certain other medicines at the same time, treatment effectiveness may change.
In such cases, the doctor may adjust the treatment or dosage regimen.
Such medicines include:

Medicines that enhance the sedative effect of alprazolam:

• sleeping tablets, sedatives;
• antipsychotic medicines, antidepressants;
• antiepileptic medicines;
• anaesthetics;
• strong centrally acting opioid analgesics;
• sedative antihistamines.

Medicines that increase the effect of alprazolam by delaying its metabolism in the liver:

• nefazodone, fluvoxamine, fluoxetine, sertraline (used in the treatment of severe depression);
• cimetidine (used to treat stomach problems);
• medicines used in the treatment of HIV;
• dextropropoxyphene;
• oral contraceptives;
• diltiazem (used to treat high blood pressure and heart disorders);
• certain antibiotics (e.g. erythromycin, clarithromycin, telithromycin, troleandomycin) and certain antifungal medicines (e.g. itraconazole, ketoconazole, posaconazole, voriconazole).

Medicines that reduce the effect of alprazolam by increasing its metabolism in the liver:

• carbamazepine or phenytoin (used in the treatment of epilepsy and other disorders);
• St John's wort (Hypericum perforatum), a herbal product;
• rifampicin (used in the treatment of tuberculosis);
• concurrent use of alprazolam and protease inhibitors of HIV virus (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.

Alprazolam may enhance the effect of medicines such as:

• digoxin (used in the treatment of heart disorders);
• muscle relaxants;
• imipramine and desipramine (used in the treatment of severe depression);
• clozapine (used in the treatment of psychoses). This increases the risk of respiratory depression and/or cardiac arrest.

Alcohol enhances the sedative effect of alprazolam.
Concurrent use of Alprazolam Aurovitas and opioids (strong painkillers, medicines used in substitution treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible.
However, if a doctor prescribes Alprazolam Aurovitas together with opioids, the dose and duration of concomitant treatment should be minimized.
Inform your doctor about all opioid medicines you are taking and strictly follow the dose prescribed by your doctor. It may be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. If such symptoms occur, contact your doctor.
At your next visit, remember to inform your doctor that you are taking Alprazolam Aurovitas.

Taking Alprazolam Aurovitas with food, drink, and alcohol
Take the tablets with a glass of water or another liquid.
Alcohol
Do not consume alcohol while taking Alprazolam Aurovitas.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Alprazolam Aurovitas should not be used during pregnancy unless the doctor considers it absolutely necessary for the mother.
There is insufficient data on the use of alprazolam in pregnant women. Alprazolam Aurovitas should not be used during pregnancy, suspected pregnancy, or when planning pregnancy, unless the doctor considers it absolutely necessary. Observations in humans suggest that alprazolam use may be harmful to the fetus (increased risk of developmental abnormalities (cleft palate)). If the patient is pregnant or planning pregnancy, she should discuss the possibility of discontinuing treatment with her doctor. If, however, the patient continues taking Alprazolam Aurovitas until delivery, she should inform her doctor, as withdrawal symptoms may occur in the newborn. High-dose use late in pregnancy or during delivery may cause the newborn to have low body temperature, respiratory depression, reduced muscle tone, and poor feeding reflex (floppy infant syndrome).
Do not use Alprazolam Aurovitas during breastfeeding. There is a risk of harmful effects on the child.

Driving and operating machinery
Due to its sedative, muscle-relaxant, and sleep-inducing effects, alprazolam may impair performance in tasks requiring special alertness, especially at the beginning of treatment and when sleep is insufficient. Therefore, do not drive or operate machinery while taking Alprazolam Aurovitas.

Alprazolam Aurovitas contains lactose monohydrate and sunset yellow (E 110) (only 0.5 mg strength)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Alprazolam Aurovitas also contains a colouring agent called sunset yellow (E 110), which may cause allergic reactions.

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

3. How to use Alprazolam Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. Your doctor will tell you how many tablets to take and when.
Do not take this medicine with alcoholic drinks.
Treatment should be started with the lowest recommended dose. Do not exceed the maximum
recommended dose.

Adults
Usually, treatment starts with one 0.25 mg tablet or one 0.5 mg tablet taken three times a day. This
gives a total daily dose of 0.75 mg to 1.5 mg.
This dose may be gradually increased, if necessary, up to a total of 4 mg per day, divided into doses taken throughout the day.
When a dose increase is needed, the evening dose is usually increased first, before the daytime dose, to ensure patients remain more alert during the day. If side effects occur, your doctor may reduce the dose.

Elderly patients
For elderly patients and/or those with impaired kidney or liver function, when a lower dose is required, treatment may be started at 0.25 mg two or three times a day.
This dose may be slowly increased, if necessary and if no adverse effects occur.

Use in children and adolescents
Alprazolam Aurovitas must not be used in children and adolescents under 18 years of age.
The tablet may 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, recommend an appropriate treatment duration, and will periodically reassess the need for continued treatment (see section 2 – Warnings and precautions).
The maximum duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended. When the medicine is used for longer than a few weeks, a reduction in its effectiveness may occur.

Taking more Alprazolam Aurovitas than recommended
If you or anyone else (e.g. a child) has taken too much of this medicine, you should seek immediate medical advice from a doctor or go to a hospital. If the person is conscious, activated charcoal should be administered promptly.
When going to the doctor or hospital, take the medicine packaging with you.
Taking too much alprazolam may cause severe drowsiness, muscle weakness (impaired coordination), and reduced level of consciousness. A drop in blood pressure, loss of consciousness, and respiratory depression may also occur. Alcohol and other central nervous system depressants may intensify the adverse effects of alprazolam.

If you miss 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 a missed dose.

Stopping Alprazolam Aurovitas
Alprazolam may cause physical and psychological dependence. The risk of dependence is highest when high doses are used over a long period, in patients who abuse alcohol or drugs, or when treatment is combined with other benzodiazepines.
Abruptly stopping treatment may cause withdrawal symptoms (e.g. headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability, and insomnia; in severe cases, depersonalization, derealization, hyperacusis, vomiting, sweating, numbness, tingling in the limbs, photophobia, hypersensitivity to sound and touch, hallucinations, and seizures).
Withdrawal symptoms may occur several days after stopping treatment.
Therefore, do not stop taking Alprazolam Aurovitas abruptly; the dose should be gradually reduced according to your doctor's instructions.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly occurring adverse reaction is fatigue, which may be associated with
ataxia (lack of coordination of movements), impaired muscle coordination and confusion. Fatigue may
occur particularly in elderly patients. The greatest intensity of fatigue symptoms occurs at the beginning
of treatment. These symptoms will usually diminish or resolve with dose reduction or during continued
treatment.
Adverse reactions associated with alprazolam treatment in patients participating in controlled clinical trials and post-marketing experience were as follows:
Very common (affects more than 1 in 10 people) :

• sedation, drowsiness,
• depression,
• difficulty in controlling movements (ataxia),
• memory impairment,
• slurred speech,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common (affects less than 1 in 10 people) :

• decreased appetite,
• confusion, disorientation, motor restlessness (akathisia),
• changes in sexual drive (decreased libido, increased libido),
• insomnia (inability to sleep or sleep disturbances),
• nervousness or feelings of anxiety or agitation,
• balance disorders, coordination disorders,
• attention disturbances,
• excessive, abnormal sleepiness (hypersomnia),
• marked weakness (somnolence),
• tremor or shakiness,
• difficulty concentrating,
• blurred vision,
• tachycardia (rapid heartbeat), palpitations,
• nasal congestion,
• nausea,
• allergic rash,
• skin inflammation (dermatitis),
• sexual dysfunction,
• weakness (asthenia),
• weight loss, weight gain.

Uncommon (affects less than 1 in 100 people) :

• loss of appetite (anorexia),
• mania (excessive activity and abnormally elevated mood),
• hallucinations, outbursts of anger, agitation,
• drug dependence,
• stimulation,
• amnesia (memory loss),
• double vision,
• vomiting,
• itching,
• muscle weakness,
• urinary incontinence, menstrual disorders,
• withdrawal syndrome.

Rare (affects less than 1 in 1,000 people) :

• low blood pressure,
• agranulocytosis (lack of certain white blood cells in the blood),
• skin reactions,
• increased appetite,
• numbness, reduced alertness,
• cholestasis (reduced bile flow),
• sporadic ovulation disorders and breast enlargement.

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

• liver inflammation (hepatitis),
• hyperprolactinaemia (abnormally high level of prolactin in the blood),
• hypomania,
• peripheral oedema (swelling of ankles, feet or fingers),
• aggressive or hostile behaviour,
• abnormal thinking,
• psychomotor stimulation,
• drug abuse,
• autonomic nervous system imbalance,
• muscle tone disorders (dystonia),
• gastrointestinal disorders (increased salivation, difficulty swallowing, diarrhoea),
• jaundice, liver function abnormalities,
• subcutaneous swelling (angioedema),
• excessive sensitivity to light (photophobia),
• urinary retention,
• increased intraocular pressure.

Alprazolam may cause physical and psychological dependence. See section "Warnings and precautions".
Abrupt discontinuation of Alprazolam Aurovitas may cause withdrawal symptoms such as anxiety, insomnia and seizures (see also "Stopping Alprazolam Aurovitas").
Reporting of suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Alprazolam Aurovitas

Keep this medicine out of sight and reach of children.
Store in the original container to protect from light and moisture.
HDPE bottle containing 1000 tablets:
Shelf life after first opening of 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 stated month.
Medicines must not be disposed of via the sewage system 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 Alprazolam Aurovitas contains

• The active substance is alprazolam. Each tablet contains 0.25 mg, 0.5 mg or 1 mg of alprazolam.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, sodium lauryl sulfate with sodium benzoate (E 211), colloidal anhydrous silica, magnesium stearate, sunset yellow (E 110), lake (only for 0.5 mg), indigo carmine (E 132), lake (only for 1 mg), erythrosine (E127), 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 score line on one side, embossed with the characters "5" and "0" on either side of the score line and "'Z" on the other side.
Alprazolam Aurovitas 0.5 mg tablets
Oval, uncoated tablets of peach colour, with a score line on one side, embossed with the characters "5" and "1" on either side of the score line and "Z" on the other side.
Alprazolam Aurovitas 1 mg tablets
Oval, uncoated tablets of lavender colour, with a score line on one side, embossed with the characters "5" and "2" on either side of the score line and "Z" on the other side.
Alprazolam Aurovitas tablets are available in blisters and HDPE bottles packed in cardboard boxes.
Pack sizes:
Blisters: 20, 30, 50 and 60 tablets.
HDPE bottles: 30, 250 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 authorised in the European Economic Area countries under the following names:
Belgium: Alprazolam AB 0.25 mg/0.5 mg/1 mg tabletten
Netherlands: Alprazolam Aurobindo 0.25 mg/0.5 mg, tabletten
Poland: Alprazolam Aurovitas
Portugal: Alprazolam Aurovitas
Spain: Alprazolam Aurovitas 0.25 mg/0.5 mg/1 mg comprimidos EFG