Alpraxil

Leaflet attached to the packaging: patient information

Alpraxil, 0.25 mg, tablets

Alpraxil, 0.5 mg, tablets

Alpraxil, 1 mg, tablets

Alprazolam

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Alpraxil and what is it used for

The active substance of Alpraxil is alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines). Alpraxil is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for the patient. This medicine is intended for short-term use only.

2. Important information before taking Alpraxil

When not to take Alpraxil:

• if the patient is allergic to alprazolam and other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has myasthenia gravis (a disease characterized by excessive fatigue and muscle weakness);
• if the patient has severe respiratory failure;
• if the patient has sleep apnea syndrome;
• if the patient has severe liver failure.
• Alpraxil should not be taken by children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Alpraxil, you should discuss it with your doctor

• if the medicine is taken for a long time, as dependence on the medicine may occur, especially in patients prone to drug or alcohol abuse. The need for further treatment should be periodically assessed by the doctor;
• if the dose of the medicine is reduced or it is stopped suddenly [possible occurrence of withdrawal symptoms (see section 4)];
• if the medicine is taken by patients with depression, with suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is taking opioids, sleeping pills, sedatives, or drinking alcohol (the effect of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or other behavioral disorders occur. In case of the occurrence of these symptoms, the use of the medicine should be stopped and the doctor should be consulted;
• if the patient has glaucoma;
• if the patient has kidney or liver function disorders. Like other benzodiazepines, Alpraxil may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such a case, the patient should have uninterrupted sleep for 7-8 hours. Benzodiazepines and similarly acting substances should be used with caution in elderly patients, due to the risk of excessive sedation and (or) muscle weakness, which may lead to falls, often with serious consequences for such a patient.

Episodes of hypomania and mania have been reported in association with the use of Alpraxil in patients with depression. Before planned surgery, the doctor should be informed about the use of Alpraxil.

Alpraxil and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Particular caution should be exercised when taking Alpraxil with opioids, as they have a depressant effect on the respiratory system (slow down and shallow breathing). This is associated with a risk of excessive sedation, respiratory depression, coma, and even death.
• Alpraxil may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, opioid analgesic, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of opioid analgesics, there may be an increase in euphoria, which can lead to an increase in psychological dependence.
• Alcohol should not be consumed during treatment with Alpraxil.
• It is not recommended to take Alpraxil at the same time as certain antifungal medicines for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction should be considered when taking Alpraxil and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when taking alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• The concomitant use of Alpraxil and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin should be closely monitored for signs of digoxin toxicity (objective and subjective).
• Theophylline may decrease the effect of benzodiazepines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine. The use of the medicine is not recommended during pregnancy. If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be examined for potential fetal risk. If it is necessary to administer the medicine in the last period of pregnancy, high doses should be avoided and the newborn should be monitored. Benzodiazepines pass into human milk in small amounts. Alpraxil should not be taken during breastfeeding.

Driving and operating machines

Alpraxil causes impairment of psychophysical fitness. Before taking Alpraxil, you should familiarize yourself with current local traffic laws. You should not drive vehicles or operate machines while taking Alpraxil.

Alpraxil contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.

Alpraxil 0.5 mg and Alpraxil 1 mg contain sodium

The medicines contain less than 1 mmol (23 mg) of sodium per tablet, which means the medicines are considered "sodium-free".

3. How to take Alpraxil

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist. Treatment should be as short as possible. The doctor should regularly assess the patient's condition and the need to extend treatment, especially if the severity of the symptoms decreases and may not require pharmacological treatment. The total treatment time should not exceed 2-4 weeks. Long-term treatment is not recommended. At the start of treatment, the doctor will inform you about the limited duration of therapy, the gradual reduction of the dose during withdrawal, and the possibility of withdrawal symptoms.

• 2 – 4 weeks. Long-term treatment is not recommended. When starting treatment, the doctor will inform about the limited duration of therapy, the gradual reduction of the dose during withdrawal, and the possibility of withdrawal symptoms.

During the use of benzodiazepines, including Alpraxil, dependence and emotional or physical dependence may develop. This risk may increase with the dose and duration of treatment, so the smallest effective dose should be used for the shortest possible time, and the need for continued treatment should be regularly assessed with the doctor. Recommended dose The dose is determined by the doctor based on the severity of symptoms and the individual patient's response to treatment. If severe side effects occur after administration of the initial dose, the doctor may decide to reduce the dose. Symptomatic treatment of anxiety disorders The recommended initial dose is 0.25 mg or 0.5 mg three times a day. The doctor may decide to increase it, depending on the patient's response to treatment, to a maximum daily dose of 4 mg, given in divided doses, taken throughout the day.

Use in children and adolescents

Alpraxil should not be taken by children and adolescents under 18 years of age.

Use in patients with kidney or liver function disorders

The use of Alpraxil is contraindicated in patients with severe liver failure.

Use in elderly patients

The recommended initial dose is 0.25 mg twice or three times a day. If necessary, the doctor may decide to gradually increase the dose, depending on the patient's tolerance to the medicine. If side effects occur, the doctor will decide to reduce the initial dose.

Use of a higher than recommended dose of Alpraxil

Taking a higher than recommended dose of Alpraxil may cause: ataxia (motor incoordination), drowsiness, speech disorders, coma, and respiratory depression. If worrying symptoms occur, you should immediately contact a doctor.

Missing a dose of Alpraxil

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Alpraxil

You should not stop taking the medicine on your own. Since the treatment is symptomatic, after its discontinuation, the symptoms of the disease may return. The doctor will decide to gradually reduce the dose. In case of any further doubts related to the use of this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following side effects persist or are troublesome, you should inform your doctor. The occurrence of some side effects depends entirely on the individual patient's susceptibility and the dose of the medicine. Side effects are usually observed at the beginning of therapy. They disappear as treatment continues or when the dose is reduced. You should stop taking Alpraxil and immediately contact your doctor if you experience:

• symptoms of angioedema, such as:
• facial swelling, tongue or throat swelling,
• difficulty swallowing,
• hives and difficulty breathing. Angioedema has been reported with an unknown frequency (frequency cannot be estimated from the available data).
• symptoms of a severe allergic reaction, which may include symptoms such as itching rash, swelling of the eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (these side effects have been observed rarely or very rarely).

The frequency of side effects observed in clinical trials and after the medicine was introduced to the market:

Very common - may occur more frequently than in 1 in 10 patients:

• depression,
• sedation,
• drowsiness,
• ataxia (motor incoordination),
• memory disorders,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common - may occur not more frequently than in 1 in 10 patients:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual desire),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• coordination disorders,
• concentration disorders,
• excessive need for sleep,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• skin rash,
• sexual disorders,
• weight loss,
• weight gain.

Uncommon - may occur not more frequently than in 1 in 100 patients:

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• amnesia,
• muscle weakness,
• urinary incontinence,
• irregular menstrual cycles,
• withdrawal syndrome.

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

• hyperprolactinemia (elevated prolactin levels),
• hypomania,
• aggressive behavior,
• hostile behavior,
• thought disorders,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system disorders (which controls the function of internal organs, smooth muscles, and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disorders,
• hepatitis,
• liver disorders,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral edema (swelling of the ankles, feet, or toes),
• increased intraocular pressure.

Additionally, especially in patients taking other psychotropic medicines, with mental disorders, or abusing alcohol, a paradoxical reaction may occur with symptoms such as anxiety. Other side effects have been observed rarely or very rarely: motor disorders, epilepsy, psychotic symptoms, a feeling of changed self, agranulocytosis (a significant decrease in the number of granulocytes), allergic reactions, or anaphylaxis (severe allergic reactions). Benzodiazepines may cause physical and psychological dependence. If physical dependence occurs, sudden discontinuation of Alpraxil may cause withdrawal symptoms: headache, muscle pain, increased anxiety, feeling of tension, agitation, disorientation, irritability, feeling of changed environment or self, hearing disorders, stiffness, and paresthesia of limbs, hypersensitivity to light, noise, and touch, hallucinations, and epileptic seizures, insomnia, and mood changes. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Alpraxil

The medicine should be stored out of sight and reach of children. Store in the original packaging to protect from light. There are no special recommendations for the storage temperature of the medicine. Do not use this medicine after the expiry date stated on the packaging after: Expiry date (EXP). The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Alpraxil contains

• The active substance of Alpraxil is alprazolam. Each tablet contains 0.25 mg, 0.5 mg, or 1 mg of alprazolam.
• The other ingredients of the medicine are: lactose monohydrate, cornstarch, crospovidone, povidone K25, magnesium stearate, polysorbate 80, erythrosine E 127, aluminum lake - only Alpraxil 0.5 mg tablets and Alpraxil 1 mg tablets, indigo carmine E 132, aluminum lake - only Alpraxil 1 mg tablets

What Alpraxil looks like and what the packaging contains

Alpraxil 0.25 mg: white or almost white, round, biconvex tablets with a diameter of 7 mm ± 0.2 mm, with a dividing line embossed on one side. Alpraxil 0.5 mg: light pink, round, biconvex tablets with a diameter of 7 mm ± 0.2 mm, with a dividing line embossed on one side. Alpraxil 1 mg: light purple, round, biconvex tablets with a diameter of 7 mm ± 0.2 mm, with a dividing line embossed on one side. The dividing line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses. The packaging contains 30 tablets in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder:

Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań Tel. +48 61 66 51 500 e-mail: [email protected]

Importer

ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia

Date of last revision of the leaflet: