Alpraxil

Package leaflet: Information for the patient

Alpraxil, 0.25 mg, tablets
Alpraxil, 0.5 mg, tablets
Alpraxil, 1 mg, tablets
Alprazolamum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Alpraxil is and what it is 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 pack and other information

1. What Alpraxil is and what it is used for

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

2. Important information before using Alpraxil

When not to use Alpraxil:

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

Warnings and precautions
Before starting treatment with Alpraxil, discuss the following with your doctor:

• if the medicine is used long-term, as dependence may occur, especially in patients prone to drug or alcohol abuse. The need for continued treatment should be periodically reviewed by the doctor;
• if the dose of the medicine is being reduced or the medicine is suddenly discontinued [withdrawal symptoms may occur (see section 4)];
• if the medicine is used in patients with depression, suicidal thoughts or tendencies;
• if the patient is using other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously using opioids, hypnotics, sedatives or consuming alcohol (the effects of these medicines or alcohol may be intensified);
• if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, inappropriate behaviour or other behavioural disturbances occur. If any of these symptoms appear, treatment with the medicine should be discontinued and the patient should contact the doctor;
• if the patient has glaucoma;
• if the patient has impaired kidney or liver function. Like other benzodiazepines, Alpraxil may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should ensure 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 patients.

Episodes of hypomania and mania have been reported with the use of Alpraxil in patients with depression.
Before a planned surgery, inform the doctor about taking Alpraxil.
Alpraxil and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

• Extreme caution is required when using Alpraxil together with opioids, as they have a depressant effect on the respiratory system (slowing and shallowing breathing). This is associated with the risk of excessive sedation, respiratory depression, coma, and even death.
• Alpraxil may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.
• When used with opioid analgesics, euphoria may be intensified, potentially increasing the risk of psychological dependence.
• Alcohol must not be consumed during treatment with Alpraxil.
• Concomitant use of Alpraxil with certain oral antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Extreme caution is required and dose reduction should be considered when Alpraxil is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
• Extreme caution is required when using alprazolam together with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin or troleandomycin).
• Concomitant use of Alpraxil and HIV protease inhibitors (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin simultaneously should be closely monitored for signs (objective and subjective) of digoxin toxicity.
• Theophylline may reduce the effect of benzodiazepines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Use of this medicine during pregnancy is not recommended.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be evaluated for potential risk to the foetus.
If administration of the medicine is necessary during the late stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. Alpraxil should not be used during breastfeeding.
Driving and operating machinery
Alpraxil may impair psycho-motor performance. Before using Alpraxil, patients should familiarise themselves with current local regulations regarding road traffic laws.
Patients should not drive or operate machinery while taking Alpraxil.
Alpraxil contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Alpraxil 0.5 mg and Alpraxil 1 mg contain sodium
These medicines contain less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicines are considered "sodium-free".

3. How to use Alpraxil

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
Treatment should last as short as possible. The physician should regularly assess the patient's condition and the need for continuing treatment, especially when the severity of the patient's symptoms decreases and may no longer require pharmacological treatment. Total treatment duration should not exceed 2–4 weeks. Long-term treatment is not recommended.
At the beginning of treatment, the physician will inform the patient about the limited duration of therapy, the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal reactions.
When using benzodiazepines, including Alpraxil, physical or emotional dependence may develop. This risk may increase with dose and duration of treatment; therefore, the lowest effective dose should be used for the shortest possible time, and the need for continued treatment should be regularly reviewed with the physician.

Recommended dose
The dose is determined by the physician according to symptom severity and the individual patient's response to treatment. If severe adverse reactions occur after the initial dose, the physician may decide to reduce the dose.

Treatment of symptomatic anxiety states
The recommended initial dose is 0.25 mg or 0.5 mg three times daily.
The physician may decide to increase the dose, depending on the patient's response to treatment, up to a maximum daily dose of 4 mg, administered in divided doses throughout the day.

Use in children and adolescents
Alpraxil should not be used in children and adolescents under 18 years of age.

Use in patients with renal or hepatic impairment
Use in patients with severe hepatic insufficiency is contraindicated.

Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily.
If necessary, the physician may decide to gradually increase the dose depending on the patient's tolerance to the medicine. If adverse reactions occur, the physician may decide to reduce the initial dose.

Use of a higher than recommended dose of Alpraxil
Using a higher than recommended dose of Alpraxil may cause: ataxia (impaired coordination), drowsiness, speech disturbances, coma, and respiratory depression. If disturbing symptoms occur, contact your doctor immediately.

Missed dose of Alpraxil
Do not take a double dose to make up for a missed dose.

Stopping Alpraxil treatment
Do not stop taking this medicine without consulting your doctor.
Since treatment is symptomatic, symptoms may return after discontinuation.
The physician will decide on a gradual reduction of the dose.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions persist or become troublesome,
you should inform your doctor. The occurrence of some adverse reactions
depends entirely on individual patient susceptibility and the dose administered. Adverse reactions
are usually observed at the beginning of therapy. They subside as treatment continues or when
the dose is reduced.

You should stop taking Alpraxil and contact your doctor immediately if the following occur:

• symptoms of angioedema, such as:
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• urticaria and breathing difficulties. Angioedema has been reported with unknown frequency (frequency cannot be estimated from available data).
• symptoms of severe allergic reaction, which may include itchy rash, swelling of the eyelids, face, lips, mouth, tongue, or throat, causing difficulty in swallowing or breathing (the following adverse reactions have been observed rarely or very rarely).

Frequency of adverse reactions observed in clinical trials and after
marketing of the medicine: Very common – may occur in more than 1 in 10 patients:

• depression,
• sedation,
• drowsiness,
• ataxia (lack of muscle coordination),
• memory disturbances,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common – may occur in no more than 1 in 10 people:

• decreased appetite,
• confusion,
• disorientation,
• decreased libido (sexual drive),
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance disorders,
• impaired coordination,
• attention disturbances,
• excessive need for sleep,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• decreased body weight,
• increased body weight.

Uncommon – may occur in no more than 1 in 100 people:

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

Frequency unknown (frequency cannot be estimated from available data):

• hyperprolactinaemia (increased prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• thought disorders,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system disorders (which control 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 oedema (swelling of ankles, feet, or fingers),
• increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders, or those abusing alcohol, a paradoxical reaction may occur, including symptoms such as anxiety.

Other adverse reactions observed rarely or very rarely include: movement disorders, seizures, psychotic symptoms, feelings of depersonalization, agranulocytosis (severe reduction in granulocyte count), allergic reactions or anaphylaxis (severe allergic reactions).

Benzodiazepines may cause physical and psychological dependence. If physical dependence develops, abrupt discontinuation of Alpraxil may lead to withdrawal symptoms:
headache, muscle pain, increased anxiety, feelings of tension, agitation, disorientation, irritability, feelings of altered surroundings or self, auditory disturbances, limb stiffness and tingling,
hypersensitivity to light, noise, and touch, hallucinations and seizures, insomnia and mood changes.
These symptoms are usually more pronounced in patients treated long-term with high doses
of benzodiazepines and in cases of abrupt or rapid discontinuation of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Alpraxil

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
No special temperature storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
date (EXP). 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. Such measures will help protect the
environment.

6. Contents of the packaging and other information

What Alpraxil contains

• The active substance is alprazolam. Each tablet contains 0.25 mg, 0.5 mg or 1 mg of alprazolam.
• The other components are: lactose monohydrate, pregelatinized corn starch, crospovidone Type B, povidone K25, magnesium stearate, polysorbate 80, erythrosine E 127, aluminium lake – exclusively in Alpraxil 0.5 mg tablets and Alpraxil 1 mg tablets, indigo carmine E 132, aluminium lake – exclusively in Alpraxil 1 mg tablets.

What Alpraxil looks like and contents of the pack
Alpraxil 0.25 mg: white or almost white, round, biconvex tablets with a diameter of 7 mm ± 0.2 mm, with a breakline embossed on one side.
Alpraxil 0.5 mg: light pink, round, biconvex tablets with a diameter of 7 mm ± 0.2 mm, with a breakline embossed on one side.
Alpraxil 1 mg: light violet, round, biconvex tablets with a diameter of 7 mm ± 0.2 mm, with a breakline embossed on one side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure division into equal doses.
Packaging contains 30 tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.

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

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