Afobam

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Afobam (Frontin)
0.5 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Afobam is and what it is used for

The active substance in this medicine, alprazolam, belongs to a group of medicines called benzodiazepine derivatives (medicines with anxiolytic activity).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where symptoms are severe, impair normal functioning, or are extremely distressing to the patient. This medicine is intended for short-term use only.

2. Important information before using Afobam

When not to use Afobam:

• if the patient is allergic to alprazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has muscle weakness ( myasthenia gravis ) (a disease characterized 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.

Afobam must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Afobam, discuss this with your doctor or pharmacist.

• if the medicine is used long-term, because dependence may occur, especially in patients prone to drug or alcohol abuse. The doctor should periodically assess the need for continued treatment;
• if the dose is being reduced or the medicine is suddenly discontinued (withdrawal symptoms may occur – see sections 3 and 4);
• if the medicine is used in patients with depression accompanied by suicidal thoughts or tendencies;
• if the patient is using other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously using opioids, sleeping medicines, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
• if restlessness, psychomotor agitation, irritability, aggression, anger, nightmares, hallucinations, psychosis, or unusual behaviour occur. If any of these symptoms appear, treatment with the medicine should be discontinued and the doctor consulted;
• if the patient has glaucoma;
• if the patient has breathing disorders;
• if the patient has impaired kidney or liver function;
• if the patient is elderly or debilitated, Afobam should be used with caution due to the risk of sedation (excessive calming) and/or skeletal muscle weakness, which may increase the likelihood of falls with serious consequences in elderly individuals. The treating physician will select the lowest effective dose. Like other benzodiazepines, Afobam may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should be ensured uninterrupted sleep for 7–8 hours.

Episodes of mania and hypomania associated with alprazolam use have been reported in patients with depression.
Before a planned surgical procedure, inform the doctor about taking Afobam.
Children and adolescents
Afobam must not be used in children and adolescents under 18 years of age.
Afobam with other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or which you plan to use.

• Afobam may enhance the effects of antipsychotics, sleeping medicines, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.
• With opioid analgesics, increased euphoria may also occur, leading to enhanced psychological dependence.
• Alcohol must not be consumed during treatment with Afobam.
• Concomitant use of Afobam with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Exercise special caution and consider dose reduction when using Afobam together with nefazodone, fluvoxamine, and cimetidine.
• Exercise special caution when using alprazolam together with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin, or troleandomycin).
• Concomitant use of Afobam and opioids (strong analgesics, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing problems (respiratory depression), and coma, which may be life-threatening. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available. If your doctor prescribes Afobam

concomitantly with opioids, the dose and duration of concurrent treatment should be
limited.

• Inform your doctor about all opioid medicines you are taking and strictly follow medical advice. It may be helpful to inform family members or friends about the possibility of the above-mentioned symptoms. If they occur, contact your doctor immediately.
• Concomitant use of Afobam and human immunodeficiency virus (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 of digoxin toxicity.
• Theophylline may reduce the effect of benzodiazepines.

Afobam and alcohol
Alcohol must not be consumed during treatment with Afobam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
If the medicine is used during pregnancy or if pregnancy occurs while taking alprazolam, the patient should be evaluated for potential fetal risk.
If administration of the medicine is necessary during late pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. Afobam should not be used during breastfeeding.
Driving and operating machinery
Afobam may impair psychomotor performance. Before using Afobam, become familiar with current local traffic regulations. Do not drive vehicles or operate machinery while using Afobam.
Afobam contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Afobam

This medicine should always be taken exactly as directed by the physician or pharmacist. In case of
doubt, consult your doctor or pharmacist.
The following products are available in commerce: Afobam 0.25 mg, Afobam 0.5 mg, and Afobam 1 mg.
Treatment should be as short as possible. The physician should regularly assess the patient's condition and the need
for continuing treatment, especially if the severity of symptoms has decreased and
pharmacological treatment may no longer be necessary. Total treatment duration should not exceed 2–
4 weeks.
Long-term treatment is not recommended.
At the beginning of therapy, the physician will inform the patient about the limited duration of treatment,
the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal
reactions.
During treatment with benzodiazepines, including Afobam, dependence and emotional or
physical 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 evaluated with the physician.
Recommended dose
The dose is determined by the physician based on symptom severity and the individual patient's response to
treatment. If severe adverse effects occur after the initial dose, the physician may decide to reduce the dose.
Treatment of anxiety symptoms
The recommended initial dose is 0.25 mg or 0.5 mg taken three times daily. Depending on the
patient's response to treatment, the physician may increase the dose up to a maximum daily dose of 4 mg,
divided into smaller doses administered throughout the day.
Use in children and adolescents under 18 years of age
Afobam must not be used in children and adolescents under 18 years of age.
Use in patients with hepatic impairment
Use in patients with severe liver dysfunction is contraindicated.
Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily. Depending on treatment tolerance, the physician may decide, if necessary, to gradually increase the dose. If adverse effects occur, the physician may decide to reduce the initial dose.
Tablets may be divided into equal doses.
Taking more than the recommended dose of Afobam
If more tablets than recommended are taken, symptoms such as ataxia (uncoordinated movements),
drowsiness, speech disturbances, coma, and respiratory depression may occur. If any
disturbing symptoms are observed, contact a physician immediately.
Missed dose of Afobam
Do not take a double dose to make up for a missed dose.
Stopping treatment with Afobam
Do not stop taking this medicine without consulting your doctor.
Since treatment is purely symptomatic, symptoms may return after discontinuation.
The physician will decide on gradual dose reduction.
If you have any further questions regarding the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following adverse reactions persist or become troublesome, consult a doctor. The occurrence of certain adverse reactions depends on the individual patient's sensitivity and the dose administered. Adverse reactions usually occur at the beginning of treatment. They tend to resolve with continued treatment or after dose reduction.
The following frequencies of adverse reactions have been reported in clinical trials and after marketing authorization:

Very common (may affect more than 1 in 10 people)

• depression,
• sedation,
• somnolence,
• ataxia (lack of muscular coordination),
• memory impairment,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common (may affect up to 1 in 10 people)

• decreased appetite,
• confusion,
• disorientation,
• decreased libido,
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance problems,
• movement coordination disorders,
• concentration difficulties,
• increased drowsiness,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• weight decrease,
• weight increase.

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• hyperprolactinaemia (increased blood prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• disordered thinking,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system imbalance (which controls the function of internal organs, smooth muscles and glands),
• dystonia (abnormal muscle tone),
• gastrointestinal disturbances,
• hepatitis,
• liver function 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, paradoxical reactions such as anxiety may occur.
Other adverse reactions observed rarely or very rarely include: movement disorders, seizures, psychotic symptoms, disturbances in self-perception, agranulocytosis (severe reduction in granulocyte count), allergic and anaphylactic reactions (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. After physical dependence has developed, abrupt discontinuation of alprazolam may lead to withdrawal symptoms such as headache, muscle pain, intensified anxiety, tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing impairment, stiffness and tingling of limbs, 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Afobam

Store below 25°C.
Keep the medicine out of sight and reach of children.
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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Afobam contains
The active substance is 0.5 mg alprazolam per tablet.
The other ingredients are: lactose monohydrate (96 mg), microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, iron oxide yellow (E 172).

What Afobam looks like and contents of the pack
Appearance:
Light yellow, oblong, biconvex tablets with a score line on one side and the markings “E” and “312” on the other side.
The tablets can be divided into equal doses.

Packaging:
Brown glass bottle closed with a white plastic cap, placed in a cardboard box with an instruction leaflet.
The pack contains 30 or 100 tablets.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in the Czech Republic, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest, Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Mátyás király u. 65.
9900 Körmend, Hungary

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorization Number in the Czech Republic, country of export: 70/274/00-C
Parallel Import Authorization Number: 328/22