PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Afobam (Frontin 0.5 mg)
0.5 mg, tablets
Alprazolamum
Afobam and Frontin 0.5 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before using the 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, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What is Afobam and what is it used for
Important information before taking Afobam
How to take Afobam
Possible side effects
How to store Afobam
Contents of the pack and other information

1. What is Afobam and what is it used for

The active substance of this medicine, alprazolam, belongs to a group of medicines called benzodiazepine derivatives (medicines with anxiolytic action).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in cases 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 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 suffers from muscle weakness ( myasthenia gravis ) (a disease 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.

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

if the medicine is used long-term, as 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 of the medicine 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 and 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, delusions, anger, nightmares, hallucinations, psychoses, or unusual behaviour occur. If any of these symptoms appear, the use of the medicine should be stopped and the doctor contacted;
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 all their 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
an uninterrupted sleep of 7–8 hours.
Episodes of mania and hypomania associated with alprazolam use have been reported in patients with
depression.
Before any 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 and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans 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 is possible, leading to intensified psychological dependence.
Alcohol consumption must not be combined with Afobam during treatment.
Concomitant use of Afobam with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
Particular caution is required and dose reduction should be considered when Afobam is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
Particular 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 Afobam and opioids (strong analgesics, medicines 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 together 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 consumption must not be combined with Afobam.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
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 in the late stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small amounts. Afobam should not be used during breastfeeding.
Driving and operating machinery
Afobam may impair psychomotor abilities. Before using Afobam, patients should familiarise themselves with current local traffic regulations.
Patients should 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 contact a doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Afobam

This medicine should always be taken exactly as directed by the physician or pharmacist. In case of
doubt, consult the physician or pharmacist.
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 the patient's symptoms decreases
and may no longer require pharmacological treatment. The total duration of treatment should not
exceed 2–4 weeks. Long-term treatment is not recommended.
At the start 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.
During treatment with benzodiazepines, including Afobam, dependence may develop, as well as
emotional or physical dependence. 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 continuing 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 reactions 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 administered 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, given in smaller divided doses 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 impairment 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 reactions occur, the physician will decide to reduce the initial dose.
Tablets may be divided into equal doses.
Use of a higher than 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.
Discontinuation of Afobam
Do not stop using this medicine without consulting the physician.
Since treatment is purely symptomatic, symptoms may return after discontinuation. The physician will decide on gradual dose reduction.
If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions persist or become troublesome, consult a doctor. The occurrence of certain adverse reactions depends on individual patient sensitivity and the dose administered. Usually, adverse reactions are observed at the beginning of treatment. They subside with continued treatment or after dose reduction.
In clinical studies and post-marketing experience, the following frequencies of adverse reactions have been observed:

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

depression,
sedation,
somnolence,
ataxia (impaired muscle coordination),
memory disturbances,
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,
restlessness,
balance problems,
motor coordination disturbances,
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,
drug 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 (affecting the function of internal organs, smooth muscles and glands),
dystonia (abnormal muscle tone),
gastrointestinal disorders,
hepatitis,
liver function disturbances,
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 alcohol abusers, paradoxical reactions such as anxiety may occur.
Other adverse reactions observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, disturbances in self-perception, agranulocytosis (severe reduction in granulocyte count), allergic reactions 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, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or of self, hearing impairment, 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Afobam

Store below 30°C, in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

What Afobam looks like and contents of the pack
Appearance:
Afobam 0.5 mg tablets:
light yellow, elongated, biconvex tablets with a score line on one side and the imprint
"E" and "312" on the other side.
The tablets can be divided into equal doses.

Pack:
Afobam, 0.5 mg, tablets:

Brown glass bottle secured with a plastic snap-fit cap (LDPE) in a cardboard box, with an instruction leaflet. The pack contains 30 or 100 tablets.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Mátyás király út 65
9900 Körmend
Hungary

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation number in Romania, country of export: 12917/2020/01
12917/2020/02

Parallel Import Authorisation number: 192/22