Package leaflet: Information for the user

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 the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Afobam is and what it is used for
What you need to know before taking Afobam
How to take Afobam
Possible side effects
How to store Afobam
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 action).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, but only 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 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 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 of the medicine is being reduced or if it 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, hallucinations, anger, nightmares, illusions, psychoses, or unusual behaviour occur. If any of these symptoms appear, treatment with the medicine should be discontinued and the patient should consult a doctor;
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 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 and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as
well as about 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.
In the case of opioid analgesics, euphoria may also be increased, leading to an increased risk of 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.
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, and may lead to life-threatening conditions. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available. If, however, your doctor prescribes Afobam together with opioids, the dose and duration of concomitant treatment should be limited.
Inform your doctor about all opioid medicines the patient is taking and strictly follow medical advice. It may be helpful to inform family members or friends about

the possibility of the above-mentioned symptoms occurring. If they occur, the patient should
contact a doctor.

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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 fetus.
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 amounts. Afobam should not be used
during breastfeeding.
Driving and operating machinery
Afobam may impair psychomotor performance. Before using Afobam, patients should
familiarize themselves with current local regulations regarding road traffic laws. Patients should not drive vehicles or operate machinery while taking 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, meaning the medicine is considered "sodium-free".

3. How to use Afobam

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt,
consult the doctor or pharmacist.
Afobam is available in the following strengths: 0.25 mg, 0.5 mg, 1 mg.
Treatment should last as short as possible. The doctor should frequently assess the patient's condition and the need
for continuing treatment, especially if the severity of the patient's symptoms decreases and
pharmacological treatment may no longer be required. Total treatment duration should not exceed 2–4
weeks. Long-term treatment is not recommended.
At the start of treatment, the doctor 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 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 adverse reactions occur after the initial dose, the doctor may decide
to reduce the dose.
Treatment of symptomatic anxiety states
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 doctor 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 hepatic 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 doctor may decide, if necessary, to gradually increase the dose. If adverse reactions occur, the doctor will decide
to reduce the initial dose.
The tablet may be divided into equal doses.
Use of a higher than recommended dose of Afobam
If more tablets than recommended are taken, ataxia (uncoordinated movements), drowsiness,
speech disturbances, coma, and respiratory depression may occur. In case of any concerning symptoms,
seek immediate medical advice.
Missed dose of Afobam
Do not take a double dose to make up for a missed dose.
Discontinuation of Afobam
Do not stop taking this medicine without consulting your doctor.
Since treatment is purely symptomatic, symptoms may return after discontinuation.
The doctor will decide on gradual dose reduction.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse symptoms persist or become bothersome, consult a doctor. The occurrence of certain adverse reactions depends on the individual sensitivity of the patient and the dose administered. Adverse reactions usually occur at the beginning of treatment. They subside as treatment continues or after reducing the dose.
The following frequency of adverse reactions has been reported in clinical trials and after the medicine was placed on the market:
Very common (may occur in more than 1 in 10 patients)

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

Common (may occur in no more than 1 in 10 patients) :

decreased appetite,
confusion,
disorientation,
decreased libido,
increased libido,
anxiety,
insomnia,
nervousness,
balance problems,
motor coordination disturbances,
concentration difficulties,
increased drowsiness,
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 patients)

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

Frequency not known (cannot be estimated from available data)

hyperprolactinemia (increased prolactin levels in blood),
hypomania,
aggressive behaviour,
hostile behaviour,
disordered thinking,
increased psychomotor activity,
medicine abuse,
disturbances in autonomic nervous system balance (which controls 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 edema (swelling of ankles, feet or fingers),
increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or those who misuse alcohol, a paradoxical reaction such as anxiety may occur.
Other adverse reactions observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, changes in self-perception, agranulocytosis (severe reduction in granulocyte count), allergic reaction and anaphylactic reaction (severe allergic reactions).
Benzodiazepines may cause physical and psychological dependence. After physical dependence has developed, abrupt discontinuation of alprazolam may cause withdrawal symptoms such as: headache, muscle pain, intensified anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or of self, impaired hearing, 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 to provide more information on the safety of the medicine.

5. How to store Afobam

Store below 25°C.
Keep the medicine in a place inaccessible and out of sight 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 dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What the medicine Afobam contains
The active substance is 0.5 mg of alprazolam in one tablet.
The other ingredients are: monohydrate lactose (96 mg), 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:
Light yellow, elongated, biconvex tablets with a dividing line on one side and the markings "E" and
"312" on the other side.
The tablets can be divided into equal doses.
Pack:
A brown glass bottle with a PE cap with a tamper-evident seal and tablet immobilizing protection,
contained in a cardboard box, with 30 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in the Czech Republic, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 70/274/00-C
Parallel import authorisation number: 233/23