Afobam

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Afobam (Frontin 0.25 mg)
0.25 mg, tablets
Alprazolamum
Afobam and Frontin 0.25 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before taking 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 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 someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

1. What Afobam is and what it is used for
2. Important information 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 properties).
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 has muscle weakness (myasthenia gravis) (a condition 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 with your doctor or pharmacist:

• if the medicine is to be 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 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 taking other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously taking opioids, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
• if symptoms such as motor restlessness, psychomotor agitation, irritability, aggression, anger, nightmares, hallucinations, delusions, psychosis, or unusual behaviour occur. If any of these symptoms appear, treatment should be discontinued and medical advice sought immediately;
• if the patient has glaucoma;
• if the patient has breathing disorders;
• if the patient has kidney or liver function disorders;
• 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 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, recently used, or planned for use.

• Afobam may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.
• In the case of opioid analgesics, euphoria may also be increased, leading to heightened psychological dependence.
• Alcohol must not be consumed during treatment with Afobam.
• Concomitant use of Afobam with certain systemic antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Exercise particular caution and consider dose reduction when using Afobam concomitantly with nefazodone, fluvoxamine, or cimetidine.
• Exercise particular 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 certain cough medicines) increases the risk of

drowsiness, breathing difficulties (respiratory depression), and coma, and 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 combined 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 occurring. If they do occur, contact your doctor immediately.
• Concomitant use of Afobam with 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 fetal risk. If administration 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 abilities. Before using Afobam, patients should become familiar with current local traffic regulations. Patients should not drive vehicles or operate machinery while taking Afobam.

Afobam contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, he or she 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 use Afobam

This medicine should always be taken as directed by a physician or pharmacist. If in
doubt, consult a physician or pharmacist.
Treatment should last as short a time 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. Total treatment duration should not exceed 2–
4 weeks. Prolonged 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 and emotional or physical
dependence may develop. This risk may increase with the 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 assessed with the physician.
Recommended dose
The dose is determined by the physician based on the severity of symptoms 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 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, divided into smaller doses administered throughout the day.
Use in children and adolescents under 18 years of age
Afobam should not be used in children and adolescents under 18 years of age.
Use in patients with hepatic function 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 physician may decide, if necessary, to gradually increase the dose. If adverse reactions occur, the physician may 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, 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 taking this medicine without consulting a physician.
Since treatment is purely symptomatic, symptoms may return after discontinuation.
The physician will decide on gradual dose reduction.
If you have any further doubts regarding the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
If any of the following adverse effects persist or become troublesome, consult a doctor. The occurrence of certain adverse effects depends on the patient's individual sensitivity and the dose administered. Adverse effects are usually observed at the beginning of treatment. They tend to subside with continued treatment or after dose reduction.
The following frequencies of adverse effects have been reported in clinical studies and following marketing authorization:

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

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

Common (may affect up to 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 affect up to 1 in 100 patients)

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

Frequency unknown (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 disturbances (which regulate the function of internal organs, smooth muscles and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disorders,
• hepatitis,
• liver function abnormalities,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral oedema (swelling of ankles, feet or fingers),
• increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic drugs, those with psychiatric disorders or those who misuse alcohol, paradoxical reactions such as anxiety may occur.
Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, disturbances in self-perception, agranulocytosis (marked decrease 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, increased anxiety, tension, agitation, disorientation, irritability, altered perception of surroundings or of 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 drug.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also 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
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects 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 no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Afobam contains
The active substance is 0.25 mg of alprazolam in one tablet.
Other components: monohydrate lactose, microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

What Afobam looks like and contents of the packaging
Appearance:
Afobam 0.25 mg tablets: white or yellowish-white, elongated, biconvex tablets with a score line on one side and the markings “E” and “311” on the other side.

Packaging:
Afobam 0.25 mg, tablets:

• Brown glass bottle secured with a plastic snap-fit cap (LDPE) placed in a cardboard box, including the package leaflet. The packaging contains 30 tablets. For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, the 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 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorization number in Romania, the country of export:
12916/2020/01

Parallel import license number: 191/22