Afobam

Package leaflet: information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Afobam (Frontin)
0.25 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names of the same medicine.
Please read the leaflet carefully before use, as it contains
important information for the patient.

• Please keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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 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 situations where symptoms are severe, impair normal functioning, or are highly 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 suffers from 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 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 accompanied by suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously taking opioids, sleeping medicines, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
• if symptoms such as restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychoses, or unusual behaviour occur. If any of these symptoms appear, treatment with the medicine should be stopped and medical advice sought;
• 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 and their serious consequences in elderly individuals. The treating physician will determine 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 you are currently taking or have recently taken, as
well as any medicines you plan to take.

• 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.
• Particular caution and consideration of dose reduction are required when Afobam is used concomitantly with nefazodone, fluvoxamine, and cimetidine.
• Particular caution is required when alprazolam is used with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin, or troleandomycin).
• Concomitant use of Afobam and opioids (strong painkillers, drugs 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 situations. 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 occurring. 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 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 must 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 risks to the fetus.
If administration of the medicine is necessary in late pregnancy, high doses should be avoided and the newborn should be closely monitored.
Benzodiazepines pass into human milk in small concentrations. Afobam must not be used during
breastfeeding.
Driving and operating machinery
Afobam may impair psychomotor performance. Before taking Afobam, patients should
familiarize themselves 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, 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 take Afobam

This medicine should always be taken as directed by the physician or pharmacist. In case of doubt,
consult a physician or pharmacist.
Afobam is available in the following doses: 0.25 mg, 0.5 mg, 1 mg.
Treatment should last as short as possible. The physician should frequently 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. 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 frequently reviewed 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,
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 reactions occur, the physician will decide to reduce the initial dose.
The tablet may be divided into equal doses.
Taking a higher than recommended dose of Afobam
If more tablets than recommended are taken, ataxia (lack of coordination), drowsiness, speech disturbances, coma, and respiratory depression may occur. If any disturbing symptoms are observed, contact a physician immediately.
Missing a dose of Afobam
Do not take a double dose to make up for a missed dose.
Stopping Afobam treatment
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 questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get 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 usually occur at the beginning of treatment. They subside during continued treatment or after dose reduction.
The following frequencies of adverse effects have been observed in clinical trials and after marketing authorization:
Very common (may affect more than 1 in 10 people)

• 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 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 prolactin blood 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 (abnormal muscle tone),
• 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 medicines, those with psychiatric disorders or alcohol abuse, paradoxical reactions such as anxiety may occur.
Other adverse effects 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, increased anxiety, feelings of 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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

Do not store above 25°C.
Keep the medicine out of the 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 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.
The other components are: monohydrate lactose, microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

What Afobam looks like and contents of the packaging
Appearance:
White or yellowish-white, elongated, biconvex tablets with a dividing line on one side and
the inscription "E" and "311" on the other side.
The tablets can be divided into equal doses.

Packaging:
A brown glass bottle closed with a white plastic cap, placed in a cardboard box, with a patient information leaflet.
The packaging contains 30 or 100 tablets.

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

Marketing Authorisation Holder in Hungary, the country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
H-1106 Budapest
Hungary

Manufacturer:
Egis Gyógyszergyár Zrt.
Mátyás király ú. 65.
H-9900 Körmend
Hungary
Egis Gyógyszergyár Zrt.
Bökényföldi út 118-120.
1165 Budapest
Hungary

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Hungarian Marketing Authorisation Numbers (country of export): OGYI-T-05967/01
OGYI-T-05967/02
Parallel Import Authorisation Number: 61/15