Afobam

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Afobam (Frontin)
1 mg, tablets
Alprazolamum
Afobam and Frontin are different brand names of the same medicinal product.
Please read carefully the entire leaflet 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 give it to others. It may harm another person, 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 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 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 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 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, psychosis, or unusual behaviour occur. If any of these symptoms appear, treatment should be discontinued 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 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 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 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, euphoria may also increase, 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 analgesics, medicines used in substitution therapy for addiction, and certain 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 concomitant 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 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 of the medicine is necessary in the late stages of pregnancy, high doses should be avoided and the newborn should be closely 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.
During treatment with Afobam, do not drive vehicles or operate machinery.

Afobam contains lactose monohydrate 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 exactly as instructed by your doctor or pharmacist. In case of
doubt, consult your 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. Your doctor should regularly assess your condition and the need
for continuing treatment, especially if your symptoms have improved and may no longer require pharmacological
treatment. Total treatment duration should not exceed 2–4 weeks. Long-term treatment is not recommended.
At the beginning of treatment, your doctor will inform you 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, physical and emotional dependence may develop.
This risk may increase with higher doses and longer 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 reviewed
with your 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 effects 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 taken three times daily. Depending on the patient's response,
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 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 doctor
may decide, if necessary, to gradually increase the dose. If adverse effects occur, the doctor may 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 (lack of coordination), drowsiness, speech
disturbances, coma, and respiratory depression may occur. If any disturbing symptoms are observed, contact your
doctor immediately.
Missed 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 your doctor.
Since treatment is purely symptomatic, symptoms may return after discontinuation.
Your doctor will decide on a gradual reduction of the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any of the following adverse effects persist or become troublesome, consult a doctor. The occurrence of certain adverse effects depends on the individual sensitivity of the patient and the dose administered. Adverse effects usually occur at the beginning of treatment. They subside with 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,
• drug withdrawal syndrome.

Frequency not known (cannot be estimated from available data)

• hyperprolactinaemia (increased prolactin levels in the blood),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• disordered thinking,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system imbalance (the system controlling 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 those abusing alcohol, paradoxical reactions such as anxiety may occur.
Other adverse effects observed rarely or very rarely include: movement disorders, 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 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 or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Afobam

Do not store above 30°C.
Keep the medicine in a place 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 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 1 mg of alprazolam in one tablet.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, red iron oxide (E 172).

What Afobam looks like and contents of the pack
Appearance: Light pink, elongated, biconvex tablets with a dividing groove on one side and the imprint "E" and "313" on the other side.
The tablets can be divided into equal doses.

Packaging:
A brown glass bottle with a plastic screw cap, packed in a cardboard box.
The pack contains 30 or 100 tablets.

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

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

Manufacturer:
Egis Gyógyszergyár Zrt.
H-9900 Körmend
Mátyás király út 65.
Hungary

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

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

Marketing Authorisation Numbers in Hungary, country of export: OGYI-T-5967/05
OGYI-T-5967/06

Parallel Import Authorisation Number: 407/17