AFOBAM

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Afobam (Frontin)
0,5 mg, tablets
Alprazolamum
Afobam and Frontin are different brand names for the same medicine.
Please read this 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 share it with others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 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, 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 the following 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 accompanied by suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is concurrently taking opioids, sleeping medicines, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, 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 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 and 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
the possibility of 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, sleeping medicines, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.
• In the case of opioid analgesics, increased euphoria may also occur, leading to intensified 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 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 consequences. Therefore, concomitant use of these medicines should be considered only
if no other treatment options are available. However, 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 instructions. It may be helpful to inform family members or friends about the possibility of the above-mentioned symptoms. If they occur, seek medical advice 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 concomitantly 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 plans 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 fetal risk.
If administration of the medicine is necessary in 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 performance. Before using Afobam, patients should
familiarize themselves with current local traffic regulations. During treatment with Afobam, patients should 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 contact the 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 prescribed by the doctor or pharmacist. In case of
doubt, consult your doctor 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 doctor 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 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, dependence and emotional or physical 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 continuing treatment should be regularly reviewed 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 anxiety symptoms
The recommended initial dose is 0.25 mg or 0.5 mg taken 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 impaired liver function
Afobam is contraindicated in patients with severe hepatic impairment.

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 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 (lack of coordination), drowsiness, speech disturbances, coma, and respiratory depression may occur. If any disturbing symptoms are observed, contact a doctor 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 your doctor.
Since treatment is purely symptomatic, symptoms may return after discontinuation. The doctor will decide on a gradual reduction of the dose.

If you have any further doubts regarding 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 experiences 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. Usually, adverse reactions are observed at the beginning of treatment. They subside during continued treatment or after dose reduction.
The following frequency of adverse reactions has been reported in clinical trials and after marketing
authorization:

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,
• nervousness,
• balance problems,
• motor coordination disorders,
• 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 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 blood prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• disordered thinking,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system imbalance (which controls the function of internal organs, smooth muscles and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disorders,
• hepatitis,
• liver function disturbances,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral oedema (swelling of ankles, feet or fingers),
• increased intraocular pressure.

In addition, particularly in patients taking other psychotropic medicines, those with psychiatric disorders or those who misuse alcohol, 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 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, 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 reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Afobam

Do not store above 25°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 properly dispose of medicines no longer in 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, iron oxide yellow (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 imprint “E” and “312” on the other side.
The tablets can be divided into equal doses.

Pack:
Brown glass bottle closed with a white plastic cap, placed in a cardboard box, with an instruction leaflet.
The pack contains 30 or 100 tablets.

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

Responsible entity in Hungary, country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38., 1106 Budapest, Hungary

Manufacturer:
Egis Gyógyszergyár Zrt.
Mátyás Király út 65., 9900 Körmend, Hungary

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

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

Marketing Authorization number in Hungary, country of export: OGYI-T-05967/03
OGYI-T-05967/04

Parallel import authorization number: 198/15