Afobam

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Afobam (Frontin)
0.25 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this 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. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions 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 cases 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 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 develop, 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 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 intensified);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or unusual behaviour occur. If any of these symptoms appear, treatment with the medicine 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 frail, 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, occurring 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 have been reported in patients with depression treated with alprazolam.
Before undergoing planned surgical procedures, 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 currently used, recently used, or planned to be used.

• 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 increase, leading to heightened 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.
• Exercise particular caution and consider dose reduction when using Afobam together 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, medicines used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing problems (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, however, your doctor prescribes Afobam

concurrently 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 instructions. 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 concurrently 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 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 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 performance. Before using Afobam, become familiar with current local traffic regulations. During treatment with Afobam, do not drive 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, meaning the medicine is considered "sodium-free".

3. How to use Afobam

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The following are available on the market: Afobam 0.25 mg, Afobam 0.5 mg, and Afobam 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 the patient about the limited duration of therapy, the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal reactions.
When using 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 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 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 should 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 doctor may decide, if necessary, to gradually increase the dose. If adverse reactions occur, the doctor may decide to reduce the initial dose.
Tablets may be divided into equal doses.

Taking 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.

Stopping treatment with Afobam
Do not stop taking this medicine without consulting a 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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience 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 and subside as treatment continues or after reducing the dose.

The following frequencies of adverse reactions have been observed in clinical trials and after marketing authorization:

Very common (may occur in 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 occur in up to 1 in 10 patients)

• 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,
• weight decrease,
• weight increase.

Uncommon (may occur in up to 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)

• hyperprolactinaemia (increased prolactin levels in blood),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• disturbed 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, altered perception of self, 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 lead to withdrawal symptoms such as: headache, muscle pain, increased anxiety, tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing impairment, limb stiffness and tingling, 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 Adverse Drug Reactions, 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 enables further collection of information on the safety of the medicine.

5. How to store Afobam

Store below 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 dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Afobam contains
The active substance is 0.25 mg of alprazolam per tablet.
The other ingredients are: monohydrate lactose (96 mg), microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

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

Pack:
A 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 marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest, Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Mátyás király u. 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 the Czech Republic, country of export: 70/273/00-C
Parallel import authorization number: 310/22