Afobam

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Afobam (Frontin)
1 mg, tablets
Alprazolamum
Afobam and Frontin are different brand names of the same medicinal product.
Please read this leaflet carefully before taking 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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 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 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, but only 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 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 the following with your doctor or pharmacist:

• if the medicine is to be used long-term, as dependence may occur, especially in patients with a history of 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 using other benzodiazepines (increased risk of dependence);
• if the patient is concurrently using 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 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 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 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, increased euphoria may also occur, 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.
• Extreme caution should be exercised and dose reduction considered when Afobam is used concomitantly with nefazodone, fluvoxamine, or cimetidine.
• Extreme caution is required when using alprazolam together with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin, or troleandomycin).
• Concurrent use of Afobam and opioids (strong painkillers, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of

drowsiness, breathing difficulties (respiratory depression), and coma, and may lead to
life-threatening effects. Therefore, concurrent 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 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.
• Concurrent use of Afobam and protease inhibitors of human immunodeficiency virus (HIV) (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 is planning 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. 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 use Afobam

This medicine should always be taken exactly as directed by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Treatment should last as short a time as possible. Your doctor should regularly assess your condition and the need
for continuing treatment, especially if your symptoms have lessened 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, your doctor will inform you about the limited duration of therapy, the need to gradually reduce the dose when discontinuing the medicine, and the possibility of withdrawal reactions.
When using 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 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 symptoms of anxiety
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, administered in smaller divided doses 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 liver function disorders
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 doctor may decide, if necessary, to gradually increase the dose. If adverse effects occur, the doctor may 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 are taken than recommended, symptoms such as ataxia (lack of coordination), drowsiness, speech disturbances, coma, and respiratory depression may occur. If any disturbing symptoms are noticed, contact your doctor immediately.
Missing a 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 your doctor.
Since treatment is purely symptomatic, symptoms may return after stopping the medicine.
Your doctor will decide on gradually reducing the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may 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 patient's individual sensitivity 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 frequencies of adverse reactions have been reported in clinical studies and after 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,
• restlessness,
• balance problems,
• motor coordination disorders,
• concentration difficulties,
• increased drowsiness,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• weight loss,
• weight gain.

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 not known (cannot be estimated from available data)

• hyperprolactinaemia (increased prolactin levels in blood),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• disordered thinking,
• increased psychomotor activity,
• drug misuse,
• autonomic nervous system disturbances (which regulate the function of internal organs, smooth muscles and glands),
• dystonia (abnormal muscle tone),
• gastrointestinal disturbances,
• hepatitis,
• liver function disorders,
• 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 reactions observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, changes 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, feelings of 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 medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Afobam

Store below 25°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. Such measures help protect the environment.

6. Contents of the pack 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 division line on one side and the markings “E”
and “313” on the other side.
The tablets can be divided into equal doses.

Pack:
A brown glass bottle in a cardboard box.
The pack contains 30 tablets.

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

Responsible party in Romania, 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

Marketing authorization number in Romania, country of export: 12918/2020/01
Parallel import authorization number: 36/21