Afobam

Package leaflet: Information for the patient

WARNING: Keep the leaflet. Information on the immediate packaging is in a foreign language.
Afobam (Frontin), 0.5 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names for the same medicine
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What is Afobam and what is it 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 is Afobam and what is it used for

The active substance in this medicine – alprazolam – belongs to a group of medicines called
benzodiazepine derivatives. Afobam has anxiolytic properties and is therefore indicated for short-term treatment of:

• generalized anxiety disorder;
• anxiety disorder with panic attacks;
• phobic anxiety disorder;
• mixed depressive and anxiety disorder.

Afobam is indicated only in cases where symptoms are severe, impair normal functioning, or cause significant distress to the patient.

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 it 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 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 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 and their serious consequences in elderly patients. The treating physician will select the lowest effective dose.

As with other benzodiazepines, Afobam may cause anterograde amnesia, which
occurs several hours after taking the medicine. In such a case, 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 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, narcotic analgesics, anticonvulsants, anaesthetics, and antihistamines.
• With narcotic 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 oral antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.
• Particular caution is required and dose reduction should be considered 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 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 your doctor prescribes Afobam together with opioids, the dose and duration of combined treatment should be minimized.
• 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, 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 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 the last stage of 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 or operate machinery while taking Afobam.

Afobam contains lactose and sodium.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient 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 directed 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 a time as possible. The doctor will regularly assess the patient's
condition and the need for continuing treatment, especially if the severity of symptoms has
decreased and may no longer require pharmacological treatment. In general, treatment should
not last longer than 8–12 weeks, including the tapering period.
At the beginning 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.
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 continuing treatment should be regularly reviewed with the doctor.

Recommended dose
The dose is determined by the doctor based on symptom severity 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.

Symptomatic treatment of generalized anxiety disorder and mixed anxiety-depressive disorder
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 divided doses.

Symptomatic treatment of anxiety disorder with panic attacks and phobic anxiety disorder
The recommended initial dose is 0.5 mg or 1 mg per day, taken before bedtime.
Depending on the patient's needs, the doctor may decide to increase the dose. The dose may be
increased by 1 mg every 3–4 days. The doctor may decide to administer additional doses,
ensuring that the total number of daily doses does not exceed 3 or 4.

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 liver 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 gradually increase the dose if necessary. 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
concerning 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 Afobam
Do not stop taking this medicine without consulting your doctor.
Since treatment is purely symptomatic, symptoms may return after stopping the medicine. The
doctor will decide on a gradual dose reduction. The recommended reduction of the daily dose of
Afobam should not exceed 0.5 mg every three days. In some patients, an even slower tapering may
be necessary.

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 not everyone 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 individual patient's sensitivity and the dose administered. Adverse effects usually occur at the beginning of treatment and subside with continued treatment or after dose reduction.

The following frequencies of adverse effects have been reported in clinical trials and following 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 loss,
• weight gain.

Uncommon (may occur in up to 1 in 100 patients):

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• memory loss,
• muscle weakness,
• urinary incontinence,
• irregular menstruation,
• withdrawal syndrome.

Frequency unknown (cannot be estimated from available data):

• hyperprolactinaemia (increased prolactin levels in blood),
• 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 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 those who misuse 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 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, intensified 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 withdrawal of the medicine.

Cases of benzodiazepine abuse have been reported.

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, 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 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 invisible and inaccessible to 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. Such practices help protect the environment.

6. Contents of the packaging and other information

What Afobam contains
The active substance is 0.5 mg of alprazolam in one tablet.
Other ingredients are:
monohydrate lactose, microcrystalline cellulose, corn starch, magnesium stearate, sodium
lauryl sulfate, colloidal anhydrous silica, yellow iron oxide (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 letters "E"
and numbers "312" on the other side.
The tablets can be divided into two equal doses.

Packaging:
Brown glass bottle secured with a white plastic cap, placed in a cardboard box. The packaging contains 30 or 100 tablets.

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

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

Manufacturer:
Egis Gyógyszergyár Zrt., 9900 Körmend, Mátyás király u. 65, Hungary

Parallel importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warsaw
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw

Marketing authorisation number in Hungary, the country of export:
OGYI-T-5967/03
OGYI-T-5967/04

Parallel import authorisation number: 149/17