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 medicinal product.
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 any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 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, solely in cases where symptoms are severe, impair normal functioning, or are extremely 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, as 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 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 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, delusions, anger, nightmares, hallucinations, psychoses, 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 determine 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
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 and 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 increased 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 is required and dose reduction should be considered 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 painkillers, medicines used in addiction substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing problems (respiratory depression), and coma, and may lead to life-threatening situations. 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 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, 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 risk to the foetus.
If administration of the medicine is necessary in the late stages 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 regulations regarding road traffic laws. 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 as directed by the doctor or pharmacist. If in doubt,
consult a 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. 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 treatment duration 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.
During treatment with benzodiazepines, including Afobam, dependence may develop, as well as
emotional or physical dependence. 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 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 should not be used in children and adolescents under 18 years of age.
Use in patients with liver function disorders
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 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.
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.
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 discontinuation.
The doctor will decide on a gradual dose reduction.
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 sensitivity of the patient and the dose administered. Adverse effects usually occur at the beginning of treatment. They tend to subside with continued treatment or after reducing the dose.

In clinical studies and after marketing of the medicine, the following frequencies of adverse effects have been observed:

Very common (may occur in more than 1 in 10 patients):

• depression,
• sedation,
• somnolence,
• ataxia (lack of voluntary coordination of muscle movements),
• memory disturbances,
• 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,
• 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 abuse,
• autonomic nervous system imbalance (the system controlling 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, a paradoxical reaction such as anxiety may occur.
Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, disturbances in self-perception, agranulocytosis (marked decrease in granulocyte count), allergic reaction and anaphylactic reaction (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 severe 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, pharmacist or nurse. 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 Warszawa
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of further information on the safety of the medicine's use.

5. How to store Afobam

Do not store above 25°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 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.
Other ingredients: monohydrate lactose, microcrystalline cellulose, maize starch,
magnesium stearate, sodium lauryl sulphate, 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 imprint “E” and
“312” on the other side.
The tablets can be divided into equal doses.
Packaging:
An amber glass bottle closed with a white plastic cap, placed in a cardboard box, with an
information leaflet.
The pack contains 30 or 100 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38.
H-1106 Budapest
Hungary
Manufacturer:
Egis Gyógyszergyár Zrt.
Mátyás király u. 65.
H-9900 Körmend
Hungary
Egis Gyógyszergyár Zrt.
Bökényföldi út 118-120.
1165 Budapest
Hungary
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Hungarian marketing authorisation number, country of export: OGYI-T-05967/03
OGYI-T-05967/04
Parallel import authorisation number: 60/15