Afobam

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the outer packaging in a foreign language!
Afobam (Frontin)
0.5 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names for the same medicine.
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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences 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 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 has 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 occur, 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 and suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously taking opioids, hypnotics, 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 the doctor consulted;
• if the patient has glaucoma;
• if the patient has respiratory 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 the serious consequences this may have for 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 a case, the patient should be ensured 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 taken or recently taken, as well as any medicines the patient plans to take.

• Afobam may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.
• With 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 is required and dose reduction should be considered when Afobam is used concomitantly with nefazodone, fluvoxamine, and 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, drugs used in substitution therapy for addiction, and certain cough medicines) increases the risk of drowsiness, breathing difficulties (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, however, 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 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 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, become familiar with current local traffic regulations. While taking Afobam, do not drive vehicles or operate machinery.

Afobam contains lactose monohydrate 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, 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.
Treatment should be 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
pharmacological treatment may no longer be required. 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 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 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 reactions occur after the initial dose,
the doctor may decide to reduce the dose.
Treatment of symptomatic anxiety states
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
Use in patients with severe hepatic insufficiency is contraindicated.
Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily. Depending on tolerance to
treatment, the doctor may, if necessary, decide on a gradual increase in 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, ataxia
(uncoordinated movements), drowsiness, speech disturbances, coma, and respiratory depression may occur. If any
disturbing symptoms are observed, contact your 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 your doctor.
Since treatment is purely symptomatic, symptoms may return after discontinuation.
The doctor will decide on gradual dose reduction.
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 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. Usually, adverse effects are observed at the beginning of treatment. They subside gradually during 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 affect more than 1 in 10 patients)

• 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 patients)

• decreased appetite,
• confusion,
• disorientation,
• decreased libido,
• increased libido,
• anxiety,
• insomnia,
• restlessness,
• balance problems,
• motor coordination disturbances,
• 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 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,
• disordered thinking,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system imbalance (affecting functions 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 drugs, 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, disturbances in self-perception, 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, intensified anxiety, tension, agitation, disorientation, irritability, altered perception of surroundings or of oneself, 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 drug.

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 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 effects allows collection of further 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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Afobam contains
The active substance is 0.5 mg of alprazolam in one tablet.
The other ingredients are: iron oxide yellow (E 172), colloidal anhydrous silica, sodium lauryl sulfate, corn starch, magnesium stearate, microcrystalline cellulose, lactose monohydrate.

What Afobam looks like and contents of the pack
Appearance:
Light yellow, elongated, biconvex tablets with a score line on one side and the markings "E" and "312" on the other side.
The tablets can be divided into equal doses.

Packaging:
A brown glass bottle with a white plastic screw cap, placed in a cardboard box.
The pack contains 30 tablets.

For further information, please contact the marketing authorisation holder or the parallel importer.

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

Manufacturer
Egis Gyógyszergyár Zrt.
Mátyás király ut. 65.
H-9900 Körmend
Hungary
Egis Gyógyszergyár Zrt
Bökényföldi út 118-120.
H-1165 Budapest
Hungary

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland

Hungarian marketing authorisation number (country of export): OGYI-T-05967/03
Parallel import authorisation number: 265/18