Afobam

Leaflet attached to the packaging: patient information

Afobam, 0.25 mg, tablets

Afobam, 0.5 mg, tablets

Afobam, 1 mg, tablets

Alprazolam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell 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 packaging and other information

1. What is Afobam and what is it used for

The active substance of this medicine is alprazolam, which belongs to a group of medicines called benzodiazepines (anxiolytic medicines).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, interfere with normal functioning, or are very troublesome for the patient. This medicine is intended for short-term use only.

2. Important information before taking Afobam

When not to take Afobam:

• if you are allergic to alprazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis (a disease characterized by excessive muscle fatigue and weakness);
• if you have severe respiratory failure;
• if you have sleep apnea syndrome;
• if you have severe liver failure.

Afobam should not be taken by 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 taken for a long time, as dependence on the medicine 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 reduced or it is suddenly stopped (possible occurrence of withdrawal symptoms - see sections 3 and 4);
• if the medicine is taken by patients with depression with suicidal thoughts or tendencies;
• if you are taking other benzodiazepines (increased risk of dependence);
• if you are taking opioids, sedatives, anxiolytics, antidepressants, or drinking alcohol (the effect of these medicines or alcohol may be enhanced);
• if you experience restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or abnormal behavior. If these symptoms occur, the use of the medicine should be discontinued and you should consult your doctor;
• if you have glaucoma;
• if you have respiratory disorders;
• if you have kidney or liver function disorders;
• if you are elderly or weakened, Afobam should be used with caution due to the risk of sedation (excessive calmness) and/or muscle weakness, which may increase the likelihood of falls with serious consequences for the elderly. The attending physician will choose the lowest effective dose.

Like other benzodiazepines, Afobam may cause anterograde amnesia, which occurs a few hours after taking the medicine. In such cases, the patient should have the opportunity for uninterrupted sleep for 7-8 hours.
Episodes of mania and hypomania associated with the use of alprazolam have been reported in patients with depression.
Before planned surgery, inform your doctor about taking Afobam.

Children and adolescents

Afobam should not be taken by 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 effect of antipsychotic, sedative, anxiolytic, antidepressant, opioid analgesic, anticonvulsant, anesthetic, and antihistamine medicines.
• In the case of opioid analgesics, there is also a possible increase in euphoria, leading to increased psychological dependence.
• Do not drink alcohol while taking Afobam.
• It is not recommended to take Afobam with certain oral antifungal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction considered when taking Afobam and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when taking alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline,

diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).

• Concomitant use of Afobam and opioids (strong painkillers, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing problems (respiratory depression), and coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered if there are no other treatment options. If, however, the doctor prescribes Afobam with opioids, the dose and duration of concomitant treatment should be limited.
• Tell your doctor about all opioid medicines you are taking and strictly follow the doctor's instructions. It may be helpful to inform your family or friends about the possibility of the above symptoms. If they occur, you should consult your doctor.
• Concomitant use of Afobam and HIV protease inhibitors (e.g., ritonavir) requires dose modification or discontinuation of alprazolam.
• Patients taking alprazolam and digoxin should be closely monitored for signs of digoxin toxicity.
• Theophylline may reduce the effect of benzodiazepines.

Afobam and alcohol

Do not drink alcohol while taking Afobam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy.
If you are taking this medicine during pregnancy or become pregnant while taking alprazolam, you should be examined for potential fetal risk.
If it is necessary to administer the medicine in the last trimester of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into breast milk in small amounts. Do not take Afobam while breastfeeding.

Driving and operating machinery

Afobam may impair psychomotor skills. Before taking Afobam, familiarize yourself with local traffic laws.
Do not drive or operate machinery while taking Afobam.

Afobam contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Afobam

Take this medicine always as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment should be as short as possible. The doctor should frequently assess the patient's condition and the need to extend treatment, especially if the severity of the symptoms decreases and may not require pharmacological treatment. The total treatment time should not exceed 2-4 weeks. Long-term treatment is not recommended.
When starting treatment, the doctor will inform you about the limited duration of therapy, the gradual reduction of the dose during withdrawal of the medicine, and the possibility of withdrawal reactions.
During the use of benzodiazepines, including Afobam, dependence and emotional or physical dependence may develop. This risk may increase with the dose and duration of treatment, so the smallest effective dose should be used for the shortest possible time, and the need for continued treatment should be frequently assessed 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 side effects occur after administration of the initial dose, the doctor may decide to reduce the dose.
Symptomatic treatment of anxiety disorders
The recommended initial dose is 0.25 mg or 0.5 mg taken three times a day. Depending on the patient's response to treatment, the doctor may increase the dose to a maximum daily dose of 4 mg taken in divided doses throughout the day.

Use in children and adolescents under 18 years of age

Afobam should not be taken by children and adolescents under 18 years of age.

Use in patients with liver function disorders

Use in patients with severe liver failure is contraindicated.

Use in the elderly

The recommended initial dose is 0.25 mg twice or three times a day. Depending on the tolerance of treatment, the doctor may decide to gradually increase the dose if necessary. If side effects occur, the doctor will decide to reduce the initial dose.
The tablet can be divided into equal doses.

Taking a higher dose of Afobam than recommended

If you take more tablets than recommended, you may experience ataxia (uncoordinated movements), drowsiness, speech disorders, coma, and respiratory depression. If you notice any worrying symptoms, 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.
Because the treatment is only symptomatic, after its discontinuation, symptoms may recur. The doctor will decide to gradually reduce the dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Afobam can cause side effects, although not everybody gets them.
If any of the following side effects persist or become troublesome, consult your doctor.
The occurrence of some side effects depends on the individual patient's sensitivity and the dose taken. Side effects are usually observed at the beginning of treatment and disappear as treatment continues or after the dose is reduced.
In clinical trials and after the medicine was marketed, the following frequency of side effects was reported:

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

• depression,
• calmness,
• drowsiness,
• ataxia (uncoordinated movements),
• memory disorders,
• 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
• coordination disorders,
• concentration disorders,
• increased drowsiness,
• lethargy,
• tremors,
• blurred vision,
• nausea,
• skin rash,
• sexual disorders,
• weight loss,
• weight gain.

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

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• amnesia,
• muscle weakness,
• urinary incontinence,
• irregular menstrual cycles,
• withdrawal syndrome.

Unknown frequency (cannot be estimated from available data)

• hyperprolactinemia (increased prolactin levels in the blood),
• hypomania,
• aggressive behavior,
• hostile behavior,
• disturbed thinking,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system imbalance (which controls the function of internal organs, smooth muscles, and glands),
• dystonia (muscle tone disorders),
• gastrointestinal disorders,
• hepatitis,
• liver function disorders,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral edema (swelling of the ankles, feet, or fingers),
• increased intraocular pressure.

Additionally, especially in patients taking other psychotropic medicines, with mental disorders, or abusing alcohol, a paradoxical reaction may occur, such as anxiety.
Other side effects have been observed rarely or very rarely: motor disorders, epilepsy, psychotic symptoms, changes in self-perception, agranulocytosis (significant decrease in granulocyte count), allergic and anaphylactic reactions (severe allergic reactions).
Benzodiazepines can cause physical and psychological dependence. After physical dependence has developed, sudden discontinuation of alprazolam may cause withdrawal symptoms, such as headache, muscle pain, increased anxiety, tension, agitation, disorientation, irritability, changes in perception of the environment or oneself, impaired hearing, stiffness, and paresthesia of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures. These symptoms are usually more severe in patients treated for a long time, with high doses of benzodiazepines, and in the case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Afobam

Afobam, 0.25 mg, 0.5 mg:
Store in a temperature below 25°C.
Store in the original packaging.
Afobam, 1 mg:
Store in a temperature below 30°C.
Store in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton.
The expiration date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Afobam contains

The active substance of the medicine is 0.25 mg, 0.5 mg, or 1 mg of alprazolam in one tablet.
The other ingredients are:
0.25 mg tablets:lactose monohydrate, microcrystalline cellulose, cornstarch, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.
0.5 mg tablets:lactose monohydrate, microcrystalline cellulose, cornstarch, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, yellow iron oxide.
1 mg tablets:lactose monohydrate, microcrystalline cellulose, cornstarch, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, red iron oxide.

What Afobam looks like and contents of the packaging

Appearance:

Afobam, 0.25 mg, tablets:white or yellowish-white, oblong, biconvex tablets with a dividing line on one side and the inscription "E" and "311" on the other side.
Afobam, 0.5 mg, tablets:light yellow, oblong, biconvex tablets with a dividing line on one side and the inscription "E" and "312" on the other side.
Afobam, 1 mg, tablets:light pink, oblong, biconvex tablets with a dividing line on one side and the inscription "E" and "313" on the other side.
The tablets can be divided into equal doses.

Packaging:

Afobam, 0.25 mg, tablets:

• Brown glass bottle with a plastic snap-fit closure (LDPE) in a carton, with a patient information leaflet. The packaging contains 30 or 100 tablets.

Afobam, 0.5 mg, tablets:

• Brown glass bottle with a plastic snap-fit closure (LDPE) in a carton, with a patient information leaflet. The packaging contains 30 or 100 tablets.
• PVC/PE/PVDC/Aluminum blisters in a carton, with a patient information leaflet. The packaging contains 30 tablets.

Afobam, 1 mg, tablets:

• Brown glass bottle (Class III hydrolytic) with a polyethylene closure, in a carton, with a patient information leaflet. The packaging contains 30 or 100 tablets.
• PVC/PE/PVDC/Aluminum blisters in a carton, with a patient information leaflet. The packaging contains 30 tablets.

Marketing authorization holder

Egis Pharmaceuticals PLC
1106 Budapest,
Keresztúri út. 30-38,
Hungary
Manufacturer:
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65
Hungary
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120
Hungary
To obtain more detailed information, contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone number: +48 22 417 92 00

Date of last revision of the leaflet: 11.07.2022