Afobam

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Afobam(Frontin 0.25 mg)

0.25 mg, tablets

Alprazolamum
Afobam and Frontin 0.25 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should 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 any not listed in this leaflet, you should 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 benzodiazepine derivatives (anxiolytic medicines).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, only in situations where the symptoms are severe, prevent 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 fatigue and muscle weakness);
• if you have severe respiratory failure;
• if you have sleep apnea syndrome;

if you have severe liver failure.
Afobam should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Afobam, you should discuss it with your doctor or pharmacist:

• if the medicine is used for a long time, as it may lead to dependence, 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 discontinued (possible occurrence of withdrawal symptoms - see sections 3 and 4);
• if the medicine is used in patients with depression with suicidal thoughts or tendencies;
• if you are taking other benzodiazepines (increased risk of dependence);
• if you are taking opioids, sleeping pills, sedatives, 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 any of these symptoms occur, you should stop taking the medicine and 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 all their 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 a case, 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 a planned surgical procedure, you should inform your doctor about taking Afobam.

Children and adolescents

Afobam should not be used in children and adolescents under 18 years of age.

Afobam and other medicines

You should 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.
• You should not drink alcohol during treatment with Afobam.
• It is not recommended to take Afobam at the same time as certain antifungal medicines for internal use (e.g., ketoconazole, itraconazole, posaconazole, voriconazole).
• Particular caution should be exercised and a dose reduction considered during concomitant use of Afobam and nefazodone, fluvoxamine, and cimetidine.
• Particular caution should be exercised when using 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. For this reason, concomitant use of these medicines can only be considered if there are no other treatment options. However, if the doctor prescribes Afobam concomitantly with opioids, the dose and duration of concomitant treatment should be limited.

• You should 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-mentioned 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 decrease the effect of benzodiazepines.

Afobam and alcohol

You should not drink alcohol during treatment with Afobam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should 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, you should avoid high doses and monitor the newborn.
Benzodiazepines pass into breast milk in small amounts. You should not take Afobam during breastfeeding.

Driving and operating machinery

Afobam may impair psychomotor skills. Before taking Afobam, you should familiarize yourself with local traffic laws. During treatment with Afobam, you should not drive vehicles or operate machinery.

Afobam contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact 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

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, you should consult a 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 duration 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 treatment with benzodiazepines, including Afobam, dependence and emotional or physical dependence may develop. This risk may increase with the dose and duration of treatment, so you should use the lowest effective dose for the shortest possible time and frequently assess the need for continued treatment 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 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, divided into smaller doses 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 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, if necessary, decide to gradually increase the dose. If side effects occur, the doctor will decide to reduce the initial dose.
The tablet can be divided into equal doses.

Use of a higher than recommended dose of Afobam

In case of taking more tablets than recommended, ataxia (uncoordinated movements), drowsiness, speech disorders, coma, and respiratory depression may occur. If you notice any worrying symptoms, you should immediately consult your doctor.

Missed dose of Afobam

You should not take a double dose to make up for a missed dose.

Discontinuation of Afobam

You should not stop taking this medicine without consulting your doctor.
Since the treatment is only symptomatic, after its discontinuation, the symptoms may return.
The doctor will decide to gradually reduce the dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects persist or become troublesome, you should consult your doctor. The occurrence of some side effects depends on the individual patient's sensitivity and the administered dose. 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 placed on the market, the following frequency of side effects was reported:

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

• depression,
• calmness,
• drowsiness,
• ataxia (lack of coordination),
• 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 the available data)

• hyperprolactinemia (elevated 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, feeling of tension, agitation, disorientation, irritability, change 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 case of sudden or rapid discontinuation of the medicine.

Reporting side effects

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

5. How to store Afobam

Store in a temperature below 30°C, in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should 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 of alprazolam in one tablet.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica.

What Afobam looks like and what the packaging contains

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

Packaging:

Afobam, 0.25 mg, tablets:

• Bottle made of brown glass, closed with a plastic cap (LDPE) of the snap-fit type, in a carton, with an information leaflet. The packaging contains 30 tablets. For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 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
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing authorization number in Romania, the country of export:

12916/2020/01
Parallel import authorization number:191/22

Date of leaflet approval: 26.10.2023

[Information about the trademark]