Afobam

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Afobam(Frontin)

1 mg, tablets

Alprazolamum
Afobam and Frontin are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking 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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 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:

Afobam should not be taken by 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.

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 planned surgery, the doctor should be informed about the use of Afobam.

Children and adolescents

Afobam should not be taken by 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, it is also possible to increase euphoria, leading to increased psychological dependence.
• Alcohol should not be consumed 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 should be considered when taking Afobam and nefazodone, fluvoxamine, and cimetidine at the same time.
• Particular caution should be exercised when taking alprazolam with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g., erythromycin, clarithromycin, or troleandomycin).
• Taking Afobam and opioids (strong painkillers, drugs used in substitution therapy for addiction, and some cough medicines) at the same time increases the risk of drowsiness, breathing problems (respiratory depression), and coma, and may be life-threatening. For this reason, taking these medicines at the same time can only be considered if there are no other treatment options. However, if the doctor prescribes Afobam

at the same time as opioids, the dose and duration of concurrent 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 a doctor.
• Taking Afobam and HIV protease inhibitors (e.g., ritonavir) at the same time requires a dose adjustment 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

Alcohol should not be consumed 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.
This medicine should not be taken during pregnancy.
If this medicine is taken during pregnancy or if you 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. Afobam should not be taken during breastfeeding.

Driving and using machines

Afobam may impair psychomotor skills. Before taking Afobam, you should familiarize yourself with current local traffic laws.
You should not drive vehicles or operate machines while taking Afobam.

Afobam contains lactose monohydrate and sodium

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

3. How to take Afobam

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Afobam is available in the following doses: 0.25 mg, 0.5 mg, 1 mg.
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 when stopping 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 take the smallest 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, taken in smaller 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.

Overdose of Afobam

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, you should immediately consult a doctor.

Missed dose of Afobam

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

Stopping treatment with Afobam

You should not stop taking this medicine without consulting your doctor.
Since the treatment is only symptomatic, after stopping it, 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 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 (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 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 (a significant decrease in granulocyte count), allergic and anaphylactic reactions (severe allergic reactions).
Benzodiazepines may 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, hearing impairment, stiffness, and paresthesia of the 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 any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Afobam

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
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 pack and other information

What Afobam contains

The active substance of the medicine is 1 mg of alprazolam per tablet.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, red iron oxide (E 172).

What Afobam looks like and what the pack contains

Appearance:Light pink, oblong, biconvex tablets with a score line on one side and the inscription "E" and "313" on the other side.
The tablets can be divided into equal doses.

Packaging:

Brown glass bottle with a plastic cap, in a cardboard box.
The packaging contains 30 or 100 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Hungary, the country of export:

Egis Gyógyszergyár Zrt.
H-1106 Budapest
Keresztúri út 30-38.
Hungary

Manufacturer:

Egis Gyógyszergyár Zrt.
H-9900 Körmend
Mátyás király út 65.
Hungary

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, the country of export:OGYI-T-5967/05
OGYI-T-5967/06
Parallel import authorization number:407/17
Date of leaflet approval: 02.12.2022
[Information about the trademark]