Afobam

Leaflet accompanying the packaging: patient information

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.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be able to read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given 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 packaging and other information

1. What is Afobam and what is it used for

The active substance of this medicine, alprazolam, 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 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 characterized by excessive fatigue and muscle weakness);
• if the patient has severe respiratory failure;
• if the patient has sleep apnea syndrome;
• if the patient has 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, the patient should discuss it with their 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 stopped abruptly (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 the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is taking opioids, sedatives, anxiolytics, antidepressants, or drinking alcohol (the effect of these medicines or alcohol may be enhanced);
• if restlessness, psychomotor agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or abnormal behavior occur. If these symptoms occur, the use of the medicine should be stopped and the doctor consulted;
• if the patient has glaucoma;
• if the patient has respiratory disorders;
• if the patient has liver or kidney function disorders;
• if the patient is 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 planned surgery, the patient should inform their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 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).
• Taking 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, concurrent use of these medicines can only be considered if there are no other treatment options. However, if the doctor prescribes Afobam

together with opioids, the dose and duration of concurrent treatment should be limited.

• The patient should tell their doctor about all opioid medicines they are taking and strictly follow the doctor's instructions. It may be helpful to inform family or friends about the possibility of the above-mentioned symptoms. If they occur, the patient should consult their doctor.
• Taking Afobam and HIV protease inhibitors (e.g., ritonavir) may require 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy.
If the medicine is taken during pregnancy or if the patient becomes pregnant while taking alprazolam, they 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. Afobam should not be taken during breastfeeding.

Driving and operating machinery

Afobam may impair psychomotor abilities. Before taking Afobam, the patient should familiarize themselves with local traffic laws.
While taking Afobam, the patient should not drive vehicles or operate machinery.

Afobam contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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, the patient should consult their 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 the patient about the limited duration of therapy, the gradual reduction of the dose during withdrawal, 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 the lowest 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 patient's individual 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, taken two or three times a day. Depending on the tolerance of the 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

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

Missed dose of Afobam

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Afobam

Treatment with this medicine should not be stopped without consulting the doctor.
Since the treatment is only symptomatic, after its discontinuation, the symptoms may recur.
The doctor will decide on a gradual reduction of the dose.
In case of any further doubts about the use of this medicine, the patient should consult their 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, the patient should consult their doctor. The occurrence of some side effects depends on the patient's individual sensitivity and the dose taken. Side effects are usually more common 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,
• sedation,
• 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,
• tremor,
• 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,
• drug 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, such as anxiety, may occur.
Other side effects have been reported 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 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, feeling of tension, agitation, disorientation, irritability, change 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 case of sudden or rapid discontinuation of the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects 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.
This medicine should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Afobam contains

The active substance of the medicine is 1 mg of alprazolam in one 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 packaging contains

Appearance

Oval, biconvex, light pink tablets, marked with "E313" on one side and a dividing line on the other side. The tablet can be divided into equal doses.

Packaging

Brown glass bottle, in a cardboard box.
The packaging contains 30 or 100 tablets.
For more detailed information, the patient should 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:

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 Romania, the country of export:12918/2020/01
12918/2020/02
Parallel import authorization number:366/18

Date of leaflet approval: 06.12.2023

[Information about the trademark]