Afobam

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Afobam (Frontin)

0.25 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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, pharmacist, or nurse. 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. Package contents and other information

1. What is Afobam and what is it used for

The active substance of this drug, alprazolam, belongs to a group of drugs called benzodiazepine derivatives (drugs with anxiolytic activity).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in situations where the symptoms are severe, prevent normal functioning, or are very troublesome for the patient. This drug 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 drug (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 used in 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 drug is used for a long time, as dependence on the drug 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 drug is reduced or it is suddenly discontinued (possible occurrence of withdrawal symptoms - see sections 3 and 4);
• if the drug is used in 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, sleeping pills, sedatives, or drinking alcohol (the effect of these drugs 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 drug should be discontinued and the doctor should be consulted;
• if the patient has glaucoma;
• if the patient has respiratory disorders;
• if the patient has kidney or liver function disorders;
• if the patient is elderly or weakened, Afobam should be used with caution due to the risk of sedation (excessive calming) and/or muscle weakness, which may increase the likelihood of falls with all their serious consequences for the elderly. The attending physician will select the lowest effective dose.

Like other benzodiazepines, Afobam may cause anterograde amnesia, which occurs a few hours after taking the drug. 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, the patient should inform their doctor about taking Afobam.

Children and adolescents

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

Afobam and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.

• Afobam may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, opioid analgesic, anticonvulsant, anesthetic, and antihistamine drugs.
• 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 drugs 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.
• 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 drugs can only be considered if there are no other treatment options. If, however, 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 drugs they are taking and strictly follow the doctor's instructions. It may be helpful to inform the family or friends about the possibility of the above-mentioned symptoms. If they occur, the patient should consult a doctor.
• Taking Afobam and HIV protease inhibitors (e.g., ritonavir) requires a dose adjustment 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

Alcohol should not be consumed during treatment with Afobam.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this drug.
This drug should not be used during pregnancy.
If the drug is used 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 drug 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 used during breastfeeding.

Driving and operating machinery

Afobam may impair psychomotor skills. Before taking Afobam, the patient should familiarize themselves with the current 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 drug.
This drug contains less than 1 mmol of sodium (23 mg) per tablet, which means the drug is considered "sodium-free".

3. How to take Afobam

This drug should always be taken as directed by the doctor or pharmacist. 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 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 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, 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 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.

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 any worrying symptoms are noticed, the patient should immediately consult their doctor.

Missing a dose of Afobam

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

Discontinuation of Afobam

The patient should not stop taking this drug without consulting their doctor.
Since the treatment is only symptomatic, after its discontinuation, the symptoms may return. The doctor will decide to gradually reduce the dose.
In case of any further doubts about the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug may cause side effects, although they do not occur in everyone.
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 administered. 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 drug was introduced to 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,
• 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 drugs, 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 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, hearing impairment, stiffness, and tingling 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 drug.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the drug.

5. How to store Afobam

Store at a temperature below 30°C, in the original packaging.
The drug should be stored out of sight and reach of children.
This drug should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Afobam contains

The active substance of the drug is 0.25 mg of alprazolam per 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 package contains

Appearance:
White or yellowish-white, elongated, biconvex tablets with a dividing line on one side and the inscription "E" and "311" on the other side.
The tablets can be divided into equal doses.
Packaging:
A brown glass bottle in a cardboard box containing 30 or 100 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király út 65
9900 Körmend
Hungary

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 12916/2020/01
12916/2020/02

Parallel import authorization number: 386/11 Date of leaflet approval: 11.09.2023

[Information about the trademark]