Afobam

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, the information on the immediate packaging in a foreign language.

Afobam (Frontin), 0.5 mg, tablets

Alprazolam
Afobam Frontinare different trade names for the same drug

You should carefully read the contents of the leaflet before using the drug, 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 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 disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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. 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. Afobam has an anxiolytic effect, therefore it is indicated for short-term treatment of:

• generalized anxiety disorder;
• anxiety disorder with panic attacks;
• anxiety disorder in the form of phobias;
• depressive and anxiety disorder mixed Afobam is indicated only in situations where symptoms are severe, disrupt normal functioning, or are very troublesome for the patient.

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 muscle fatigue and 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, you should discuss it with your doctor or pharmacist.

• if the drug is used for a long time, as it may lead to dependence on the drug, 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 any of 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 breathing 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 calmness) 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 in patients with depression have been reported.
Before a planned surgical procedure, the doctor should be informed about the use of Afobam.

Children and adolescents

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

Afobam and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.

• Afobam may enhance the effect of antipsychotic, sedative, anxiolytic, antidepressant, narcotic analgesic, anticonvulsant, anesthetic, and antihistamine drugs.
• In the case of narcotic 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 using 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 may be life-threatening. Therefore, concomitant use of these drugs 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 reduced.
• You should tell your doctor about all opioid drugs 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 a 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

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 using this drug.
This drug should not be used during pregnancy.
If the drug is used 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 drug 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 used during breastfeeding.

Driving and operating machinery

Afobam may impair psychomotor skills. Before using Afobam, you should familiarize yourself with the current local traffic regulations.
While using Afobam, you should not drive vehicles or operate machinery.

Afobam contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your 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 according to the doctor's or pharmacist's instructions. In case of doubts, you should consult a 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 will regularly 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. Generally, treatment should not last longer than 8-12 weeks, including the dose reduction period.
At the start of treatment, the doctor will inform you 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 you should use the lowest effective dose for the shortest possible time and regularly 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 generalized anxiety disorder and mixed depressive and anxiety disorder
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.
Symptomatic treatment of anxiety disorder with panic attacks and anxiety disorder in the form of phobias
The recommended initial dose is 0.5 mg or 1 mg per day, taken before bedtime.
Depending on the patient's needs, the doctor may decide to increase the dose. The dose may be increased by 1 mg at intervals of 3-4 days. The doctor may decide to administer an additional dose in such a way that the total number of doses does not exceed 3 or 4 doses per 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 two equal doses.

Use of a higher than recommended dose of Afobam

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

Missing a 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 drug without consulting your doctor.
Since treatment is only symptomatic, after its discontinuation, symptoms may return. The doctor will decide to gradually reduce the dose. The recommended reduction of the daily dose of Afobam should not exceed 0.5 mg every three days. In some patients, it may be necessary to reduce the dose even more slowly.
In case of any further doubts related to the use of this drug, you should consult a 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, you should consult a doctor. The occurrence of some side effects depends on the individual patient's sensitivity and the dose used. 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,
• 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,
• 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,
• memory loss,
• muscle weakness,
• urinary incontinence,
• irregular menstrual cycles,
• drug withdrawal syndrome.

Unknown frequency (cannot be determined 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 toes),
• 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: movement 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, tension, agitation, disorientation, irritability, mood changes, impaired hearing, 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 withdrawal of the drug.
Cases of benzodiazepine abuse have been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
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 drug.

5. How to store Afobam

Do not store above 30°C.
The drug should be stored in a place invisible and inaccessible to children.
Do not use this drug after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Drugs should not be disposed of in sewage or household waste containers. You should ask your 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 0.5 mg of alprazolam in one tablet.
The other ingredients are:

What Afobam looks like and what the package contains

Appearance:

Light yellow, oblong, biconvex tablets with a dividing line on one side and the inscription "E" and "312" on the other side.
The tablets can be divided into two equal doses.

Package:

Brown glass bottle with a white plastic cap, in a cardboard box. The package contains 30 or 100 tablets.
For more detailed information, you should contact the marketing authorization holder or 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., 9900 Körmend, Mátyás király u. 65, Hungary

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 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
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Authorization number in Hungary, the country of export:OGYI-T-5967/03
OGYI-T-5967/04
Parallel import authorization number:149/17
Date of leaflet approval: 28.04.2022
[Information about the trademark]