Afobam

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Afobam (Frontin)
0.25 mg, tablets
Alprazolamum
Afobam and Frontin are different trade names for the same medicine.
Please read the following information carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Afobam is and what it is used for
2. What you need to know 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 Afobam is and what it is used for

The active substance in this medicine, alprazolam, belongs to a group of medicines called benzodiazepine derivatives (medicines with anxiolytic action).
Afobam is indicated for the treatment of symptoms of anxiety disorders in adults, exclusively in situations where symptoms are severe, impair normal functioning, or cause significant distress to the patient. This medicine is intended for short-term use only.

2. Important information before using Afobam

When not to use Afobam:

• if the patient is allergic to alprazolam, other benzodiazepines, or any of the other components of this medicine (listed in section 6);
• if the patient suffers from muscle weakness (myasthenia gravis) (a disease characterised by excessive fatigue and muscle weakness);
• if the patient has severe respiratory insufficiency;
• if the patient has sleep apnoea syndrome;
• if the patient has severe hepatic insufficiency.

Afobam must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Afobam, discuss the following with your doctor or pharmacist:

• if the medicine is to be used long-term, as dependence may occur, particularly in patients prone to drug or alcohol abuse. The doctor should periodically assess the need for continued treatment;
• if the dose is being reduced or the medicine is suddenly discontinued (withdrawal symptoms may occur – see sections 3 and 4);
• if the medicine is used in patients with depression accompanied by suicidal thoughts or tendencies;
• if the patient is taking other benzodiazepines (increased risk of dependence);
• if the patient is concurrently taking opioids, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be enhanced);
• if symptoms such as restlessness, psychomotor agitation, irritability, aggression, hallucinations, nightmares, delusions, psychosis, or unusual behaviour occur. If any of these symptoms appear, treatment with the medicine should be discontinued and medical advice sought;
• if the patient has glaucoma;
• if the patient has breathing disorders;
• if the patient has impaired kidney or liver function;
• if the patient is elderly or debilitated, Afobam should be used with caution due to the risk of sedation (excessive calming) and/or skeletal muscle weakness, which may increase the likelihood of falls and their serious consequences in elderly individuals. The treating physician will determine the lowest effective dose.

Like other benzodiazepines, Afobam may cause anterograde amnesia, which occurs several hours after taking the medicine. In such cases, the patient should be ensured uninterrupted sleep for 7–8 hours.
Episodes of mania and hypomania associated with alprazolam use have been reported in patients with depression.
Before a planned surgical procedure, inform the doctor about taking Afobam.

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

Afobam with other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

• Afobam may enhance the effects of antipsychotics, hypnotics, anxiolytics, sedatives, antidepressants, opioid analgesics, anticonvulsants, anaesthetics, and antihistamines.

• With opioid analgesics, increased euphoria may occur, leading to heightened psychological dependence.

• Alcohol must not be consumed during treatment with Afobam.

• Concomitant use of Afobam with certain systemic antifungal medicines (e.g. ketoconazole, itraconazole, posaconazole, voriconazole) is not recommended.

• Particular caution is required and dose reduction should be considered when Afobam is used concomitantly with nefazodone, fluvoxamine, or cimetidine.

• Exercise particular caution when using alprazolam together with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, and macrolide antibiotics (e.g. erythromycin, clarithromycin, or troleandomycin).

• Concomitant use of Afobam and opioids (strong analgesics, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing problems (respiratory depression), and coma, which may be life-threatening. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available. If your doctor prescribes Afobam together with opioids, the dose and duration of combined treatment should be limited.

• Inform your doctor about all opioid medicines you are taking and strictly follow medical instructions. It may be helpful to inform family members or friends about the possibility of the above-mentioned symptoms. If they occur, contact your doctor immediately.

• Concomitant use of Afobam and protease inhibitors of human immunodeficiency virus (HIV) (e.g. ritonavir) requires dose adjustment or discontinuation of alprazolam.

• Patients taking alprazolam and digoxin concomitantly should be closely monitored for signs of digoxin toxicity.

• Theophylline may reduce the effect of benzodiazepines.

Afobam and alcohol
Alcohol must not be consumed during treatment with Afobam.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
If the medicine is used during pregnancy or if a patient becomes pregnant while taking alprazolam, she should be evaluated for potential fetal risk.
If administration of the medicine is necessary during the late stages of pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small amounts. Afobam should not be used during breastfeeding.

Driving and operating machinery
Afobam may impair psychomotor performance. Before using Afobam, become familiar with current local traffic regulations. During treatment with Afobam, do not drive vehicles or operate machinery.

Afobam contains lactose monohydrate and sodium
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is considered "sodium-free".

3. How to use Afobam

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Afobam is available in the following strengths: 0.25 mg, 0.5 mg, 1 mg.
Treatment should be as short as possible. Your doctor should regularly assess your condition and the need for continuing treatment, especially if your symptoms have improved and may no longer require pharmacological treatment. The total duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended.
At the beginning of treatment, your doctor will inform you about the limited duration of therapy, the need for gradual dose reduction when discontinuing the medicine, and the possibility of withdrawal reactions.
When using benzodiazepines, including Afobam, dependence and emotional or physical dependence may develop. This risk increases with higher doses and longer duration of treatment. Therefore, the lowest effective dose should be used for the shortest possible time, and the need for continuing treatment should be regularly reviewed 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 adverse reactions occur after the initial dose, the doctor may decide to reduce the dose.

Treatment of symptomatic anxiety states
The recommended initial dose is 0.25 mg or 0.5 mg taken three times daily. Depending on the patient's response to treatment, the doctor may increase the dose up to a maximum daily dose of 4 mg, divided into smaller doses administered throughout the day.

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

Use in patients with impaired liver function
Afobam is contraindicated in patients with severe liver impairment.

Use in elderly patients
The recommended initial dose is 0.25 mg two or three times daily. Depending on treatment tolerance, the doctor may gradually increase the dose if necessary. If adverse reactions occur, the doctor may decide to reduce the initial dose.
Tablets may be divided into equal doses.

Taking more Afobam than recommended
If you take more tablets than recommended, symptoms such as ataxia (lack of coordination), drowsiness, speech disturbances, coma, and respiratory depression may occur. If any disturbing symptoms appear, contact your doctor immediately.

Missing a dose of Afobam
Do not take a double dose to make up for a missed dose.

Stopping Afobam treatment
Do not stop taking this medicine without consulting your doctor.
Since treatment is purely symptomatic, symptoms may return after discontinuation. Your doctor will decide on a gradual reduction of the dose.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects persist or become troublesome, consult your doctor. The occurrence of certain adverse effects depends on the individual patient's sensitivity and the dose administered. Usually, adverse effects are observed at the beginning of treatment. They tend to resolve with continued treatment or after dose reduction.

The following frequencies of adverse effects have been reported in clinical trials and following marketing authorization:

Very common (may affect more than 1 in 10 people)

• depression,
• sedation,
• drowsiness,
• ataxia (lack of muscle coordination),
• memory impairment,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common (may affect up to 1 in 10 people)

• decreased appetite,
• confusion,
• disorientation,
• decreased libido,
• increased libido,
• anxiety,
• insomnia,
• nervousness,
• balance problems,
• motor coordination disorders,
• concentration difficulties,
• increased drowsiness,
• lethargy,
• tremor,
• blurred vision,
• nausea,
• skin inflammation,
• sexual dysfunction,
• weight decrease,
• weight increase.

Uncommon (may affect up to 1 in 100 people)

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• amnesia,
• muscle weakness,
• urinary incontinence,
• irregular menstruation,
• drug withdrawal syndrome.

Frequency not known (cannot be estimated from available data)

• hyperprolactinaemia (increased blood prolactin levels),
• hypomania,
• aggressive behaviour,
• hostile behaviour,
• disordered thinking,
• increased psychomotor activity,
• drug abuse,
• autonomic nervous system imbalance (which controls the function of internal organs, smooth muscles, and glands),
• dystonia (abnormal muscle tone),
• gastrointestinal disorders,
• hepatitis,
• liver function disturbances,
• jaundice,
• angioedema,
• photosensitivity reactions,
• urinary retention,
• peripheral oedema (swelling of ankles, feet, or fingers),
• increased intraocular pressure.

Additionally, particularly in patients taking other psychotropic medicines, those with psychiatric disorders, or those who misuse alcohol, paradoxical reactions such as anxiety may occur.

Other adverse effects observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, disturbances in self-perception, agranulocytosis (marked decrease in granulocyte count), allergic and anaphylactic reactions (severe allergic reactions).

Benzodiazepines may cause physical and psychological dependence. After physical dependence has developed, abrupt discontinuation of alprazolam may lead to withdrawal symptoms such as headache, muscle pain, increased anxiety, feelings of tension, agitation, disorientation, irritability, altered perception of surroundings or of self, hearing impairment, limb stiffness and tingling, hypersensitivity to light, noise, and touch, hallucinations and seizures, insomnia, and mood changes.

These symptoms are usually more pronounced in patients treated long-term with high doses of benzodiazepines and in cases of abrupt or rapid drug discontinuation.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse effects helps to provide more information on the safety of the medicine.

5. How to store Afobam

Do not store above 25°C.
Keep the medicine out of the 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Afobam contains
The active substance is 0.25 mg of alprazolam in one tablet.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

What Afobam looks like and contents of the pack
Appearance
White or yellowish-white, elongated, biconvex tablets with a score line on one side and
the markings "E" and "311" on the other side.
The tablets can be divided into equal doses.

Packaging
Brown glass bottle closed with a white plastic cap, placed in a cardboard box, with an
instruction leaflet.
The packaging contains 30 or 100 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Hungary, the country of export:
Egis Gyógyszergyár Zrt.
Keresztúri út 30-38., 1106 Budapest, Hungary

Manufacturer:
Egis Gyógyszergyár Zrt.
Mátyás király út 65., 9900 Körmend, Hungary
Egis Gyógyszergyár Zrt.
Bökényföldi út 118-120., 1165 Budapest, Hungary

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing authorisation numbers in Hungary, the country of export: OGYI-T-05967/01
OGYI-T-05967/02

Parallel import authorisation number: 197/15