Afobam

Patient Information Leaflet

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Afobam is and what it is 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 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, only in cases where symptoms are severe, impair normal functioning, or are very distressing 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 ingredients of this medicine (listed in section 6);
• if the patient has muscle weakness (myasthenia gravis) (a disease characterized 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 it with your doctor or pharmacist.

• if the medicine is used long-term, because dependence 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 being reduced or it is suddenly discontinued (withdrawal symptoms may occur – see sections 3 and 4);
• if the medicine is used in patients with depression and suicidal thoughts or tendencies;
• if the patient is using other benzodiazepines (increased risk of dependence);
• if the patient is simultaneously using opioids, hypnotics, sedatives, or consuming alcohol (the effects of these medicines or alcohol may be intensified);
• if restlessness, psychomotor agitation, irritability, aggression, hallucinations, anger, nightmares, illusions, psychosis, or unusual behaviour occur. If any of these symptoms appear, treatment should be discontinued and medical advice sought;
• 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 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 select 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
an uninterrupted sleep of 7–8 hours.
Episodes of mania and hypomania associated with alprazolam use have been reported in patients with
depression.
Before any 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 to be used.

• 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 enhanced 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.
• Exercise particular caution and consider dose reduction when using Afobam together with nefazodone, fluvoxamine, or cimetidine.
• Exercise particular caution 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 analgesics, medicines 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

concomitantly 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 advice. It may be helpful to inform family members or friends about the possibility of the above-mentioned symptoms. If they occur, seek medical advice 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 the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
If the medicine is used during pregnancy or if the patient becomes pregnant while taking alprazolam, she should be evaluated for potential fetal risk.
If administration is necessary in late pregnancy, high doses should be avoided and the newborn should be monitored.
Benzodiazepines pass into human milk in small concentrations. Afobam should not be used during breastfeeding.
Driving and operating machinery
Afobam may impair psychomotor performance. Before using Afobam, patients should familiarize themselves with current local traffic regulations.
Patients should not drive or operate machinery while taking Afobam.
Afobam contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Afobam

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Afobam is available in the following doses: 0.25 mg, 0.5 mg, 1 mg.
Treatment should last as short as possible. The doctor should frequently assess the patient's condition and the need for continuing treatment, especially if the severity of the patient's symptoms has decreased 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 start of treatment, the doctor will inform the patient about the limited duration of therapy, the need for gradual dose reduction when discontinuing 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 higher doses and longer duration of treatment; therefore, the lowest effective dose should be used for the shortest possible time, and the need for continued treatment should be regularly reviewed with the doctor.

Recommended dose
The dose is determined by the doctor based on symptom severity 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, administered in smaller divided doses 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 liver function disorders
Use in patients with severe hepatic impairment is contraindicated.

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

Taking more than the recommended dose of Afobam
If more tablets are taken than recommended, symptoms such as ataxia (lack of coordination), drowsiness, speech disturbances, coma, and respiratory depression may occur. If any disturbing symptoms are observed, contact a doctor immediately.

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

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

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions persist or become bothersome, consult a doctor. The occurrence of certain adverse reactions depends on the individual sensitivity of the patient and the dose administered. Usually, adverse reactions are observed at the beginning of treatment. They subside with continued treatment or after dose reduction.
In clinical trials and post-marketing surveillance, the following frequencies of adverse reactions have been observed:

Very common (may occur in more than 1 in 10 patients)

• depression,
• sedation,
• somnolence,
• ataxia (impaired coordination of movement),
• memory disturbances,
• speech disorders,
• dizziness,
• headache,
• constipation,
• dry mouth,
• fatigue,
• irritability.

Common (may occur in no more than 1 in 10 patients)

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

Uncommon (may occur in no more than 1 in 100 patients)

• mania,
• hallucinations,
• anger,
• agitation,
• dependence,
• amnesia,
• decreased muscle strength,
• urinary incontinence,
• irregular menstruation,
• 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 (affecting internal organ function, smooth muscles, and glands),
• dystonia (disturbance of muscle tone),
• gastrointestinal disorders,
• hepatitis,
• liver function abnormalities,
• 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 alcohol abusers, paradoxical reactions such as anxiety may occur.
Other adverse reactions observed rarely or very rarely include: motor disturbances, seizures, psychotic symptoms, changes 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, tension, agitation, disorientation, irritability, altered perception of surroundings or self, hearing impairment, stiffness and tingling of limbs, hypersensitivity to light, noise and touch, hallucinations and epileptic 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 discontinuation of the medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Afobam

Store below 30°C, in the original packaging.
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 must 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 1 mg of alprazolam in each tablet.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, corn starch,
magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silicon dioxide, iron oxide red (E 172).

What Afobam looks like and contents of the pack
Appearance
Oval, biconvex, light pink tablets, marked with "E313" on one side and a dividing line on the other.
The tablet can be divided into equal doses.

Packaging
Brown glass bottle in a cardboard box.
The pack contains 30 or 100 tablets.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, 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
Poland

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

Marketing Authorisation Number in Romania, country of export: 12918/2020/01
12918/2020/02

Parallel Import Licence Number: 366/18