Alprazolam Ibsa

Patient Information Leaflet

Alprazolam IBSA 0.25 mg oral solution in single-dose container, 0.50 mg oral solution in single-dose container, 0.75 mg oral solution in single-dose container, 1 mg oral solution in single-dose container

alprazolam
Please read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Alprazolam IBSA is and what it is used for
2. What you need to know before taking Alprazolam IBSA
3. How to take Alprazolam IBSA
4. Possible side effects
5. How to store Alprazolam IBSA
6. Contents of the pack and other information

1. What Alprazolam IBSA is and what it is used for

Alprazolam IBSA contains the active substance alprazolam. Alprazolam belongs to a group of medicines known as benzodiazepine derivatives (anxiolytic medicines).
Alprazolam IBSA is used in adults for the treatment of anxiety symptoms when the disorder is severe, disabling, or causing the patient severe distress. This medicine is indicated only for short-term treatment.

2. What you should know before taking Alprazolam IBSA

Do not take Alprazolam IBSA

• if you are allergic to alprazolam, to benzodiazepines, or to any of the other ingredients of this medicine listed in section 6;
• if you have severe muscle weakness ( myasthenia gravis );
• if you have severe breathing difficulties;
• if you suffer from sleep apnoea syndrome;
• if you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alprazolam IBSA:

• if you have glaucoma;
• if you are depressed, as treatment with Alprazolam IBSA may increase the risk of suicidal thoughts and self-harm;
• episodes of hypomania and mania (excessive activity and abnormally elevated excitement) have been reported in association with alprazolam use in patients with depression;

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• benzodiazepines and benzodiazepine-like substances should be used with caution in elderly patients due to the risk of sedation and/or muscle-relaxant effects, which may increase the risk of falls, often with serious consequences in this population;
• if you have lung, kidney, or liver problems;
• a certain loss of effectiveness (tolerance) may occur after prolonged use of alprazolam;
• dependence (physical and psychological), abuse, misuse, and addiction are known risks associated with alprazolam and other benzodiazepines;
• once dependence has developed, a rapid dose reduction or abrupt discontinuation of treatment may lead to adverse effects such as withdrawal symptoms (see section 3 “If you stop taking Alprazolam IBSA” and the end of section 4). The risk of dependence increases with higher doses and longer treatment duration, and is greater in patients with a history of drug or alcohol abuse. Therefore, to minimize these risks, the lowest effective dose should be used for the shortest possible duration;
• episodes of memory impairment (anterograde amnesia), usually within a few hours after taking benzodiazepines, have been reported;
• during treatment with benzodiazepines, reactions such as restlessness, agitation, irritability, aggression, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral effects may occur. If this happens, consult your doctor or pharmacist. These reactions occur more frequently in children and elderly patients.

Drinking alcohol during treatment may enhance the effects of benzodiazepines, particularly stupor; therefore, alcohol consumption is not recommended during treatment with Alprazolam IBSA.
Children and adolescents
Alprazolam is not recommended for children and adolescents under 18 years of age.
Other medicines and Alprazolam IBSA
Benzodiazepines, the class to which alprazolam belongs, have an additive depressant effect on the central nervous system (CNS) when taken concomitantly with other psychotropic agents, anticonvulsants (medicines for treating epileptic seizures), antihistamines (medicines for treating allergies), alcohol, and other CNS-active substances (see section on concomitant use of Alprazolam IBSA and opioids).
The following medicines may increase the effect of alprazolam:

• ketoconazole, itraconazole, or other azole antifungals (used to treat fungal infections). Therefore, concomitant use with alprazolam is not recommended;
• nefazodone, fluvoxamine, fluoxetine (used to treat depression), propoxyphene (a strong painkiller), sertraline, oral contraceptives, diltiazem (used to treat high blood pressure), macrolide antibiotics such as erythromycin and clarithromycin, cimetidine (which reduces gastric acid secretion).

The following medicines may reduce the effect of alprazolam:

• carbamazepine, phenobarbital, phenytoin (used in patients with epilepsy);
• rifampicin (used to treat tuberculosis);
• St. John’s wort (a herbal medicine used in patients with depression).

Inform your doctor if you are taking digoxin (used to treat heart failure), as monitoring or dose adjustment of Alprazolam IBSA may be necessary.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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Concomitant use of Alprazolam IBSA and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Alprazolam IBSA together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioids you are taking and follow their dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if these symptoms occur.
Alprazolam IBSA with food, drinks, and alcohol
Drinking alcohol during treatment may enhance the effects of benzodiazepines, particularly stupor; therefore, do not drink alcohol during treatment with Alprazolam IBSA.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of benzodiazepines is not recommended during pregnancy and breastfeeding.
Alprazolam IBSA contains propylene glycol; if you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring during treatment (see section 2 “This medicine contains”).
Driving and using machines
Benzodiazepines may impair reaction ability (particularly reaction speed); therefore, it is recommended not to drive or operate certain tools or machinery.
This medicine contains:

• 123 mg of alcohol (ethanol) in each ml of oral solution (14.8% v/v). The amount in 1 ml of this medicine is equivalent to less than 3 ml of beer or 1.2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects;
• up to 763.66 mg of propylene glycol in each ml of oral solution. If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
• less than 1 mmol of sodium (23 mg) in each ml of oral solution, i.e. essentially “sodium-free”.

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3. How to take Alprazolam IBSA

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
You may experience mild drowsiness at the beginning of treatment, but this effect usually diminishes
with continued therapy. If you notice this effect, consult your doctor.
Dosage:
For individual treatment, Alprazolam IBSA is available in single-dose containers containing
between 0.25 and 1 mg of alprazolam. Whenever possible, you should take only one single-dose
container per dose. Otherwise, take the minimum number of units from the available dosages to
achieve the prescribed dose.
Adults
SYMPTOMATIC TREATMENT OF ANXIETY
Generally, at the start of treatment, your doctor will prescribe: 0.25 mg to 0.50 mg of alprazolam
three times a day. If necessary, the dose may be adjusted.
The maximum daily dose for the treatment of anxiety and tension-related disorders is 4 mg.
Elderly patients
In elderly patients and in patients who are debilitated or have chronic respiratory insufficiency,
or hepatic or renal impairment, the usual initial dose prescribed by the doctor is: 0.25 mg 2–3
times a day. Again, the doctor may decide to adjust the dose if necessary.
Duration and discontinuation of treatment
The risk of dependence and abuse increases proportionally with dose and duration of treatment. Therefore, your doctor will prescribe the lowest effective dose for the shortest possible duration and will regularly reassess the need to continue treatment (see section 2 “Warnings and precautions”).
The maximum duration of treatment should not exceed 2–4 weeks. Long-term treatment is not recommended.
How to take the medicine:

1. Open the aluminium sachet by tearing along the dotted line.
2. Remove from the strip the single-dose container to be used immediately. Reinsert any unused containers back into the sachet before storage.
3. Hold the container vertically (with the cap facing upwards) between your thumb and index finger without squeezing it. Carefully open the container by rotating the cap until it is completely detached, without applying pressure to the container.
4. Administration of Alprazolam IBSA directly into the mouth:
   • Invert the single-dose container.
   • Squeeze the soft central part of the container between your thumb and index finger to release the liquid medicine into the mouth.
   • Keeping the container inverted, repeat this step quickly two more times, or until no more liquid comes out.
5. Dispose of the empty container and any residual content. If you take more Alprazolam IBSA than you should Contact your doctor, pharmacist, or nearest emergency department immediately if you have taken an excessive amount of Alprazolam IBSA. Do not give anything to drink to the patient if they are not fully conscious.

INFORMATION FOR THE DOCTOR
An intravenous dose of flumazenil may be used as an antidote in cases of severe poisoning with
coma or respiratory failure.
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The use of flumazenil as an antidote is contraindicated in the following cases:

• use of tricyclic antidepressants
• concomitant use of medicines that lower the seizure threshold
• abnormalities on ECG, such as QRS complex widening or QT interval prolongation (suggesting concomitant use of tricyclic antidepressants).

If you forget to take Alprazolam IBSA
If you forget to take a dose at the scheduled time, take it as soon as possible, unless it is almost time
for the next dose. In that case, skip the missed dose and continue with your regular schedule. Do not take a
double dose to make up for the missed dose.
If you stop taking Alprazolam IBSA
Treatment must not be stopped abruptly, but only gradually, as directed by your doctor. Sudden
discontinuation may lead to withdrawal symptoms such as irritability, insomnia, cramps, nausea, sweating, seizures, and delirium, especially in patients treated with high doses.
For this reason, your doctor will gradually reduce the dose at the end of treatment. The tapering schedule depends on individual needs and various factors (e.g., duration of treatment and daily dose). Ask your doctor how to gradually reduce the dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects associated with alprazolam treatment have been observed in participants of controlled clinical trials and reported during post-marketing experience (*):

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

• depression
• sedation (drowsiness), sleepiness, lack of coordination, memory disturbances, difficulty speaking (dysarthria), dizziness, headache
• constipation, dry mouth
• fatigue, irritability

Common side effects (may affect up to 1 in 10 people):

• loss of appetite
• confusion, disorientation, decreased sexual desire, anxiety, insomnia, nervousness, increased sexual desire
• balance disorders, coordination abnormalities, inability to concentrate, excessive sleepiness (hypersomnia), lethargy (extreme weakness), instability
• blurred vision
• nausea
• skin inflammation (dermatitis)*
• sexual disorders*
• weight loss, weight gain

Uncommon side effects (may affect up to 1 in 100 people):

• drug dependence
• mania* (excessive activity and abnormally elevated mood) (see section 2 “Warnings and precautions”), hallucinations*, rage*, agitation*
• amnesia
• muscle weakness
• incontinence*
• irregular menstruation*
• medicine withdrawal syndrome*

Side effects of unknown frequency

• autonomic nervous system imbalance*, changes in muscle tone (dystonia)*
• angioedema*
• photosensitivity*
• increased prolactin production*
• hypomania*, aggression*, hostility*, abnormal thoughts*, psychomotor hyperactivity*
• gastrointestinal disorders*
• liver inflammation (hepatitis)*, liver problems*, jaundice*
• urinary retention*
• increased eye pressure*
• peripheral edema*
• drug abuse*

The following side effects have also been reported:
Rare side effects (may affect up to 1 in 1,000 people):

• cholestasis (reduced bile flow)
• agranulocytosis (reduced white blood cell count)
• respiratory depression in patients with non-specific chronic respiratory disorders
• allergic reactions or severe potentially fatal allergic reactions (anaphylaxis)
• ovulation disorders and breast enlargement
• anorexia (loss of appetite)

The following side effects of benzodiazepines have been reported rarely or only in exceptional cases:
fatigue, signs of paranoia, psychological and physical dependence, withdrawal symptoms (headache, muscle pain, severe anxiety, irritability, feeling of detachment from reality (derealization), depersonalization (loss of perception of physical or mental reality), hearing loss, stiffness and tingling in the extremities, hypersensitivity to noise and physical touch, epileptic seizures).
When treatment is discontinued, rebound phenomena may occur, such as insomnia and anxiety, as well as mood changes, anxiety, sleep disturbances, and agitation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alprazolam IBSA

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
After first opening of the sachet: use the unit-dose containers within 2 months.
After first opening of the unit-dose container: use immediately.
Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
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6. Package contents and other information

What Alprazolam IBSA contains

• The active substance is alprazolam.
• The other components are: ethanol 96% (alcohol), propylene glycol, sodium saccharin, grapefruit flavour, and water.

Description of the appearance of Alprazolam IBSA and contents of the pack
Single-dose container made of low-density polyethylene (LDPE), transparent, 1 ml, in a strip of 5 single-dose containers inside a pouch made of polyethylene terephthalate/aluminum/polyethylene (PET/Alu/PE).
Alprazolam IBSA is supplied in pouches made of polyethylene terephthalate/aluminum/polyethylene (PET/Alu/PE), each containing 5 single-dose containers.
Alprazolam IBSA is available in packs containing 10 single-dose containers of 1 ml and 20 single-dose containers of 1 ml.

Marketing Authorization Holder and Manufacturer
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia, 2, 26900 Lodi, Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
BE, LU: Alprazolam IBSA
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