Alprazolam Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Alprazolam Zentiva 0.75 mg/ml oral drops, solution

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet:

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

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

Alprazolam Zentiva contains the active substance alprazolam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress to the individual.
This medicine is indicated:

• for the treatment of anxiety, tension, and other anxiety-related disorders;
• for the treatment of panic attacks, including those caused by discomfort in open spaces (agoraphobia).

2. What you should know before taking Alprazolam Zentiva

Do not take Alprazolam Zentiva:

• if you are allergic to alprazolam or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (benzodiazepines);
• if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have breathing difficulties during sleep (sleep apnea);
• if you have severe liver problems (severe hepatic insufficiency) that may worsen mental confusion (hepatic encephalopathy);
• if you have high eye pressure due to a condition called closed-angle glaucoma. However, the medicine may be used if you have open-angle glaucoma and are receiving appropriate treatment;
• if you are in the first three months of pregnancy or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alprazolam Zentiva.
Avoid taking this medicine if you have alcohol or drug dependence (including medications that depress the central nervous system), unless your doctor considers it absolutely necessary.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly or debilitated (see section 3 “How to take Alprazolam Zentiva”). In this case, your doctor may decide to reduce the dose;
• if you have respiratory problems (chronic respiratory insufficiency). Your doctor may decide to reduce the dose;
• if you have previously abused alcohol or drugs;
• if you have any liver or kidney problems, even mild (hepatic or renal insufficiency);
• if you are taking other psychotropic medicines.

If you suffer from panic attacks but are not currently taking medication for this condition, do not take Alprazolam Zentiva as the sole treatment.
Tolerance
If after a few weeks the medicine seems less effective, consult your doctor.
Dependence
There is a risk of dependence when taking this medicine, meaning a need to continue taking it. The risk increases with higher doses and longer treatment duration. The risk is greater if you currently or previously have abused drugs or alcohol. If dependence develops, abrupt discontinuation or rapid dose reduction must be avoided, as withdrawal symptoms may occur (see next section).
Stopping treatment and withdrawal
When stopping this medicine, you may experience a temporary condition in which the symptoms that led to benzodiazepine treatment reappear in a worsened form (rebound syndrome). Other symptoms may also occur, such as mood changes, anxiety, restlessness, or sleep disturbances. Abrupt discontinuation of treatment—especially if dependence has developed (see previous section)—may lead to withdrawal symptoms such as headache, mood disturbances (dysphoria), insomnia, muscle cramps, abdominal cramps, vomiting, sweating, tremor, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: disturbances in thought and behavior such as derealization (feeling that things are not real) and depersonalization (feeling detached from the surrounding environment), hearing disturbances (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that do not exist), and epileptic seizures (sudden, uncontrollable movements). To minimize these effects, a gradual dose reduction is recommended (see section “If you stop taking Alprazolam Zentiva”).
During discontinuation in patients with panic disorder, symptoms related to the recurrence of panic attacks—mimicking typical withdrawal symptoms—may sometimes occur.
Treatment should be gradually discontinued; otherwise, the symptoms for which you were being treated may reappear more intensely than before (rebound anxiety). The risk of developing these symptoms is higher if you stop taking Alprazolam Zentiva suddenly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.
Duration of treatment
Treatment duration should be as short as possible. For anxiety treatment, it should not exceed 8–12 weeks, including a gradual tapering-off period. Treatment beyond this period should only occur after medical evaluation.
Amnesia
This medicine may cause amnesia (memory loss), especially within the first few hours after taking it.
Behavioral reactions
During treatment with this medicine, you may experience behavioral disturbances such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), and behavioral changes. These reactions are more common in children and elderly patients. If you experience such symptoms, contact your doctor immediately.
Depression
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
For athletes
The use of medicines containing ethanol, including Alprazolam Zentiva oral drops, may lead to a positive result in anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
The use of Alprazolam Zentiva is not recommended in children and adolescents under 18 years of age without careful medical evaluation of the actual need for treatment.
Elderly
Elderly patients should use benzodiazepines and related products with caution, as the risk of sedation and/or musculoskeletal weakness may lead to falls, often with serious consequences.
Other medicines and Alprazolam Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking the following medicines:

• antipsychotics or neuroleptics, used to treat mental disorders;
• antidepressants such as nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine;
• hypnotics, medicines used to help sleep;
• anxiolytics/sedatives, used to treat anxiety;
• certain strong painkillers and cough sedatives (narcotic analgesics, e.g., propoxyphene, opioids), which may cause increased feelings of well-being when taken with Alprazolam Zentiva. This may increase your desire to continue taking these medicines (dependence), particularly in elderly patients;
• antiepileptics, used for epilepsy;
• anesthetics, used during surgical procedures;
• antihistamines with sedative effects, used to treat allergies;
• medicines used for fungal infections such as ketoconazole, itraconazole, posaconazole, voriconazole;
• certain antibiotics used against bacterial infections (erythromycin, clarithromycin, telithromycin, troleandomycin);
• ritonavir and other medicines used to treat HIV (protease inhibitors);
• cimetidine, used to treat stomach lesions (ulcers);
• oral contraceptives;
• diltiazem, used to treat high blood pressure;
• digoxin, a medicine used to treat certain heart problems (arrhythmias);
• medicines that, by acting on certain liver enzymes, may increase the effect of Alprazolam Zentiva.

Concomitant use of Alprazolam Zentiva and opioids (strong analgesics, medicines for addiction treatment, and certain cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Alprazolam Zentiva together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Alprazolam Zentiva and alcohol
Avoid alcohol during treatment with this medicine, as it may increase the sedative effect. This negatively affects your ability to drive or operate machinery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Alprazolam Zentiva during the first three months of pregnancy. In later stages, take this medicine only if necessary and at low doses, always under strict medical supervision.
If your doctor considers it necessary for you to take Alprazolam Zentiva during late pregnancy or during labor, your baby may experience, even after low doses, symptoms such as loss of muscle tone (hypotonia), feeding difficulties (sucking problems) with poor weight gain, and, in severe cases, breathing problems (respiratory depression or apnea), and reduced body temperature (hypothermia).
If you have taken Alprazolam Zentiva on medical prescription during late pregnancy or during labor, your baby may develop dependence and experience neonatal withdrawal symptoms such as hyperexcitability, agitation, and tremors.
Breastfeeding
Do not take this medicine if you are breastfeeding, as alprazolam passes into breast milk.
Driving and using machines
The use of Alprazolam Zentiva may affect your ability to drive or operate machinery, as you may experience difficulty concentrating, forgetfulness, drowsiness, or muscle problems. These effects may be worse if you have not had enough sleep. If this occurs, do not drive or operate machinery. Taking alcohol during treatment with this medicine negatively affects your ability to drive or operate machinery.
Alprazolam Zentiva contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Alprazolam Zentiva contains propylene glycol
This medicine contains 855.13 mg of propylene glycol per 1 ml (30 drops) of solution, equivalent to 0.75 mg of alprazolam.
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
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.
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.

3. How to take Alprazolam Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you to stop.
Always use the lowest effective dose and do not exceed the maximum dose recommended by your doctor to avoid
unwanted effects such as drowsiness and difficulty coordinating movements (ataxia). The evening dose should
be taken just before going to bed.
If high doses are required, your doctor may recommend using an alternative, more suitable dosage form than oral drops,
to make it easier to follow the prescribed regimen.
Treatment duration should be as short as possible. Your doctor will determine the optimal dosage based on the severity of your
condition and your response to the medicine.
Your doctor will periodically review your health status.
Take Alprazolam Zentiva oral drops as follows:

• To open the bottle: press down on the cap and simultaneously unscrew it (Fig. 1).
• Let the drops fall into a glass, holding the bottle vertically with the opening facing downward (Fig. 2).
• To close the bottle: screw the cap back on until tightly sealed (Fig. 3).

Treatment of anxiety
The recommended starting dose is 0.25 to 0.50 mg (10–20 drops of oral solution), taken 3 times daily. This dose may be
increased by your doctor up to a maximum of 4 mg daily, divided into several doses.
Dose increases should be gradual to avoid unwanted effects, and the evening dose should be increased first, followed by the daytime doses.
Treatment duration should generally not exceed 8–12 weeks, including a period of gradual discontinuation.
In elderly patients or those with severe illness (debilitated patients), or with kidney problems (impaired renal function), the recommended
starting dose is 0.25 mg (10 drops of oral solution) 2 or 3 times daily, which may be increased if needed and well tolerated.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.

Treatment of panic attacks and fear of open spaces (agoraphobia)
The initial dose is 0.5–1 mg (20–40 drops of oral solution) daily, taken at bedtime, for the first 1 or 2 days of treatment.
Thereafter, the dose may be adjusted by your doctor according to your response. Any dose increases should not exceed 1 mg every 3 or 4 days.
Dose increases should first be made at midday, then in the morning, and finally in the afternoon and evening, until reaching a dosing frequency of 3 or 4 times daily.
Treatment duration should not exceed 8 months.
Your doctor will regularly monitor your condition at the start of treatment and may reduce the dose or dosing frequency if necessary.

If you take more Alprazolam Zentiva than you should
If you (or someone else) have taken an excessive amount of Alprazolam Zentiva, or if you suspect a child may have taken this medicine,
contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause severe depression of the central nervous system, with symptoms such as drowsiness,
difficulty speaking (dysarthria), muscle and movement problems (ataxia, motor incoordination), confusion,
breathing difficulties, coma, and even death—especially if this medicine is taken together with alcohol or other drugs that depress the central nervous system.

If you forget to take Alprazolam Zentiva
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Alprazolam Zentiva
Do not stop treatment with Alprazolam Zentiva suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur (see section 2: “Warnings and precautions – Discontinuation of treatment and withdrawal”).
If your doctor decides to stop treatment, your dose will be gradually reduced (by no more than 0.5 mg every 3 days) to minimize withdrawal symptoms.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience depression or mental disorders such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations (seeing or hearing things that are not real), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), or behavioural changes. If you experience any of these side effects, treatment must be stopped immediately. These reactions are more common in children and elderly patients.

Side effects associated with alprazolam generally occur at the beginning of treatment and usually resolve with continued therapy or by reducing the dose.

The following side effects may occur:

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

• depression;
• drowsiness and sedation;
• difficulty controlling movements (ataxia);
• impaired memory;
• speech difficulties (dysarthria);
• headache, dizziness;
• constipation, dry mouth;
• fatigue (asthenia);
• irritability.

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

• decreased appetite;
• confusion, disorientation;
• changes in sexual desire (increased or decreased);
• anxiety and nervousness;
• coordination and balance problems;
• attention disturbances;
• sleep disorders, such as lack of sleep or excessive sleepiness (insomnia, hypersomnia), lethargy;
• tremors and dizziness;
• chewing and speech disturbances (slurred speech);
• difficulty concentrating;
• blurred vision;
• nausea;
• skin inflammation (dermatitis);
• sexual behaviour disorders;
• weight gain or weight loss.

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

• hallucinations, anger, agitation;
• mental disorders (mania) (see section “Warnings and precautions”);
• memory loss (amnesia) (see section “Warnings and precautions”);
• vomiting;
• muscle weakness;
• involuntary urination (incontinence);
• menstrual irregularities.

Frequency not known (frequency cannot be estimated from the available data):

• increased prolactin (a hormone) in the blood;
• mental disorders (hypomania), hostile behaviour, aggression, abnormal thoughts;
• excitement (psychomotor hyperactivity);
• disorders of the autonomic nervous system (such as changes in body temperature, changes in blood pressure);
• difficulty maintaining posture (dystonia);
• stomach and intestinal problems (gastrointestinal disorders);
• inflammation and other liver problems (hepatitis and changes in liver function), jaundice (yellowing of the skin and whites of the eyes);
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema);
• swelling in the legs and ankles (peripheral edema);
• sensitivity to light (photosensitivity);
• difficulty urinating (urinary retention);
• increased pressure inside the eye.

If you think you are misusing or are dependent on this medicine, stopping treatment may lead to withdrawal or rebound effects (see sections “Warnings and precautions” and “If you stop taking Alprazolam Zentiva”). Contact your doctor, who will advise you on how to gradually discontinue the medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alprazolam Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Oral drops must be used within 3 months after first opening the bottle. After this period, any remaining medicine must be discarded.
Do not dispose of medicines 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 pack and other information

What Alprazolam Zentiva contains
The active substance is alprazolam. Each ml of solution contains 0.75 mg of alprazolam.
The other components are: ethyl alcohol, purified water, grapefruit flavour, propylene glycol, sodium saccharin.
Description of the appearance of Alprazolam Zentiva and contents of the pack
Pack containing one 20 ml bottle of solution.
Marketing Authorization Holder
Zentiva Italia S.r.l. – Viale L. Bodio, 37/B – 20158 Milano
Manufacturer
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, Località San Bernardo, 10015 Ivrea (TO)