Alprazolam Aurobindo Pharma Italia

Italy
Brand name Alprazolam Aurobindo Pharma Italia
Form drops, oral solution
Active substance / Dosage
ALPRAZOLAM
Prescription type Prescription only
ATC code
N05BA12
Registration number 035856
Manufacturer AUROBINDO PHARMA (ITALIA) S.R.L.

Table of Contents

Package leaflet: information for the patient

Alprazolam Aurobindo Pharma Italia 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, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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 Aurobindo Pharma Italia is and what it is used for
  2. What you need to know before taking Alprazolam Aurobindo Pharma Italia
  3. How to take Alprazolam Aurobindo Pharma Italia
  4. Possible side effects
  5. How to store Alprazolam Aurobindo Pharma Italia
  6. Contents of the pack and other information

1. What Alprazolam Aurobindo Pharma Italia is and what it is used for

Alprazolam Aurobindo Pharma Italia contains the active substance alprazolam, which belongs to a group of medicines called benzodiazepines (anxiolytic medicines).
Alprazolam Aurobindo Pharma Italia is used in adult patients for the treatment of symptoms of anxiety when the condition is severe, disabling, or causing the individual severe distress. This medicine is indicated only for short-term use.

2. What you should know before taking Alprazolam Aurobindo Pharma Italia

Do not take Alprazolam Aurobindo Pharma Italia

  • if you are allergic to alprazolam, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from myasthenia gravis, a disease causing severe muscle weakness;
  • if you have severe breathing problems (respiratory failure);
  • if you have severe liver problems (hepatic insufficiency) that may cause mental confusion (hepatic encephalopathy);
  • if you have breathing difficulties during sleep ( sleep apnea );
  • if you suffer from a type of eye disease called acute angle-closure glaucoma, a condition caused by increased pressure inside the eyes;
  • if you are in the first three months of pregnancy or if you are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
This medicine may reduce or even abolish consciousness, may cause a significant reduction in spontaneous breathing ability, coma, and death if taken together with other medicines acting on the brain and mind (e.g., opioids, antipsychotics, hypnotic-sedatives) (see section Other medicines and Alprazolam Aurobindo Pharma Italia).
Talk to your doctor or pharmacist before taking Alprazolam Aurobindo Pharma Italia if:

  • you are elderly and/or debilitated. Your doctor will prescribe a reduced dose of this medicine; remember to use this medicine with caution as it may cause sedation and/or musculoskeletal weakness, increasing your risk of falls, which may have serious consequences;
  • you have chronic breathing problems (chronic respiratory insufficiency), as this medicine may worsen your condition;
  • you have kidney problems (renal insufficiency) or liver problems of mild to moderate severity (mild to moderate hepatic insufficiency);
  • you suffer from severe depression. Alprazolam Aurobindo Pharma Italia, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression, as it may worsen suicidal tendencies and cause mood changes;
  • you suffer from psychosis, a serious mental illness affecting behavior and causing difficulties in social interaction. Alprazolam Aurobindo Pharma Italia is not recommended as the primary treatment for this condition;
  • you are being treated with other medicines acting on the brain and mind, as Alprazolam Aurobindo Pharma Italia may enhance the effects of these medicines (see section “Other medicines and Alprazolam Aurobindo Pharma Italia”);
  • you have or have previously had problems with alcohol, drug, or medicine abuse and dependence, as you may be at higher risk of developing dependence on Alprazolam Aurobindo Pharma Italia (see section “Development of dependence”);
  • you suffer from rare inherited disorders of intolerance to a specific sugar (galactose).

Memory disturbances
A few hours after taking Alprazolam Aurobindo Pharma Italia, you may experience difficulty remembering events that occurred after taking the medicine.

Paradoxical reactions
Alprazolam Aurobindo Pharma Italia may cause effects opposite to those expected (paradoxical reactions) (see section 4 “Possible side effects”). These effects are more common in children and elderly patients. If you experience such effects, consult your doctor, as treatment with Alprazolam Aurobindo Pharma Italia should be discontinued.

Development of tolerance
After several weeks of treatment, you may experience a decrease in the effectiveness of Alprazolam Aurobindo Pharma Italia.

Development of dependence
Alprazolam Aurobindo Pharma Italia causes dependence (you may experience an increasing desire to take the medicine or develop physical symptoms that decrease or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses and longer treatment duration.
Therefore, your doctor will prescribe the most appropriate treatment based on your condition, using the lowest effective dose for the shortest possible duration. Your doctor will also advise you on when to schedule follow-up visits to monitor your health in relation to Alprazolam Aurobindo Pharma Italia therapy.

Incorrect use of Alprazolam Aurobindo Pharma Italia
You must take this medicine ONLY if prescribed by a doctor and obtained from a pharmacy. Some individuals tend to abuse Alprazolam Aurobindo Pharma Italia and other similar medicines known as benzodiazepines.
Additionally, some people obtain these medicines illegally (e.g., black market, internet, friends, family, etc.), sometimes to resell them. DO NOT take Alprazolam Aurobindo Pharma Italia if it has not been prescribed by your doctor. DO NOT take Alprazolam Aurobindo Pharma Italia if you are unsure whether the medicine was purchased from a pharmacy.

Children and adolescents
The efficacy and safety of Alprazolam Aurobindo Pharma Italia in children and adolescents under 18 years of age are unknown. Your doctor will decide whether Alprazolam Aurobindo Pharma Italia can be administered to children and adolescents based on their individual condition.

Other medicines and Alprazolam Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.

The concomitant use of Alprazolam Aurobindo Pharma Italia and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Alprazolam Aurobindo Pharma Italia together with opioids, the dose and duration of concomitant therapy 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 about the signs and symptoms listed above. Contact your doctor if such symptoms occur.

Be especially cautious and inform your doctor if you are taking the following medicines:

  • medicines acting on the brain and mind * such as:
    • antipsychotics, medicines used to treat certain mental illnesses;
    • hypnotics, sleep-inducing medicines;
    • sedatives, tranquilizers;
    • anxiolytics, medicines used to treat anxiety;
    • antidepressants (e.g., nefazodone, fluvoxamine, fluoxetine, imipramine, desipramine), medicines used to treat depression;
    • narcotic analgesics, opioids, medicines used to treat severe pain;
    • antiepileptics, medicines used to treat epileptic seizures;
    • anesthetics. Anesthetics, when administered together with Alprazolam Aurobindo Pharma Italia, may cause euphoria, increasing the risk of developing dependence on Alprazolam Aurobindo Pharma Italia;
    • sedating antihistamines, medicines used to treat allergic symptoms; * If you take Alprazolam Aurobindo Pharma Italia together with one or more of these medicines, or together with alcoholic beverages, these substances may contribute to reduced brain and mind function, potentially leading to decreased spontaneous breathing, coma, and death (see section Warnings and precautions).
  • analgesics and cough suppressants based on opium and its derivatives. These medicines, like Alprazolam Aurobindo Pharma Italia, reduce spontaneous breathing ability;
  • cimetidine, a medicine used to reduce stomach acidity;
  • propoxyphene, a medicine used to treat pain;
  • oral contraceptives;
  • diltiazem, a medicine used to lower blood pressure;
  • digoxin, a medicine used to increase the heart’s contraction strength. If you are elderly, taking Alprazolam Aurobindo Pharma Italia may increase the risk of digoxin-related toxic effects.

The following medicines may increase the effects of Alprazolam Aurobindo Pharma Italia:

  • ketoconazole, itraconazole, posaconazole, and voriconazole, medicines used to treat fungal infections;
  • erythromycin, clarithromycin, telithromycin, and troleandomycin (antibiotics);
  • protease inhibitors (e.g., ritonavir), medicines used to treat HIV infection. If you are being treated with protease inhibitors, your doctor may advise discontinuing Alprazolam Aurobindo Pharma Italia due to interaction with these medicines.

Alprazolam Aurobindo Pharma Italia and alcohol
DO NOT drink alcohol during treatment with this medicine, as alcohol enhances its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine must not be taken during the first three months of pregnancy as it may cause congenital malformations in the fetus. Your doctor will assess whether you may take this medicine during the second and third trimesters of pregnancy.
If you take this medicine during the last months of pregnancy or during labor, the newborn may show the following symptoms:

  • poor muscle tone (axial hypotonia);
  • breathing difficulties (respiratory depression or apnea) and difficulty feeding;
  • low body temperature (hypothermia);
  • withdrawal symptoms (see section 3 “If you stop taking Alprazolam Aurobindo Pharma Italia”). These effects are reversible and may last from several days up to 1–3 weeks after birth.

Breastfeeding
DO NOT breastfeed while taking Alprazolam Aurobindo Pharma Italia, as this medicine passes into breast milk.

Driving and using machines
DO NOT drive or operate machinery if, during treatment with Alprazolam Aurobindo Pharma Italia, you experience loss of concentration or muscle control, or feel drowsy or dizzy.
These effects may be intensified if you have not slept enough or have consumed alcoholic beverages.

Alprazolam Aurobindo Pharma Italia oral drops contain ethanol (alcohol) and propylene glycol
This medicine contains 165.98 mg of alcohol (ethanol) per dose, equivalent to 3.32 mg/kg.
The volume amount of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine is unlikely to cause significant effects.
Alprazolam Aurobindo Pharma Italia contains 172.9 mg of propylene glycol per dose, equivalent to 3.458 mg/kg.
If the child is under 5 years of age, speak with 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 advised 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 advised by your doctor. Your doctor may perform additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Alprazolam Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Anxiety treatment
The recommended starting dose is 0.25 to 0.50 mg (10-20 drops) three times daily.
The dose may be gradually increased, up to a maximum of 4 mg per day, taken in divided doses. You should first increase the evening dose, followed by the daytime dose.
If you are elderly, have liver or kidney problems and/or are debilitated
The recommended starting dose is 0.25 mg (10 drops) two to three times daily.
The duration of treatment with Alprazolam Aurobindo Pharma Italia should be as short as possible.
The maximum duration of treatment should not exceed 2-4 weeks. Prolonged treatment is not recommended. Your doctor will decide whether treatment may continue beyond the recommended maximum period.
Instructions for opening and using the bottle:
The bottle has a child-resistant cap to prevent tampering by children. To open, press down on the cap and turn it; to dispense the drops, hold the bottle in an upright position with the opening facing downward. After use, close the bottle tightly with the cap, turning it until securely sealed (see figure).

  1. To open, press and unscrew simultaneously.
Diagram showing a vertical downward arrow and a curved lateral arrow indicating the
  1. To dispense drops, hold the bottle in an upright position with the opening facing downward.
Black and white drawing showing a hand pouring liquid from a vial into a small glass held by the
  1. To close, screw the cap back on completely.

If you take more Alprazolam Aurobindo Pharma Italia than you should
If you (or someone else) have taken an excessive dose of Alprazolam Aurobindo Pharma Italia, or if you suspect that a child may have ingested this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.

  • In mild cases, symptoms may include: mental confusion, drowsiness, difficulty speaking.
  • In more severe cases, symptoms may include: loss of motor coordination, reduced muscle tone, low blood pressure, breathing difficulties, coma, death.

If you forget to take Alprazolam Aurobindo Pharma Italia
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 Aurobindo Pharma Italia
Do not stop treatment with Alprazolam Aurobindo Pharma Italia abruptly. Always consult your doctor before stopping Alprazolam Aurobindo Pharma Italia. You must gradually reduce the dose to avoid withdrawal symptoms such as:

  • withdrawal symptoms, including:
    • severe symptoms: feelings of detachment from oneself or the external world, numbness and tingling in the arms or legs, increased sensitivity to light, sound, and physical touch, hallucinations, epileptic seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions;
    • other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mild depression of mood, insomnia;
  • rebound symptoms, such as anxiety. These symptoms are the same ones for which Alprazolam Aurobindo Pharma Italia was prescribed, and may temporarily reappear more intensely after abrupt discontinuation of treatment.

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 experiences them.
Contact your doctor immediately if you experience any of the following side effects, as treatment with Alprazolam Aurobindo Pharma Italia must be discontinued:

  • effects opposite to those expected (paradoxical effects) (see section 2, "Paradoxical disorders"), such as:
    • restlessness;
    • agitation;
    • irritability;
    • aggression;
    • feelings of disappointment;
    • anger;
    • nightmares;
    • hallucinations;
    • disturbances in thinking;
    • behavioral changes.

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

  • swelling of the face, tongue, and throat leading to difficulty swallowing and breathing (angioedema);
  • difficulty remembering events occurring after taking the medicine (see section 2, "Memory disorders");
  • unmasking of pre-existing depression;
  • dependence (see section 2, "Development of dependence");
  • withdrawal symptoms and rebound symptoms (see section 3, "If you stop treatment with Alprazolam Aurobindo Pharma Italia").

Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

  • depression;
  • sedation;
  • drowsiness;
  • loss of ability to coordinate movements;
  • memory disturbances;
  • difficulty speaking;
  • dizziness;
  • headache;
  • constipation;
  • dry mouth due to lack of saliva;
  • fatigue;
  • irritability.

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

  • decreased appetite, decreased or increased body weight;
  • confusion, disorientation;
  • increased or decreased sexual desire, sexual dysfunction;
  • anxiety;
  • insomnia, excessive sleepiness;
  • nervousness;
  • balance disorders, problems with coordination of movements;
  • loss of attention and concentration;
  • excessive drowsiness (lethargy);
  • tremors;
  • dizziness;
  • slurred speech;
  • blurred vision;
  • nausea;
  • dermatitis;
  • irritability.

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

  • obsessive thoughts and behaviors;
  • inability to recall recent life events;
  • vomiting;
  • muscle weakness;
  • incontinence;
  • menstrual cycle irregularities;
  • drug dependence;
  • drug withdrawal syndrome.

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

  • increased levels of prolactin (a natural hormone) in the blood;
  • mood changes;
  • hostile behaviors, abnormal thoughts;
  • impulsivity and motor hyperactivity;
  • disturbances in the autonomic nervous system responsible for bodily functions that cannot be voluntarily controlled (e.g., internal organs and glands);
  • involuntary muscle contractions causing unnatural postures;
  • stomach and intestinal problems;
  • inflammatory liver diseases (hepatitis);
  • altered liver function;
  • yellow/yellowish discoloration of the skin and mucous membranes (jaundice);
  • skin reactions due to exposure to sunlight;
  • inability to completely empty the bladder;
  • swelling of the hands or feet due to fluid retention;
  • increased pressure inside the eye;
  • misuse of this medicine (tendency to excessive or inappropriate use of Alprazolam Aurobindo Pharma Italia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may 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 Aurobindo Pharma Italia

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 container to protect the medicine from light.
Validity after first opening of the bottle: 12 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Alprazolam Aurobindo Pharma Italia contains
The active substance is alprazolam. 1 ml of solution contains 0.75 milligrams of alprazolam.
The other components are propylene glycol, ethanol, sodium saccharin, cherry flavor, purified water.

Description of the appearance of Alprazolam Aurobindo Pharma Italia and package contents
Pack containing 1 bottle of 20 ml oral solution.

Marketing Authorization Holder
Aurobindo Pharma (Italia) Srl, Via San Giuseppe 102, 21047 Saronno (VA)

Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 (TO) – Ivrea – Italy