Alprazig

Patient Information Leaflet

Alprazig 0.25 mg tablets, 0.50 mg tablets, 1 mg tablets, 0.75 mg/ml oral drops, solution

Alprazolam
Equivalent medicine
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, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Alprazig is and what it is used for

Alprazig contains the active substance alprazolam, which belongs to a group of medicines called benzodiazepines.
Alprazig is indicated in adult patients for the treatment of anxiety symptoms only when the disorder is severe, disabling and causing severe distress.
This medicine should be used for the shortest possible duration. Do not exceed 2–4 weeks.

2. What you need to know before taking Alprazig

Do not take Alprazig if:

• you are allergic to alprazolam or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from myasthenia gravis, a muscle disease causing weakness and fatigue;
• you have severe breathing problems (severe respiratory insufficiency);
• you suffer from a condition causing frequent interruptions in breathing during sleep (sleep apnoea);
• you have severe liver problems (severe hepatic insufficiency);
• you suffer from a condition causing increased pressure in the eye and vision problems (acute closed-angle glaucoma);
• you have acute intoxication due to excessive use of alcohol, hypnotics (medicines inducing sleep), analgesics (medicines used to relieve pain), or psychotropics (medicines used to treat mental disorders);
• you are in the first 3 months of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Alprazig.
Treatment must be carried out under medical supervision, and its duration should be as short as possible. Your doctor will determine the most appropriate dose and duration of treatment for you.
Treatment should be short-term, and your doctor will explain how to gradually reduce the dose before stopping.
When stopping Alprazig, the symptoms that led to treatment may reappear. After several weeks of therapy, the medicine may partially lose its effectiveness; this effect is known as tolerance.
The use of benzodiazepines may lead to physical and psychological dependence on these medicines, meaning you may experience an increasing desire to take the medicine or develop physical symptoms that only improve or disappear after taking the medicine.
This risk increases with higher doses and longer treatment duration, and is more common in patients with a history of drug or alcohol abuse.
Once physical dependence has developed, abruptly stopping treatment will be accompanied by withdrawal symptoms (see “If you stop taking Alprazig”).
The duration of treatment should be as short as possible and must not exceed 2–4 weeks (see “How to take Alprazig”).
Taking this medicine may cause anterograde amnesia, meaning you may forget events occurring after taking it.
During treatment, paradoxical adverse reactions (effects opposite to those expected) may occur; in such cases, treatment must be discontinued. Therefore, you are advised to contact your doctor (see “Possible side effects”).
Take this medicine with caution and always under medical supervision in the following cases:

• you are elderly and/or debilitated. In this case, 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, often with serious consequences;
• you have kidney and/or liver problems;
• you suffer from depression or anxiety associated with depression. Alprazig, like other benzodiazepines, should not be used alone to treat depression or anxiety related to depression, as it may worsen suicidal tendencies;
• you suffer from psychosis, a serious mental illness affecting behaviour and causing difficulties in social interactions; you are being treated with other psychotropic medicines (medicines used to treat mental illnesses) (see “Other medicines and Alprazig”);
• you have or have had a history of alcohol, drug, or substance abuse (psychoactive substances capable of altering your mental and physical state), as your risk of developing dependence on Alprazig is higher. Alprazig may cause sedation. This effect is enhanced by alcohol (see “Alprazig and alcohol”, “Driving and use of machinery”, and “Possible side effects”).

Incorrect use of Alprazig
You must take this medicine ONLY if prescribed by a doctor and after purchasing it from a pharmacy. Some people tend to abuse Alprazig and other similar medicines known as benzodiazepines. In addition, some people obtain these medicines illegally (e.g. black market, internet, friends, family), sometimes to resell them.
DO NOT take Alprazig if it has not been prescribed to you by a doctor.
DO NOT take Alprazig if you are unsure that this medicine was purchased from a pharmacy.

Other medicines and Alprazig
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Concomitant use of Alprazig and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, slow and ineffective breathing (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 Alprazig together with opioids, the dose and duration of concomitant treatment must be determined by your doctor.
Inform your doctor about all opioid-containing medicines you are taking and carefully follow your doctor’s dosage recommendations.
It may be helpful to inform friends and family about the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Caution is required when Alprazig is taken together with the following medicines:

• antipsychotics (medicines for treating certain mental illnesses);
• hypnotics (medicines that induce sleep);
• anxiolytics (medicines for treating anxiety);
• sedatives (calming agents);
• antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine, desipramine, St. John’s wort, and sertraline), used to treat depression;
• narcotic analgesics and opioids (medicines for treating severe pain, substitution therapy medicines, and some cough medicines), which when taken together with Alprazig may cause sedation, breathing difficulties, euphoria, and increased risk of developing dependence on Alprazig;
• antiepileptics, medicines for treating epileptic seizures;
• anaesthetics, medicines that reduce pain sensitivity and cause sedation, used for pain therapy and during surgical procedures;
• anticonvulsants (medicines against seizures);
• sedating antihistamines (medicines for treating allergies);
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine for treating pain;
• oral contraceptives;
• diltiazem, a medicine used to lower blood pressure or treat heart rhythm disorders;
• digoxin, a medicine used to increase the heart’s contraction strength in heart failure or to treat heart rhythm disorders. If you are elderly, Alprazig may increase the toxic effects of digoxin. Pay special attention and inform your doctor if you are taking any of the following medicines that may increase the effects of Alprazig:
• ketoconazole, itraconazole, posaconazole, voriconazole (medicines for treating fungal infections);
• erythromycin, clarithromycin, telithromycin, troleandomycin, rifampicin (antibiotics, medicines used to treat bacterial infections);
• protease inhibitors, e.g. ritonavir (medicines for treating viral infections such as HIV). In this case, your doctor may reduce the dose or guide you in stopping Alprazig treatment. Pay special attention and inform your doctor if you are taking any of the following medicines that may reduce the effects of Alprazig:
• carbamazepine and phenytoin, medicines used to treat epilepsy.
  Additionally, inform your doctor if you are taking any of the following medicines that may interact with Alprazig:
• muscle relaxants, medicines that reduce muscle tone;
• clozapine, a medicine used to treat mental disorders, as it increases the risk of respiratory and/or cardiac arrest.
  No interaction has been observed between Alprazig and the following medicines:
• disulfiram, a medicine used to treat alcoholism;
• propranolol, a medicine used to treat high blood pressure or heart rhythm disorders;
• warfarin, a medicine used to delay blood clotting.

Alprazig and alcohol
Do not consume alcohol during treatment with Alprazig, as alcohol increases the sedative effect of the medicine. This negatively affects your ability to drive and operate machinery (see “Driving and use of machinery”).

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
Do not use Alprazig during the first 3 months of pregnancy, as it may cause congenital malformations of the palate and lip. These birth defects, present from birth, are known as cleft lip and cleft palate.
Your doctor will assess whether you may take this medicine during the second and third trimesters of pregnancy.
If this medicine is prescribed during the last months of pregnancy, the newborn may develop symptoms of the “floppy infant” syndrome:

• reduced muscle tone (axial hypotonia);
• sucking difficulties leading to poor weight gain.
  High doses during the final stage of pregnancy may cause effects in the newborn such as respiratory depression (slow and ineffective breathing), apnoea (temporary suspension of breathing), and hypothermia (reduced body temperature). These effects gradually resolve, and their duration correlates with the time required to eliminate the medicine from the body. Moreover, newborns from mothers who chronically used benzodiazepines during advanced pregnancy stages may develop physical dependence and may be at risk of neonatal withdrawal symptoms, such as hyperexcitability, agitation, and tremors, even several days after birth.
  Breastfeeding
  Do not breastfeed while taking Alprazig, as this medicine passes into breast milk. If Alprazig must be used, breastfeeding should be discontinued.

Driving and use of machinery
Alprazig impairs your ability to drive vehicles and operate machinery, as it may cause sedation, amnesia (a memory disorder), impaired concentration, and altered muscle function.
If sleep duration is insufficient or if alcohol or other medicines that may reduce reaction times are taken, the likelihood of impaired alertness may increase (see “Warnings and precautions”, “Other medicines and Alprazig”, and “Possible side effects”).
Caution is required when driving or performing tasks requiring full alertness.
These effects are intensified if alcohol or other medicines that reduce reaction times are taken simultaneously.

Alprazig tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Alprazig tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

Alprazig 0.50 mg tablets contain sunset yellow (E110)
May cause allergic reactions.

Alprazig 0.75 mg/ml oral drops contain ethanol (ethyl alcohol)
This medicine contains 44.90 mg of alcohol (ethanol) per 0.33 ml dose (10 drops). The amount in 10 drops of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Alprazig 0.75 mg/ml oral drops contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

Alprazig 0.75 mg/ml oral drops contain benzyl alcohol
This medicine contains 0.25 mg of benzyl alcohol per 0.33 ml dose (10 drops). Benzyl alcohol (contained in the cherry flavour) may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease, as large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).

Alprazig 0.75 mg/ml oral drops contain propylene glycol
This medicine contains 247.1 mg of propylene glycol per 0.33 ml dose (10 drops).
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 have 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 Alprazig

Take this medicine exactly as prescribed 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.
Your doctor will determine the correct dose for you based on your health condition and your response to the medicine. Never exceed the dose prescribed by your doctor.
During treatment, your doctor may adjust the dosage: always follow carefully the prescribed dose.
Treatment should start with the lowest effective dose.
The recommended starting dose is 0.25 to 0.50 mg (equivalent to 10 and 20 drops of oral solution), taken 3 times daily.
If a higher dose is needed, increase the dose gradually to avoid risks of adverse effects, up to a maximum of 4 mg per day, given in divided doses.
Do not exceed the maximum recommended dose.
If you have never previously used anxiolytics (medicines used to reduce anxiety), sedatives, antidepressants (medicines used to treat depression), hypnotics (medicines that induce sleep), or abused alcohol, you may require lower doses.
If your doctor prescribes an increase in dose, it is recommended to first increase the evening dose, followed by the daytime dose.

Discontinuation of treatment
Alprazig treatment should be discontinued gradually.
It is recommended to reduce the daily dose by no more than 0.5 mg (equivalent to 20 drops) every 3 days.
In some cases, a more gradual reduction may be necessary (see "Warnings and precautions").
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the dose or frequency of administration if necessary. If you are elderly, have severe liver or kidney problems, or are debilitated, the recommended starting dose is 0.25 mg (equivalent to 10 drops) 2–3 times daily, which may be increased if needed and if tolerated (see "Warnings and precautions").
The safety and efficacy of alprazolam in children and adolescents have not been established.

Treatment duration should be as short as possible.
The maximum treatment duration should not exceed 2–4 weeks. Prolonged treatment is not recommended.
In certain cases, your doctor may decide to extend treatment beyond the recommended maximum period after evaluating your health condition.
Your doctor will regularly monitor your condition.

Instructions for use
For oral use.
The evening dose should be taken before going to bed.

If you take more Alprazig than you should
If you have taken an excessive dose of Alprazig, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest emergency department.
An overdose of Alprazig can be life-threatening and may cause ataxia (reduced motor coordination and gait), drowsiness, mental confusion, lethargy (deep sleep), dysarthria (impaired ability to articulate words), motor incoordination, decreased muscle tone, low blood pressure, slow and ineffective breathing, coma (loss of consciousness), death.

If you forget to take Alprazig
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 Alprazig
Do not stop Alprazig treatment suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur, such as:

• headache,
• muscle pain and cramps,
• severe anxiety,
• tension,
• restlessness,
• confusion,
• irritability.
  In severe cases, the following may occur:
• derealization (feeling of detachment from the external world),
• depersonalization (feeling of detachment from one's own body),
• hyperacusis (increased sensitivity to sound),
• numbness and tingling in the extremities,
• hypersensitivity to light, noise, and physical contact,
• hallucinations (seeing or hearing things that are not real),
• epileptic seizures (uncontrolled body movements and loss of consciousness).

After stopping treatment, anxiety may temporarily return and in a worsened form (this effect is known as rebound). In addition, other symptoms may occur, such as mood changes, anxiety, restlessness, or sleep disturbances (see "Possible side effects").
Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, your doctor will explain how to gradually reduce the dose until treatment is stopped.
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 everybody gets them.
If any of the following paradoxical reactions (effects opposite to those expected) occur, Alprazig must be discontinued (see "Warnings and precautions").
Contact your doctor immediately if you experience:

• restlessness;
• agitation;
• irritability;
• aggression;
• anxiety;
• delirium (misinterpretation of reality);
• anger;
• nightmares;
• hallucinations (seeing or hearing things that do not exist);
• psychosis (thought disorders);
• behavioural changes;
• sleepwalking (performing movements during sleep such as sitting up in bed, walking, eating, dressing). These side effects occur more frequently in children and elderly patients.

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

• constipation;
• dry mouth;
• fatigue;
• sedation;
• drowsiness;
• ataxia (reduced motor coordination and gait)*;
• memory impairment*;
• dysarthria (reduced ability to articulate words);
• dizziness;
• headache*;
• depression*;
• irritability*.

Common (may affect up to 1 in 10 people)

• blurred vision;
• vertigo (sensation of movement or spinning);
• nausea;
• asthenia (weakness);
• weight decrease or increase;
• decreased appetite;
• coordination problems;
• difficulty concentrating attention;
• mental dullness*;
• balance disorders;
• attention disturbance*;
• hypersomnia (excessive daytime sleepiness);
• lethargy (altered consciousness);
• tremor;
• slurred speech*;
• confusion*;
• disorientation;
• decreased or increased sexual desire;
• anxiety;
• insomnia (inability to fall asleep);
• nervousness*;
• substance abuse dependence*;
• sexual dysfunction;
• dermatitis (skin inflammation).

Uncommon (may affect up to 1 in 100 people)

• hyperprolactinaemia (increased prolactin, a hormone);
• blood disorder;
• diplopia (double vision);
• vomiting;
• diarrhoea;
• drug withdrawal syndrome*;
• paradoxical drug reaction (presentation of effects opposite to those expected)*;
• altered liver function;
• jaundice (yellowing of the skin and whites of the eyes);
• increased intraocular pressure;
• muscle weakness;
• amnesia (loss or reduction of memory)*;
• dystonia (altered muscle tone)*;
• psychomotor hyperactivity*;
• mania (mental disorder with obsessive characteristics)*;
• anger*;
• psychiatric disorders*;
• hallucinations (perception of non-existent things)*;
• aggression*;
• hostility*;
• agitation*;
• changes in sexual desire;
• abnormal thoughts*;
• urinary incontinence (difficulty in holding urine);
• urinary retention (inability to empty the bladder);
• menstrual irregularities;
• skin reaction.

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

• tachycardia (increased heart rate);
• hypotension (reduced blood pressure);
• increased salivation;
• dysphagia (difficulty swallowing);
• gastrointestinal disorders;
• peripheral oedema (fluid accumulation in legs and ankles);
• hepatitis (liver inflammation);
• abnormal weight gain;
• anorexia (reduced or absent appetite);
• emotional blunting (emotional indifference)*;
• reduced alertness;
• autonomic neuropathy (condition characterized by tingling in extremities, dizziness, fainting, weakness, gastrointestinal, urinary and sexual disorders)*;
• hypomania (excitement, increased productivity and optimism)*;
• drug or substance abuse (tendency to excessive use of a medicine or use of substances capable of altering mental and physical state)*;
• nasal congestion (stuffy nose);
• angioedema (swelling of the face, lips, mouth, tongue and throat that may cause difficulty in swallowing and breathing);
• photosensitivity (immune system reaction to sunlight manifesting as a skin rash accompanied by itching).

*: see "Warnings and precautions"

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 Alprazig

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.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light.
Oral drops must be used within 3 months after first opening the bottle. Unused medicine must be discarded.
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.

6. Package contents and other information

What Alprazig contains
Alprazig 0.25 mg tablets
The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium docusate, colloidal silica, maize starch, magnesium stearate.
Alprazig 0.50 mg tablets
The active substance is alprazolam. Each tablet contains 0.50 mg of alprazolam.
The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium docusate, colloidal silica, maize starch, magnesium stearate, sunset yellow (E110), aluminium lake.
Alprazig 1 mg tablets
The active substance is alprazolam. Each tablet contains 1 mg of alprazolam.
The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium docusate, colloidal silica, maize starch, magnesium stearate, indigo carmine (E132), aluminium lake.
Alprazig 0.75 mg/ml oral drops, solution
The active substance is alprazolam. 100 ml of solution contain 75 mg of alprazolam.
The other ingredients are ethanol, propylene glycol, sodium saccharin, cherry-blossom flavour, purified water.

Description of the appearance of Alprazig and contents of the pack
Tablets: packs containing 20 tablets of 0.25 mg, 0.50 mg and 1 mg.
Oral drops, solution: 20 ml bottle.

Marketing Authorization Holder
LABORATORI BALDACCI S.p.A.
Via San Michele degli Scalzi, 73
56124 - Pisa (PI)
Italy

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

January 2026