Alprazolam Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ALPRAZOLAM DOC Generici 0.75 mg/ml oral drops, solution

Equivalent medicine
Please read this entire 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, 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ALPRAZOLAM DOC Generici is and what it is used for
What you need to know before taking ALPRAZOLAM DOC Generici
How to take ALPRAZOLAM DOC Generici
Possible side effects
How to store ALPRAZOLAM DOC Generici
Contents of the pack and other information

1. What ALPRAZOLAM DOC Generici is and what it is used for

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

2. What you need to know before taking ALPRAZOLAM DOC Generici

Do not take ALPRAZOLAM DOC Generici:

if you are allergic to alprazolam, to 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 serious breathing problems (respiratory failure);
if you have serious liver problems (hepatic failure);
if you have difficulty breathing during sleep ( sleep apnoea );
if you have an eye disease called acute angle-closure glaucoma, a condition caused by increased pressure inside the eyes;
during the first 3 months of pregnancy and 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, hypnotics-sedatives) (see section “Other medicines and ALPRAZOLAM DOC Generici”).
Talk to your doctor or pharmacist before taking ALPRAZOLAM DOC Generici 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, often with 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 DOC Generici, 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 behaviour and causing difficulties in social interactions. ALPRAZOLAM DOC Generici is not recommended as primary treatment for this condition;
you are being treated with other medicines acting on the brain and mind, as ALPRAZOLAM DOC Generici may enhance the effects of these medicines (see section “Other medicines and ALPRAZOLAM DOC Generici”);
you have or have had in the past problems with abuse and dependence on alcohol, drugs, or other medicines, as there is a higher risk of developing dependence on ALPRAZOLAM DOC Generici (see section “Development of dependence”).

Memory disturbances
A few hours after taking ALPRAZOLAM DOC Generici, you may experience difficulty remembering events that occurred after taking the medicine.

Paradoxical reactions
ALPRAZOLAM DOC Generici may cause effects opposite to those expected ( paradoxical effects ) (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 DOC Generici should be discontinued.

Development of tolerance
After several weeks of treatment, a decrease in the effectiveness of ALPRAZOLAM DOC Generici may occur.

Development of dependence
ALPRAZOLAM DOC Generici causes dependence (i.e. you may develop an increasing desire to take the medicine or may develop physical symptoms that diminish or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses and longer duration of treatment. 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 during treatment with ALPRAZOLAM DOC Generici.

Incorrect use of ALPRAZOLAM DOC Generici
You must take this medicine ONLY if prescribed by a doctor and after purchasing it from a pharmacy.
Some individuals may tend to abuse ALPRAZOLAM DOC Generici and other similar medicines called benzodiazepines.
Moreover, some people obtain such medicines illegally (e.g. black market, internet, friends, family, etc.), sometimes with the intention of reselling them. DO NOT take ALPRAZOLAM DOC Generici if this medicine has not been prescribed to you by a doctor. DO NOT take ALPRAZOLAM DOC Generici if you are not sure that this medicine was purchased from a pharmacy.

Children and adolescents
The efficacy and safety of ALPRAZOLAM DOC Generici in children and adolescents under 18 years of age have not been established. Your doctor will decide whether ALPRAZOLAM DOC Generici can be administered to children and adolescents based on their individual condition.

Other medicines and ALPRAZOLAM DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of ALPRAZOLAM DOC Generici 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. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes ALPRAZOLAM DOC Generici together with opioids, the dose and duration of concomitant treatment must be strictly limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s recommendations regarding dosage. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
Caution is required when ALPRAZOLAM DOC Generici is taken together with 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, tranquillisers;
anxiolytics, used to treat anxiety;
antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine);
narcotic analgesics, opioids, medicines used to treat severe pain;
antiepileptics, medicines used to treat epileptic seizures;
anaesthetics. Anaesthetics, when administered together with ALPRAZOLAM DOC Generici, may cause euphoria, increasing the likelihood of developing dependence on ALPRAZOLAM DOC Generici;
sedating antihistamines, medicines used to treat allergic symptoms.

* If you take ALPRAZOLAM DOC Generici together with one or more of these medicines or with alcoholic beverages, these substances may contribute to reduced brain and mental function, potentially leading to reduced spontaneous breathing, coma, and death (see section Warnings and precautions).

Cough suppressants with analgesic and sedative properties (cough sedatives), based on opium and its derivatives. These medicines, like ALPRAZOLAM DOC Generici, 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 force of heart contractions). If you are elderly, taking ALPRAZOLAM DOC Generici may increase the likelihood of developing digoxin-related toxic effects.

The following medicines may increase the effects of ALPRAZOLAM DOC Generici:

ketoconazole, itraconazole, posaconazole, voriconazole, medicines used to treat fungal infections; concomitant administration with ALPRAZOLAM DOC Generici is not recommended;
erythromycin, clarithromycin, telithromycin, troleandomycin (antibiotics); co-administration should be performed with caution, and a substantial dose reduction should be considered;
protease inhibitors (e.g. ritonavir), medicines used to treat HIV infection. If you are being treated with protease inhibitors, your doctor may advise discontinuing treatment with ALPRAZOLAM DOC Generici due to interaction with these medicines.

ALPRAZOLAM DOC Generici and alcohol
Do not drink alcohol while taking ALPRAZOLAM DOC Generici, as alcohol enhances the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine must not be taken during the first 3 months of pregnancy as it may cause congenital malformations in the foetus. 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 labour, the newborn may show the following symptoms:

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

Breastfeeding
Do not take this medicine if you are breastfeeding, as alprazolam passes into breast milk.

Driving and using machines
Do not drive or operate machinery if, during treatment with ALPRAZOLAM DOC Generici, 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 DOC Generici contains alcohol
This medicine contains up to 122 mg of alcohol (ethanol) per 20-drop dose (corresponding to 0.50 mg of alprazolam) and up to 61 mg of alcohol (ethanol) per 10-drop dose (corresponding to 0.25 mg of alprazolam).
The amount in 20 drops of this medicine is equivalent to 3 ml of beer or 1.3 ml of wine.
The amount in 10 drops of this medicine is equivalent to 1.5 ml of beer or 0.61 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

ALPRAZOLAM DOC Generici contains propylene glycol
This medicine contains 462 mg of propylene glycol per 20-drop dose (corresponding to 0.50 mg of alprazolam).
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.
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.

ALPRAZOLAM DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. it is essentially ‘sodium-free’.

3. How to take ALPRAZOLAM DOC Generici

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Treatment of anxiety
The recommended starting dose ranges from 0.25 mg (10 drops) to 0.50 mg (20 drops) three times daily.
The dose may be gradually increased up to a maximum of 4 mg per day, divided into several doses.
You should first increase the evening dose, followed by the daytime doses.
If you are elderly, have liver or kidney problems and/or are debilitated
The recommended starting dose is 0.25 mg (10 drops) two or three times daily.
The duration of treatment 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.
If you take more ALPRAZOLAM DOC Generici than you should
If you (or someone else) have taken an excessive dose of ALPRAZOLAM DOC Generici or if you suspect that a
child may have taken 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 coordination, poor muscle tone, low blood pressure, breathing difficulties, coma, and death.
If you forget to take ALPRAZOLAM DOC Generici
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 a forgotten dose.
If you stop taking ALPRAZOLAM DOC Generici
Do not stop treatment with ALPRAZOLAM DOC Generici abruptly. Always consult your doctor before stopping
treatment with ALPRAZOLAM DOC Generici. You must gradually reduce the dose to avoid experiencing:
Withdrawal symptoms such as:

severe symptoms: feeling detached from yourself or the external world, numbness and tingling in arms or legs, increased sensitivity to light, sounds 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, insomnia;

Rebound symptoms, for example, anxiety. These symptoms are the same ones for which you were prescribed
ALPRAZOLAM DOC Generici 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 everybody will experience them.
Contact your doctor immediately if you experience any of the following side effects, because treatment with ALPRAZOLAM DOC Generici must be stopped:

opposite effects to those expected (paradoxical effects) (see section 2 "Paradoxical reactions") such as:

restlessness
agitation
irritability
aggressiveness
feelings of disappointment
anger
nightmares
hallucinations
disturbances in thinking
behavioural 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, causing difficulty in swallowing and breathing (angioedema)
difficulty remembering events that occurred after taking the medicine (see section 2 "Memory disturbances")
unmasking of an existing depression
dependence (see section 2 "Development of dependence")
withdrawal symptoms and rebound symptoms (see section 3 "If you stop taking ALPRAZOLAM DOC Generici")

Contact your doctor immediately 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 control and coordinate movements
memory disturbances
difficulty speaking
dizziness
headache
constipation
dry mouth due to lack of saliva
fatigue (asthenia)
irritability

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

decreased appetite, weight gain or loss
confusion and disorientation
increased or decreased sexual desire, sexual dysfunction
anxiety
insomnia, excessive sleepiness
nervousness
balance disorders, problems with movement coordination
loss of attention and concentration
excessive drowsiness (lethargy)
tremors
vertigo
blurred vision
nausea
skin inflammation (dermatitis)

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

obsessive thoughts and behaviours
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 prolactin (a natural hormone) in the blood
mood changes
hostile behaviour, abnormal thoughts
impulsiveness and motor hyperactivity
disturbances of the nervous system controlling bodily functions that cannot be voluntarily controlled (e.g. internal organs and glands)
involuntary muscle contractions causing unnatural postures
stomach and intestinal disorders
inflammatory liver diseases (hepatitis)
altered liver function
yellow/yellowish skin and mucous membrane discoloration (jaundice)
skin reactions due to exposure to sunlight
inability to completely empty the bladder
swelling of the hands and feet due to fluid accumulation
increased pressure inside the eye
misuse of this medicine (tendency to excessive or inappropriate use of ALPRAZOLAM DOC Generici)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform 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 DOC Generici

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.
The solution must be used within 30 days after first opening the bottle. Any excess product should be discarded.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Contents of the package and other information

What ALPRAZOLAM DOC Generici contains
ALPRAZOLAM DOC Generici 0.75 mg/ml oral drops, solution
The active substance is alprazolam.
10 drops of solution contain 0.25 mg of alprazolam.
The other components are: propylene glycol, ethanol, sodium saccharin, grapefruit flavour, purified water.

Description of the appearance of ALPRAZOLAM DOC Generici and contents of the pack
Amber glass bottle of 20 ml solution with dropper cap.

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 - 20121 Milan.

Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1, 29016 Cortemaggiore (PC), Italy.
VAMFARMA S.R.L, Via Kennedy 5, 26833 Comazzo (LO), Italy
ABC FARMACEUTICI S.P.A., Via Cantone Moretti 29, Località S. Bernardo – 10015 Ivrea (TO), Italy

PATIENT INFORMATION LEAFLET

ALPRAZOLAM DOC Generici 0.25 mg tablets, 0.50 mg tablets

Equivalent medicinal product
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 others, even if their symptoms are the same as yours, as it could be dangerous.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ALPRAZOLAM DOC Generici is and what it is used for
What you need to know before taking ALPRAZOLAM DOC Generici
How to take ALPRAZOLAM DOC Generici
Possible side effects
How to store ALPRAZOLAM DOC Generici
Contents of the pack and other information

1. What ALPRAZOLAM DOC Generici is and what it is used for

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

2. What you should know before taking ALPRAZOLAM DOC Generici

Do not take ALPRAZOLAM DOC Generici:

if you are allergic to alprazolam, to 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 failure);
if you have breathing difficulties during sleep ( sleep apnea );
if you have an eye condition called acute angle-closure glaucoma, a problem caused by increased pressure inside the eyes;
during the first 3 months of pregnancy and if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine may reduce or even abolish consciousness, may cause a marked reduction in spontaneous breathing, coma, and death if taken together with other medicines acting on the brain and mind (e.g. opioids, antipsychotics, and hypnotic-sedatives) (see section “Other medicines and ALPRAZOLAM DOC Generici”).
Talk to your doctor or pharmacist before taking ALPRAZOLAM DOC Generici 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, often with serious consequences;
you have chronic breathing problems (chronic respiratory failure), as this medicine may worsen your condition;
you have kidney problems (renal failure) or liver problems of mild to moderate severity (mild to moderate hepatic impairment);
you suffer from severe depression. ALPRAZOLAM DOC Generici, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression, as it may increase suicidal tendencies and cause mood changes;
you suffer from psychosis, a serious mental illness altering behavior and causing difficulties in social interactions. ALPRAZOLAM DOC Generici 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 DOC Generici may enhance the effects of these medicines (see section “Other medicines and ALPRAZOLAM DOC Generici”);
you have or have previously had problems with alcohol, drug, or medicine abuse and dependence, as you have a higher risk of developing dependence on ALPRAZOLAM DOC Generici (see section “Development of dependence”).

Memory disturbances
A few hours after taking ALPRAZOLAM DOC Generici, you may experience difficulty remembering events that occurred after taking the medicine.

Development of tolerance
After several weeks of treatment, a reduction in the effectiveness of ALPRAZOLAM DOC Generici may occur.

Development of dependence
ALPRAZOLAM DOC Generici causes dependence (i.e., you may experience an increasing desire to take the medicine or may 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 during treatment with ALPRAZOLAM DOC Generici.

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

Other medicines and ALPRAZOLAM DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of ALPRAZOLAM DOC Generici and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes ALPRAZOLAM DOC Generici together with opioids, the dose and duration of concomitant treatment must be strictly limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or family members to watch for the symptoms listed above. Contact your doctor if you experience such symptoms.
Caution is required when ALPRAZOLAM DOC Generici is taken together with 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, tranquillizers;
anxiolytics, used to treat anxiety;
antidepressants (e.g., nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine);
narcotic analgesics, opioids, medicines used to treat severe pain;
antiepileptics, medicines used to treat epileptic seizures;
anesthetics. Anesthetics, when administered together with ALPRAZOLAM DOC Generici, may cause euphoria, increasing the risk of developing dependence on ALPRAZOLAM DOC Generici;
sedating antihistamines, medicines used to treat allergic symptoms.

* If you take ALPRAZOLAM DOC Generici together with one or more of these medicines or with alcoholic beverages, these substances may contribute to reduced brain and mental functions, potentially leading to decreased spontaneous breathing, coma, and death (see section Warnings and precautions).

Analgesics and sedative cough medicines (cough suppressants) containing opium or its derivatives. These medicines, like ALPRAZOLAM DOC Generici, reduce spontaneous breathing capacity;
cimetidine, a medicine used to reduce stomach acidity;
propoxyphene, a medicine used for pain relief;
oral contraceptives;
diltiazem, a medicine used to lower blood pressure;
digoxin (a medicine used to increase the strength of heart contractions). If you are elderly, taking ALPRAZOLAM DOC Generici may increase the likelihood of digoxin-related toxic effects.

The following medicines may increase the effects of ALPRAZOLAM DOC Generici:

ketoconazole, itraconazole, posaconazole, voriconazole, medicines used to treat fungal infections – co-administration with ALPRAZOLAM DOC Generici is not recommended;
erythromycin, clarithromycin, telithromycin, troleandomycin (antibiotics) – co-administration should be done with caution, and a substantial dose reduction should be considered;
protease inhibitors (e.g., ritonavir), medicines used to treat HIV infection. If you are being treated with protease inhibitors, your doctor may advise discontinuing treatment with ALPRAZOLAM DOC Generici due to interaction with these medicines.

ALPRAZOLAM DOC Generici and alcohol
Do NOT drink alcohol while taking ALPRAZOLAM DOC Generici, as alcohol enhances the effects of this medicine.

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 3 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 DOC Generici”). These effects are reversible and may last from several days up to 1–3 weeks after birth.

Breastfeeding
Do NOT take this medicine if you are breastfeeding, as alprazolam passes into breast milk.

Driving and use of machinery
Do NOT drive or operate machinery if, during treatment with ALPRAZOLAM DOC Generici, 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 alcohol.

ALPRAZOLAM DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

ALPRAZOLAM DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., it is essentially ‘sodium-free’.

ALPRAZOLAM DOC Generici 0.50 mg contains the colouring agent sunset yellow (E 110)
It may cause allergic reactions.

3. How to take ALPRAZOLAM DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Treatment of anxiety
The recommended starting dose is 0.25 mg to 0.50 mg three times daily.
The dose may be gradually increased up to a maximum of 4 mg per day, divided into several doses.
You should first increase the evening dose, followed by the daytime doses.
If you are elderly, have liver or kidney problems and/or are debilitated
The recommended starting dose is 0.25 mg two or three times daily.
The duration of treatment 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 be continued beyond the recommended maximum period.
If you take more ALPRAZOLAM DOC Generici than you should
If you (or someone else) have taken an excessive dose of ALPRAZOLAM DOC Generici or if you suspect that a
child may have taken 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, and death.
If you forget to take ALPRAZOLAM DOC Generici
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 forgotten dose.
If you stop taking ALPRAZOLAM DOC Generici
Do not stop treatment with ALPRAZOLAM DOC Generici suddenly. Always consult your doctor before stopping ALPRAZOLAM DOC Generici. You must gradually reduce the dose to avoid experiencing:
Withdrawal symptoms such as:

severe symptoms: feeling detached from yourself or the external world, numbness and tingling in arms or legs, increased sensitivity to light, sounds 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 low mood, insomnia;

Rebound symptoms, for example, anxiety. These symptoms are the same ones for which you were prescribed ALPRAZOLAM DOC Generici and may temporarily reappear more intensely after abrupt discontinuation of treatment.
If you have any questions 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 everybody will experience them.

Contact your doctor immediately if you experience any of the following side effects, because treatment with ALPRAZOLAM DOC Generici must be stopped:

paradoxical reactions (opposite effects to those expected) (see section 2 “Paradoxical disorders”), such as:
- restlessness
- agitation
- irritability
- aggression
- feelings of disappointment
- anger
- nightmares
- hallucinations
- disturbances in thinking
- changes in behaviour

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, causing difficulty in swallowing and breathing (angioedema)
difficulty in remembering events following the intake of the medicine (see section 2 “Memory disturbances”)
unmasking of pre-existing depression
dependence (see section 2 “Development of dependence”)
withdrawal symptoms and rebound symptoms (see section 3 “If you stop taking ALPRAZOLAM DOC Generici”)

Contact your doctor immediately 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 and control movements
memory disturbances
difficulty speaking
dizziness
headache
constipation
dry mouth due to lack of saliva
fatigue (asthenia)
irritability

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

decreased appetite, weight gain or loss
confusion and disorientation
increased or decreased sexual desire, sexual dysfunction
anxiety
insomnia, excessive sleepiness
nervousness
loss of balance, problems with movement coordination
loss of attention and concentration
excessive drowsiness (lethargy)
tremors
vertigo
blurred vision
nausea
skin inflammation (dermatitis)

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

obsessive thoughts and behaviours
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 prolactin (a natural hormone) in the blood
mood changes
hostile behaviour, abnormal thoughts
impulsivity and motor hyperactivity
disturbances of the autonomic nervous system responsible for bodily functions that cannot be voluntarily controlled (e.g. internal organ and gland functions)
involuntary muscle contractions causing unnatural postures
stomach and intestinal disorders
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 hands and feet due to fluid retention
increased intraocular pressure
misuse of this medicine (tendency to excessive or inappropriate use of ALPRAZOLAM DOC Generici)

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 DOC Generici

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 below 25°C and in the original packaging, to protect the medicine from light.
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 ALPRAZOLAM DOC Generici contains
ALPRAZOLAM DOC Generici 0.25 mg tablets
The active substance is alprazolam. Each tablet contains 0.25 mg of alprazolam.
The other components are: microcrystalline cellulose (PH 101 and PH 102), lactose monohydrate, sodium
croscarmellose, magnesium stearate.
ALPRAZOLAM DOC Generici 0.50 mg tablets
The active substance is alprazolam. Each tablet contains 0.50 mg of alprazolam.
The other components are: microcrystalline cellulose (PH 101 and PH 102), lactose monohydrate, sodium
croscarmellose, magnesium stearate, sunset yellow (E 110).
Description of the appearance of ALPRAZOLAM DOC Generici and contents of the pack
Box containing 20 tablets of 0.25 mg and 0.50 mg.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 - 20121 Milan.
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De Stampi, 20089 Rozzano (MI), Italy