ALPRAZOLAM 0,25 MG Tabletka powlekana

Treść ulotki

1. ALPRAZOLAM DOC Generici 0.75 mg/ml oral drops, solution
   1. What is ALPRAZOLAM DOC Generici and what is it used for
   2. What you need to know before taking ALPRAZOLAM DOC Generici
   3. How to take ALPRAZOLAM DOC Generici
   4. Possible side effects
   5. How to store ALPRAZOLAM DOC Generici
   6. Package Contents and Other Information
2. ALPRAZOLAM DOC Generici 0.25 mg tablets, 0.50 mg tablets
   1. What is ALPRAZOLAM DOC Generici and what is it used for
   2. What you need to know before taking ALPRAZOLAM DOC Generici
   3. How to take ALPRAZOLAM DOC Generici
   4. Possible side effects
   5. How to store ALPRAZOLAM DOC Generici
   6. Contents of the pack and other information

ALPRAZOLAM DOC Generici 0.75 mg/ml oral drops, solution

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ALPRAZOLAM DOC Generici contains the active ingredient alprazolam.
Alprazolam belongs to a group of medicines called benzodiazepines (medicines with an anxiolytic action).
ALPRAZOLAM DOC Generici is used in adult patients for the treatment of anxiety symptoms when
the disorder is severe, disabling or causes significant distress to the individual.
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 allergicto 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 that causes severe muscle weakness;
• if you have serious problemswith breathing (respiratory failure);
• if you have serious liver problems(hepatic failure);
• if you have problems breathing during sleep (sleep apnea);
• if you have an eye disease called acute angle-closure glaucoma, a problem caused by increased pressure inside the eyes;
• during the first 3 months of pregnancyand if you are breastfeeding(see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine can reduce up to cancel the state of consciousness, can cause a considerable reduction
of the spontaneous ability to breathe, coma and death if taken together with other medicines that
act on the brain and mind (for example opioids, antipsychotics and hypnotic-sedatives) (section Other
medicines and ALPRAZOLAM DOC Generici).
Consult your doctor or pharmacist beforetaking ALPRAZOLAM DOC Generici if:

• you are elderly and/or debilitated. The doctor will prescribe a reduced dose of this medicine; remember to use this medicine with caution because it may cause sedation and/or musculoskeletal weakness and expose you to falls, often with serious consequences;
• you have chronic breathing problems(chronic respiratory failure), because this medicine may worsen your condition;
• you have kidney problems(renal failure) or liver problemsof mild or moderate severity (mild to moderate hepatic failure).
• you suffer from severe depression. ALPRAZOLAM DOC Generici, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression because it can worsen the tendency to suicide and cause mood changes;
• you suffer from psychosis, a serious mental illness that alters behavior and causes difficulty relating to other people. ALPRAZOLAM DOC Generici is not recommended as the primary treatment for this condition
• you are being treated with other medicinesthat act on the brain and mind, because ALPRAZOLAM DOC Generici can increase the effects of these medicines (see section “Other medicines and ALPRAZOLAM DOC Generici”);
• you have or have had in the past problems of abuse and dependenceon alcohol, drugs or other medicines, because there is a greater risk of developing dependence on ALPRAZOLAM DOC Generici (see section “Development of dependence”);

Memory disorders
A few hours after taking ALPRAZOLAM DOC Generici, you may have difficulty remembering
what happened aftertaking the medicine.
Paradoxical reactions
ALPRAZOLAM DOC Generici can cause effects opposite to those expected (paradoxical effects)
(see section 4 “Possible side effects”). These effects are more common in children and the elderly. If you experience these effects, consult your doctor because treatment with ALPRAZOLAM
DOC Generici must be discontinued.
Development of tolerance
After a few 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 experience an increasing desire to take
the medicine or develop physical disorders that decrease or disappear only after taking
the medicine). The probability of developing dependence increases with increasing dose and duration of
treatment. Therefore, the doctor will prescribe the most appropriate treatment based on your disorders and your
conditions, using the lowest effective dose possible to be taken for the shortest possible period. The doctor
will also indicate when to undergo check-ups to assess the progress of your health in
relation to therapy with ALPRAZOLAM DOC Generici.
Incorrect use of ALPRAZOLAM DOC Generici
You must take this medicine ONLYif prescribed by your doctor and after purchasing it at a pharmacy.
Some people tend to abuse ALPRAZOLAM DOC Generici and other similar medicines,
called benzodiazepines.
In addition, some people obtain these medicines illegally (e.g. black market, internet, friends,
family, etc.), sometimes in order to resell them to others. DO NOTtake ALPRAZOLAM DOC Generici if this
medicine has not been prescribed by your doctor. DO NOTtake ALPRAZOLAM DOC Generici if you are
not sure that this medicine has been purchased from a pharmacy.

Children and adolescents
The efficacy and safety in children and adolescents under 18 years of age are not known. The doctor
will decide whether ALPRAZOLAM DOC Generici can be administered to children and adolescents based
on their conditions.

Other medicines and ALPRAZOLAM DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of ALPRAZOLAM DOC Generici and opioids (strong painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use
should only be considered when other treatment options are not possible.
However, if your doctor prescribes ALPRAZOLAM DOC Generici together with opioids, the dose and duration
of concomitant treatment must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow your doctor's recommendations
on dosage. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms above
indicated. Consult your doctor if you experience these symptoms.
Caution is required when ALPRAZOLAM DOC Generici is taken together with the following medicines:

medicinesthat act on the brainand the mind* such as:

• antipsychotics, medicines for the treatment of some mental illnesses;
• hypnotics, sleep inducers;
• sedatives, tranquilizers;
• anxiolytics, used to treat anxiety
• antidepressants(e.g. nefazodone, fluvoxamine, fluoxetine, imipramine and desipramine);
• narcotic analgesics, opioids, medicines for the treatment of severe pain;
• antiepileptics, medicines for the treatment of epileptic seizures;
• anesthetics. Anesthetics, administered together with ALPRAZOLAM DOC Generici, can cause euphoria with increased probability of developing dependence on ALPRAZOLAM DOC Generici;
• antihistamines with sedative effect, medicines to counteract allergic reactions.

* If you take ALPRAZOLAM DOC Generici together with one or more of these medicines or together with
alcoholic beverages, these substances can contribute to decreasing the functions of your brain and your
mind to the point of causing a reduction in the spontaneous ability to breathe, coma and death (section

Warnings and precautions).

• Analgesics and cough suppressants(cough sedatives) based on opium and its derivatives. These medicines, like ALPRAZOLAM DOC Generici, reduce the spontaneous ability to breathe;
• cimetidine, a medicine used to decrease stomach acidity;
• propoxyphene, a medicine used against pain;
• oral contraceptives;
• diltiazem, a medicine used to reduce blood pressure;
• digoxin(a medicine used to increase the force of heart contraction). If you are elderly, taking ALPRAZOLAM DOC Generici may increase the likelihood of developing toxic effects due to digoxin.

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

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

ALPRAZOLAM DOC Generici with alcohol
Donot drink alcohol while taking ALPRAZOLAM DOC Generici because alcohol increases the effects of
this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy

This medicine should not be taken in the first 3 months of pregnancyas it can cause congenital malformations
in the fetus. The doctor will assess whether you can take this medicine during the second and third
trimesters of pregnancy.
If you take this medicine in the last months of pregnancyor during labor, the newborn may
manifest the following symptoms:

• poor muscle tone (axial hypotonia);
• difficulty breathing (respiratory depression or apnea) and taking milk;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking ALPRAZOLAM DOC Generici”). These effects are reversible and can last from a few days to 1-3 weeks after the baby is born.

Breastfeeding

Donot take this medicine if you are breastfeeding, as alprazolam passes into breast milk.

Driving and using machines
Donot drive or operate machinery if you experience
loss of concentration or muscle control while taking ALPRAZOLAM DOC Generici or if you feel drowsy or dizzy. These effects can
be increased if you have not slept enough or if you have consumed alcoholic beverages.

ALPRAZOLAM DOC Generici contains alcohol
This medicine contains up to 122 mg of alcohol (ethanol) per dose of 20 drops (corresponding to 0.50 mg
of alprazolam) and up to 61 mg of alcohol (ethanol) per dose of 10 drops (corresponding to 0.25 mg of alprazolam).
The amount of 20 drops of this medicine is equivalent to 3 ml of beer or 1.3 ml of wine.
The amount of 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 dose of 20 drops (corresponding to 0.50 mg of
alprazolam).
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by
your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended
by your doctor. The doctor may perform further checks during therapy.
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.

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 following exactly the instructions of your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

Treatment of anxiety
The recommended initial dose is from 0.25 mg (10 drops) to 0.50 mg (20 drops) 3 times a day.
The dose may be gradually increased, up to a maximum of 4 mg per day, to be divided into several
doses. You should first increase the dose to be taken in the evening and then the dose to be taken during the
day.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended initial dose is 0.25 mg (10 drops) 2 or 3 times a day.

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.
The doctor will decide whether the treatment can 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 think a
child may have taken this medicine, inform your doctor immediately or go to the Emergency Room of the
nearest hospital.
In mild cases, the symptoms may be: mental confusion, drowsiness, difficulty speaking.
In more severe cases, the symptoms may be: loss of coordination, poor muscle tone, low blood pressure, breathing problems, coma and death.

If you forget to take ALPRAZOLAM DOC Generici
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost
time to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking ALPRAZOLAM DOC Generici
Donot suddenly stop the treatment with ALPRAZOLAM DOC Generici. Always consult your
doctor before stopping taking ALPRAZOLAM DOC Generici. You must reduce the doses
gradually to avoid manifesting:

Withdrawal symptomssuch as:

• severe symptoms: feeling of detachment from oneself or from the external world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, 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,for example, anxiety. These symptoms are the same for which you have been advised to take
treatment with ALPRAZOLAM DOC Generici and may reappear temporarily in a more
intense way after abrupt discontinuation of treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience the following side effects because the intake of
ALPRAZOLAM DOC Generici must be stopped:
effects opposite to those expected (paradoxical effects) (see section 2 “Paradoxical reactions”) such as:

• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• anger
• nightmares
• hallucinations
• thought disorders
• behavioral changes

Contact your doctor immediatelyif you experience any of the following side effects because they may be

serious:

• swelling of the face, tongue and throat resulting in inability to swallow and breathe (angioedema)
• difficulty rememberingwhat happened after taking the medicine (see section 2 “Memory problems”)
• unmasking of pre-existing depression
• dependence(see section 2 “Development of dependence”)
• withdrawal symptomsand rebound symptoms(see section 3 “If you stop taking ALPRAZOLAM DOC Generici”)

Contact your doctor immediately if you experience any of the following effects:

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

• depression
• sedation
• drowsiness
• loss of ability to control and coordinate movements
• memory problems
• 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
• decreased or increased 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
• vertigo
• blurred vision
• nausea
• skin inflammations (dermatitis)

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

• obsessive ideas and behaviors
• inability to remember recent life events
• vomiting
• muscle weakness
• incontinence
• irregular menstrual cycle
• drug dependence
• drug withdrawal syndrome

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

• increased prolactin (a natural hormone) in the blood
• mood changes
• hostile behaviors, abnormal thoughts
• impulsivity and motor hyperactivity
• alterations of the nervous system responsible for the functions of the body that cannot be controlled voluntarily (e.g. the functions of internal organs and glands)
• involuntary muscle contractions that force you to assume unnatural positions
• stomach and intestinal diseases
• inflammatory liver diseases (hepatitis)
• impaired liver function
• yellowing/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 and feet due to fluid accumulation
• increased pressure inside the eye
• abuse of this medicine (tendency to excessive or incorrect use of ALPRAZOLAM DOC Generici)

Reporting ofside effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
The solution must be used within 30 days of first opening the bottle. Excess product must
be discarded.
Store in the original packaging, to protect the medicine from light.
Do not dispose of any medicine in 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 0.75 mg/ml oral drops, solution
The active ingredient is alprazolam.
10 drops of solution contain 0.25 mg of alprazolam.
The other ingredients are: propylene glycol, ethanol, sodium saccharin, grapefruit aroma, purified water.

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

Marketing Authorisation 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

ALPRAZOLAM DOC Generici 0.25 mg tablets, 0.50 mg tablets

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ALPRAZOLAM DOC Generici contains the active ingredient alprazolam. Alprazolam belongs to a group
of medicines called benzodiazepines (medicines with an anxiolytic effect).
ALPRAZOLAM DOC Generici is used in adult patients for the treatment of anxiety symptoms when
the disorder is severe, disabling or causes significant distress to the individual.
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 allergicto 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 that causes severe muscle weakness;
• if you have serious breathing problems(respiratory failure);
• if you have serious liver problems(hepatic failure);
• if you have trouble breathing during sleep (sleep apnea);
• if you have an eye disease called acute angle-closure glaucoma, a problem caused by increased pressure inside the eyes;
• during the first 3 months of pregnancyand if you are breastfeeding(see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine can reduce or even abolish the state of consciousness, can cause a considerable reduction
in the spontaneous ability to breathe, coma and death if taken together with other medicines that
act on the brain and mind (e.g. opioids, antipsychotics and hypnotic-sedatives) (section Other
medicines and ALPRAZOLAM DOC Generici).
Consult your doctor or pharmacist beforetaking ALPRAZOLAM DOC Generici if:

• you are elderly and/or debilitated. The doctor will prescribe a reduced dose of this medicine; remember to use this medicine with caution because it may cause sedation and/or musculoskeletal weakness and expose you to falls, often with serious consequences;
• you have chronic breathing problems(chronic respiratory failure), because this medicine may worsen your condition;
• you have kidney problems(renal failure) or liver problemsof mild or moderate severity (mild to moderate hepatic failure).
• you suffer from severe depression. ALPRAZOLAM DOC Generici, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression because it may worsen suicidal tendencies and cause mood changes;
• you suffer from psychosis, a serious mental illness that alters behavior and causes difficulty relating to other people. ALPRAZOLAM DOC Generici is not recommended as the primary treatment for this condition
• you are being treated with other medicinesthat act on the brain and mind, because ALPRAZOLAM DOC Generici may increase the effects of these medicines (see section “Other medicines and ALPRAZOLAM DOC Generici”);
• you have or have had problems with abuse and dependenceon alcohol, drugs or other medicines in the past, because there is a greater risk of developing dependence on ALPRAZOLAM DOC Generici (see section “Development of dependence”);

Memory disorders
A few hours after taking ALPRAZOLAM DOC Generici, you may have difficulty remembering
what happened aftertaking the medicine.
Paradoxical reactions
ALPRAZOLAM DOC Generici can cause effects opposite to those expected (paradoxical effects)
(see section 4 “Possible side effects”). These effects are more common in children and the elderly. If you experience these effects, consult your doctor because treatment with ALPRAZOLAM
DOC Generici must be discontinued.
Development of tolerance
After a few 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 experience an increasing desire to take the medicine or develop physical disorders that diminish or disappear only after taking
the medicine). The likelihood of developing dependence increases with increasing dose and duration of
treatment. Therefore, the doctor will prescribe the most appropriate treatment based on your disorders and conditions, using the lowest effective dose possible to be taken for the shortest possible period. The doctor
will also tell you when to undergo check-ups to assess the progress of your health
in relation to therapy with ALPRAZOLAM DOC Generici.
Incorrect use of ALPRAZOLAM DOC Generici.
You must take this medicine ONLYif prescribed by your doctor and after purchasing it at a pharmacy.
Some people tend to abuse ALPRAZOLAM DOC Generici and other similar medicines,
called benzodiazepines.
In addition, some people obtain these medicines illegally (e.g. black market, internet, friends,
family, etc.), sometimes in order to resell them to others. DO NOTtake ALPRAZOLAM DOC Generici if this
medicine has not been prescribed by your doctor. DO NOTtake ALPRAZOLAM DOC Generici if you are
not sure that this medicine was purchased from a pharmacy.

Children and adolescents
The efficacy and safety in children and adolescents under 18 years of age are not known. The doctor
will decide whether ALPRAZOLAM DOC Generici can be administered to children and adolescents based
on their conditions.

Other medicines and ALPRAZOLAM DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of ALPRAZOLAM DOC Generici and opioids (strong painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use
should be considered only when other treatment options are not possible. However, if your
doctor prescribes ALPRAZOLAM DOC Generici together with opioids, the dose and duration
of concomitant treatment must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow your doctor's recommendations
on dosage. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms above
indicated. Consult your doctor if you experience these symptoms.
Caution is required when ALPRAZOLAM DOC Generici is taken together with the following medicines:
medicines that act on the brain and mind* such as:

• antipsychotics, medicines for the treatment of some mental illnesses;
• hypnotics, sleep inducers;
• sedatives, tranquilizers;
• anxiolytics, used to treat anxiety
• antidepressants(e.g. nefazodone, fluvoxamine, fluoxetine, imipramine and desipramine);
• narcotic analgesics, opioids, medicines for the treatment of severe pain;
• antiepileptics, medicines for the treatment of epileptic seizures;
• anaesthetics. Anaesthetics, administered together with ALPRAZOLAM DOC Generici, can cause euphoria with an increased probability of developing dependence on ALPRAZOLAM DOC Generici;
• antihistamines with sedative effect, medicines to counteract allergic reactions.

* If you take ALPRAZOLAM DOC Generici together with one or more of these medicines or with
alcoholic beverages, these substances can contribute to decreasing the functions of your brain and
mind to the point of causing a reduction in the spontaneous ability to breathe, coma and death (section

Warnings and precautions).

• Analgesics and cough sedatives(cough sedatives) based on opium and its derivatives. These medicines, like ALPRAZOLAM DOC Generici, reduce the spontaneous ability to breathe;
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine used against pain;
• oral contraceptives;
• diltiazem, a medicine used to lower blood pressure;
• digoxin(a medicine used to increase the force of heart contraction). If you are elderly, taking ALPRAZOLAM DOC Generici may increase the likelihood of developing toxic effects due to digoxin.

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

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

ALPRAZOLAM DOC Generici with alcohol
Donot drink alcohol while taking ALPRAZOLAM DOC Generici because alcohol increases the effects of
this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy

This medicine should not be taken during the first 3 months of pregnancybecause it can cause birth defects
in the fetus. The doctor will assess whether you can take this medicine during the second and third
trimesters of pregnancy.
If you take this medicine in the last months of pregnancyor during labor, the newborn may
manifest the following symptoms:

• poor muscle tone (axial hypotonia);
• difficulty breathing (respiratory depression or apnea) and taking milk;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking ALPRAZOLAM DOC Generici”). These effects are reversible and can last from a few days to 1-3 weeks after the baby is born.

Breastfeeding

Donot take this medicine if you are breastfeeding, because alprazolam passes into breast milk.

Driving and using machines
Donot drive or operate machinery if you experience
loss of concentration or muscle control, or if you feel drowsy or dizzy while taking ALPRAZOLAM DOC Generici. These effects may
be increased if you have not slept enough or if you have consumed alcoholic beverages.

ALPRAZOLAM DOC Generici contains lactoseIf your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.

ALPRAZOLAM DOC Generici containssodium
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 yellow sunset dye (E 110)
May cause allergic reactions.

3. How to take ALPRAZOLAM DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

Treatment of anxiety
The recommended initial dose is from 0.25 mg to 0.50 mg 3 times a day.
The dose may be gradually increased, up to a maximum of 4 mg per day, to be divided into several
doses. You should first increase the dose to be taken in the evening and then the dose to be taken during the
day.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended initial dose is 0.25 mg 2 or 3 times a day.

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.
The doctor will decide whether the treatment can 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 think a
child may have taken this medicine, inform your doctor immediately or go to the Emergency
Room of the nearest hospital.
In mild cases, the symptoms may be: mental confusion, drowsiness, difficulty speaking.
In more severe cases, the symptoms may be: loss of coordination, poor muscle tone, low blood
pressure, breathing problems, coma and death.

If you forget to take ALPRAZOLAM DOC Generici
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost
time to take the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking ALPRAZOLAM DOC Generici
Donot suddenly stop treatment with ALPRAZOLAM DOC Generici. Always consult your
doctor before stopping taking ALPRAZOLAM DOC Generici. You must reduce the doses
gradually to avoid experiencing:

Withdrawal symptomssuch as:

• severe symptoms: feeling detached from oneself or from the outside world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, 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 for which you have been advised to
treatment with ALPRAZOLAM DOC Generici and may temporarily reappear more
intense after abrupt discontinuation of treatment.
If you have any doubts 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.
Contact your doctor immediatelyif you experience the following side effects because the intake of
ALPRAZOLAM DOC Generici must be stopped:
effects opposite to those expected (paradoxical effects) (see section 2 “Paradoxical reactions”) such as:

• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• anger
• nightmares
• hallucinations
• thought disorders
• behavioral changes

Contact your doctor immediatelyif you experience any of the following side effects because they may be

serious:

• swelling of the face, tongue and throat resulting in inability to swallow and breathe (angioedema)
• difficulty rememberingwhat happened after taking the medicine (see section 2 “Memory problems”)
• unmasking of pre-existing depression
• dependence(see section 2 “Development of dependence”)
• withdrawal symptomsand rebound symptoms(see section 3 “If you stop taking ALPRAZOLAM DOC Generici”)

Contact your doctor immediately if you experience any of the following effects:

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

• depression
• sedation
• drowsiness
• loss of ability to coordinate and control movements
• memory problems
• 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 coordination of movements
• loss of attention and concentration
• excessive drowsiness (lethargy)
• tremors
• vertigo
• blurred vision
• nausea
• skin inflammations (dermatitis)

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

• obsessive ideas and behaviors
• inability to remember recent life events
• vomiting
• muscle weakness
• incontinence
• irregular menstrual cycle
• drug dependence
• drug withdrawal syndrome

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

• increased prolactin (a natural hormone) in the blood
• mood changes
• hostile behaviors, abnormal thoughts
• impulsivity and motor hyperactivity
• alterations of the nervous system responsible for the functions of the body that cannot be controlled voluntarily (e.g. the functions of internal organs and glands)
• involuntary muscle contractions that force you to assume unnatural positions
• diseases of the stomach and intestines
• inflammatory liver diseases (hepatitis)
• impaired liver function
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice);
• skin reactions due to exposure to the sun
• inability to completely empty the bladder
• swelling of the hands and feet due to fluid accumulation
• increased pressure inside the eye
• abuse of this medicine (tendency to excessive or incorrect use of ALPRAZOLAM DOC Generici)

Reporting ofside effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C and in the original packaging, to protect the medicine from
light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALPRAZOLAM DOC Generici contains
ALPRAZOLAM DOC Generici 0.25 mg tablets
The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
The other ingredients are: microcrystalline cellulose (PH 101 and PH 102), lactose monohydrate, sodium
croscarmellose, magnesium stearate.

ALPRAZOLAM DOC Generici 0.50 mg tablets
The active ingredient is alprazolam. Each tablet contains 0.50 mg of alprazolam.
The other ingredients 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
Blister pack of 20 tablets of 0.25 mg and 0.50 mg.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati, 40 - 20121 Milano.

Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De Stampi, 20089 Rozzano (MI), Italy