Prazene

Package leaflet: Information for the user

PRAZENE 10 mg tablets, 20 mg tablets

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

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

Contents of this leaflet

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

1. What Prazene is and what it is used for

Prazene contains the active substance prazepam. Prazepam belongs to a group of medicines called benzodiazepines and acts on the central nervous system by reducing anxiety (anxiolytic effect), improving mood, decreasing the intensity of emotional responses to psychological stress (tranquilizing effect), and promoting muscle relaxation (muscle relaxant effect).
Prazene is used to treat the following conditions when they are severe and cause distress in normal daily life:

• anxiety, emotional tension, and other physical and psychological symptoms associated with anxiety.

2. What you should know before taking Prazene

Do not take Prazene:

• if you are allergic to prazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have a disease causing severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have serious breathing problems (severe respiratory insufficiency);
• if you have serious liver problems (severe hepatic insufficiency). Prazene may worsen brain-related symptoms that can be associated with serious liver problems, such as mental confusion, altered level of consciousness, or coma;
• if you suffer from episodes of breathing interruption for several seconds during sleep (sleep apnea);
• if you are in the first 3 months of pregnancy or are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
The duration of treatment with Prazene should be as short as possible. It is recommended not to
exceed 8–12 weeks of treatment, including the period needed for gradual dose reduction.
Talk to your doctor or pharmacist before taking Prazene if you think any of the following
conditions apply to you (see also section 4 Possible side effects):

• you suffer or have ever suffered from breathing problems, because this medicine may reduce your spontaneous breathing ability. Your doctor may prescribe a lower dose;
• you suffer or have ever suffered from depression, anxiety associated with depression, or suicidal thoughts. Prazene, like other benzodiazepines, should not be used alone to treat depression or anxiety related to depression, as it may worsen suicidal tendencies;
• you suffer or have ever suffered from impaired ability to correctly interpret reality associated with thought disorders. Prazene is not the appropriate medicine for treating these disorders specifically;
• you have or have had problems with alcohol or drug abuse and dependence, because Prazene may also cause dependence (see section Development of dependence);
• you have or have ever had significant brain diseases, especially cerebral arteriosclerosis. Your doctor will advise you on the most suitable dosage for your condition;
• you have or have ever had heart problems (heart failure). Your doctor will advise you on the most suitable dosage for your condition.

Memory disturbances
After taking Prazene, you may experience difficulty remembering events that occurred after taking
the medicine. Therefore, it is advisable that you are able to sleep for 7–8 hours after taking this
medicine.
Paradoxical reactions
Prazene may cause mental reactions and effects opposite to those expected (paradoxical effects)
(see section 4 Possible side effects), such as restlessness, agitation, irritability,
aggressiveness, delusions, anger, nightmares, hallucinations, psychosis, and behavioral changes. These
effects are more common in children and elderly people. If you experience these effects, consult your
doctor, who will advise you on the correct way to discontinue this medicine.
Development of tolerance and dependence, withdrawal reactions, and drug abuse
The effectiveness of this medicine (tolerance) may decrease after prolonged use. This medicine is recommended for short-term treatment only.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other
medicines affecting brain function. Therefore, talk to your doctor if you are taking
alcohol or medicines of this type.
The use of benzodiazepines, including Prazene, may lead to dependence. The risk of dependence increases
with higher doses and prolonged use. The risk of dependence is also higher if you have a history of
alcohol or drug abuse, or if you have significant personality disorders.
Talk to your doctor if:

• you have taken or are currently taking illegal substances;
• you regularly consume alcohol or have previously frequently consumed large amounts of alcohol;
• you have previously or currently have a desire to take large quantities of medicines.

In principle, benzodiazepines should only be used for short periods and discontinued
gradually. Before starting treatment, you and your doctor should agree on how long you will take the medicine.
Once dependence has developed, abruptly stopping the medicine or rapidly reducing the dose may lead to withdrawal reactions. Do not stop
this medicine abruptly. Ask your doctor for advice on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal reactions may include: headache, seizures, tremor, muscle and abdominal cramps, vomiting, nausea, sweating, diarrhea, loss of appetite, muscle pain, feelings of anxiety, tension, insomnia, agitation, depression, dizziness, vertigo, confusion, and irritability. More severe withdrawal symptoms, including life-threatening reactions, may include: feelings of detachment or alienation from oneself and the external world, excessive increase in noise perception, tingling and numbness in limbs, increased sensitivity to light, noise, and physical contact, involuntary movements, agitation, increased awareness of heartbeat (palpitations), rapid heartbeat (tachycardia), panic attacks, hyperactive reflexes, short-term memory loss, increased body temperature (hyperthermia), delirium tremens, hallucinations, depression, mania, psychosis, seizures, and suicide.
The symptoms for which this medicine was prescribed may also reappear briefly (rebound phenomena).
Do not give Prazene to family members or friends. Store this medicine securely so that it cannot harm others.
If you have specific health conditions
If you are elderly and/or debilitated, or suffer from liver or kidney problems, you may be more sensitive to the effects of Prazene. Therefore, in these cases, your doctor will recommend the lowest possible dose.
Elderly patients
Talk to your doctor or pharmacist before taking Prazene if you are over 65 years old. Some elderly patients may experience dizziness, drowsiness, or muscle weakness after taking Prazene and may be at risk of falls.
Children
The efficacy and safety of Prazene in children are not known. Your doctor will decide whether this medicine
can be given to children based on their condition. The duration of treatment should be as short as possible.
Other medicines and Prazene
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Concomitant use of Prazene and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Prazene together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. Contact your doctor if such symptoms occur.
Tell your doctor or pharmacist if you are taking any of the following medicines together with Prazene, as caution is required:

• medicines causing strong reduction of all brain functions, such as:
  • sedatives and sleep-inducing medicines (hypnotics/sedatives)
  • medicines for treating inability to correctly interpret reality associated with thought disorders (neuroleptics)
  • medicines for treating anxiety (anxiolytics)
  • medicines for treating depression (antidepressants)
  • medicines for treating acute or chronic severe pain (narcotic analgesics, opioids)
  • medicines for treating epileptic seizures (antiepileptics)
  • anesthetics
  • medicines to counter allergic reactions (sedating antihistamines). Prazene, when administered together with narcotic anesthetics, may cause euphoria, increasing the likelihood of developing psychological dependence;
• oral contraceptives, as they may enhance the effects of Prazene;
• clozapine (a medicine used for thought disorders), as taking it together with Prazene may cause severe confusion, low blood pressure, and reduced spontaneous breathing ability. Your doctor may decide to reduce the dose of Prazene.

Prazene and alcohol
Do not drink alcohol while taking Prazene, as alcohol enhances the effects of this medicine.
This may also severely impair your ability to drive or operate machinery (see section Driving and use of machines).
Pregnancy and breastfeeding
If you are pregnant, think 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 pregnancy, especially during the first and third
trimesters, as it may cause congenital malformations in the fetus.
If you take this medicine during the last 3 months of pregnancy, the newborn may experience:

• severe lung damage leading to inability to breathe, low blood oxygen levels unresponsive to external oxygen supply (respiratory distress syndrome)
• low muscle tone, excessive sleepiness, poor emotional response to external stimuli, difficulty breastfeeding (floppy infant syndrome)
• tremor, irritability, increased muscle tone, diarrhea, vomiting, vigorous sucking (withdrawal syndrome)

Breastfeeding
Do not breastfeed while taking Prazene, as this medicine may pass into breast milk. Consult your doctor if you have any doubts.
Driving and use of machines
Do not drive or operate machinery if you experience any of the following side effects: drowsiness, amnesia (memory disturbances), impaired concentration, or muscle function. Your alertness may be impaired, especially if you have not slept long enough after taking Prazene.
Prazene 10 mg and 20 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Prazene

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will advise you on the dose, the number of daily administrations, and the duration of treatment with Prazene, ensuring that you take the lowest possible dose for the shortest possible time. Do not change or exceed the prescribed dose. To discontinue treatment, the dose must be gradually reduced under your doctor’s supervision. This reduces the risk of withdrawal reactions, which in some cases may be life-threatening (see section 2).
Prazene tablets should be taken orally, with a little water. The tablets must not be chewed.

Adults
For repeated administration, the recommended average dose is 30 mg per day, equivalent to one 10 mg tablet taken three times daily.
Your doctor may adjust the dose between 20 mg and 60 mg of prazepam per day, depending on your response to treatment. Your doctor will advise you on how to take Prazene throughout the day.
For single administration, take Prazene before going to bed. The recommended initial dose is 20 mg, equivalent to one 20 mg tablet.
The optimal dosage is usually between 20 and 40 mg per day. Your doctor may adjust the dose depending on your response to treatment.
Your doctor will advise you on how to take Prazene as a single dose.

If you are elderly, debilitated, or have liver or kidney problems
The recommended adult doses should be halved.

Use in children
Your doctor will assess whether treatment is truly necessary in children. The dose used should be the lowest possible, and the duration of treatment should be as short as possible.

Duration of treatment
Treatment with Prazene should be as short as possible. It is recommended not to exceed 8–12 weeks of treatment, including the time needed for gradual dose reduction. The need for extending treatment will be carefully evaluated by your doctor.

If you take more Prazene than you should
It is important that you never take more medicine than prescribed. Generally, there is no life-threatening risk if you accidentally take a higher dose than prescribed, unless you also consume alcohol or other medicines at the same time.

Symptoms
In mild cases, symptoms may include:

• blurred vision, drowsiness, disorientation, and reduced sensory function;
• mental confusion;
• prolonged sleep and reduced response to normal stimuli.

In more severe cases—such as when large amounts of the medicine are taken with suicidal intent, or when taken together with alcoholic beverages or other medicines that depress consciousness and major brain functions—symptoms may include:

• loss of coordination;
• reduced muscle tone;
• low blood pressure;
• reduced spontaneous breathing;
• coma;
• death.

Treatment
Contact your doctor immediately or go to the nearest emergency room if you take more Prazene than prescribed. If you are conscious, vomiting will be induced within one hour of taking the medicine; if you are unconscious, gastric lavage will be performed. If these measures are insufficient, activated charcoal may be administered to reduce absorption of Prazene, or flumazenil, a medicine that counteracts the effects of Prazene.

If you forget to take Prazene
If you forget to take a dose, take it as soon as you remember, but only if you can rest immediately afterwards for a sufficient period (7–8 hours). Do not take a double dose to make up for a missed dose. If you think you have missed more than one dose, consult your doctor.

If you stop taking Prazene
Do not stop taking Prazene suddenly, as the doses must be gradually reduced. Your doctor will advise you on how to discontinue treatment.
If you stop taking Prazene or reduce the dose abruptly, you may temporarily develop withdrawal symptoms or rebound symptoms (see section 2, Development of dependence).
If, for any reason, you wish to stop taking this medicine and switch to another medicine of the same type, consult your doctor. He or she will advise you on how to proceed.
If you have any doubts 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 everyone gets them.
Usually, side effects occur at the beginning of treatment and generally disappear with continued
treatment.
Contact your doctor immediately if you experience any of the following side effects, because
treatment with Prazene must be discontinued:

• paradoxical reactions (opposite effects to those expected) (see section 2, Paradoxical disorders), such as:
  • restlessness
  • agitation
  • irritability
  • aggression
  • feelings of disappointment
  • anger
  • nightmares
  • hallucinations
  • difficulty interpreting reality correctly and disturbances in thinking
  • behavioural changes

Dependence
The use of benzodiazepines (even at therapeutic doses) may lead to the development of physical dependence: stopping treatment may cause rebound or withdrawal phenomena (see section 2. Warnings and precautions). Psychological dependence may also occur. Abuse of benzodiazepines has been reported (see section 2. Warnings and precautions).
Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

• difficulty remembering events after taking the medicine (anterograde amnesia) (see section 2. Memory disturbances)
• depression or unmasking of pre-existing depression prior to administration of the medicine
• drug abuse and drug dependence (see section 2. Development of tolerance and dependence, withdrawal reactions and drug abuse)
• withdrawal syndrome (see section 2. Development of tolerance and dependence, withdrawal reactions and drug abuse)
• rebound symptoms (see section 2. Development of tolerance and dependence, withdrawal reactions and drug abuse)

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

• drowsiness (during the day)

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

• confusion
• particularly vivid dreams with strong emotional involvement
• loss of ability to coordinate movements
• dizziness
• headache
• hyperactivity (excitability)
• sensation of emptiness in the head
• slurred or difficult speech
• tremors
• blurred vision
• awareness of heartbeat (palpitations)
• dry mouth
• stomach and intestinal disturbances
• excessive sweating beyond normal
• skin rashes
• joint pain
• kidney problems
• genital organ problems
• fatigue
• general weakness

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

• transient loss of consciousness (syncope)
• itching
• swelling of the feet

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• vertigo
• liver problems
• muscle weakness
• reduction in blood arterial pressure
• changes in laboratory test values for liver function
• weight gain

Other reported side effects include:

• reduced ability to experience emotions
• reduced level of consciousness
• double vision

These phenomena mainly occur at the beginning of therapy and usually disappear with subsequent doses.
Other adverse reactions have been occasionally reported, including:

• changes in sexual desire
• excessive dilation of the pupil
• reduction in white blood cells in the blood.

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 the following website: 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 Prazene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Prazene contains
The active substance is prazepam.
One 10 mg Prazene tablet contains 10 mg of prazepam.
The other components are: lactose (see section 2 Prazene 10 mg and 20 mg tablets contain
lactose), microcrystalline cellulose, maize starch, magnesium stearate, anhydrous colloidal silica.
One 20 mg Prazene tablet contains 20 mg of prazepam.
The other components are: lactose (see section 2 Prazene 10 mg and 20 mg tablets contain
lactose), microcrystalline cellulose, maize starch, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Prazene and contents of the pack
The 10 mg Prazene tablets are convex, white tablets with a score line on one side. The tablets are available in PVC/PVDC/Aluminum blisters in packs of 30 tablets.
The 20 mg Prazene tablets are flat, round, white tablets with a score line on one side. The tablets are available in blisters in packs of 20 tablets.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee, 1
79108 Freiburg Im Breisgau
Germany

Package leaflet: Information for the user

PRAZENE 15 mg/ml oral drops, solution

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

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

Contents of this leaflet

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

1. What Prazene is and what it is used for

Prazene contains the active substance prazepam. Prazepam belongs to a group of medicines called benzodiazepines and acts on the central nervous system by reducing anxiety (anxiolytic effect), improving mood, decreasing the intensity of emotional responses to psychological stress (tranquilizing effect), and promoting muscle relaxation (muscle relaxant effect).
Prazene is used to treat the following conditions when they are severe and cause distress in normal daily life:

• anxiety, emotional tension states, and other physical and psychological symptoms associated with anxiety.

2. What you should know before taking Prazene

Do not take Prazene:

• if you are allergic to prazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have a disease causing severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have serious breathing problems (severe respiratory insufficiency);
• if you have serious liver problems (severe hepatic insufficiency). Prazene may worsen cerebral symptoms associated with serious liver problems, such as mental confusion, altered level of consciousness, or coma;
• if you suffer from episodes of breathing interruption lasting several seconds during sleep (sleep apnea);
• if you are in the first 3 months of pregnancy or are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
The duration of treatment with Prazene should be as short as possible. It is recommended not to
exceed 8–12 weeks of treatment, including the period needed for gradual dose reduction.
Talk to your doctor or pharmacist before taking Prazene if you think any of the following
conditions apply to you (also see section 4 Possible side effects):

• you suffer or have ever suffered from breathing problems, as this medicine may reduce your spontaneous breathing ability. Your doctor may prescribe a lower dose;
• you suffer or have ever suffered from depression, anxiety associated with depression, or suicidal thoughts. Prazene, like other benzodiazepines, should not be used alone to treat depression or anxiety linked to depression, as it may worsen suicidal tendencies;
• you suffer or have ever suffered from impaired ability to correctly interpret reality associated with thought disorders. Prazene is not the appropriate medicine for treating these specific disorders;
• you have or have had problems with alcohol or drug abuse and dependence, as Prazene may also cause dependence (see section Development of dependence);
• you have or have ever had serious brain diseases, especially cerebral arteriosclerosis. Your doctor will advise the most suitable dosage for your condition;
• you have or have ever had heart problems (heart failure). Your doctor will advise the most suitable dosage for your condition.

Memory disturbances
After taking Prazene, you may experience difficulty remembering events that occurred after taking
the medicine. Therefore, it is advisable to sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Prazene may cause mental reactions and effects opposite to those expected (paradoxical effects)
(see section 4 Possible side effects), such as restlessness, agitation, irritability,
aggression, delusions, anger, nightmares, hallucinations, psychosis, and behavioral changes. These
effects are more common in children and elderly patients. If you experience these effects, contact your
doctor, who will advise you on the proper way to discontinue this medicine.
Development of tolerance and dependence, withdrawal reactions, and drug abuse
A reduction in effectiveness (tolerance) of this medicine may occur after prolonged use. This medicine is recommended for short-term treatment only.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other
medicines affecting brain function. Therefore, talk to your doctor if you are taking
alcohol or such medicines.
The use of benzodiazepines, including Prazene, may lead to dependence. The risk of dependence increases
with higher doses and prolonged use. The risk of dependence is also higher if you have a history of
alcohol or drug abuse, or if you have significant personality disorders.
Contact your doctor if:

• you have taken or are currently taking illegal substances;
• you regularly consume alcohol or have frequently consumed large amounts of alcohol in the past;
• you have had or currently have a desire to take large quantities of medicines.

In principle, benzodiazepines should only be used for short periods and discontinued
gradually. Before starting treatment, you and your doctor should agree on how long you will take the medicine.
Once dependence has developed, abruptly stopping or rapidly reducing the dose may lead to withdrawal reactions. Do not stop
this medicine abruptly. Consult your doctor on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal reactions may include: headache, seizures, tremor, muscle and abdominal cramps, vomiting, nausea, sweating, diarrhea, loss of appetite, muscle pain, anxiety, tension, insomnia, agitation, depression, dizziness, vertigo, confusion, and irritability. More severe withdrawal symptoms, including life-threatening reactions, may include: feelings of detachment or alienation from oneself and the external world, excessive increase in noise perception, tingling and numbness in limbs, increased sensitivity to light, noise, and physical touch, involuntary movements, agitation, increased awareness of heartbeat (palpitations), rapid heartbeat (tachycardia), panic attacks, hyperactive reflexes, short-term memory loss, increased body temperature (hyperthermia), delirium tremens, hallucinations, depression, mania, psychosis, seizures, and suicide.
The symptoms for which this medicine was prescribed may also reappear briefly (rebound phenomena).
Do not give Prazene to family members or friends. Store this medicine securely so it cannot harm others.
If you have specific health conditions
If you are elderly and/or debilitated, or have liver or kidney problems, you may be more sensitive to the effects of Prazene. In such cases, your doctor will recommend the lowest possible dose.
Elderly patients
Talk to your doctor or pharmacist before taking Prazene if you are over 65 years old. Some elderly patients may experience dizziness, drowsiness, or muscle weakness after taking Prazene and may be at risk of falls.
Children
The efficacy and safety of Prazene in children are not known. Your doctor will decide whether this medicine can be given to children based on their condition. The duration of treatment should be as short as possible.
Other medicines and Prazene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Concomitant use of Prazene and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Prazene together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives about the signs and symptoms listed above. Contact your doctor if such symptoms occur.
Inform your doctor or pharmacist if you are taking any of the following medicines together with Prazene, as caution is required:

• medicines that cause strong suppression of all brain functions, such as:
  • sedatives and sleep-inducing medicines (hypnotics/sedatives)
  • medicines for treating inability to correctly interpret reality associated with thought disorders (neuroleptics)
  • medicines for treating anxiety (anxiolytics)
  • medicines for treating depression (antidepressants)
  • medicines for treating severe acute or chronic pain (narcotic analgesics, opioids)
  • medicines for treating epileptic seizures (antiepileptics)
  • anesthetics
  • medicines for treating allergic reactions (sedating antihistamines). Prazene, when administered together with narcotic anesthetics, may cause euphoria, increasing the risk of developing psychological dependence;
• oral contraceptives, as they may enhance the effects of Prazene;
• clozapine (a medicine used for thought disorders), as taking it together with Prazene may cause severe confusion, low blood pressure, and reduced spontaneous breathing ability. Your doctor may decide to reduce the dose of Prazene.

Prazene with alcohol
Do not drink alcohol while taking Prazene, as alcohol enhances the effects of this medicine.
This may also severely impair your ability to drive or operate machinery (see section Driving and use of machines).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine should not be taken during pregnancy, especially during the first and third trimesters, as it may cause congenital malformations in the fetus.
If you take this medicine during the last 3 months of pregnancy, the newborn may experience:

• severe lung damage leading to breathing difficulties, low blood oxygen levels unresponsive to external oxygen (respiratory distress syndrome)
• low muscle tone, excessive sleepiness, poor emotional response to external stimuli, difficulty breastfeeding (floppy infant syndrome)
• tremors, irritability, increased muscle tone, diarrhea, vomiting, vigorous sucking (withdrawal syndrome)

Breastfeeding
Do not breastfeed while taking Prazene, as this medicine may pass into breast milk. Consult your doctor if you have any doubts.
Driving and use of machines
Do not drive or operate machinery if you experience any of the following side effects: drowsiness, amnesia (memory disturbances), impaired concentration, or muscle function. Your alertness may be impaired, especially if you have not slept long enough after taking Prazene.
Prazene 15 mg/ml oral drops contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per millilitre of oral solution, i.e., essentially 'sodium-free'.
Prazene 15 mg/ml oral drops contains propylene glycol
This medicine contains approximately 497 mg of propylene glycol in 20 drops, equivalent to 746 mg of propylene glycol per millilitre.
If your child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
If you 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 Prazene

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will advise you on the dose, the number of daily administrations, and the duration of treatment with Prazene, ensuring that you take the lowest possible dose for the shortest possible time. Do not change or exceed the prescribed dose. To discontinue treatment, the dose must be gradually reduced under medical supervision. This reduces the risk of withdrawal reactions, which in some cases may be life-threatening (see section 2).
Prazene drops should be diluted with a small amount of water or another beverage.

Adults
For repeated administration, the recommended average dose is 30 mg per day, equivalent to 20 drops (bearing in mind that 20 drops contain 10 mg of active substance), taken 3 times a day.
Your doctor may adjust the dose between 20 mg and 60 mg of prazepam per day, depending on your response to treatment. Your doctor will advise you on how to take Prazene throughout the day.
For single administration, take Prazene before going to bed. The recommended initial dose is 20 mg, equivalent to 40 drops.
The optimal dosage usually ranges between 20 and 40 mg per day. Your doctor may adjust the dose depending on your response to treatment.
Your doctor will advise you on how to take Prazene for single administration.

If you are elderly, debilitated, or suffer from liver or kidney problems
The recommended adult doses should be halved.

Use in children
Your doctor will assess the actual need for treatment in children. The dose used should be as low as possible, and the duration of treatment as short as possible.

Duration of treatment
Treatment with Prazene should be as short as possible. It is recommended not to exceed 8–12 weeks of treatment, including the period required for gradual dose reduction. The need for extending treatment will be carefully evaluated by your doctor.

If you take more Prazene than you should
It is important that you never take more medicine than prescribed. Generally, there is no life-threatening risk if you accidentally take a higher dose than prescribed, unless you also consume alcohol or other medicines at the same time.

Symptoms
In mild cases, symptoms may include:

• blurred vision, drowsiness, disorientation, and reduced sensory function;
• mental confusion;
• continuous sleep and reduced response to normal stimuli.

In more severe cases, such as when large quantities of the medicine are taken with suicidal intent, or when this medicine is taken together with alcoholic beverages or other medicines that reduce consciousness and major brain functions, symptoms may include:

• loss of motor coordination;
• reduced muscle tone;
• low blood pressure;
• reduced spontaneous breathing;
• coma;
• death.

Treatment
Contact your doctor immediately or go to the nearest emergency room if you take more Prazene than prescribed. If you are conscious, vomiting will be induced within one hour of taking the medicine; if you are unconscious, gastric lavage will be performed. If these measures are insufficient, activated charcoal may be administered to reduce absorption of Prazene, or flumazenil, a medicine that counteracts the effects of Prazene.

If you forget to take Prazene
If you forget to take a dose, take it as soon as you remember, but ensure that you can rest immediately afterwards for a sufficient period (7–8 hours). Do not take a double dose to make up for a missed dose. If you think you have missed more than one dose, consult your doctor.

If you stop taking Prazene
Do not stop taking Prazene abruptly, as doses must be gradually reduced. Your doctor will advise you on how to discontinue treatment.
If you stop taking Prazene or reduce the dose suddenly, you may temporarily develop withdrawal symptoms or rebound symptoms (see section 2 Dependence).
If, for any reason, you wish to stop taking this medicine and switch to another medicine of the same type, consult your doctor. He or she will advise you on how to proceed.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually, side effects occur at the beginning of treatment and generally disappear with continued
treatment.
Contact your doctor immediately if you experience any of the following side effects, as treatment with Prazene must be discontinued:

• paradoxical reactions (opposite effects to those expected) (see section 2, Paradoxical reactions), such as:
  • restlessness
  • agitation
  • irritability
  • aggression
  • feelings of disappointment
• anger
• nightmares
• hallucinations
• difficulty correctly interpreting reality and disturbances in thinking
• changes in behaviour

Dependence
The use of benzodiazepines (even at therapeutic doses) may lead to physical dependence: stopping treatment may cause rebound phenomena or withdrawal symptoms (see section 2, Warnings and precautions). Psychological dependence may also occur. Abuse of benzodiazepines has been reported (see section 2, Development of tolerance and dependence, withdrawal reactions and drug abuse).
Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

• difficulty remembering events that occurred after taking the medicine (anterograde amnesia) (see section 2, Memory disturbances)
• depression or unmasking of pre-existing depression prior to administration of the medicine
• drug abuse and drug dependence (see section 2, Development of tolerance and dependence, withdrawal reactions and drug abuse)
• withdrawal syndrome (see section 2, Development of tolerance and dependence, withdrawal reactions and drug abuse)
• rebound symptoms (see section 2, Development of tolerance and dependence, withdrawal reactions and drug abuse)

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

• drowsiness (during the day)

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

• confusion
• vivid dreams with strong emotional involvement
• loss of ability to coordinate movements
• dizziness
• headache
• hyperactivity (excitability)
• sensation of emptiness in the head
• slurred and difficult speech
• tremors
• blurred vision
• awareness of heartbeats (palpitations)
• dry mouth
• stomach and intestinal disturbances
• excessive sweating beyond normal
• skin rashes
• joint pain
• kidney problems
• genital organ problems
• fatigue
• general weakness

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

• transient loss of consciousness (syncope)
• itching
• swelling of the feet

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• vertigo
• liver problems
• muscle weakness
• reduction in blood arterial pressure
• changes in laboratory test values indicating liver function abnormalities
• weight gain

Other reported side effects include:

• reduced ability to experience emotions
• reduced level of consciousness
• double vision

These phenomena occur mainly at the beginning of treatment and usually disappear with subsequent doses.
Other adverse reactions have been occasionally reported, including:

• changes in sexual desire
• excessive pupil dilation
• reduction in white blood cells in the blood.

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

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 carton and on the bottle after
"Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Prazene contains
The active substance is prazepam.
1 ml of solution contains 15 mg of prazepam.
The other components are: propylene glycol (E1520), ethylene diethyl glycol, polysorbate 80, sodium saccharin, levomenthol, anethole, patent blue V (see Section 2 “Prazene 15 mg/ml oral drops contains propylene glycol” and “Prazene 15 mg/ml oral drops contains sodium”).
Description of the appearance of Prazene and contents of the pack
Prazene 15 mg/ml oral drops, solution is a blue-coloured solution supplied in a 20 ml glass bottle with dropper.
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Delpharm Orléans
5 Avenue de Concyr
45071 Orléans Cedex 2
France