Delorazepam Doc Generici: detailed information

PATIENT INFORMATION LEAFLET

DELORAZEPAM DOC Generici 1 mg/ml oral drops, solution

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

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

Contents of this leaflet:

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

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

DELORAZEPAM DOC Generici contains the active substance delorazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are indicated in cases where the condition is severe, disabling, and causes severe distress to the individual.
This medicine is indicated for the treatment of:

anxiety, tension, and other anxiety-related disorders
sleep disorders (insomnia).

2. What you should know before taking DELORAZEPAM DOC Generici

Do not take DELORAZEPAM DOC Generici

if you are allergic to delorazepam, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue
if you suffer from severe respiratory insufficiency
if you have severe liver problems (severe hepatic insufficiency)
if you have breathing difficulties during sleep (sleep apnea)
if you have a narrow-angle glaucoma eye disease
if you have alcohol intoxication or intoxication from other medicines that depress the nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)
if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking DELORAZEPAM DOC Generici.
Use of this medicine may cause serious, life-threatening breathing problems (respiratory depression) and
severe allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling of the tongue, larynx, and throat,
which may cause breathing and swallowing difficulties (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting.
Some patients have required emergency treatment. If angioedema affects the tongue, glottis, or larynx, airway obstruction may occur, which could be fatal.
Your doctor will continuously assess the need to continue treatment.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly. In this case, your doctor may reduce the dose or avoid treating you with this medicine. Use of benzodiazepines may be associated with muscle weakness, dizziness, drowsiness, fatigue, exhaustion, progressive loss of muscle coordination (ataxia), which may increase the risk of falls and fractures
if you have respiratory problems (respiratory insufficiency). In this case, your doctor may decide to reduce the dose
if you have liver problems (hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy)
if you have severe kidney problems (severe renal insufficiency)
if you have low blood pressure or heart problems (cardiac insufficiency). In this case, your doctor will perform regular checks
if you suffer from depression or have previously abused alcohol or drugs.

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: When taking this medicine, there is a risk of physical and psychological dependence, i.e., the need to continue taking the medicine.
The risk increases with dose and duration of treatment. It is higher if you have previously suffered from psychiatric disorders or have abused drugs or alcohol.
Withdrawal: When you stop taking DELORAZEPAM DOC Generici, you may experience withdrawal symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe withdrawal cases, derealization (feeling that things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures may occur, even if you have taken the medicine at recommended doses and for a short period of time (see section If you stop treatment with DELORAZEPAM DOC Generici). Withdrawal symptoms may appear within the first days after stopping treatment. When different benzodiazepines are used concomitantly, there is a high risk of medicine dependence, regardless of anxiety and hypnotic symptoms. Cases of abuse have also been reported.
To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Duration of treatment: Treatment duration should be as short as possible and should not exceed 4 weeks for insomnia treatment and 8–12 weeks for anxiety treatment, including a gradual discontinuation period.
Amnesia: This medicine may cause anterograde amnesia (memory loss). This occurs more frequently several hours after taking the medicine. To reduce the risk of amnesia, take the medicine just before going to bed and ensure uninterrupted sleep of 7–8 hours.
Rebound insomnia and anxiety: After stopping this medicine, you may experience a transient condition in which the symptoms being treated may reappear more severely (rebound symptoms). This condition may be accompanied by other symptoms, including mood changes, anxiety, restlessness, or sleep disturbances. Since the risk of rebound symptoms is higher after abrupt discontinuation of the medicine, your doctor will advise you to stop treatment gradually by reducing the dose.
Behavioral disturbances: This medicine, like other similar medicines, may cause a condition characterized by behavioral disturbances (e.g., restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, self-harm, or other behavioral changes). These reactions are more frequent in elderly patients and children. If this occurs, contact your doctor and stop taking this medicine.
Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression, anxiety, or insomnia associated with depression, as suicidal thoughts may occur in such patients.
For athletes: The use of medicines containing ethyl alcohol may result in positive anti-doping tests according to alcohol concentration limits indicated by some sports federations.
Children and adolescents
In children and adolescents under 18 years of age, DELORAZEPAM DOC Generici should be used only when absolutely necessary, and treatment duration should be as short as possible.

Other medicines and DELORAZEPAM DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pay particular attention and inform your doctor if you are taking the following medicines:

antipsychotics (neuroleptics) and antidepressants, used to treat mental disorders
hypnotics, medicines used to promote sleep
anxiolytics, tranquillizers, and sedatives, used to treat anxiety
certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with DELORAZEPAM DOC Generici. This may increase your desire to continue taking these medicines (psychological dependence)
antiepileptics, used for epilepsy
antihistamines with sedative effects, used to treat allergies
anesthetics, used during surgery
medicines that increase or decrease delorazepam levels in the blood
theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly.

Concomitant use of DELORAZEPAM DOC Generici and opioids (strong painkillers, medicines
for addiction therapy, 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 possible.
However, if your doctor prescribes DELORAZEPAM DOC Generici together with opioids, the dose and duration of concomitant treatment must be limited by the 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 family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

DELORAZEPAM DOC Generici with alcohol
Avoid alcohol consumption during treatment with this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take DELORAZEPAM DOC Generici during pregnancy, as it may harm the baby.
If your doctor considers it necessary for you to take this medicine during the late stages of pregnancy or during childbirth, the newborn may exhibit floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
Moreover, if DELORAZEPAM DOC Generici has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
If you start treatment with DELORAZEPAM DOC Generici and are of childbearing age, consult your doctor, whether you plan to become pregnant or suspect you are pregnant, as it may be necessary to discontinue the medicine.
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.

Driving and using machines
Use of DELORAZEPAM DOC Generici may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects increase if you have not slept enough. If this happens, avoid driving or operating machinery. Alcohol consumption during treatment with this medicine negatively affects your ability to drive and operate machinery.

DELORAZEPAM DOC Generici contains ethanol (alcohol)
This medicine contains 13 vol% ethanol (alcohol), for example up to 100 mg per 26-drop dose, equivalent to 2.6 ml of beer and 1.1 ml of wine per dose. It may be harmful to alcoholics. Consider this in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

DELORAZEPAM DOC Generici contains propylene glycol

This medicine contains 761 mg of propylene glycol per 26-drop dose (equivalent to 1 mg of delorazepam).
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.
If you are pregnant, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional checks 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 checks during treatment.

DELORAZEPAM 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 DELORAZEPAM DOC Generici
Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you to stop.
Your doctor will adjust the dose according to your needs.

Treatment of anxiety, tension, and other anxiety-related disorders: The dose varies according to your needs, as prescribed by your doctor.
The recommended average dose is 13–26 drops, 2 or 3 times daily.
In neuropsychiatry, the dose may be increased to 26–50 drops, 2 or 3 times daily, as prescribed by the doctor.
Treatment duration should be as short as possible and generally should not exceed 8–12 weeks, including a gradual discontinuation period.
In specific cases, your doctor may decide to extend treatment after evaluating your health condition.

Treatment of insomnia: The dose varies according to your needs, as prescribed by your doctor.
The recommended dose is 13, 26, or 52 drops daily, taken in the evening before bedtime, diluted with a small amount of water.
Treatment duration should be as short as possible and generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual discontinuation period.
In specific cases, your doctor may decide to extend treatment after evaluating your health condition.
Treatment should start with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment to reduce, if necessary, the dose or frequency of administration.

Use in elderly and debilitated patients
In elderly and debilitated patients, or in patients with kidney or liver problems, respiratory insufficiency, or brain disorders (organic cerebral problems), a reduced dose should be administered under close observation.

If you take more DELORAZEPAM DOC Generici than you should
If you (or someone else) have taken an excessive dose of DELORAZEPAM DOC Generici, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause severe depression of the central nervous system, with symptoms such as drowsiness, fatigue, progressive loss of muscle coordination (ataxia), vision disturbances, confusion, lethargy, deep sleep, stupor, unconsciousness, reduced muscle tone (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), nervous system depression that may worsen to coma and death.

If you forget to take DELORAZEPAM DOC Generici
Do not take a double dose to make up for the missed dose.

If you stop treatment with DELORAZEPAM DOC Generici
Do not stop treatment with DELORAZEPAM DOC Generici abruptly or without prior agreement with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize withdrawal symptoms such as:

headache, muscle pain, tension
severe anxiety, confusion, restlessness, irritability
in severe withdrawal cases: derealization (feeling that things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusia), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures. Other symptoms include: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscle pain (cramps), tremor, muscle pain (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia).

Treatment must be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher when stopping DELORAZEPAM DOC Generici abruptly.
You may also experience mood changes, anxiety, restlessness, and sleep disturbances.
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.
Contact your doctor immediately if you experience:

depression and behavioural reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), changes in behaviour. If any of these side effects occur, treatment must be stopped. These reactions are more likely to occur in children and elderly patients (see section Warnings and precautions).

Other possible side effects include:
Very common (may affect more than 1 in 10 people):

loss of muscle coordination (ataxia).

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

confusion, reduced alertness
reduced emotional responsiveness
drowsiness, sedation
increased heart rate (tachycardia)
muscle weakness
fatigue, reduced muscle strength (asthenia).

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

changes in sexual desire.

Rare (may affect up to 1 in 1,000 people):

decrease in platelet count (thrombocytopenia), decrease in white blood cell count (agranulocytosis), decrease in all blood cells (pancytopenia)
disturbance in the secretion of antidiuretic hormone (SIADH)
reduced or loss of inhibition, intense feeling of well-being (euphoria), tendency towards self-harm (suicidal thoughts/attempts)
tremors, dizziness, headache (cephalalgia), speech problems (dysarthria/difficulty in articulating speech), memory loss, coma
paradoxical reactions and amnesia (see section Warnings and precautions)
double vision, blurred vision
decrease in blood pressure (hypotension)
nausea, constipation
yellowing of the skin and whites of the eyes (jaundice)
increased liver enzyme levels (transaminases, alkaline phosphatase), increased bilirubin
skin rash, hair loss (alopecia)
involuntary loss of urine (incontinence)
decrease in body temperature (hypothermia).

Frequency not known (cannot be estimated from the available data):

hypersensitivity reactions, sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema)
changes in appetite, reduced sodium levels in the blood (hyponatraemia)
anxiety, agitation, sleep disturbances
seizures, epileptic fits, disturbances in balance, attention and concentration, disorientation
respiratory depression, apnoea, breathing difficulties during sleep (sleep apnoea), worsening of lung diseases (pulmonary obstructive disease)
stomach and intestinal disorders
skin reactions
medicine dependence, drug abuse, withdrawal symptoms (see sections Warnings and precautions and If you stop taking DELORAZEPAM 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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
.

5. How to store DELORAZEPAM 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 packaging after "Exp.".
The expiry date refers to the last day of that month.
The expiry date refers to the product when kept in its original, unopened packaging and stored correctly.
Oral drops must be used within 12 months after first opening the bottle. Any excess product should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DELORAZEPAM DOC Generici contains

The active substance is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
The other components are: ethanol, glycerol (E 422), purified water, ammonium glycyrrhizinate, sodium saccharin, propylene glycol (E 1520).

Description of the appearance of DELORAZEPAM DOC Generici and contents of the pack
Pack containing 1 bottle of 20 ml.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe 1- 29016 Cortemaggiore (Piacenza) – Italy.