DELORAZEPAM 1 мг/мл Оральные капли, раствор

Содержание инструкции

1. DELORAZEPAM DOC Generici 1 mg/ml oral drops, solution
   1. What is DELORAZEPAM DOC Generici and what it is used for
   2. What you need to know before taking DELORAZEPAM DOC Generici
   3. Possible side effects
   4. How to store DELORAZEPAM DOC Generici
   5. Contents of the pack and other information

DELORAZEPAM DOC Generici 1 mg/ml oral drops, solution

Equivalent 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

DELORAZEPAM DOC Generici contains the active ingredient delorazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are indicated in cases where the disorder is severe, debilitating and subjects the individual to
significant distress.
This medicine is indicated for the treatment of:

• anxiety, tension and other disorders associated with anxiety
• sleep disorders (insomnia).

2. What you need to 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 that causes muscle weakness and fatigue
• if you suffer from severe respiratory failure
• if you have serious problems with your liver (severe hepatic insufficiency)
• if you have trouble breathing during sleep (sleep apnea)
• if you have an eye disease called narrow-angle glaucoma
• if you have an intoxication from alcohol or other medicines that depress the nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)
• if you are pregnant or if you are breastfeeding (see section Pregnancy and breastfeeding).

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

• if you are elderly. In this case, the doctor may reduce the dose or avoid treating you with this medicine. The use of benzodiazepines may be associated with muscle weakness, dizziness, drowsiness, fatigue, exhaustion, progressive loss of muscle coordination (ataxia), which can increase the risk of falls and fractures
• if you have breathing problems (respiratory failure). In this case, the 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 (heart failure). In this case, the doctor will perform regular checks
• if you suffer from depression or if you have abused alcohol or drugs in the past.

Tolerance:If after a few weeks you feel that the medicine no longer works as well as it did at the beginning of
treatment, consult your doctor.

Dependence:When you take this medicine there is a risk of physical and psychological dependence, that is
the need to continue taking the medicine. The risk increases with the dose and duration of treatment.
It is higher if you have suffered from mental disorders in the past 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 cases of withdrawal, derealization (feeling that things are not
real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds
(hyperacusis), numbness and tingling of hands and feet, sensitivity to light, noise and physical contact,
hallucinations (seeing and hearing things that do not exist) or seizures may appear, even if you have taken the medicine at
the recommended doses and for a short period of time (see section If you stop taking DELORAZEPAM DOC Generici). Withdrawal symptoms may appear within the first few days
after stopping treatment. If multiple benzodiazepines are used in combination, there is a high risk
of drug 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:The duration of treatment should be as short as possible and should not exceed
4 weeks for the treatment of insomnia and 8-12 weeks for the treatment of anxiety, including a
period of gradual withdrawal.

Amnesia: This medicine can induce anterograde amnesia (memory loss). This happens more often
several hours after taking the medicine. To reduce the risk of amnesia, take the medicine just
before going to bed and make sure you get 7-8 hours of uninterrupted sleep.

Rebound insomnia and anxiety:after stopping taking this medicine you may experience
a transient condition in which the symptoms for which you were being treated may reappear in a more severe form
(rebound symptoms). This condition may be accompanied by other symptoms including mood changes, anxiety, restlessness or sleep disturbances. Because the risk of developing rebound symptoms is
higher after abrupt discontinuation of the medicine, the doctor will tell you to stop treatment
with a gradual reduction in dose.

Behavioral disturbances:this medicine, like other similar medicines, can cause a condition
that manifests with behavioral disturbances (for example restlessness, agitation, irritability,
aggression, delirium, anger, nightmares, hallucinations, psychosis, self-harm or other alterations of
behavior). These reactions are more frequent in the elderly and in children. If this should happen,
contact your doctor and stop taking this medicine.
Benzodiazepines are not recommended for psychotic illnesses and should not be used alone for
treating depression, anxiety or insomnia associated with depression, as suicidal thoughts may occur in such patients.

For those who play sports: the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Children and adolescents
In children and adolescents under the age of 18 years, DELORAZEPAM DOC Generici should be used
only in cases of absolute necessity and the duration of treatment should be as short as possible.

Other medicines and DELORAZEPAM DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Be particularly careful 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, tranquilizers and sedatives, used to treat anxiety
• some strong painkillers (opioids), which can cause an increased sense of well-being when taken with DELORAZEPAM DOC Generici. This can increase your desire to continue taking these medicines (psychological dependence).
• antiepileptics, used for epilepsy
• antihistamines with a sedative effect, used to treat allergies
• anesthetics, used during a surgical operation
• medicines that increase or decrease the levels of delorazepam in the blood
• theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly.

The concomitant use of DELORAZEPAM DOC Generici and opioids (strong painkillers, medicines
for addiction therapy and some medicines for cough) increases the risk of
drowsiness, difficulty breathing (respiratory depression), coma and may be
life-threatening. For this reason, concomitant use should only be considered when other treatment options are not 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.
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 family to
pay attention to the signs and symptoms above. Contact your doctor if
you experience these symptoms.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take DELORAZEPAM DOC Generici during pregnancy, as it can cause harm to the baby.
If your doctor believes you should take this medicine in the late stages of pregnancy or during
childbirth, your baby may experience the floppy baby syndrome at birth, characterized by low
body temperature, loss of muscle tone, difficulty breathing.
In addition, 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 while of childbearing potential, consult your doctor, whether
you intend to become pregnant or suspect you are pregnant, as it may be necessary to stop
taking the medicine.
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.

Driving and using machines
The use of DELORAZEPAM DOC Generici can affect your ability to drive vehicles and operate
machinery because you may feel confused, forgetful, drowsy, with muscle tone problems. These
effects are increased if you have not had enough sleep. If this happens to you, avoid driving vehicles or
operating machinery. Drinking alcohol during treatment with this medicine negatively affects
the ability to drive vehicles and operate machinery.

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

DELORAZEPAM DOC Generici contains propylene glycol

• This medicine contains 761 mg of propylene glycol per dose of 26 drops (equivalent to 1 mg of delorazepam).
• If the child is less than 5 years old, talk to your doctor or pharmacist before giving 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. 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.

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

3. How to take DELORAZEPAM DOC Generici

3. How to take DELORAZEPAM DOC Generici

Take this medicine exactly as your doctor or pharmacist has told you. If you have
doubts, ask your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The doctor will adjust the dose according to your needs.

Treatment of anxiety, tension and other disorders associated with anxiety:the dose varies according to your
needs, according to your doctor's prescription.
The average recommended dose is 13-26 drops, 2 or 3 times a day.
In neuropsychiatry the dose may be increased to 26-50 drops, 2 or 3 times a day, according to
doctor's prescription.
The duration of treatment should be as short as possible and generally, should not exceed 8-12
weeks, including a period of gradual withdrawal.
In certain cases, the doctor may decide to prolong the treatment, after assessing your health conditions.

Treatment of insomnia:the dose varies according to your needs, according to your doctor's prescription.
The recommended dose is 13 drops or 26 drops or 52 drops per day to be taken in the evening before going to
bed, diluted with a little water.
The duration of treatment 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 period of gradual withdrawal.
In certain cases, the doctor may decide to prolong the treatment, after assessing your health conditions.
Treatment should be started with the lowest recommended dose. The maximum dose should not be
exceeded.
The doctor will regularly monitor your condition at the beginning of treatment to decrease, if necessary, the
dose or frequency of intake.

Use in the elderly and debilitated patients
In elderly patients and debilitated patients, with kidney problems, liver problems, respiratory insufficiency or with
problems with the head (organic brain disorders), a reduced dose should be administered while keeping the
patient 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, immediately notify your doctor or go to the Emergency Room of the
nearest hospital.
An overdose can cause severe depression of the nervous system with symptoms such as drowsiness,
fatigue, progressive loss of muscle coordination (ataxia), visual disturbances, mental confusion,
lethargy, deep sleep, clouded consciousness, unconsciousness, reduced muscle tone (hypotonia),
lowering of blood pressure (hypotension), breathing problems (respiratory depression),
depression of the nervous system which can worsen to coma and death.

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

If you stop taking DELORAZEPAM DOC Generici
Do not suddenly stop treatment with DELORAZEPAM DOC Generici or without first having
agreed with your doctor, because withdrawal symptoms may occur.
If your doctor has decided to stop treatment, they will gradually reduce the dose to minimize
withdrawal symptoms, such as:

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

Treatment should be discontinued gradually otherwise the symptoms for which you were being treated may
reappear even more intensely than before (rebound insomnia and anxiety). The risk of developing these
symptoms is greater when you suddenly stop taking DELORAZEPAM DOC Generici.
You may also experience mood changes, anxiety, restlessness and sleep disturbances.
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.
Seek immediate medical attention if you experience:

• depression and behavioral reactions, such as restlessness, agitation, irritability, aggression, delirium, anger, 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 behavior. If these side effects occur, treatment should be stopped. These reactions are more common in children and the elderly (see section Warnings and precautions).

The following side effects can also occur

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 capacity
• drowsiness, sedation
• increased heart rate (tachycardia)
• muscle weakness
• fatigue, reduced muscle strength (asthenia).

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

• altered sex drive.

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

• decreased number of platelets (thrombocytopenia), decreased number of white blood cells (agranulocytosis), decreased number of all blood cells (pancytopenia)
• alteration of the secretion of the antidiuretic hormone (SIADH)
• decreased or loss of inhibition, strong feeling of well-being (euphoria), tendency to self-harm (thoughts of suicide/suicide attempts)
• tremors, dizziness, headache, speech problems (dysarthria/difficulty articulating speech), memory loss, coma
• paradoxical reactions and amnesia (see section Warnings and precautions)
• double vision, blurred vision
• decreased blood pressure (hypotension)
• nausea, constipation
• yellowing of the skin and whites of the eyes (jaundice)
• increased levels of liver enzymes (transaminases, alkaline phosphatase), increased bilirubin
• skin rash, hair loss (alopecia)
• involuntary loss of urine (incontinence)
• decreased body temperature (hypothermia).

Frequency not known(the frequency 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 that can cause difficulty breathing and swallowing (angioedema)
• changes in appetite, reduced levels of sodium in the blood (hyponatremia)
• anxiety, agitation, sleep disorders
• convulsions, seizures, disorders of balance, attention and concentration, disorientation
• respiratory depression, apnea, problems breathing during the night (sleep apnea), worsening of lung diseases (obstructive pulmonary disease)
• stomach and intestinal disorders
• skin reactions
• dependence on the medicine, drug abuse, withdrawal symptoms (see sections Warnings and precautions and If you stop taking DELORAZEPAM DOC Generici).

Reporting of side 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
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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Oral drops must be used within 12 months of first opening the bottle. Excess product
must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DELORAZEPAM DOC Generici contains

• The active ingredient is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
• The other ingredients 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 Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe 1- 29016 Cortemaggiore (Piacenza) – Italy.