Delorazepam Eg

Italy
Brand name Delorazepam Eg
Form drops, oral solution
Active substance / Dosage
DELORAZEPAM
Prescription type Prescription only
ATC code
N05BA
Registration number 036424
Manufacturer EG S.P.A.

Table of Contents

Package leaflet: Information for the patient

DELORAZEPAM EG 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 other people, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DELORAZEPAM EG is and what it is used for

DELORAZEPAM EG contains the active substance delorazepam, which belongs to a group of medicines
called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress to the patient.
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 EG

Do not take DELORAZEPAM EG

  • 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 (hepatic insufficiency);
  • if you have breathing difficulties during sleep (sleep apnea);
  • if you have a condition of the eye called narrow-angle glaucoma;
  • if you have intoxication due to alcohol or other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium);
  • if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking DELORAZEPAM EG.
Be cautious when using this medicine, as it may cause severe, life-threatening breathing problems
(respiratory depression) and serious 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. Your doctor will continuously assess the need to
continue treatment.
If you have previously experienced angioedema while taking benzodiazepines, you must not be treated with
DELORAZEPAM EG.
Take this medicine with caution and always under medical supervision in the following cases:

  • if you are elderly. In this case, your doctor may decide to reduce the dose to avoid undesirable effects such as muscle weakness, dizziness, drowsiness, fatigue, tiredness, 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 severe liver problems (hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
  • if you have severe kidney problems (renal insufficiency);
  • if you have low blood pressure or heart problems (heart failure). In this case, your doctor may decide to perform regular check-ups;
  • if you suffer from depression or have previously abused alcohol or drugs.

Taking this medicine may cause:

  • Tolerance: if after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
  • Dependence: taking this medicine may lead to dependence, i.e., the need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously suffered from psychiatric disorders or have abused drugs or alcohol.

Withdrawal – discontinuation symptoms: when you stop taking DELORAZEPAM EG, you may
experience withdrawal or rebound symptoms (such as headache, muscle pain, extreme anxiety, tension,
restlessness, confusion, and irritability), even if you have taken the medicine at the recommended doses and for a short
period (see section “If you stop treatment with DELORAZEPAM EG”).

  • Withdrawal symptoms may appear within the first few days after stopping treatment. To minimize these symptoms, it is recommended to gradually reduce the dose. Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine (such as DELORAZEPAM EG) to a short-acting one. Therefore, such substitution is not recommended.
  • Memory loss: to reduce the risk of amnesia (memory loss), ensure uninterrupted sleep of 7–8 hours.
  • Behavioral changes: in some patients, a syndrome involving various memory and behavioral disturbances may occur, such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), and behavioral changes. This syndrome may be accompanied by potentially dangerous behaviors towards oneself or others, such as unusual behavior, self-harm (self-injury), or aggression (especially towards people trying to limit their activity). If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. “Possible side effects”). These reactions are more frequent in children and the elderly.

Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
Duration of treatment: treatment duration should be as short as possible and must not exceed 4
weeks for insomnia and 8–12 weeks for anxiety, including a gradual discontinuation period.
Children and adolescents
In children and adolescents under 18 years of age, DELORAZEPAM EG should be used only
when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and DELORAZEPAM EG
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 psychiatric 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 EG. This may increase your desire to continue taking these medicines (dependence);
  • antiepileptics, used for epilepsy;
  • sedating antihistamines, used to treat allergies;
  • anesthetics, used during surgery;
  • medicines that increase or decrease the metabolism of delorazepam;
  • theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly.

Concomitant use of DELORAZEPAM EG and opioids (strong painkillers, medicines for substitution therapy, 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 therapeutic options are possible.
However, if your doctor prescribes DELORAZEPAM EG 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 relatives about the signs and symptoms listed above.
Contact your doctor if these symptoms occur.
DELORAZEPAM EG and alcohol
Avoid alcohol consumption during treatment with this medicine, as it may enhance the sedative effect
of the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Contact your doctor if you suspect you are pregnant, as it will be necessary to discontinue the medicine.
Do not take DELORAZEPAM EG during pregnancy, as it may harm the unborn baby.
If your doctor considers it necessary for you to take this medicine during the late stages of pregnancy or during labor, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
If DELORAZEPAM EG has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.
Discontinue breastfeeding if the medicine needs to be taken regularly.
Fertility
If you start treatment with DELORAZEPAM EG and are of childbearing age, consult your doctor if you intend to become pregnant, as it will be necessary to discontinue the medicine.
Driving and using machines
The use of DELORAZEPAM EG may affect your ability to drive or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are more pronounced if you have not slept enough. If this occurs, avoid driving or operating machinery.
Consuming alcohol during treatment with this medicine negatively affects your ability to drive and use machinery.
DELORAZEPAM EG contains ethanol (alcohol)
This medicine contains up to 208 mg of alcohol (ethanol) per 52-drop dose (2 ml). The amount in 2 ml of this medicine is equivalent to less than 5.2 ml of beer and 2.16 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
DELORAZEPAM EG contains sodium and propylene glycol
This medicine contains less than 1 mmol (23 mg of sodium) per dose, i.e., essentially “sodium-free”.
This medicine contains up to 1542 mg of propylene glycol per 52-drop dose (equivalent to 2 mg of delorazepam).
If you are pregnant or breastfeeding, or if you have liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take DELORAZEPAM EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor instructs you to do so.
Take DELORAZEPAM EG drops as follows:

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

Treatment of insomnia: The dose varies according to your individual needs, as prescribed by your doctor. The recommended average dose is 13, 26 or 52 drops per day, to be taken in the evening before going to bed, diluted with a small amount of 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 discontinuation.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.

Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the dose or frequency of administration if necessary.

Use in elderly patients and in patients with kidney or liver problems
In elderly and debilitated patients, a reduced dose should be administered, with close monitoring of the patient.

If you take more DELORAZEPAM EG than you should
If you (or someone else) have taken an excessive dose of DELORAZEPAM EG, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause marked depression of the central nervous system, with symptoms such as drowsiness, fatigue, progressive loss of muscle coordination (ataxia), visual disturbances, confusion, lethargy, unconsciousness, reduced muscle tone (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), central nervous system depression which may worsen to coma and death.
Take this leaflet, the bottle and its packaging with you to the hospital or doctor so they know which medicine has been taken.

If you forget to take DELORAZEPAM EG
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DELORAZEPAM EG
Do not stop treatment with DELORAZEPAM EG suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, your dose will be gradually reduced 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 sound (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. 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, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, and increased body temperature (hyperthermia).

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may return more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is greater if you stop taking DELORAZEPAM EG abruptly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.

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 experiences them.
Contact your doctor immediately if you experience:

  • depression and behavioural reactions such as restlessness, agitation, irritability, aggression, 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 discontinued. These reactions are more commonly observed 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 muscular 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):

  • altered sexual desire.

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

  • decrease in platelets (thrombocytopenia), decrease in white blood cells (agranulocytosis), decrease in all blood cells (pancytopenia);
  • alteration in antidiuretic hormone secretion (SIADH);
  • disinhibition, euphoria, tendency towards self-harm (suicidal ideation/suicide attempts);
  • tremors, dizziness, headache (cephalalgia), speech problems (dysarthria/difficulty in articulating speech), memory loss, coma;
  • double vision, blurred vision;
  • reduced blood pressure (hypotension);
  • nausea, constipation;
  • jaundice, a condition characterised by yellowing of the skin and whites of the eyes;
  • increased liver enzyme levels (transaminases), increased bilirubin, increased alkaline phosphatase;
  • skin rash, hair loss (alopecia);
  • involuntary loss of urine (incontinence);
  • reduced body temperature (hypothermia).

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

  • sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause breathing or swallowing difficulties (angioedema);
  • changes in appetite, reduced sodium levels in the blood (hyponatremia);
  • 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 disturbances;
  • skin reactions.

Use of this medicine may cause:
dependence, withdrawal symptoms – withdrawal reactions, paradoxical reactions and amnesia (see sections "Warnings and precautions" and "If you stop taking DELORAZEPAM EG").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DELORAZEPAM EG

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 kept in its original, undamaged packaging and stored correctly.
Oral drops should be used within 12 months after first opening the bottle. Any excess product
should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DELORAZEPAM EG contains

  • The active substance is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
  • The other components are: ethanol 96 percent, glycerol, purified water, ammonium glycyrrhizinate, sodium saccharin, propylene glycol.

Description of the appearance of DELORAZEPAM EG and contents of the pack
Pack containing 1 bottle of 20 ml oral solution.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Manufacturers
DOPPEL Farmaceutici S.r.l - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
MIPHARM S.p.A. - Via Quaranta, 12 - 20141 - Milan
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo - 10015 Ivrea (TO) - Italy