DELORAZEPAM 1 mg /Ml Oral Drops, Solution

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1. DELORAZEPAM EG 1 mg/ml oral drops, solution
   1. What is DELORAZEPAM EG and what is it used for?
   2. What you need to know before you take 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

DELORAZEPAM EG 1 mg/ml oral drops, solution

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effect occurs, including those not listed in this leaflet, tell 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 you take 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 is DELORAZEPAM EG and what is it used for?

DELORAZEPAM EG contains the active ingredient delorazepam, which belongs to a group of medicines
called benzodiazepines.
Benzodiazepines are used to relieve severe states of anxiety, which subject the individual to severe
discomfort.
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 you take 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 that causes muscle weakness and fatigue;
• if you suffer from severe respiratory failure;
• if you have serious liver problems (hepatic insufficiency);
• if you have problems 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, breastfeeding and fertility”).

Warnings and precautions
Consult your doctor or pharmacist before taking DELORAZEPAM EG.
Pay attention to the use of the medicine because it can cause serious respiratory problems, life-threatening
(respiratory depression) and serious allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling
of the tongue, larynx and throat that can cause problems with breathing and swallowing (angioedema),
shortness of breath (dyspnea), closure of the throat, nausea and vomiting. The doctor will continuously assess the need to
continue therapy.
If you have experienced angioedema in the past with the use of benzodiazepines, you should not be treated with
DELORAZEPAM EG.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you are elderly. In this case, the doctor may decide to reduce the dose to avoid undesirable effects such as muscle weakness, dizziness, drowsiness, fatigue, loss of progressive muscle coordination (ataxia), which can increase the risk of falls and fractures;
• if you have respiratory problems (respiratory failure). In this case, the doctor may decide to reduce the dose;
• if you have serious liver problems (hepatic insufficiency) or suffer from mental confusion due to hepatic insufficiency (hepatic encephalopathy);
• if you have serious kidney problems (renal insufficiency);
• if you have low blood pressure or heart problems (heart failure). In this case, the doctor may decide to subject you to regular checks;
• if you suffer from depression or if you have abused alcohol or drugs in the past. Taking this medicine can cause:
• Tolerance: if after a few weeks it seems to you that the medicine does not work as well as at the beginning of the treatment, consult your doctor.
• Dependence:when you take this medicine there is a risk of dependence, that is the need to continue taking the medicine. The risk increases with the dose and duration of treatment. It is greater if you have suffered from psychiatric disorders in the past 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 of time (see section “If you stop taking DELORAZEPAM EG”).

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

Benzodiazepines are not recommended for psychotic illnesses 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: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.

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

Other medicines and DELORAZEPAM EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention and tell 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 EG. This may increase your desire to continue taking these medicines (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 metabolism of delorazepam;
• theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly.

The concomitant use of DELORAZEPAM EG and opioids (strong painkillers, medicines for substitution
therapy and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory
depression), coma and can be life-threatening. For this reason, concomitant use should be
considered only when other therapeutic options are not possible.
However, if your doctor prescribes DELORAZEPAM EG together with opioids, the dose and duration of concomitant therapy
must be limited by your doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow your doctor’s recommendations
on dosage. It may be helpful to inform friends or relatives of the signs and symptoms above. Contact your doctor when these symptoms occur.

DELORAZEPAM EG with alcohol
Avoid drinking alcohol during treatment with this medicine, as it can increase the sedative
effect of the medicine.

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

Pregnancy
Consult your doctor if you suspect you are pregnant, as you will need to stop taking the
medicine.
Do not take DELORAZEPAM EG during pregnancy, as it can cause harm to the fetus.
If your doctor believes you should take this medicine in the later stages of pregnancy, or during
labor, your baby may develop floppy baby syndrome characterized by low
body temperature, loss of muscle tone, difficulty breathing.
If DELORAZEPAM EG has been taken regularly during the later 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.
Stop breastfeeding if the medicine needs to be taken regularly.

Fertility
If you start treatment with DELORAZEPAM EG in your fertile age, consult your doctor if you intend to start a
pregnancy, as you will need to stop taking the medicine.

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

DELORAZEPAM EG contains ethanol (alcohol)
This medicine contains 208 mg of alcohol (ethanol). 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, propylene glycol
This medicine contains less than 1 mmol (23 mg of sodium) per dose, that is essentially ‘sodium-free’.
This medicine contains up to 1542 mg of propylene glycol per dose of 52 drops (equivalent to 2mg
of delorazepam).
If you are pregnant or breastfeeding, or 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.

3. How to take DELORAZEPAM EG

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist
You must continue to take this medicine until your doctor tells you to stop.
Take the drops of DELORAZEPAM EG as follows:

Treatment of anxiety:the dose varies according to your needs, as prescribed by your doctor: 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, 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 prolong the treatment, after assessing your
health conditions.

Treatment of insomnia:the dose varies according to your needs, as prescribed by your doctor: the
average 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 discontinuation.
In certain cases, your 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.
Your doctor will regularly check your condition at the beginning of treatment to decrease, if necessary, the
dose or frequency of administration.

Use in the elderly and in people with kidney and liver problems
In the elderly and debilitated patients, a reduced dose should be administered while keeping the patient under
close observation.

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 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, unconsciousness, reduced muscle tone (hypotonia), lowering of blood pressure (hypotension), breathing problems (respiratory depression), nervous system depression that
can worsen to coma and death.
Bring this leaflet, the bottle and its container 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 of the medicine, take it as soon as you remember, unless it is almost
time to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DELORAZEPAM EG
Do not stop treatment with DELORAZEPAM EG suddenly or without first agreeing
with your doctor, because withdrawal symptoms may occur.
If your doctor has decided to stop the treatment, they will gradually reduce the dose to minimize the
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 occur. Other symptoms are: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensitivity of hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (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 EG. You may
also experience changes in mood, 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, aggressiveness, delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses contact 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 may 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 platelets (thrombocytopenia), decreased white blood cells (agranulocytosis), decreased of all blood cells (pancytopenia);
• alteration of the secretion of the antidiuretic hormone (SIADH);
• disinhibition, euphoria, tendency to self-harm (suicidal ideation/attempts);
• tremors, dizziness, headache, speech problems (dysarthria/difficulty articulating speech), memory loss, coma;
• double vision, blurred vision;
• reduced blood pressure (hypotension);
• nausea, constipation;
• jaundice, a disease characterized by a yellowish discoloration of the skin and whites of the eyes;
• increased levels of liver enzymes (transaminases), increased bilirubin, increased alkaline phosphatase;
• skin rash, hair loss (alopecia);
• involuntary loss of urine (incontinence);
• reduced body temperature (hypothermia).

Frequency not known(the 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 that may cause difficulty breathing and swallowing (angioedema);
• changes in appetite, reduced sodium levels in the blood (hyponatremia);
• anxiety, agitation, sleep disorders;
• convulsions, seizures, balance, attention and concentration disorders, disorientation;
• respiratory depression, apnea, problems breathing during the night (sleep apnea), worsening of lung diseases (obstructive pulmonary disease);
• stomach and intestinal disorders;
• skin reactions. Taking this medicine may cause:

dependence, withdrawal – withdrawal symptoms, paradoxical reactions and amnesia (see sections “Warnings
and precautions” and “If you stop taking DELORAZEPAM EG”).

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
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 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
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DELORAZEPAM EG contains

• The active substance is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
• The other ingredients are: 96 percent ethanol, 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 of oral solution.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano

Manufacturers
DOPPEL Farmaceutici S.r.l - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
MIPHARM S.p.A. - Via Quaranta, 12 - 20141 - Milano
ABC Farmaceutici S.p.A. - Via Cantone Moretti, 29 (loc. San Bernardo) - 10015 Ivrea (TO)