Delorazepam Hexal: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Delorazepam Hexal 1 mg/ml oral drops, solution

Generic Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Delorazepam Hexal is and what it is used for

Delorazepam Hexal contains the active substance delorazepam, which belongs to a group of medicines called benzodiazepines.
This medicine is indicated for the treatment of:

anxiety disorders
sleep disorders (insomnia).

Benzodiazepines are used only when the disorders are severe, cause the patient marked distress, and impair normal daily functioning.

2. What you should know before taking Delorazepam Hexal

Do not take Delorazepam Hexal

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 have myasthenia gravis, a disease causing muscle weakness and fatigue
if you have severe respiratory insufficiency
if you have severe liver problems (hepatic insufficiency)
if you have breathing difficulties during sleep (sleep apnea)
if you have a type of eye disease called narrow-angle glaucoma
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 Hexal.
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 lead to breathing and swallowing difficulties (angioedema),
shortness of breath (dyspnea), throat closure, nausea, and vomiting. Your doctor will continuously assess the need
to continue treatment and will instruct you to stop treatment if angioedema occurs.
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 unwanted effects such as muscle weakness, dizziness, drowsiness, fatigue, tiredness, and 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 (cardiac insufficiency). In this case, your doctor may recommend regular monitoring.
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 dependence, meaning a 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: When stopping Delorazepam Hexal, 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 recommended doses and for a short period (see section “If you stop taking Delorazepam Hexal”). 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 and 8–12 weeks for anxiety, including a gradual discontinuation period.
Amnesia: To reduce the risk of amnesia (memory loss), ensure uninterrupted sleep of 7–8 hours.
Behavioral reactions: If you experience behavioral disturbances such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, or other behavioral changes, stop taking the medicine immediately (see section 4. Possible side effects).
These reactions are more common 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 they may induce suicidal thoughts in such patients.
Children and adolescents
In children and adolescents under 18 years of age, Delorazepam Hexal should be used only when absolutely necessary, and treatment duration should be as short as possible.

Other medicines and Delorazepam Hexal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking the following medicines:

antipsychotics (neuroleptics), used to treat psychiatric disorders
antidepressants
hypnotics, medicines used to promote sleep
anxiolytics, tranquillizers, and sedatives, used to treat anxiety; some strong painkillers (opioids), which may cause increased feelings of well-being when taken with Delorazepam Hexal. 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
medicines belonging to the opioid class. The concomitant use of Delorazepam Hexal and opioids (strong analgesics, 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 available. However, if your doctor prescribes Delorazepam Hexal together with opioids, the dose and duration of concomitant treatment 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 to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

Delorazepam Hexal and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive or 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.
Pregnancy
Do not take Delorazepam Hexal during pregnancy, as it may harm the unborn child.
If your doctor considers it necessary for you to take this medicine during the later stages of pregnancy, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
If Delorazepam Hexal has been taken regularly during the later stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
If you start treatment with Delorazepam Hexal and are of childbearing age, consult your doctor both if you plan to become pregnant and if you suspect you are pregnant, as it will be necessary to discontinue the medicine.
Breastfeeding
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.
Driving and using machines
The use of Delorazepam Hexal may affect your ability to drive or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects may worsen 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 oral drops contain:

Ethanol (alcohol) This medicine contains 12.4 vol% ethanol (alcohol), for example up to 195 mg per maximum dose (equal to 52 drops), equivalent to 4.6 ml of beer and 2.07 ml of wine per dose. This may be harmful for alcoholics. This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
Propylene glycol This medicine contains 4386 mg of propylene glycol per maximum daily dose.

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 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.

Sodium This medicine contains less than 1 mmol (23 mg) of sodium per maximum dose (equal to 52 drops), i.e., essentially "sodium-free".

3. How to take Delorazepam Hexal

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 tells you to do so.
Your doctor will adjust the dose according to your individual needs.
Treatment of anxiety disorders: The dose varies according to your individual needs and 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 26–52 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 withdrawal.
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 drops, 26 drops, or 52 drops daily, 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 withdrawal.
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 in order to reduce, if necessary, the
dose or frequency of administration.
Use in elderly patients and patients with kidney or liver problems
In elderly patients and in patients with kidney or liver impairment, a reduced dose should be administered, with
close monitoring of the patient.
If you take more Delorazepam Hexal than you should
If you (or someone else) have taken an excessive dose of Delorazepam Hexal 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 profound 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 that they know which medicine has been taken.
If you forget to take Delorazepam Hexal
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Delorazepam Hexal
Do not stop treatment with Delorazepam Hexal suddenly or without first discussing it 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 cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment 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 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, tremor, muscle inflammation (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 even more intensely than before (rebound insomnia and anxiety). The risk of developing these
symptoms is greater if you stop taking Delorazepam Hexal suddenly. 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), behavioural changes, sleepwalking, and brief loss of consciousness (syncope). These symptoms may be accompanied by other potentially dangerous disturbances for the patient or others, such as unusual behaviour, self-harming tendencies (self-injury) or direct aggression, especially if people close to the patient try to limit their activity. Mechanical acts performed without will (automatisms) may follow memory loss (post-event amnesia). If any of these side effects occur, treatment must be discontinued. These reactions are more likely to occur in children and elderly patients (see section Warnings and precautions).

The following side effects may also occur. These are usually observed at the beginning of treatment and generally decrease in intensity or disappear as therapy progresses, or when the dose is reduced:

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):

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 the secretion of antidiuretic hormone (SIADH)
disinhibition, euphoria, self-harming tendencies (suicidal ideation/suicide attempts)
tremors, dizziness, headache (cephalalgia), speech problems (dysarthria/difficulty articulating speech), memory loss, coma
paradoxical reactions and amnesia (see section Warnings and precautions)
double vision, blurred vision
reduced blood pressure (hypotension)
nausea, constipation
jaundice, a condition characterized by yellowing 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 (frequency cannot be estimated from the available data):

allergic reactions, even severe and potentially fatal (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 levels of sodium in the blood (hyponatraemia)
anxiety, agitation, sleep disorders
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 Hexal).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Hexal

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 applies to the product in its original, unopened packaging, 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 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. Pack contents and other information

What Delorazepam Hexal contains
DELORAZEPAM HEXAL 1 mg/ml oral drops, solution

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

Description of the appearance of Delorazepam Hexal and pack contents
Pack containing 1 bottle of 20 ml of oral solution.
Marketing Authorization Holder
Sandoz S.p.A. - Largo U. Boccioni 1 - 21040 Origgio (VA)
Manufacturers
DOPPEL FARMACEUTICI Srl - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
MIPHARM Spa – Via B. Quaranta 12 – 20141 Milano