Delorazepam Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Delorazepam Sandoz 1 mg/ml oral drops, solution

Generic 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 pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Delorazepam Sandoz 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 marked distress to the individual,
and limit their normal functioning.

2. What you need to know before taking Delorazepam Sandoz

Do not take Delorazepam Sandoz

• 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 narrow-angle glaucoma, an eye disease
• if you have intoxication from alcohol or 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 Sandoz.
Be cautious when using this medicine, as it 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 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 therapy.
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, tiredness, fatigue, 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 decide to perform regular check-ups
• 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: There is a risk of dependence when taking this medicine, meaning a need to continue taking it. 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 Sandoz, 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 time (see section If you stop taking Delorazepam Sandoz). 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, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children and elderly patients.
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.
For athletes: The use of Delorazepam Sandoz oral drops or other medicines containing ethyl alcohol may result in positive anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
In children and adolescents under 18 years of age, Delorazepam Sandoz should be used only when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and Delorazepam Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Delorazepam Sandoz 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 Sandoz 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 carefully follow the doctor’s dosage recommendations. 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.
Pay particular 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 Sandoz. This may increase your desire to continue taking these medicines (dependence)
• antiepileptics, used for epilepsy
• sedative antihistamines, used to treat allergies
• anesthetics, used during surgery
• medicines that increase or decrease delorazepam metabolism
• theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly.

Delorazepam Sandoz and alcohol
Avoid alcohol consumption during treatment with this medicine, as it may enhance 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.
Pregnancy
Do not take Delorazepam Sandoz during pregnancy, as it may harm the unborn child.
If your doctor considers it necessary for you to take this medicine during late pregnancy, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
If Delorazepam Sandoz has been taken regularly during late pregnancy, your baby may develop physical dependence and withdrawal symptoms.
If you start treatment with Delorazepam Sandoz and are of childbearing age, consult your doctor whether you plan to become pregnant or suspect you are pregnant, as it will be necessary to discontinue the medicine.
Breastfeeding
Do not take this medicine while breastfeeding, as delorazepam passes into breast milk.
Driving and using machines
Taking Delorazepam Sandoz may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are more pronounced if you have not had sufficient sleep. If this occurs, avoid driving or operating machinery.
Consuming alcohol during treatment with this medicine negatively affects your ability to drive and operate machinery.
Delorazepam Sandoz oral drops contain ethanol (alcohol)
This medicine contains 13 vol% ethanol (alcohol), for example up to 197 mg per dose, equivalent to 5.2 ml of beer and 2.16 ml of wine per dose. This may be harmful for people suffering from alcoholism or with impaired alcohol metabolism. This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver problems or epilepsy.

3. How to take Delorazepam Sandoz

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 depending on your individual needs and as prescribed by
your doctor:

• drops: the recommended average dose is 13–26 drops, taken 2 or 3 times daily.

In neuropsychiatry, the dose may be increased to 1 tablet of 1–2 mg or 26–52 drops, 2 or 3 times daily, according to the doctor's prescription.
The duration of treatment should be as short as possible and generally should not exceed 8–12 weeks, including a gradual withdrawal period.
In certain cases, the doctor may decide to extend the treatment after evaluating your health condition.

Treatment of insomnia: the dose varies depending on your individual needs, as prescribed by your doctor:

• drops: the recommended average dose is 13 drops or 26 drops or 52 drops per day, 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 gradual withdrawal period.
In certain cases, the 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 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 Sandoz than you should
If you (or someone else) have taken an excessive dose of Delorazepam Sandoz 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 severe 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 Sandoz
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 Sandoz
Do not stop treatment with Delorazepam Sandoz 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 withdrawal cases: 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 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, 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 return more intensely than before (rebound insomnia and rebound anxiety). The risk of developing these symptoms is higher if you stop taking Delorazepam Sandoz suddenly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, sleepwalking, or 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-harm) or direct aggression, particularly if people close to the patient try to limit their activity. These may be followed by mechanically performed acts without will (automatisms) following memory loss (post-event amnesia). If any of these side effects occur, treatment must be discontinued. These reactions are more frequent 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 by reducing the dosage:

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 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
• reduction in blood pressure (hypotension)
• nausea, constipation
• jaundice, a condition characterised 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)
• reduction in 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 disturbances
• seizures, epileptic fits, disturbances in balance, attention and concentration, disorientation
• respiratory depression, apnoea, breathing difficulties during sleep (sleep apnoea), worsening of lung diseases (obstructive lung disease)
• stomach and intestinal disorders
• skin reactions
• dependence on the medicine, medicine abuse, withdrawal symptoms (see sections Warnings and precautions and If you stop taking Delorazepam Sandoz)

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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 should be used within 12 months of first opening the bottle. Any remaining product should be discarded.
Do not dispose of medicines 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 Sandoz 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, glicasol N, sodium saccharin, propylene glycol.

Description of the appearance of Delorazepam Sandoz and contents of the pack
Pack containing 1 bottle of 20 ml oral solution.
Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturers
Consorzio Farmaceutico e Biotecnologico Bioprogress-Strada Paduni 240-03012 Anagni (FR)
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO)