Delorazepam Zentiva

Delorazepam Zentiva

Patient Information Leaflet: Information for the Patient

Delorazepam Zentiva 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 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 others, even if they have the same symptoms as yours, because it could 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 Zentiva is and what it is used for
2. What you need to know before taking Delorazepam Zentiva
3. How to take Delorazepam Zentiva
4. Possible side effects
5. How to store Delorazepam Zentiva
6. Contents of the pack and other information

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

Delorazepam Zentiva contains the active substance delorazepam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety disorders, which cause significant distress to the individual.
This medicine is indicated for the treatment of:

• anxiety disorders;
• sleep disorders (insomnia).

2. What you should know before taking Delorazepam Zentiva

Do not take Delorazepam Zentiva

• if you are allergic to delorazepam or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other similar medicines (benzodiazepines)
• if you have myasthenia gravis, a disease causing muscle weakness and fatigue
• if you have severe respiratory insufficiency
• if you have severe liver problems (severe 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 from alcohol or other medicines that depress the central 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 Zentiva.
Delorazepam Zentiva
Be cautious when using this medicine as it may cause serious, potentially life-threatening breathing problems
(respiratory depression) and severe allergic reactions (anaphylactic/anaphylactoid reactions) associated with
swelling of the face, lips, mouth, tongue, and throat, which may cause breathing and swallowing difficulties
(angioedema, including fatal cases), shortness of breath (dyspnea), throat closure, nausea, and vomiting. Your doctor will
periodically assess the need to continue treatment.
If you experience symptoms of angioedema, stop taking the medicine immediately and contact your doctor without delay.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly. In this case, your doctor will prescribe an appropriate dose to avoid side effects such as muscle weakness, dizziness, drowsiness, fatigue, exhaustion, 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 suffer from mental confusion, which may be due to liver insufficiency (hepatic encephalopathy)
• if you have severe kidney problems (renal insufficiency)
• if you have low blood pressure or heart problems (cardiac insufficiency). In this case, you should undergo regular check-ups as prescribed by your doctor
• if you suffer from depression or other mental disorders such as psychotic illnesses (see below). Benzodiazepines, the class of medicines to which this medicine belongs, should not be used alone to treat depression or insomnia or anxiety associated with depression, as suicidal thoughts may occur in such patients
• if you have previously abused alcohol or drugs.

Tolerance: If after a few weeks you feel that the medicine is less effective, consult your doctor.
Dependence: When taking this medicine, there is a risk of dependence, meaning the need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment, but may also occur at therapeutic doses. The risk is greater if you have previously abused drugs or alcohol. If dependence develops, abrupt discontinuation or rapid dose reduction should be avoided, as withdrawal symptoms may occur (see next section).
Stopping treatment and withdrawal
When you stop taking Delorazepam Zentiva, you may experience a temporary condition in which the symptoms that led to treatment with benzodiazepines reappear in a worsened form (rebound syndrome). Other symptoms may also occur, such as mood changes, anxiety, restlessness, or sleep disturbances. If dependence has developed during treatment (see above), abrupt discontinuation of treatment will be accompanied by withdrawal symptoms, which may include: headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: disturbances in thought and behavior such as derealization (feeling that things are not real) and depersonalization (feeling detached from the surrounding environment), hearing disturbances (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not real), epileptic seizures (sudden, uncontrollable movements). Other symptoms related to treatment discontinuation may include: depression, insomnia, sweating, persistent perception of noise (tinnitus), involuntary movements, vomiting, altered skin sensation (paresthesia), altered sensations, abdominal and muscle cramps, tremor, muscle pain, agitation, altered or rapid heartbeat (palpitations, tachycardia), panic attacks, dizziness, increased nervous reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia).
Withdrawal symptoms may appear within the first few days after stopping treatment. To minimize these symptoms, it is recommended to gradually reduce the dose (see section “If you stop taking Delorazepam Zentiva”).
Delorazepam Zentiva
Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may return more intensely than before (rebound syndrome). The risk of developing these symptoms is higher if you stop taking Delorazepam Zentiva abruptly.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Amnesia: This medicine may cause amnesia (memory loss), especially within the first few hours after intake. To reduce the risk of amnesia, 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 (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), stop taking the medicine immediately (see section 4 “Possible side effects”). These reactions are more common in children and the elderly.
Children and adolescents
In children and adolescents under 18 years of age, Delorazepam Zentiva should only be used after careful assessment of the actual need, and the duration of treatment should be as short as possible.
Other medicines and Delorazepam Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics), antidepressants, and psychotropic medicines in general, used to treat mental disorders
• hypnotics, medicines used to promote sleep
• anxiolytics, tranquillizers, and sedatives, used to treat anxiety
• certain strong painkillers (narcotic analgesics), which may cause increased feelings of well-being when taken with Delorazepam Zentiva. This may increase your desire to continue taking these medicines (dependence)
• antiepileptics, used for epilepsy
• antihistamines with sedative effects, used to treat allergies
• anesthetics, used during surgery
• medicines that increase or decrease the activity of delorazepam (consult your doctor for further information)
• theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly. Concomitant use of Delorazepam Zentiva 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. For this reason, concomitant use should only be considered when other treatment options are not feasible. However, if your doctor prescribes Delorazepam Zentiva 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 family members or friends to watch for the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

Delorazepam Zentiva
Delorazepam Zentiva and alcohol
Avoid consuming alcohol, including medicines containing alcohol, during treatment with this medicine, as it may enhance the sedative effect of the medicine. This may negatively affect your ability to drive or operate machinery.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Delorazepam Zentiva during pregnancy, as it may harm the unborn child.
If your doctor considers it necessary for you to take this medicine during the last stages of pregnancy or during labor (at high doses), your baby may experience low body temperature, loss of muscle tone, and breathing difficulties.
If Delorazepam Zentiva has been taken regularly during the last stages of pregnancy, your baby may develop dependence and show withdrawal symptoms.
If you start treatment with Delorazepam Zentiva 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 Zentiva may negatively affect your ability to drive and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are worsened by lack of sleep or alcohol consumption. If you experience these effects, avoid driving or operating machinery. Consuming alcohol during treatment with this medicine negatively affects your ability to drive and operate machinery.
Delorazepam Zentiva oral drops contain ethanol (alcohol)
This medicine contains 13 vol% ethanol (alcohol), i.e., up to 211 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.
Delorazepam Zentiva oral drops contain propylene glycol
This medicine contains 745.5 mg of propylene glycol per ml, equivalent to 26 drops.
If the child is under 5 years of age, consult 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.
Delorazepam Zentiva
Delorazepam Zentiva tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Delorazepam Zentiva tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
Delorazepam Zentiva 1 mg tablets contain the colouring agent sunset yellow FCF (E110)
This medicine contains the colouring agent sunset yellow, which may cause allergic reactions.

3. How to take Delorazepam Zentiva

Take this medicine exactly as instructed 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.
Instructions for use of Delorazepam Zentiva 1 mg/ml oral drops, solution:

• To open the bottle: press down on the cap and simultaneously unscrew it (Fig. 1).
• Let the drops fall into a glass, holding the bottle vertically with the opening facing downwards (Fig. 2).
• To close the bottle: screw the cap back on until it is tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
Your doctor will determine the dose according to your individual needs.
Treatment of anxiety: the dose varies depending on your needs, as prescribed by your doctor:

• Tablets: the recommended average dose is 1 tablet of 0.5 mg or 1 mg taken 2 or 3 times daily.
• Oral drops: the recommended average dose is 13–26 drops, taken 2 or 3 times daily, diluted in a small amount of water.

Treatment of certain mental disorders (in neuropsychiatry): the dose may be increased to 1 tablet of 1–2 mg or 26–52 drops, taken 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 gradual withdrawal period.
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 doctor’s prescription:

• Tablets: the recommended average dose is 1 tablet of 0.5 mg, 1 mg, or 2 mg daily, taken in the evening before going to bed.

Delorazepam Zentiva

• Oral drops: the recommended average dose is 13, 26, or 52 drops daily, taken in the evening before going to bed, diluted in 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, 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, debilitated individuals, or patients with kidney or liver problems
In these patients, a reduced dose should be administered, with close monitoring.
If you take more Delorazepam Zentiva than you should
If you (or someone else) have taken an excessive dose of Delorazepam Zentiva, 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 significant depression of the central nervous system: in mild cases, confusion or drowsiness may occur; in more severe cases: deep sleep, fatigue, progressive loss of muscle coordination (ataxia), mental confusion, lethargy, unconsciousness, reduced muscle tone (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), rarely loss of consciousness (coma), and very rarely death.
Take this leaflet and the medicine packaging, along with any remaining medicine, with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take Delorazepam Zentiva
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 a missed dose.
If you stop taking Delorazepam Zentiva
Do not stop treatment with Delorazepam Zentiva suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur. If your doctor decides to discontinue treatment, the dose will be gradually reduced to minimize withdrawal symptoms (see section 2, “Warnings and precautions – Discontinuation of treatment and withdrawal”).
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, aggressiveness, delirium, rage, nightmares, hallucinations (seeing and 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),
Delorazepam Zentiva
changes in behaviour. Treatment must be discontinued if these side effects occur.
These side effects are more frequent in children and elderly patients.

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 responsiveness
• drowsiness, sedation
• increased heart rate (tachycardia)
• muscle weakness and fatigue (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)
• disturbance in the secretion of antidiuretic hormone (SIADH)
• disinhibition, euphoria, self-harming behaviour (suicidal thoughts/attempts)
• tremors, dizziness, headache (cephalalgia), speech problems (dysarthria/difficulty in articulating speech), memory loss, coma
• behavioural reactions (see above)
• double vision, blurred vision
• reduction in blood pressure (hypotension)
• nausea, constipation
• yellowing of the skin and whites of the eyes (jaundice)
• 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):

• sudden allergic reactions (hypersensitivity reactions, anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue and throat which may cause difficulty in breathing and swallowing (angioedema)
• changes in appetite, reduced levels of sodium in the blood
• anxiety, agitation, sleep disturbances
• seizures, epileptic fits, disturbances in balance, attention and concentration, disorientation
• respiratory depression (dose-dependent: more severe depression occurs with increasing dose), apnoea, breathing difficulties during sleep (sleep apnoea), worsening of lung diseases (pulmonary obstructive disease)
• changes in skin colour, blood pressure, heart rate, pupil size and erection of body hair (autonomic manifestations)
• stomach and intestinal disorders
• skin disorders
• dependence on the medicine, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Delorazepam Zentiva”)

Delorazepam Zentiva
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 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 Zentiva

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 should be used within 12 months after first opening the bottle. Any remaining product after this time
should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Delorazepam Zentiva contains
Delorazepam Zentiva 0.5 mg tablets

• The active substance is delorazepam. Each tablet contains 0.5 mg of delorazepam.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silica, magnesium stearate, sodium dioctyl sulfosuccinate.

Delorazepam Zentiva 1 mg tablets

• The active substance is delorazepam. Each tablet contains 1 mg of delorazepam.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silica, magnesium stearate, sodium dioctyl sulfosuccinate, orange yellow S (E110).

Delorazepam Zentiva 2 mg tablets

• The active substance is delorazepam. Each tablet contains 2 mg of delorazepam.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silica, magnesium stearate, sodium dioctyl sulfosuccinate, erythrosine.

Delorazepam Zentiva 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 percent, glycerol, purified water, glicasol N, sodium saccharin, propylene glycol.

Description of the appearance of Delorazepam Zentiva and package contents
Pack containing 20 divisible tablets of 0.5 mg.
Pack containing 20 divisible tablets of 1 mg.
Pack containing 20 divisible tablets of 2 mg.
Pack containing 1 bottle of 20 ml oral solution.
Delorazepam Zentiva
The 0.5 mg tablets are white, round, flat, 7 mm in diameter, and have a score line.
The 1.0 mg tablets are pale yellow, round, flat, 7 mm in diameter, and have a score line.
The 2 mg tablets are pale pink, round, flat, 7 mm in diameter, and have a score line.
All tablets can be divided into two equal doses.
The oral drops, solution, are a clear, colourless solution.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa 7, 20121 Milano
Manufacturer
ICE S.p.A., Canton Moretti 29, 10015 San Bernardo d'Ivrea (TO)