Delorazepam PensA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Delorazepam Pensa 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 1 mg/ml oral drops, solution

Delorazepam
Generic medicine
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, consult 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 you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

DELORAZEPAM PENSA contains the active substance delorazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used for severe disorders that cause significant distress and impair the patient's normal daily activities.
This medicine is indicated:

• for the treatment of anxiety, tension, and other conditions associated with anxiety (somatic or psychiatric manifestations)
• for the treatment of sleep disorders (insomnia)

2. What you should know before taking DELORAZEPAM PENSA

Do not take DELORAZEPAM PENSA 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);
• you suffer from a severe disorder affecting muscle function (myasthenia gravis);
• you have severe respiratory problems (severe respiratory insufficiency);
• you have severe liver problems (severe hepatic insufficiency);
• you have breathing difficulties during sleep (sleep apnoea syndrome);
• you have a specific eye disease called narrow-angle glaucoma;
• you have intoxication due to alcohol or other hypnotic, analgesic, or psychotropic medicines (e.g., neuroleptics, antidepressants, lithium);
• you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking DELORAZEPAM PENSA.
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Be cautious when using this medicine, as it may cause serious respiratory problems (respiratory depression) potentially fatal, severe allergic reactions (anaphylactic/anaphylactoid reactions), swelling of the tongue, larynx, and throat (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting. Some patients have required emergency treatment. Swelling of the tongue, larynx, and throat (angioedema) may lead to airway obstruction, which could be fatal. Patients who develop angioedema after treatment with DELORAZEPAM PENSA or medicines of the same class must not be re-treated with these drugs.
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, vomiting, progressive loss of muscle coordination (ataxia);
• if you have respiratory problems (chronic 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 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 anxiety associated with depression, or if you have previously abused alcohol or drugs.

This medicine is not contraindicated in patients with celiac disease.
Duration of treatment
The duration of treatment should be as short as possible depending on the indication (see "How to take DELORAZEPAM PENSA") and must not exceed 4 weeks for the treatment of insomnia and 8–12 weeks for the treatment of anxiety, including a gradual withdrawal period. Only your doctor can decide whether to extend therapy beyond the periods indicated above. In such cases, regular blood tests and liver function checks will be required.
Tolerance
After repeated use over several weeks, a certain loss of effectiveness of this medicine may occur.
Dependence
Taking this medicine may lead to the development of physical and psychological dependence, characterized by an absolute and uncontrollable need to take the medicine. The risk of dependence increases with dose and duration of treatment. It is higher if you have previously suffered from psychiatric disorders or have abused drugs or alcohol.
Withdrawal symptoms
Once physical dependence has developed, abruptly stopping treatment or rapidly reducing the dose will be accompanied by withdrawal or rebound symptoms (see "If you stop taking DELORAZEPAM PENSA"). To minimize such symptoms, a gradual reduction of the dose is recommended.
Rebound insomnia and anxiety
Upon discontinuation of treatment, a transient syndrome may occur in which the symptoms that led to treatment with DELORAZEPAM PENSA reappear in an aggravated form. This syndrome may be accompanied by other reactions, including mood changes, anxiety, restlessness, or sleep disturbances. Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, a gradual dose reduction is recommended.
Amnesia
Benzodiazepines may cause anterograde amnesia, i.e., the inability to memorize new information. This occurs more frequently several hours after taking the medicine. To reduce these risks, take this medicine immediately before going to bed (see "How to take DELORAZEPAM PENSA") and ensure uninterrupted sleep of 7–8 hours.
Behavioural reactions
If you experience restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, or behavioural changes, stop taking the medicine immediately (see section 4. "Possible side effects"). Such reactions are more frequent in elderly patients and children.
In patients suffering from mental disorders (psychosis) and severe depressive states, symptoms of the illness may worsen with delorazepam use.
Therefore, benzodiazepines are not recommended for the treatment of mental illnesses (psychotic disorders) and should not be used alone to treat depression or anxiety associated with depression, as suicidal tendencies may be increased in such patients.
For athletes: DELORAZEPAM PENSA oral drops, solution contains ethyl alcohol; the use of medicines containing ethyl alcohol may result in positive anti-doping tests according to the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
In children and adolescents under 18 years of age, DELORAZEPAM PENSA should only be used when absolutely necessary, under strict medical supervision, and the duration of treatment should be as short as possible.
Other medicines and DELORAZEPAM PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The concomitant use of DELORAZEPAM PENSA 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 no other treatment options are available.
However, if your doctor prescribes DELORAZEPAM PENSA 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 relatives to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Be especially careful and inform your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics), used to treat mental disorders
• antidepressants, used to treat depression
• hypnotics/sedatives, medicines used to promote sleep
• anxiolytics/tranquillisers, used to treat anxiety
• certain strong painkillers (narcotic analgesics), which may cause increased feelings of well-being when taken with DELORAZEPAM PENSA. This may increase the absolute and uncontrollable need to take these medicines (psychological dependence)
• antiepileptics, medicines used to treat epilepsy
• antihistamines with sedative effect, used to treat allergies
• anaesthetics, used during surgery
• medicines that inhibit the Cytochrome P450 enzyme, as they may increase the activity of DELORAZEPAM PENSA
• theophylline and aminophylline, used to treat asthma, as they may reduce the effect of DELORAZEPAM PENSA.

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DELORAZEPAM PENSA and alcohol
Do not consume alcohol during treatment with this medicine, as it may increase 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 PENSA during pregnancy, as it may harm your baby.
If your doctor considers it necessary for you to take this medicine during the late stages of pregnancy or during labour at high doses, your baby may show low body temperature (hypothermia), low muscle tone (hypotonia), and breathing difficulties (respiratory depression) due to the pharmacological effect of the medicine.
If DELORAZEPAM PENSA has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and show withdrawal symptoms after birth.
If you start treatment with DELORAZEPAM PENSA and are of childbearing age, consult your doctor both if you plan to become pregnant and if you suspect you are pregnant, as administration of the medicine will need to be discontinued.
Breastfeeding
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.
Driving and using machines
During treatment with DELORAZEPAM PENSA, you may feel confused, forgetful, drowsy, or have difficulty concentrating or moving properly, and your ability to drive vehicles and use machinery may be negatively affected. These effects may vary from person to person, depending on the dose and time of taking the medicine. If sleep duration has been insufficient, the likelihood of impaired alertness may increase. If this happens to you, avoid driving vehicles or operating machinery. Consuming alcohol during treatment with this medicine negatively affects your ability to drive vehicles and use machinery.
DELORAZEPAM PENSA oral drops, solution contains alcohol (ethanol), sodium, and propylene glycol
This medicine contains 105 mg of alcohol (ethanol) per ml (26 drops), equivalent to 13% (v/v). The amount in 1 ml of this medicine (26 drops) is equivalent to less than 3 ml of beer or 1.05 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per ml (26 drops), i.e., essentially 'sodium-free'.
This medicine contains 745.6 mg of propylene glycol per ml (26 drops). If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
DELORAZEPAM PENSA tablets contain lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.
DELORAZEPAM PENSA 1 mg tablets contain the colouring agent orange yellow (E110)
This medicine contains the colouring agent orange yellow, which may cause allergic reactions.

3. How to take DELORAZEPAM PENSA

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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.
To achieve optimal results, your doctor will determine the dose, frequency of administration, and duration of
treatment based on your response to this medicine.
Your doctor will prescribe the lowest possible dose for the shortest possible time and will instruct you on how
to gradually reduce the daily dose.
It is recommended to take DELORAZEPAM PENSA oral drops, solution, mixed with a little water.
One drop of DELORAZEPAM PENSA contains 38.5 mcg of delorazepam; 13 drops = 0.5 mg.
Treatment of anxiety: the dose varies depending on your condition, according to your doctor's prescription:

• tablets: the recommended dose is 1 tablet of 0.5 mg or 1 mg taken two or three times a day.
• drops: the recommended dose is 13–26 drops, taken two or three times a day.

In neuropsychiatry, the dose may be increased to 1 tablet of 1–2 mg or 26–52 drops, taken two or three
times a day, according to your 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, your doctor may decide to extend the treatment after evaluating your condition.
Treatment of insomnia: the dose varies depending on your condition, according to your doctor's prescription:

• tablets: the recommended dose is 1 tablet of 0.5 mg, 1 mg, or 2 mg once daily, to be taken in the evening before going to bed.
• drops: the recommended dose is 13 drops, 26 drops, or 52 drops once daily, to be taken in the evening before going to bed, 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 gradual withdrawal period.
In certain cases, your doctor may decide to extend the treatment after evaluating your 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 to reduce, if necessary, the
dose or frequency of administration.
Use in elderly patients, patients with kidney and/or liver problems, and debilitated patients
In elderly patients and in patients with impaired liver or kidney function, the dose must be carefully determined
by the doctor, who may consider reducing the above-mentioned doses. In debilitated or particularly sensitive
patients and in those with specific conditions (patients with organic brain changes—especially arteriosclerotic—or
with respiratory insufficiency), it is advisable to start with low doses, which may subsequently be adjusted based
on the results achieved.
If you take more DELORAZEPAM PENSA than you should
If you ingest/absorb an excessive dose of DELORAZEPAM PENSA, contact your doctor immediately or go
to the nearest hospital.
As with other medicines belonging to the same class as DELORAZEPAM PENSA, an overdose should not
pose a life-threatening risk unless other substances that depress the central nervous system (including alcohol)
are taken simultaneously.
An overdose may cause depression of the central nervous system, which may vary in severity. Symptoms may
include drowsiness, fatigue, impaired muscle coordination (ataxia), vision disturbances, mental and sensory
clouding (obnubilation), confusion, and tendency toward prolonged sleep (lethargy). In more severe cases, the
following may occur: deep sleep, unconsciousness, reduced muscle tone (hypotonia), low blood pressure
(hypotension), breathing difficulties (respiratory depression), rarely coma, and very rarely death.
Bring this leaflet, the bottle, and its container with you to the hospital or doctor so they know which medicine
has been taken.
If you forget to take DELORAZEPAM PENSA
If you forget to take a dose of the medicine, 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 PENSA
Do not stop treatment with DELORAZEPAM PENSA suddenly or without first discussing it with your
doctor, as withdrawal symptoms may occur.
Indeed, once physical dependence has developed, abruptly stopping treatment or rapidly reducing the dose
may be accompanied by withdrawal symptoms such as: extreme anxiety, tension, restlessness, confusion,
irritability, headache, and muscle pain.
In severe cases, derealization (feeling that things are not real), depersonalization (feeling of detachment from
the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling in hands and feet,
increased sensitivity to light, noise, and physical contact, hallucinations (seeing and hearing things that do not
exist), and epileptic seizures may occur.
Other symptoms include: depression, insomnia, sweating, persistent ringing in the ears (persistent tinnitus),
involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception,
abdominal and muscle cramps, tremor, muscle pain (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).
Furthermore, upon discontinuation of treatment, a temporary syndrome may occur in which the symptoms that
led to treatment with DELORAZEPAM PENSA reappear in an aggravated form. This is known as rebound
insomnia and anxiety (see "Warnings and precautions").
Since the risk of rebound/withdrawal phenomena is higher when treatment is abruptly discontinued, your
doctor will gradually reduce your dose.
Nevertheless, keep in mind the possibility of these rebound phenomena occurring when stopping this medicine.
You may also experience mood changes, anxiety, restlessness, and sleep disturbances (see "Warnings and
precautions").
If you have any doubts about using 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, restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (a mental condition in which a person loses touch with reality and the ability to think and judge clearly), behavioural changes. If any of these side effects occur, treatment must be stopped. These reactions are more frequent in children and elderly patients (see "Warnings and precautions").
Side effects, if they occur, are usually observed at the beginning of treatment and generally decrease in intensity or disappear as therapy progresses, or by reducing the dose.
Additionally, the following side effects may occur:
Very common (may affect more than 1 in 10 people):

• impaired 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)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• disinhibition, euphoria, self-harming tendencies (suicidal ideation/suicide attempts)
• tremors, dizziness, headache (cephalalgia), difficulty in speaking (dysarthria), memory loss, coma
• 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 certain liver enzymes (hepatic transaminases, bilirubin, 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 (hypersensitivity), including severe reactions (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 (hyponatremia)
• anxiety, agitation, sleep disturbances
• seizures, epileptic fits, disturbances in balance, attention and concentration, disorientation
• difficulty breathing (respiratory depression, apnoea), worsening of breathing difficulties during the night (nocturnal apnoea) and other lung problems (pulmonary obstructive disease, autonomic manifestations)
• gastrointestinal disorders of various kinds
• skin reactions
• medicine dependence, rebound insomnia and anxiety, withdrawal symptoms, depression and amnesia (see "Warnings and precautions" and "If you stop taking DELORAZEPAM PENSA")
  The extent of respiratory depression depends on the dose; more severe depression occurs with higher doses.

In case of relative overdose (increased levels of medicine in the blood), more pronounced symptoms may rarely occur, which usually resolve spontaneously within a few days or following dose adjustment:
impaired muscle coordination, difficulty in speaking, urinary retention, dizziness, tremors, skin rashes, changes in sexual desire.
The occurrence of drowsiness (sedation) and unsteadiness increases with age.
The use of benzodiazepines (even at therapeutic doses) may lead to physical and psychological dependence (see "Warnings and precautions" and "If you stop taking DELORAZEPAM PENSA"). Abuse of benzodiazepines has been reported.
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 PENSA

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 "Expiry:".
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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DELORAZEPAM PENSA contains
DELORAZEPAM PENSA 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 carboxymethylcellulose, colloidal silica, magnesium stearate, sodium dioctyl sulfosuccinate.

DELORAZEPAM PENSA 1 mg tablets

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

DELORAZEPAM PENSA 2 mg tablets

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

DELORAZEPAM PENSA 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 PENSA and package contents
Pack containing 20 divisible tablets of 0.5 mg.
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Pack containing 20 divisible tablets of 1 mg.
Pack containing 20 divisible tablets of 2 mg.
Pack containing 1 bottle of 20 or 30 ml oral drops, solution.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via E. Tazzoli, 6
20154 Milan - Italy

Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO) – Italy
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