DELORAZEPAM 0.5 MG Tablets

Зміст інструкції

1. Delorazepam Pensa 0.5 mg tablets, 1 mg tablets, 2 mg tablets
2. Delorazepam
   1. What is DELORAZEPAM PENSA 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. Package Contents and Other Information

Delorazepam Pensa 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Delorazepam Pensa 1 mg/ml oral drops, solution

Delorazepam

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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is DELORAZEPAM PENSA and what it is used for

DELORAZEPAM PENSA contains the active ingredient delorazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used for severe disorders, which subject the individual to severe discomfort and limit their normal activity.
This medicine is indicated:

• to treat anxiety, tension and other disorders associated with anxiety (somatic or psychiatric manifestations)
• to treat sleep disorders (insomnia)

2. What you need to 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 of muscle function (myasthenia gravis);
• you have serious breathing problems (severe respiratory insufficiency);
• you have serious liver problems (severe hepatic insufficiency);
• you have problems breathing during sleep (sleep apnea syndrome);
• you have an eye disease called narrow-angle glaucoma;
• you have an intoxication due to the consumption of 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
Consult your doctor or pharmacist before taking DELORAZEPAM PENSA.
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Be careful when using the medicine because it can cause serious breathing problems (respiratory depression) potentially life-threatening, serious allergic reactions (anaphylactic/anaphylactoid reactions), swelling involving the tongue, larynx and throat (angioedema), shortness of breath (dyspnea), closure of the throat, nausea and vomiting. Some patients have needed emergency care. Swelling of the tongue, larynx and throat (angioedema) can lead to obstruction of the airways which could be fatal.
Patients who develop angioedema after treatment with DELORAZEPAM PENSA or with medicines belonging to the same class should not be treated again with these drugs.
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, exhaustion, progressive loss of muscle coordination (ataxia);
• if you have breathing problems (chronic respiratory insufficiency). 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 liver insufficiency (hepatic encephalopathy);
• if you have kidney problems (renal insufficiency);
• if you have low blood pressure or have heart problems (heart failure). In this case, the doctor may decide to subject you to regular checks;
• if you suffer from depression or anxiety related to depression or if you have abused alcohol or drugs in the past.

The medicine is not contraindicated for subjects affected by 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 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. Only the doctor will decide whether to prolong the therapy beyond the periods indicated above. In this case, they will have you undergo regular blood tests and checks to assess liver function.

Tolerance
After repeated use for a few weeks, some loss of effectiveness of this medicine may occur.

Dependence
Taking this medicine can lead to the development of physical and psychological dependence, which manifests as an absolute and irresistible need to take the medicine. The risk of dependence 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 symptoms
Once physical dependence has developed, sudden discontinuation of treatment or a rapid decrease in the dose will be accompanied by withdrawal symptoms or rebound(see “If you stop taking DELORAZEPAM PENSA”). To minimize these symptoms, it is recommended to gradually reduce the dose.

Rebound insomnia and anxiety
Upon discontinuation of treatment, a transient syndrome may occur in which the symptoms that led to treatment with DELORAZEPAM PENSA recur 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, it is suggested to effect a gradual decrease in the dose.

Amnesia
Benzodiazepines can induce anterograde amnesia, i.e. the inability to memorize new information. This happens more often several hours after ingestion of the medicine. To reduce these risks, take this medicine immediately before going to bed (see “How to take DELORAZEPAM PENSA”) and ensure an uninterrupted sleep of 7-8 hours.

Behavioral reactions
If you experience restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, changes in behavior, stop taking the medicine immediately (see section 4. “Possible side effects”). These reactions are more common in the elderly and in children.
In patients suffering from mental disorders (psychoses) and severe depressive states, the symptoms of the disease may worsen with the use of delorazepam.
Therefore, benzodiazepines are not recommended for the treatment of mental illnesses (psychotic) and should not be used alone to treat depression or anxiety associated with depression, as in such patients, suicidal tendencies may be potentiated.

For those who play sports:DELORAZEPAM PENSA oral drops, solution contains ethyl alcohol; the use of medicines containing ethyl alcohol may determine positivity to doping tests in relation to the concentration limits of alcohol concentration indicated by some sports federations.

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

Other medicines and DELORAZEPAM PENSA
Tell 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 painkillers, medicines for addiction therapy and some medicines for cough) increases the risk of drowsiness, difficulty in breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not possible.
However, if the doctor prescribes DELORAZEPAM PENSA together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform the doctor about all opioid medicines you are taking and carefully follow the doctor’s recommendation on the dose. It may be helpful to inform friends or relatives to pay attention to 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 mental disorders
• antidepressants, used to treat depression
• hypnotics/sedatives, medicines used to promote sleep
• anxiolytics/tranquilizers, used to treat anxiety
• some strong painkillers (narcotic analgesics), which can cause an increased sense of well-being when taken with DELORAZEPAM PENSA. This may increase the absolute and irresistible need to take these medicines (psychological dependence)
• antiepileptics, medicines used to treat epilepsy
• antihistamines with a sedative effect, used to treat allergies
• anesthetics, used during a surgical operation
• medicines that inhibit the Cytochrome P450 enzyme because they can increase the activity of DELORAZEPAM PENSA
• theophylline and aminophylline, used to treat asthma because they can reduce the effect of DELORAZEPAM PENSA.

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DELORAZEPAM PENSA with alcohol
Do not drink alcohol during treatment with this medicine, as it can increase the sedative effect of the medicine. This negatively affects the ability to drive vehicles and use machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take DELORAZEPAM PENSA during pregnancy, as it can cause harm to your baby.
If, for serious reasons, the doctor believes that you should take this medicine in the late stages of pregnancy or during labor at high doses, your baby may experience low body temperature (hypothermia), low muscle tone (hypotonia) and difficulty breathing (respiratory depression) due to the pharmacological action of the medicine.
If DELORAZEPAM PENSA has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and manifest withdrawal symptoms after birth.
If you start treatment with DELORAZEPAM PENSA in your childbearing years, consult your doctor, whether you intend to become pregnant or suspect you are pregnant, because the administration of the medicine will need to be stopped.
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, with 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 ingestion of the medicine. If the duration of sleep has been insufficient, the probability that vigilance is altered may be increased. 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 PENSA oral drops, solution contains alcohol (ethanol), sodium and propylene glycol
This medicine contains 105 mg of alcohol (ethanol) per ml (26 drops) which is 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. The doctor may perform further checks during therapy.

DELORAZEPAM PENSA tablets contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 contains the yellow orange dye (E110)
This medicine contains the yellow orange dye which may cause allergic reactions.

3. How to take DELORAZEPAM PENSA

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Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
To achieve optimal results, your doctor will establish the dose, frequency of administration and duration of
therapy based on your response to this medicine.
The doctor will prescribe the lowest dose for the shortest possible time and will tell you how to make a
gradual decrease in the daily dose.
It is recommended to take DELORAZEPAM PENSA oral drops, solution 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 according to your condition, as prescribed by your doctor:

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

In neuropsychiatry, the dose may be increased to 1 tablet of 1-2 mg or 26-52 drops, two or
three 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 evaluating your condition.

Treatment of insomnia:the dose varies according to your condition, as prescribed by your doctor:

• tablets: the recommended dose is 1 tablet of 0.5 mg or 1 mg or 2 mg once a day, to be taken in the evening, before going to bed.
• drops: the recommended dose is 13 drops or 26 drops or 52 drops once a day, 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 period of gradual discontinuation.
In certain cases, your doctor may decide to prolong the treatment after evaluating your condition.
Treatment should be started with the lowest recommended dose. The maximum dose should not be
exceeded.
The doctor will regularly monitor your condition at the beginning of treatment to decrease, if necessary, the
dose or frequency of intake.

Use in the elderly, people with kidney and/or liver problems and debilitated subjects
In the elderly and patients with impaired liver or kidney function, the dose must be carefully
established by the doctor who will assess a possible reduction of the doses indicated above. Also in debilitated
subjects or particularly sensitive and with particular conditions (subjects with organic changes
cerebral - especially arteriosclerotic - or with respiratory failure) it is appropriate to start with low doses that
may subsequently be adjusted based on the results obtained.

If you take more DELORAZEPAM PENSAthan you should
In case of ingestion/taking an excessive dose of DELORAZEPAM PENSA, immediately
inform your doctor or go to the nearest hospital.
As with other medicines belonging to the same class as DELORAZEPAM PENSA, an excessive dose
should not pose a risk to life, unless other
substances that depress the central nervous system (including alcohol) are taken at the same time.
An overdose can cause depression of the central nervous system, which can be of varying severity. Symptoms such as drowsiness, fatigue, altered muscle coordination (ataxia),
visual disturbances, blurring of the senses and reason (obnubilation), mental confusion,
predisposition to continuous sleep (lethargy) may occur. In more severe cases, the following may occur: deep sleep,
unconsciousness, reduced muscle tone (hypotonia), lowering of blood pressure (hypotension),
breathing problems (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 to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DELORAZEPAM PENSA
Donot suddenly stop treatment with DELORAZEPAM PENSA or without first
agreeing with your doctor, as withdrawal symptomsmay occur.
Indeed, once physical dependence has developed, sudden discontinuation of intake or a rapid
decrease in 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 of hands and feet, increased sensitivity to light, noise and
physical contact, hallucinations (seeing and hearing things that do not exist) and seizures may appear.
Other symptoms are: depression, insomnia, sweating, persistent ringing in the ear (persistent tinnitus),
involuntary movements, vomiting, altered sensitivity of hands and feet (paresthesia), altered
perception, abdominal and muscle cramps, tremor, muscle pain (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).
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. In this case we
speak of rebound insomnia and anxiety(See “Warnings and precautions”).
Because the risk of rebound/withdrawal phenomena is higher if treatment is stopped abruptly,
your doctor will gradually reduce the dose.
However, keep in mind the possibility of these rebound phenomena when discontinuing
the use of 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, 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, restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations
(seeing or hearing things that are not there), psychosis (a condition of the mind in which a person loses
contact with reality and the ability to think and judge clearly), changes in behaviour.
If any of these side effects occur, treatment should be stopped. These reactions are more likely to occur in
children and the elderly (see “Warnings and precautions”).
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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.
The following side effects may also 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 capacity
• drowsiness, sedation
• increased heart rate (tachycardia)
• muscle weakness
• fatigue, reduced muscle strength (asthenia)

Uncommon(may affect up to 1 in 100 people):

• changes in libido

Rare(may affect up to 1 in 1,000 people):

• decreased platelets (thrombocytopenia), decreased white blood cells (agranulocytosis), decrease of all blood cells (pancytopenia)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• disinhibition, euphoria, tendency to self-harm (suicidal ideation/attempts)
• tremors, dizziness, headache, difficulty in articulating speech (dysarthria), memory loss, coma
• double vision, blurred vision
• decreased blood pressure (hypotension)
• nausea, constipation
• jaundice, a condition characterized by a yellowish discoloration 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)
• decreased body temperature (hypothermia)

Frequency not known(the frequency cannot be estimated from the available data):

• allergic reactions (hypersensitivity) including severe ones (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat that can cause difficulty in breathing and swallowing (angioedema)
• changes in appetite, decreased sodium levels in the blood (hyponatremia)
• anxiety, agitation, sleep disturbances
• convulsions, epileptic seizures, balance disorders, attention and concentration disorders, disorientation
• difficulty breathing (respiratory depression, apnea), worsening of breathing difficulties during the night (sleep apnea) and other lung problems (obstructive pulmonary pathology, autonomic manifestations)
• various gastrointestinal disorders
• skin reactions
• dependence on the medicine, rebound insomnia and anxiety, withdrawal symptoms, depression and amnesia (see “Warnings and precautions” and “If you stop taking DELORAZEPAM PENSA”) The severity of respiratory depression depends on the dosage; more severe depression occurs with higher doses.

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In case of relative overdose (increased levels of the medicine in the blood), more significant symptoms may rarely
be observed, which usually disappear spontaneously within a few days or with dose adjustment:
impaired muscle coordination, difficulty in articulating speech, urinary retention,
dizziness, tremors, skin rashes, altered libido.
The occurrence of drowsiness (sedation) and a feeling of instability increases with age.
The use of benzodiazepines (even at therapeutic doses) can lead to the development of physical and
psychic dependence (see “Warnings and precautions” and “If you stop taking DELORAZEPAM
PENSA”). Benzodiazepine abuse has been reported.

Reporting ofside effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 PENSA

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 “Expiry.”.
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. Package Contents and Other Information

What DELORAZEPAM PENSA contains
DELORAZEPAM PENSA 0.5 mg tablets

• The active ingredient is delorazepam. Each tablet contains 0.5 mg of delorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, colloidal silicon dioxide, magnesium stearate, sodium dioctylsulfosuccinate.

DELORAZEPAM PENSA 1 mg tablets

• The active ingredient is delorazepam. Each tablet contains 1 mg of delorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, colloidal silicon dioxide, magnesium stearate, sodium dioctylsulfosuccinate, yellow orange S (E110).

DELORAZEPAM PENSA 2 mg tablets

• The active ingredient is delorazepam. Each tablet contains 2 mg of delorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, colloidal silicon dioxide, magnesium stearate, sodium dioctylsulfosuccinate, erythrosine.

DELORAZEPAM PENSA 1 mg/ml oral drops, solution

• The active ingredient is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
• The other ingredients are: 96 percent ethanol, glycerol, purified water, glycasol N, sodium saccharin, propylene glycol.

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

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano

Manufacturer
ABC Farmaceutici S.p.A.
Canton Moretti 29, Località San Bernardo
10090 Ivrea (TO)
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