PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORAZEPAM PENSA 1 mg film-coated tablets, 2.5 mg film-coated tablets

Lorazepam
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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

LORAZEPAM PENSA contains the active substance lorazepam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress and impair normal functioning.
This medicine is indicated:

for the treatment of anxiety, tension, and other anxiety-related disorders (somatic or psychiatric manifestations);
for the treatment of sleep disorders (insomnia);

2. What you need to know before taking LORAZEPAM PENSA

Do not take LORAZEPAM PENSA if:

you are allergic to lorazepam, 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 serious breathing problems (severe respiratory insufficiency, severe chronic obstructive pulmonary disease);
you have serious liver problems (severe hepatic insufficiency);
you have breathing difficulties during sleep (sleep apnea);
you have a specific eye disease called narrow-angle glaucoma;
you have intoxication due to alcohol or other medicines (hypnotics, analgesics, or neuroleptic psychotropic drugs, antidepressants, lithium);
you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LORAZEPAM PENSA.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly, as the use of LORAZEPAM PENSA may increase the risk of falls; this is due to certain side effects of this medicine such as loss of coordination and muscle weakness, dizziness, drowsiness, fatigue, and tiredness (see section 4 “Possible side effects”). In this case, your doctor may decide not to prescribe this medicine or to reduce the dose (see section 3 “How to take LORAZEPAM PENSA – Use in the elderly”);
if you have heart problems (heart failure) and low blood pressure; in this case, your doctor will monitor you regularly during treatment with this medicine;
if you have breathing difficulties (chronic respiratory insufficiency);
if you have previously abused alcohol or drugs;
if you have serious liver problems (severe hepatic insufficiency) and/or suffer from mental confusion due to liver failure (hepatic encephalopathy);
if you have serious kidney problems (severe renal insufficiency). Be cautious when using this medicine, as it may cause severe breathing 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 LORAZEPAM PENSA or with medicines belonging to the same class must not be treated again with these drugs. LORAZEPAM PENSA has not shown significant benefits in treating stomach and intestinal (gastrointestinal) or heart and circulatory (cardiovascular) disorders that may occur together with anxiety. Moreover, when anxiety and tension arise from occasional situations that are part of everyday life, the use of anxiolytics is generally not necessary. The use of this medicine in patients predisposed to dependence, such as alcoholics or drug-dependent individuals, should be avoided entirely if possible, due to their increased susceptibility to habituation and dependence. Lorazepam is not intended for the treatment of primary depressive disorders or as primary treatment for mental illnesses (psychosis).

Duration of treatment: The duration of treatment should be as short as possible depending on the indication (see section “How to take LORAZEPAM PENSA”) and should 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.
Tolerance: After repeated use for 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 overwhelming and irresistible need to continue taking the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol.
The likelihood of dependence is reduced when Lorazepam Pensa is used at the appropriate dose for a short-term treatment.
Withdrawal symptoms: When stopping treatment with LORAZEPAM PENSA, or if you have previously taken similar medicines (long-acting benzodiazepines) for prolonged periods or at high doses, you may experience withdrawal or rebound symptoms (see section “If you stop taking LORAZEPAM PENSA”). To minimize such symptoms, it is recommended to gradually reduce the dose.
Rebound insomnia and anxiety: Upon discontinuation of treatment, a temporary syndrome may occur in which the symptoms that led to treatment with LORAZEPAM PENSA reappear in a worsened form (see section “If you stop taking LORAZEPAM PENSA”).
Since the risk of rebound/withdrawal phenomena is higher when treatment is abruptly stopped, your doctor will gradually reduce your dose.
Nonetheless, keep in mind the possibility of these rebound phenomena occurring when stopping use of this medicine.
Amnesia: Medicines belonging to the same class as LORAZEPAM PENSA 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 section “How to take LORAZEPAM PENSA”) and ensure an uninterrupted sleep of 7–8 hours.
Behavioral reactions: If you experience restlessness, agitation, irritability, aggression, delirium, delusion, rage, anger, nightmares, hallucinations, psychosis, inappropriate behavior, or other behavioral changes, stop taking the medicine immediately (see section 4 “Possible side effects”). Such reactions may be more frequent in elderly patients and in patients with reduced mental function (organic brain syndrome).
In patients suffering from mental disorders (endogenous psychoses) and severe depressive states, symptoms of the illness may worsen with the use of lorazepam.
Therefore, patients suffering from depression or anxiety associated with depression should not be treated with benzodiazepines, as suicidal tendencies may be enhanced in such patients.
Children
In children under 18 years of age, LORAZEPAM PENSA should be used only when strictly necessary, and the duration of treatment should be as short as possible.
Other medicines and LORAZEPAM PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines interact with LORAZEPAM PENSA; therefore, inform your doctor if you are taking:

antipsychotics (neuroleptics) used to treat psychiatric disorders; for example, concomitant use of clozapine and LORAZEPAM PENSA may cause marked drowsiness, excessive salivation, and impaired muscle coordination (ataxia); concomitant use of LORAZEPAM PENSA with loxapine has caused excessive cognitive impairment (stupor), significant reduction in respiratory rate, and, in one case, low blood pressure (hypotension);
antidepressants used to treat depression;
hypnotics/sedatives, medicines used to promote sleep;
anxiolytics/tranquilizers used to treat anxiety;
certain strong painkillers (narcotic analgesics), which may increase euphoria when taken with LORAZEPAM PENSA. This may lead to an overwhelming and irresistible need to take these medicines (psychological dependence);
antiepileptics, used for epilepsy; for example, valproate increases blood levels of LORAZEPAM PENSA and reduces its elimination from the body; therefore, when administered together with valproate, the dose of LORAZEPAM PENSA should be reduced;
anesthetics, used during surgical procedures;
antihistamines with sedative effects, used to treat allergies;
medicines that inhibit the enzyme Cytochrome P450, as they may increase the activity of LORAZEPAM PENSA;
probenecid, used to treat gout, which prolongs the effect of LORAZEPAM PENSA; therefore, when administered together with probenecid, the dose of LORAZEPAM PENSA should be reduced;
theophylline and aminophylline, used to treat asthma, as they may reduce the effect of LORAZEPAM PENSA.

Concomitant use of LORAZEPAM 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 LORAZEPAM 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 follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
LORAZEPAM PENSA and alcohol
Do not consume alcohol during treatment with this medicine, as the sedative effect of the medicine may increase. 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 LORAZEPAM PENSA during pregnancy, as it may harm your baby.
If your doctor considers it necessary for you to take LORAZEPAM PENSA during the late stages of pregnancy or during labor at high doses, your baby may show low body temperature, low muscle tone, low blood pressure, difficulty sucking (“infant hypotonia”), and breathing difficulties.
If LORAZEPAM PENSA has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and experience withdrawal symptoms.
Additionally, increased blood bilirubin levels (hyperbilirubinemia) may occur in the newborn.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk.
Driving and using machines
The use of LORAZEPAM PENSA may affect your ability to drive vehicles and operate machinery, as you may feel unfocused, forgetful, drowsy, or have impaired muscle function.
These effects may vary depending on the time of intake, the dose of the medicine, individual sensitivity, and whether you have consumed alcohol (see section “LORAZEPAM PENSA and alcohol”).
If you have not slept enough, reduced vigilance is more likely.
LORAZEPAM PENSA contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take LORAZEPAM PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
LORAZEPAM PENSA is taken orally.
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.
Treatment of anxiety: The treatment duration should be as short as possible. Overall treatment duration
should generally 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.
The recommended dose is generally 2–3 mg per day for mild cases. For severe cases, the dose may be
increased up to 7.5–10 mg per day. Take the highest dose preferably in the evening before going to bed.
Treatment of insomnia: The treatment duration should be as short as possible. Treatment duration
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.
The recommended dose is generally 1–2 mg of LORAZEPAM PENSA per day for mild cases. In more
severe cases, your doctor may increase the dose up to 2.5–5 mg per day to be taken at bedtime.
Pre-surgical therapy: The recommended dose is 2–4 mg of LORAZEPAM PENSA to be taken the
evening before and/or 1–2 hours prior to surgery.
Treatment should be initiated with the lowest recommended dose.
The maximum dose must not be exceeded.
LORAZEPAM PENSA may be taken at any time, regardless of meals.
Your doctor will determine the daily doses and duration of treatment.
Use in elderly patients
In elderly and debilitated patients, the dose may be reduced.
The recommended dose is generally 1–2 mg per day, divided into multiple doses according to patient needs
and tolerability.
Use in patients with kidney or liver problems
In patients with kidney or liver problems (impaired renal and/or hepatic function), the dose should be reduced.
If you take more LORAZEPAM PENSA than you should
An excessive dose of LORAZEPAM PENSA should not be life-threatening unless other medicines that
depress the central nervous system (including alcohol) have been taken simultaneously.
Overdose usually causes central nervous system depression, which may vary in severity. Symptoms may
include drowsiness, fatigue, impaired muscle coordination (ataxia), visual disturbances, mental and cognitive
clouding (obnubilation), confusion, and excessive drowsiness (lethargy). Higher doses may lead to unconsciousness,
low muscle tone (hypotonia), low blood pressure, respiratory depression, rarely coma, and very rarely death.
If you accidentally ingest or take an excessive dose of LORAZEPAM PENSA, contact your doctor immediately
or go to the nearest hospital.
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 LORAZEPAM PENSA
Do not take a double dose to make up for the missed tablet.
If you stop taking LORAZEPAM PENSA
Do not stop treatment with LORAZEPAM PENSA suddenly or without first discussing it with your doctor,
as withdrawal symptoms may occur.
Indeed, once physical dependence has developed, abrupt discontinuation of the medicine 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), sound intolerance (hyperacusis), numbness and tingling in hands and feet,
increased sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that are not real),
and epileptic seizures may occur.
Other symptoms include: depression, insomnia, sweating, 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, and increased body temperature (hyperthermia).
Furthermore, upon discontinuation of treatment, a temporary syndrome may occur in which the symptoms that
led to treatment with LORAZEPAM PENSA reappear in a worsened form. This is known as rebound insomnia
and anxiety (See section “Warnings and precautions”).
Since the risk of rebound/withdrawal phenomena is higher when treatment is stopped abruptly, your doctor
will gradually reduce your dose.
Keep in mind, however, that these rebound phenomena may still occur when discontinuing this medicine. You
may also experience restlessness, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis,
behavioral changes, and amnesia (See section “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 everyone experiences them.
Contact your doctor immediately if you experience:
restlessness, agitation, irritability, aggression, delirium, delusion, anger, 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 discontinued (see section “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.
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 (emotional blunting);
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 (libido);

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

decreased platelets (thrombocytopenia) or white blood cells (agranulocytosis) in the blood, decreased levels of all blood cells (pancytopenia);
disturbances in antidiuretic hormone secretion (SIADH);
disinhibition, euphoria, suicidal ideation/attempts;
tremors, dizziness, headache (cephalalgia), difficulty in speaking (dysarthria), memory disturbances (amnesia), coma;
double vision (diplopia), blurred vision;
low blood pressure (hypotension);
nausea, constipation;
jaundice (yellowing of the skin and whites of the eyes), increased levels of liver enzymes (hepatic transaminases, alkaline phosphatase) or bilirubin;
skin rashes, hair loss (alopecia);
involuntary loss of urine (urinary incontinence);
lowered 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, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema);
changes in appetite, reduced levels of sodium in the blood (hyponatremia);
anxiety, agitation, sleep disturbances;
seizures/epileptic fits, balance disturbances, attention and concentration problems, disorientation;
difficulty breathing (respiratory depression, apnoea), worsening of breathing difficulties during sleep (nocturnal apnoea), and other lung problems (pulmonary obstructive disease and autonomic manifestations);
stomach and intestinal disorders of various kinds;
skin reactions;
depression;
medicine dependence, leading to withdrawal or rebound symptoms (see sections “Warnings and precautions” and “If you stop taking LORAZEPAM PENSA”).

The extent of respiratory depression depends on the dose; more severe depression occurs with higher doses.
In cases 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 after dose adjustment: impaired muscle coordination, difficulty in speaking, urinary retention, dizziness, tremors, skin rashes, changes in sexual desire.
The occurrence of drowsiness (sedation) and a sense of instability increases with age.
The use of benzodiazepines (even at therapeutic doses) may lead to physical and psychological dependence (see sections “Warnings and precautions” and “If you stop taking LORAZEPAM 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 LORAZEPAM 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 "Exp.".
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LORAZEPAM PENSA contains
LORAZEPAM PENSA 1 mg film-coated tablets

The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
The other components are:
- tablet core: monohydrate lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate;
- tablet coating: hypromellose, macrogol 6000, titanium dioxide, talc.

LORAZEPAM PENSA 2.5 mg film-coated tablets

The active substance is lorazepam. Each tablet contains 2.5 mg of lorazepam.
The other components are:
- tablet core: monohydrate lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate;
- tablet coating: hypromellose, macrogol 6000, titanium dioxide, talc.

Description of the appearance of LORAZEPAM PENSA and package contents
1 mg film-coated tablets in blister packs containing 20 tablets.
2.5 mg film-coated tablets in blister packs containing 20 divisible tablets.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 – Milano
Manufacturer
Doppel Farmaceutici s.r.l.
Via Volturno, 48
Quinto de’ Stampi, Rozzano (Milano)