Lorazepam Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORAZEPAM DOC Generici 1 mg film-coated tablets, 2.5 mg film-coated tablets

Generic Medicinal Product
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, consult 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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LORAZEPAM DOC Generici is and what it is used for

LORAZEPAM DOC Generici contains the active substance lorazepam, which belongs to a group of
medicines called benzodiazepines.
This medicine is indicated:

for the treatment of anxiety, tension, and other anxiety-related disorders;
for the treatment of sleep disorders (insomnia).

Benzodiazepines are used only when the condition is severe, causes the individual severe distress, and
impairs their normal functioning.

2. What you need to know before taking LORAZEPAM DOC Generici

Do not take LORAZEPAM DOC Generici

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);
if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
if you have severe breathing problems (respiratory failure), for example, severe chronic obstructive pulmonary disease;
if you have severe liver problems (severe hepatic insufficiency);
if you have breathing difficulties during sleep (sleep apnea);
if you have a type of eye disease called narrow-angle glaucoma;
if you have acute intoxication from alcohol or other medicines that depress the central nervous system, such as hypnotic, analgesic, or psychotropic medicines (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 LORAZEPAM DOC Generici.
Use of this medicine may cause serious, life-threatening breathing problems (respiratory depression),
severe allergic reactions (anaphylactic/anaphylactoid reactions) with swelling of the tongue, larynx,
and throat (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting. Your doctor will
continuously assess the need to continue treatment and, if you develop angioedema, will instruct you not to restart
treatment.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly or debilitated. In this case, a dose reduction is necessary (see section 3 How to take LORAZEPAM DOC Generici – Use in the elderly).
if you have reduced blood flow to the brain (arteriosclerosis);
if you have heart and breathing problems (cardiorespiratory insufficiency);
if you have low blood pressure;
if you have breathing difficulties (chronic respiratory insufficiency);
if you have previously abused alcohol or drugs;
if you have liver problems (hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
if you have severe kidney problems (renal insufficiency).

Tolerance: Consult your doctor if, after a few weeks, you feel the medicine is no longer working as well as at the beginning of treatment.
Dependence: When taking this medicine, there is a risk of dependence, i.e., the need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. It is greater if you have previously abused drugs or alcohol. Dependence on the medicine may occur even at therapeutic doses and even if you have no risk factors.
Withdrawal: When you abruptly stop taking LORAZEPAM DOC Generici, you may experience withdrawal or rebound symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, insomnia, dizziness, nausea, diarrhea, loss of appetite. In severe withdrawal cases, derealization (feeling that things are unreal), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or seizures may occur, even if you have taken the medicine at recommended doses and for a short period of time (see section If you stop taking LORAZEPAM DOC Generici). To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Duration of treatment: The treatment duration should be as short as possible and must not exceed 4 weeks for insomnia treatment and 8–12 weeks for anxiety treatment, including a gradual discontinuation period.
Amnesia: Memory loss (amnesia) may occur. This is more likely several hours after taking the medicine. To reduce the risk of amnesia, ensure uninterrupted sleep of 7–8 hours.
Behavioral reactions: You may experience behavioral disturbances (paradoxical psychiatric reactions). If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children and the elderly.
Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
Elderly

In elderly patients, there is an increased risk of falls due to a higher likelihood of adverse effects (see section 4. Possible side effects).
Elderly patients should take a reduced dose or should not be treated at all.
Children
In patients under 18 years of age, LORAZEPAM DOC Generici should be used only when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and LORAZEPAM DOC Generici
Tell 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, e.g., loxapine) and antidepressants (e.g., clozapine), used to treat mental disorders;
hypnotics/sedatives, medicines used to promote sleep;
anxiolytics, used to treat anxiety;
certain strong painkillers (narcotic analgesics), which may cause a strong sense of well-being when taken with LORAZEPAM DOC Generici. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy (barbiturates, valproate);
anesthetics, used during surgical procedures;
antihistamines with sedative effects, used to treat allergies;
probenecid, used to treat gout;
medicines that increase or decrease lorazepam blood levels;
theophylline and aminophylline, used to treat asthma.

Concomitant use of LORAZEPAM DOC Generici and opioids (strong painkillers, 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 possible.
However, if your doctor prescribes LORAZEPAM DOC Generici together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and follow carefully the doctor’s recommendations regarding dosage. 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.
LORAZEPAM DOC Generici and alcohol
Avoid alcohol during treatment with this medicine, as it may enhance its sedative effect. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take LORAZEPAM DOC Generici during pregnancy, as it may harm your baby.
If your doctor considers it necessary for you to take LORAZEPAM DOC Generici in the late stages of pregnancy or during childbirth, your baby may show at birth low body temperature, loss of muscle tone, breathing difficulties, and feeding problems.
Moreover, if LORAZEPAM DOC Generici has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.

Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk.
Driving and using machines
The use of LORAZEPAM DOC Generici may impair your ability to drive vehicles and use machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are worsened if you have not slept enough or have consumed alcohol. If this happens, avoid driving or operating machinery.
LORAZEPAM DOC Generici 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 DOC Generici

Take this medicine exactly as prescribed 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 instructs; your doctor will determine the dose and duration of treatment based on your condition. Additionally, your doctor will gradually reduce your dose to minimize withdrawal symptoms (see below).
Treatment should begin with the lowest recommended dose, and the duration of treatment should be as short as possible. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment and may adjust the dose or frequency of administration if necessary.
LORAZEPAM DOC Generici can be taken at any time of day, regardless of food intake.
The tablet may be divided into equal parts.

Treatment of anxiety:
The treatment duration should be as short as possible. Generally, treatment should not exceed 8–12 weeks, including a gradual discontinuation period.
The recommended dose is 2–3 mg per day for mild cases. For severe cases, the dose may be increased up to 7.5–10 mg per day. It is advisable to take the highest dose in the evening before bedtime.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.

Treatment of insomnia:
The treatment duration should be as short as possible. Treatment generally lasts from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual discontinuation period.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.
The recommended dose is 1–2 mg per day for mild cases. For severe cases, the dose may be increased up to 2.5–5 mg per day, administered at bedtime.

Pre-surgical therapy:
The recommended dose is 2–4 mg taken the evening before and/or 1–2 hours before surgery.

Use in elderly patients:
A reduced dose must be administered in elderly and debilitated patients.
Generally, the recommended dose is 1–2 mg per day, divided into multiple daily doses according to the patient's response.

Use in patients with kidney or liver problems:
In patients with severe kidney or liver problems (renal or hepatic insufficiency), the dose should be reduced according to the patient's response.

If you take more LORAZEPAM DOC Generici than you should:
If you (or someone else) have taken an excessive dose of LORAZEPAM DOC Generici, or if you suspect a child has taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause profound depression of the central nervous system, with symptoms such as drowsiness, fatigue, confusion, muscle problems (ataxia, hypotonia), visual disturbances, lethargy, deep sleep, and unconsciousness, low blood pressure, breathing difficulties, and rarely coma or death.

If you forget to take LORAZEPAM DOC Generici:
Do not take a double dose to make up for the missed dose.

If you stop taking LORAZEPAM DOC Generici:
Do not stop treatment with LORAZEPAM DOC Generici suddenly or without consulting your doctor first, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize withdrawal symptoms, which may include:

headache, muscle pain, tension;
severe anxiety, confusion, restlessness, irritability;
mood disturbances (dysphoria), dizziness;
nausea, diarrhoea, loss of appetite;
in severe cases of withdrawal: derealization (feeling that things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that are not real), or epileptic seizures.

Other symptoms may include: depression, insomnia, sweating, ringing in the ears (persistent tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paraesthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, and increased body temperature (hyperthermia).
After stopping treatment, rebound phenomena may occur, meaning the symptoms that led you to take this medicine (rebound insomnia and anxiety) may return more intensely, and you may also experience other symptoms such as mood changes, anxiety, and restlessness. The risk of developing these symptoms is higher if you stop taking LORAZEPAM DOC Generici suddenly.
If you have any questions about how to use 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: depression and mental disorders such as restlessness,
agitation, irritability, aggression, delirium, delusion, anger, nightmares, hallucinations (seeing or hearing things that
do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the
ability to think and judge clearly), changes in behaviour. If any of these side effects occur, treatment must be
discontinued. These reactions are more likely to occur in children and elderly patients (see section 2 “Warnings and precautions”).

Side effects usually occur at the beginning of treatment and generally decrease in intensity or disappear during treatment, or by reducing the dose.
The following side effects may 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 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 sexual desire.

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

decrease in platelets or a type of white blood cells (thrombocytopenia, agranulocytosis);
decrease in all blood cells (pancytopenia);
disturbances in the secretion of antidiuretic hormone (SIADH);
reduced or lost inhibition, intense feeling of well-being (euphoria), tendency to self-harm (suicidal thoughts and attempts);
tremors and muscle stiffness (extrapyramidal symptoms), dizziness, headache (cephalalgia), difficulty speaking (dysarthria), coma;
memory loss (amnesia) (see section “Warnings and precautions”);
double vision (diplopia), blurred vision;
low blood pressure (hypotension);
nausea, constipation;
jaundice (yellowing of the skin and whites of the eyes) and increased liver enzymes or bilirubin levels due to liver problems;
skin rashes, hair loss (alopecia);
urinary problems (urinary incontinence);
reduced body temperature (hypothermia).

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

sudden potentially fatal allergic reactions (anaphylactic/anaphylactoid reactions);
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, potentially fatal (angioedema);
changes in appetite;
reduced sodium levels in the blood (hyponatremia);
anxiety, agitation, sleep disturbances;
seizures, epileptic fits, balance disorders, disorientation;
attention and concentration difficulties;
difficulty breathing (respiratory depression, including respiratory failure and worsening of pre-existing obstructive lung disease);
worsening of breathing problems during sleep (apnoea);
gastrointestinal disorders of various kinds;
skin reactions. The use of medicines such as LORAZEPAM DOC Generici may lead to physical and psychological dependence. The risk increases with higher doses and prolonged duration of treatment, and is greater in
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patients with a history of alcohol or drug abuse. For this reason, treatment should be as short as possible (see section 2 “Warnings and precautions”).
You may experience amnesia (partial or complete memory loss) during treatment with LORAZEPAM DOC Generici. The risk increases with higher doses. To avoid this side effect, it is important that you have an uninterrupted sleep of 7–8 hours (see section 2 “Warnings and precautions”).
Reporting of side effects
If you experience any side effects, 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 LORAZEPAM DOC Generici

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.
Do not store above 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 DOC Generici contains
LORAZEPAM DOC Generici 1 mg film-coated tablets

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

LORAZEPAM DOC Generici 2.5 mg film-coated tablets

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

Description of the appearance of LORAZEPAM DOC Generici and package contents
Film-coated tablet.
Pack of 20 divisible tablets.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati, 40, 20121 Milano (MI)
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De’ Stampi, 20089 Rozzano (MI)