Lorazepam Doc Generici: detailed information

Package leaflet: Information for the patient

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

Lorazepam
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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

LORAZEPAM DOC contains the active substance lorazepam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are indicated only when the condition is severe, disabling, or causes the individual severe distress.
LORAZEPAM DOC is indicated:

for the treatment of anxiety, tension, and other conditions associated with anxiety;
for the treatment of sleep disorders (insomnia).

2. What you should know before taking LORAZEPAM DOC

Do not take LORAZEPAM DOC

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 have myasthenia gravis, a disease causing muscle weakness and fatigue;
if you have breathing problems (severe respiratory insufficiency, severe chronic obstructive pulmonary disease);
if you have breathing difficulties during sleep (sleep apnea);
if you have a specific eye condition characterized by high eye pressure and visual impairment (narrow-angle glaucoma);
if you have liver problems (severe hepatic insufficiency);
if you have acute intoxication from alcohol or medicines that depress the central nervous system, such as hypnotics, analgesics, 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.
Be cautious when using this medicine, as it may cause serious breathing problems (respiratory depression) that could potentially be fatal, or severe allergic reactions (anaphylactic/anaphylactoid reactions) with swelling of the tongue, larynx, and throat (angioedema), shortness of breath (dyspnea), nausea, and vomiting. These conditions may require emergency treatment.
Use this medicine with caution and only under medical supervision in the following cases:

if you are under 18 years of age, elderly, or debilitated. In such cases, your doctor may decide to reduce the dose (see section 3 How to take LORAZEPAM DOC – Use in the elderly);
if you have reduced blood flow to the brain (arteriosclerosis);
if you have heart problems (cardiorespiratory insufficiency);
if you have low blood pressure;
if you have breathing problems (chronic respiratory insufficiency);
if you have previously abused alcohol or drugs;
if you have liver problems (severe hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
if you have kidney problems (severe renal insufficiency);
if you have psychiatric disorders (psychotic illnesses).

Tolerance: After several weeks, a certain loss of effectiveness may occur in the treatment of sleep disorders.
Dependence: Taking this medicine may lead to dependence, meaning a need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs or alcohol.
Withdrawal: When you stop taking LORAZEPAM DOC, you may experience withdrawal or rebound symptoms (see section If you stop taking LORAZEPAM DOC). To minimize these symptoms, it is recommended to gradually reduce the dose.
Duration of treatment: Treatment duration should be as short as possible and must not exceed 4 weeks for insomnia, and 8–12 weeks for anxiety, including a period of gradual discontinuation.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioral reactions: If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more common in the elderly and in patients with reduced mental function (organic brain syndrome), and may be more severe if you suffer from certain mental disorders (psychoses), such as depression.

Children
In children under 18 years of age, LORAZEPAM DOC should only be used when absolutely necessary, and treatment duration should be as short as possible.

Other medicines and LORAZEPAM DOC
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) and antidepressants (e.g., clozapine, loxapine), used to treat psychiatric disorders;
hypnotics/sedatives, medicines used to promote sleep;
anxiolytics, used to treat anxiety;
certain strong painkillers (narcotic analgesics), which may cause intense feelings of well-being when taken with LORAZEPAM DOC. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy (valproate);
anesthetics, used during surgical procedures;
sedating antihistamines, used to treat allergies;
probenecid, used to treat gout;
theophylline and aminophylline, used to treat asthma.

Concomitant use of LORAZEPAM DOC and opioids (strong analgesics, medicines for opioid substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes LORAZEPAM DOC 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 carefully the doctor’s recommendations regarding dosage. It may be helpful to inform family members or friends to watch for the signs and symptoms listed above. Contact your doctor immediately if you experience any of these symptoms.

LORAZEPAM DOC and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This may negatively affect your ability to drive or operate machinery.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take LORAZEPAM DOC during pregnancy, as it may harm your baby.
If your doctor considers it necessary for you to take LORAZEPAM DOC during the last stages of pregnancy or during labor, your baby may experience low body temperature, reduced muscle tone, breathing difficulties, and feeding problems.
If LORAZEPAM DOC has been taken regularly during the last stages of pregnancy, your baby may experience withdrawal symptoms.

Breastfeeding
Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk.

Driving and using machines
Taking LORAZEPAM DOC may affect your ability to drive or use machinery, as you may feel confused, drowsy, or experience muscle weakness. These effects may be worse if you have not slept enough or if you have consumed alcohol. If this occurs, avoid driving or operating machinery.

LORAZEPAM DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take LORAZEPAM DOC

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 instructs you to do so.
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 in order to reduce, if necessary,
the dose or frequency of administration.
Treatment of anxiety: The duration of treatment should be as short as possible. Generally, treatment
should not exceed 8–12 weeks, including a period of gradual withdrawal.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
The recommended dose is 2–3 mg per day. In severe cases, the dosage may be increased up to 7.5–10
mg per day.
Treatment of insomnia: The duration of treatment 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 period of gradual
withdrawal.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
The recommended dose is 1–2 mg per day. In more severe cases, your doctor may increase the dose up to 2.5–5
mg per day.
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
In elderly and debilitated patients, a reduced dose should be administered.
The recommended dose is 1–2 mg per day, divided into multiple daily doses according to your
tolerance.
Use in patients with kidney or liver problems
In patients with severe kidney or liver problems (renal or hepatic insufficiency), the dosage should be
reduced.
If you take more LORAZEPAM DOC than you should
If you (or someone else) have taken an excessive dose of LORAZEPAM DOC, or if you think a child may
have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
If you take excessive doses of this medicine for a prolonged period, you may develop dependence, especially
if you are predisposed.
An overdose may cause profound depression of the central nervous system, with symptoms such as drowsiness,
fatigue, muscle problems (ataxia, hypotonia), visual disturbances, mental and sensory confusion (obnubilation),
mental confusion, excessive drowsiness (lethargy), unconsciousness, low blood pressure, breathing difficulties,
coma, and death.
Take this leaflet and the entire medicine package with you to the hospital or doctor so they know which medicine
has been taken.
If you forget to take LORAZEPAM DOC
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do
not take a double dose to make up for the missed dose.
If you stop taking LORAZEPAM DOC
Do not stop treatment with LORAZEPAM DOC suddenly or without first discussing it with your doctor, as
withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize withdrawal
symptoms, such as:

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

Other symptoms include: depression, insomnia, aggression, delirium, anger, nightmares, psychosis, changes in
behavior, sweating, ringing in the ears (persistent tinnitus), involuntary movements, vomiting, altered sensation in
hands and feet (paresthesia), 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, increased body temperature
(hyperthermia).
Treatment must be discontinued gradually; otherwise, the symptoms for which you were being treated may
reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is
higher if you stop taking LORAZEPAM DOC suddenly.
If you have any doubts 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 everybody will experience them.
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 responsiveness (emotional blunting);
drowsiness and 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 white blood cells (thrombocytopenia, agranulocytosis), decrease in all blood cells (pancytopenia);
disturbances in antidiuretic hormone secretion (SIADH);
disinhibition, euphoria, suicidal thoughts and suicide attempts;
tremors, dizziness, headache, difficulty speaking (dysarthria), coma;
double vision (diplopia), blurred vision;
memory loss (amnesia) (see section Warnings and precautions);
low blood pressure (hypotension);
nausea, constipation;
increased bilirubin, yellowing of the skin and whites of the eyes (jaundice), increased liver transaminases, increased alkaline phosphatase;
skin rash and hair loss (alopecia);
involuntary urine leakage (urinary incontinence);
reduced body temperature (hypothermia).

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

allergic reactions, even severe and potentially fatal (anaphylactic/anaphylactoid reactions), swelling of face, lips, mouth, tongue or throat which may cause potentially life-threatening difficulty in swallowing or breathing (angioedema);
altered appetite, reduced sodium levels in the blood (hyponatremia);
anxiety, agitation, sleep disturbances;
seizures/epileptic fits, balance disorders, attention and concentration problems, disorientation;
breathing difficulties (respiratory depression, apnea), worsening of nighttime breathing difficulties and other lung problems (pulmonary obstructive disease);
stomach and intestinal problems;
skin allergic reactions (skin reactions);
medicine dependence, leading to withdrawal or rebound symptoms (see sections Warnings and precautions and If you stop taking LORAZEPAM DOC).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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

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 contains

The active substance is lorazepam. Each tablet contains 1 or 2.5 mg of lorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, potassium polacrilin, magnesium stearate. Coating film: hypromellose, macrogol 6000, titanium dioxide, talc.

Description of the appearance of LORAZEPAM DOC and contents of the pack
1 mg tablets in blister packs containing 20 divisible tablets.
2.5 mg tablets in blister packs containing 20 divisible tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC GENERICI S.R.L
VIA TURATI, 40, 20121 MILAN
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de' Stampi, Rozzano (MI)
Italy.