Lorazepam Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORAZEPAM ZENTIVA 1 mg tablets, 2.5 mg tablets

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

Contents of this leaflet:

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

1. What Lorazepam Zentiva is and what it is used for

Lorazepam Zentiva contains the active substance lorazepam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to relieve anxiety states only when the disorder is severe, causes severe distress, and impairs the patient's normal functioning.
This medicine is indicated:

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

2. What you need to know before taking Lorazepam Zentiva

Do not take Lorazepam Zentiva

• if you are allergic to lorazepam or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (benzodiazepines);
• if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have severe liver problems (severe hepatic insufficiency);
• if you have breathing difficulties during sleep (sleep apnoea syndrome);
• if you have a narrow-angle glaucoma, a type of eye disease;
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam Zentiva.
Avoid taking this medicine if you have an alcohol or drug dependence on central nervous system depressants, unless absolutely necessary, as there is an increased risk of developing dependence on this medicine.

Be cautious when using this medicine, as it may cause severe respiratory problems (respiratory depression, even fatal), serious allergic reactions (anaphylactic reactions) with swelling of the tongue, larynx and throat (angioedema), shortness of breath (dyspnoea), nausea and vomiting. Your doctor will periodically assess whether continued treatment is necessary.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly or debilitated. In this case, your doctor will prescribe a reduced dose (see section 3 “How to take Lorazepam Zentiva – Use in the elderly”).
• if you have reduced blood flow to the brain (arteriosclerosis);
• if you have heart problems (heart failure);
• if you have low blood pressure;
• if you have breathing difficulties due to chronic lung diseases (chronic respiratory insufficiency and chronic obstructive pulmonary disease);
• if you have previously abused alcohol or drugs;
• if you have kidney or liver problems (in case of severe hepatic insufficiency, the medicine must not be taken, see previous section).

Tolerance: If after a few weeks you feel the medicine is less effective, consult your doctor.
Dependence: When taking this medicine, there is a risk of dependence, meaning a need to continue taking the medicine, which may lead to excessive use (abuse). The risk increases with higher doses and longer treatment duration. The risk is greater if you have previously abused drugs, medicines acting on the central nervous system, or alcohol. The risk of dependence is reduced if the medicine is taken at the prescribed dose and for a short-term treatment. If dependence develops, abrupt discontinuation of treatment must be avoided, as withdrawal symptoms may occur (see below).
Stopping treatment and withdrawal: When you stop taking Lorazepam Zentiva, you may experience withdrawal symptoms. These are more common in patients who have received excessively high doses for a prolonged period, but may also occur in patients treated with recommended doses and for a short duration. To minimize such disturbances, abrupt discontinuation of treatment is not recommended and the dose should be gradually reduced (see section “If you stop taking Lorazepam Zentiva”).
Withdrawal symptoms may include:

• sleep disturbances (rebound insomnia);
• 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 of detachment from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that do not exist), delirium (mental disturbances) or epileptic seizures or convulsions may occur. Seizures/epileptic seizures are more common in patients with a history of epilepsy or those taking other medicines such as antidepressants.

Other symptoms include: depression, insomnia, sweating, ringing in the ears (persistent tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paraesthesia), altered perception, abdominal and muscular 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).
It is important that you always consult your doctor before modifying the dose or stopping the medicine.

Duration of treatment: The treatment duration should be as short as possible and should not exceed 4 weeks for insomnia and 8–12 weeks for anxiety, including a period of gradual dose reduction.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances such as restlessness, agitation, irritability, aggressiveness, delusions, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), behavioural changes, anxiety states, hostility, excitement, sleep disturbances/insomnia, sexual excitement, sedation, fatigue, drowsiness, loss of muscle coordination (ataxia), confusion, depression, unmasking of depression, dizziness, changes in sexual desire, impotence, reduced orgasm, contact your doctor immediately, as they may decide to discontinue the medicine (see section 4 “Possible side effects”). Some of these reactions are more frequent in children and elderly patients.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
Children and Adolescents
Lorazepam Zentiva must not be given to children and adolescents without careful assessment by the doctor of the actual need for treatment; treatment duration should be as short as possible.
The efficacy and safety of the medicine have not been established in children under 12 years of age.
Elderly patients
Lorazepam should be used with caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness, which may increase the risk of falls, with serious consequences in this population. Elderly patients should be given a reduced dose (see section “How to take Lorazepam Zentiva”).
Other medicines and Lorazepam Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
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 a strong sense of well-being when taken with Lorazepam Zentiva. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy (barbiturates, valproate). When administered with valproate, your doctor will halve the lorazepam dose;
• anaesthetics, used during surgical procedures;
• antihistamines with sedative effect, used to treat allergies;
• probenecid, used to treat gout; if taken concomitantly, your doctor will halve the lorazepam dose;
• theophylline and aminophylline, used to treat asthma.

The concomitant use of Lorazepam Zentiva 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. Therefore, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes Lorazepam Zentiva 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 dosing 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.
Lorazepam Zentiva and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may enhance 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Lorazepam Zentiva during pregnancy, as it may harm your baby.
If your doctor considers it medically necessary for you to take Lorazepam Zentiva in the late stages of pregnancy or during labour, your baby may experience low body temperature (hypothermia), reduced muscle tone (hypotonia), breathing difficulties (respiratory depression).
If Lorazepam Zentiva has been taken regularly during the late stages of pregnancy, your baby may develop dependence and experience withdrawal symptoms. In addition, your baby may develop hyperbilirubinaemia (increased bilirubin in the blood).
Consult your doctor or pharmacist before taking any medicine that may cause sedation, irritability and inability to suckle in your baby.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk and may cause sedation, irritability and inability to suckle in your baby.
Driving and using machines
The use of Lorazepam Zentiva may negatively affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are increased if you have not slept enough or have consumed alcohol. If this occurs, avoid driving or operating machinery.
Lorazepam Zentiva 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 Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you otherwise. Your doctor will inform you whether to stop treatment and how to gradually reduce the dose.
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 and may adjust the dose or frequency of administration if necessary.

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 dose reduction.
Take the highest dose in the evening, preferably before going to bed.

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In severe cases, your doctor may decide to extend the treatment after evaluating your health status.
The recommended dose is 2–3 tablets of 1 mg per day. In severe cases, the dosage may be increased up to 3–4 tablets of 2.5 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 dose reduction.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.
Take the tablets just before going to bed.
The recommended dose is 1–2 tablets of 1 mg per day. If symptoms persist, use of the 2.5 mg tablets is advised.

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

Use in the elderly
In elderly patients and in debilitated patients, a reduced dose of approximately 50% should be administered.
The recommended dose is 1–2 mg per day, divided into multiple daily doses according to your tolerance and needs. Clarify the insertion.

Use in patients with kidney or liver problems
In patients with kidney or liver problems (renal or hepatic insufficiency), lower doses are generally prescribed. Follow your doctor’s instructions carefully.

If you take more Lorazepam Zentiva than you should
If you (or someone else) have taken an excessive dose of Lorazepam Zentiva, or if you suspect a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
An overdose may cause marked depression of the central nervous system, with symptoms such as drowsiness, difficulty speaking (dysarthria), mental dullness, confusion, muscle problems (ataxia, hypotonia), low blood pressure, hypnosis, heart and circulation problems (cardiovascular depression), breathing difficulties, nervous system problems (nervous system depression), coma, and death.
More severe problems generally occur when other medicines or alcohol are also taken.
Bring this leaflet and the medicine packaging with you to the hospital or doctor, so they know which medicine has been taken.

If you forget to take Lorazepam Zentiva
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 forgotten dose.

If you stop taking Lorazepam Zentiva
Do not stop treatment with Lorazepam Zentiva suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur (see section 2 “Warnings and precautions – Discontinuation of treatment and withdrawal”).
Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may return, even more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking Lorazepam Zentiva abruptly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects, if they occur, are usually observed at the beginning of treatment and generally decrease in intensity or disappear as treatment continues, or by reducing the dose.
The most frequently observed side effects include:

• drowsiness, particularly during the day when the medicine is used as a hypnotic;
• reduced alertness, confusion;
• reduced emotional responsiveness;
• fatigue, muscle weakness;
• loss of muscle coordination, feeling of instability.

Other side effects observed include:

• tremors and muscle stiffness (extrapyramidal symptoms);
• dizziness, tremors;
• difficulty speaking (dysarthria);
• double or blurred vision and other vision disturbances;
• disorientation, depression;
• nausea, changes in appetite;
• headache;
• epileptic seizures/convulsions;
• disinhibition, euphoria, coma, agitation;
• suicidal attempts and suicidal thoughts;
• sleep disturbances;
• changes in sexual desire;
• allergic skin reactions;
• sudden potentially fatal allergic reactions (anaphylactic/anaphylactoid reactions);
• hair loss (alopecia);
• stomach and intestinal disturbances, constipation;
• jaundice (yellowing of the skin and whites of the eyes) and increased liver enzyme or bilirubin levels due to liver problems;
• decrease in platelets or white blood cells (thrombocytopenia, agranulocytosis);
• decrease in all blood cells (pancytopenia);
• changes in antidiuretic hormone secretion (SIADH);
• reduced sodium levels in the blood (hyponatremia);
• reduced body temperature (hypothermia);
• low blood pressure (hypotension);
• breathing difficulties (respiratory depression, including respiratory failure and worsening of pre-existing obstructive lung disease);
• breathing problems during sleep (apnoea);
• memory loss (amnesia) (see section “Warnings and precautions”);
• medicine dependence, leading to withdrawal or rebound symptoms (see sections 2 and 3, “Warnings and precautions” and “If you stop taking Lorazepam Zentiva”);
• behavioural disturbances (see section 2 “Warnings and precautions – Behavioural reactions”).

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 Zentiva

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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. Contents of the pack and other information

What Lorazepam Zentiva contains
Lorazepam Zentiva 1 mg tablets

• The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
• The other components are: monohydrate lactose, microcrystalline cellulose, maize starch, magnesium stearate, polacriline potassium.

Lorazepam Zentiva 2.5 mg tablets

• The active substance is lorazepam. Each tablet contains 2.5 mg of lorazepam.
• The other components are: monohydrate lactose, microcrystalline cellulose, maize starch, magnesium stearate, polacriline potassium.

Description of the appearance of Lorazepam Zentiva and contents of the pack
1 mg tablets in blister pack containing 20 divisible tablets.
2.5 mg tablets in blister pack containing 20 divisible tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa, 7, 20121 Milan
Manufacturer
ICE S.p.A., Canton Moretti 29, 10015 San Bernardo d'Ivrea (TO)

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