Lorazepam Sandoz

Package leaflet: information for the patient

Lorazepam Sandoz 1 mg tablets, 2.5 mg tablets

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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lorazepam Sandoz 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 disorders are severe, cause the individual severe
distress, and limit normal daily activities.

2. What you should know before taking Lorazepam Sandoz

Do not take Lorazepam Sandoz

• 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 severe breathing problems (respiratory failure);
• if you have severe liver problems (hepatic failure);
• if you have breathing difficulties during sleep (sleep apnoea);
• if you have high eye pressure (narrow-angle glaucoma);
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam Sandoz.
Avoid taking this medicine if you have alcohol or drug dependence involving central nervous system depressants, unless absolutely necessary.
Be cautious when using this medicine, as it may cause serious breathing problems (respiratory depression), severe allergic reactions (anaphylactic reactions) with swelling of the tongue, larynx, and throat (angioedema), shortness of breath (dyspnoea), nausea, and vomiting. Your doctor will continuously assess the need to continue treatment.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly or debilitated, as this increases the risk of falls due to certain side effects of this medicine (see section 4 “Possible side effects”). In such cases, your doctor may decide to reduce the dose (see section 3 “How to take Lorazepam Sandoz – 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 and lung problems (chronic respiratory insufficiency and chronic obstructive pulmonary disease);
• if you have breathing difficulties at night (sleep apnoea syndrome);
• if you have previously abused alcohol or drugs;
• if you have severe liver problems (hepatic failure) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
• if you have kidney problems (renal failure).

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: When taking this medicine, there is a risk of 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, medicines, or alcohol, or if you suffer from severe personality disorders.
Withdrawal: When stopping treatment with Lorazepam Sandoz, 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, even if you have taken the medicine at recommended doses and for a short time (see section “If you stop taking Lorazepam Sandoz”). To minimize these symptoms, a gradual dose reduction is recommended.
Duration of treatment: Treatment duration should be as short as possible and should not exceed 4 weeks for insomnia and 8–12 weeks for anxiety, including a gradual discontinuation period.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances, stop taking the medicine immediately (see section 4. Possible side effects). Such reactions are more common in children and the elderly.
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
In children under 12 years of age, Lorazepam Sandoz should be used only in cases of absolute necessity, and treatment duration should be as short as possible.

Other medicines and Lorazepam Sandoz
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 (e.g. clozapine or loxapine), used to treat mental disorders;
• antidepressants;
• 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 Sandoz. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy (valproate);
• anaesthetics, 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 Sandoz 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 Sandoz 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 carefully follow the doctor’s dosing recommendations. It may be helpful to inform friends or family members to watch for the symptoms listed above. Contact your doctor if you experience such symptoms.

Lorazepam Sandoz and alcohol
Avoid alcohol consumption during treatment with this medicine, as it may enhance the sedative effect of the medicine. This negatively affects your ability to drive vehicles or operate machinery.

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

Pregnancy
Do not take Lorazepam Sandoz during pregnancy, as it may harm your baby.
If your doctor considers it necessary for you to take Lorazepam Sandoz during the late stages of pregnancy or during labour, your baby may experience: reduced response to stimuli (hypoactivity), low body temperature (hypothermia), reduced muscle tone (hypotonia), breathing difficulties, feeding problems, and altered metabolic responses due to reduced cold resistance.
If Lorazepam Sandoz has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Consult your doctor or pharmacist before taking any medicine.

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

Driving and using machines
Taking Lorazepam Sandoz may affect your ability to drive vehicles or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are more pronounced if you have not had sufficient sleep. If this occurs, avoid driving or using machinery.

Lorazepam Sandoz 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 Sandoz

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 until your doctor tells you otherwise.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be
exceeded. This medicine can be taken regardless of food intake.
Your doctor will regularly monitor your condition at the beginning of treatment 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 duration
should not exceed 8–12 weeks, including a period of gradual discontinuation.
Take the highest dose preferably in the evening before going to bed.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.
The recommended dose is 2–3 mg per day. For 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
discontinuation.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.
Take the dose just before going to bed.
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 to be 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 doses according to your
tolerance.

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

If you take more Lorazepam Sandoz than you should
If you (or someone else) have taken an excessive dose of Lorazepam Sandoz 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 severe depression of the central nervous system, with symptoms such as mental and
sensory clouding (obnubilation), confusion, drowsiness (lethargy), difficulty speaking (dysarthria), deep sleep,
muscle problems (ataxia, hypotonia), unconsciousness, low blood pressure, heart and circulatory problems
(cardiovascular depression), hypnosis, breathing difficulties, coma, and death.
Bring this leaflet and the medicine container with you to the hospital or doctor so they know which medicine has
been taken.

If you forget to take Lorazepam Sandoz
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 Sandoz
Do not stop treatment with Lorazepam Sandoz 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 unreal), 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 touch, hallucinations (seeing and hearing things that do not exist), delirium, epileptic seizures or convulsions. Seizures and epileptic fits may occur more commonly in patients with epilepsy or those taking other medicines used for depression.

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 pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat (palpitations),
increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyper-reflexia), short-term
memory loss, increased body temperature (hyperthermia).
Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may
reappear even more intensely than before (rebound insomnia and anxiety). The risk of developing these
symptoms is higher if you stop taking Lorazepam Sandoz suddenly. You may also experience mood changes,
anxiety, restlessness, and sleep disturbances.
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 gets them.

• Contact your doctor immediately if you experience: mental disturbances such as restlessness, agitation, irritability, aggression, delusions, 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), behavioural changes, anxiety states, hostility, excitement, sleep disturbances/insomnia, increased sexual arousal, sedation, fatigue, drowsiness, loss of muscle coordination (ataxia), confusion, depression, unmasking of depression, dizziness, changes in sexual desire, impotence, reduced orgasm. Dependence on the medicine may occur, leading to withdrawal symptoms or rebound effects (see sections “Warnings and precautions” and “If you stop taking Lorazepam Sandoz”). If any of these side effects occur, treatment must be discontinued. These reactions are more frequent in children and elderly patients.

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 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.

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

• decrease in platelets or white blood cells (thrombocytopenia, agranulocytosis), reduction in all blood cells (pancytopenia);
• disturbances in the secretion of antidiuretic hormone (SIADH);
• disinhibition, euphoria, suicidal thoughts and suicide attempts;
• tremors, dizziness, headache, difficulty 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) and increased liver enzymes or bilirubin levels due to liver problems;
• allergic skin reactions (skin rashes);
• hair loss (alopecia);
• involuntary loss of urine (urinary incontinence);
• reduction in body temperature (hypothermia).

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

• difficulty breathing (respiratory depression, apnoea), worsening of breathing difficulties at night and other lung problems (pulmonary obstructive disease), autonomic manifestations;
• allergic reactions, including severe and potentially fatal reactions (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause potentially life-threatening difficulty in swallowing or breathing (angioedema);
• change in appetite, reduced sodium levels in the blood (hyponatraemia);
• anxiety, agitation, sleep disturbances;
• seizures/epileptic fits, balance disorders, attention and concentration problems, disorientation;
• stomach and intestinal problems;
• skin reactions.

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 the website
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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 Sandoz contains
Lorazepam Sandoz 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, potassium polacrilin.

Lorazepam Sandoz 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, potassium polacrilin.

Description of the appearance of Lorazepam Sandoz and package contents
1 mg tablets in blister packs containing 20 divisible tablets.
2.5 mg tablets in blister packs containing 20 divisible tablets.
Marketing Authorization Holder
Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA)
Manufacturers
Consorzio Farmaceutico e Biotecnologico Bioprogress s.c. a r.l. - Strada Paduni, 240 - 03012 Anagni (FR)
Mipharm S.p.A. - Via B. Quaranta, 12 - 20141 Milan

Patient information leaflet

Lorazepam Sandoz 2 mg/ml oral drops, solution

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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lorazepam Sandoz 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 conditions associated with anxiety;
• for the treatment of sleep disorders (insomnia).

Benzodiazepines are used only when the disorders are severe, cause significant distress to the patient, and impair normal daily activities.

2. What you should know before taking Lorazepam Sandoz

Do not take Lorazepam Sandoz

• 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);
• if you have severe liver problems (hepatic failure);
• if you have breathing difficulties during sleep (sleep apnoea);
• if you have high eye pressure (narrow-angle glaucoma);
• if you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam Sandoz.
Avoid taking this medicine if you have alcohol or drug dependence involving central nervous system depressants, unless absolutely necessary.
Be cautious when using this medicine, as it may cause serious breathing problems (respiratory depression), severe allergic reactions (anaphylactic reactions) with swelling of the tongue, larynx, and throat (angioedema), shortness of breath (dyspnoea), nausea, and vomiting. Your doctor will continuously 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, as this increases the risk of falls due to certain side effects of this medicine (see section 4 “Possible side effects”). In such cases, your doctor may decide to reduce the dose (see section 3 “How to take Lorazepam Sandoz – 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 or lung problems (chronic respiratory insufficiency and chronic obstructive pulmonary disease);
• if you have breathing difficulties at night (sleep apnoea syndrome);
• if you have previously abused alcohol or drugs;
• if you have severe liver problems (hepatic failure) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
• if you have kidney problems (renal failure).

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: There is a risk of dependence when taking this medicine, meaning a need to continue taking it. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs, medicines, or alcohol, or if you suffer from severe personality disorders.
Withdrawal: When stopping treatment with Lorazepam Sandoz, or if you have previously taken similar long-acting medicines (benzodiazepines) for prolonged periods or at high doses, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at recommended doses and for a short time (see section “If you stop taking Lorazepam Sandoz”). To minimize these symptoms, a gradual dose reduction is recommended.
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.
Behavioural reactions: If you experience behavioural disturbances, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more common in children and the elderly.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
For athletes: The use of medicines containing ethanol may result in positive anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
In children under 12 years of age, Lorazepam Sandoz should only be used when absolutely necessary, and treatment duration should be as short as possible.

Other medicines and Lorazepam Sandoz
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 (e.g. clozapine or loxapine), used to treat mental disorders;
• antidepressants;
• 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 Sandoz. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy (valproate);
• anaesthetics, used during surgical procedures;
• antihistamines with sedative effects, used to treat allergies;
• probenecid, used to treat gout;
• theophylline and aminophylline, used to treat asthma;
• medicines that inhibit certain liver enzymes (particularly cytochrome P450).

The concomitant use of Lorazepam Sandoz and opioids (strong analgesics, medicines for addiction therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Lorazepam Sandoz 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 the 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 any of these symptoms.

Lorazepam Sandoz 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 or operate machinery.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Lorazepam Sandoz during pregnancy, as it may harm your baby.
If your doctor considers it necessary to take Lorazepam Sandoz during late pregnancy or during labour, your baby may experience: reduced responsiveness to stimuli (hypoactivity), low body temperature (hypothermia), loss of muscle tone (hypotonia), breathing difficulties, feeding problems, and altered metabolic responses due to reduced cold tolerance.
If Lorazepam Sandoz has been taken regularly during late pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Talk to your doctor or pharmacist before taking any medicine.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk.

Driving and using machines
Taking Lorazepam Sandoz may affect your ability to drive or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are worse if you have not had enough sleep. If this happens, avoid driving or using machinery.

Lorazepam Sandoz contains ethanol (ethyl alcohol)
This medicine contains 70% ethanol (alcohol), for example up to 284 mg per dose, equivalent to 5.7 ml of beer or 2.4 ml of wine per dose. This may be harmful for people suffering from alcoholism or with impaired alcohol metabolism. This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to take Lorazepam Sandoz

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 until your doctor tells you to stop.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be
exceeded. This medicine can be taken regardless of food intake.
Your doctor will regularly monitor your condition at the beginning of treatment 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 discontinuation.
Take the highest dose preferably in the evening before going to bed.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
The recommended dose is 2–3 mg (40–60 drops) 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. Generally, treatment varies 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 extend the treatment after evaluating your health condition.
Take the dose just before going to bed.
The recommended dose is 1–2 mg (20–40 drops) 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 (40–80 drops) to be 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 (20–40 drops) per day, divided into multiple doses according to tolerance.
Use in patients with kidney or liver problems
In patients with kidney or liver problems (renal or hepatic insufficiency), the dosage should be reduced
according to the patient's response.
Instructions for use

• Press on the cap and unscrew to open the bottle.
• Press on the white plug to release the powder into the bottle.
• Shake the bottle until the powder is completely dissolved.
• Remove the cap and pour the drops into a glass. 20 drops (0.5 ml) equal 1 mg of lorazepam. The resulting solution is valid for 30 days.
• Apply the cap by pressing and screwing simultaneously.

If you take more Lorazepam Sandoz than you should
If you (or someone else) have taken an excessive dose of Lorazepam Sandoz, or if you suspect that a child
may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency room.
An overdose may cause profound depression of the central nervous system, with symptoms such as
mental and sensory clouding (obnubilation), confusion, excessive drowsiness (lethargy),
difficulty speaking (dysarthria), deep sleep, muscle problems (ataxia, hypotonia), unconsciousness,
low blood pressure, heart and circulation problems (cardiovascular depression), hypnosis, breathing
difficulties, coma, or even death.
Take this leaflet and the medicine container with you to the hospital or doctor so they know which
medicine has been taken.
If you forget to take Lorazepam Sandoz
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 Sandoz
Do not stop treatment with Lorazepam Sandoz 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, sensitivity to light, noise and physical touch, hallucinations (seeing or hearing things that are not real), delirium, epileptic seizures or convulsions. Seizures and epileptic fits may occur more commonly in patients with epilepsy or those taking other medicines used for depression.

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 muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased
heart rate (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased
reflexes (hyper-reflexia), short-term memory loss, increased body temperature (hyperthermia).
Treatment should 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 Sandoz abruptly. You may also experience mood
changes, anxiety, restlessness, and sleep disturbances.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Contact your doctor immediately if you experience: mental disturbances such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations (seeing or hearing things that are not real), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), changes in behaviour, anxiety, hostility, excitement, sleep disorders/insomnia, increased sexual arousal, sedation, fatigue, drowsiness, loss of muscle coordination (ataxia), confusion, depression, unmasking of depression, dizziness, changes in sexual desire, impotence, reduced orgasm, medicine dependence, leading to withdrawal or rebound symptoms (see sections “Warnings and precautions” and “If you stop taking Lorazepam Sandoz”). If any of these side effects occur, treatment must be discontinued. These reactions are more common in children and elderly patients.

Side effects usually occur at the beginning of treatment and generally decrease in intensity or disappear during continued 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 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.

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 the secretion of antidiuretic hormone (SIADH);
• disinhibition, euphoria, suicidal thoughts and suicide attempts;
• tremor, dizziness, headache, difficulty 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) and increased liver enzymes or bilirubin levels due to liver problems;
• skin allergic reactions (rashes);
• hair loss (alopecia);
• involuntary loss of urine (urinary incontinence);
• reduced body temperature (hypothermia).

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

• difficulty breathing (respiratory depression, apnoea), worsening of breathing difficulties at night and other lung problems (pulmonary obstructive disease), and autonomic manifestations;
• allergic reactions, even severe and potentially fatal (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, potentially fatal (angioedema);
• change in appetite, reduced sodium levels in the blood (hyponatraemia);
• anxiety, agitation, sleep disturbances;
• seizures/epileptic fits, balance disorders, attention and concentration problems, disorientation;
• stomach and intestinal problems;
• skin 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 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 Sandoz

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.
The medicine should be used within 30 days of first opening the bottle. Any excess product
should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lorazepam Sandoz contains

• The active substance is lorazepam. 1 ml of reconstituted solution (20 drops) contains 2 mg of lorazepam.
• The other component of the powder is mannitol.
• The other components of the solution are: ethanol 95 percent, purified water.

Description of the appearance of Lorazepam Sandoz and contents of the pack
Pack containing one 10 ml vial with reservoir cap (containing 20 mg of lorazepam) and dropper.
Marketing Authorization Holder
Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA)
Manufacturers
Consorzio Farmaceutico e Biotecnologico Bioprogress s.c. a r.l. - Strada Paduni, 240 - 03012 Anagni (FR)
Doppel Farmaceutici s.r.l. - Via Volturno, 48 - Quinto de’ Stampi – 20089 Rozzano (MI)