Package leaflet: Information for the patient

Lexotan 3 mg hard capsules, 2.5 mg/mL oral drops solution, 1.5 mg tablets, 3 mg tablets

Bromazepam
Please read all of 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lexotan is and what it is used for

Lexotan contains the active substance bromazepam, which belongs to a class of medicines called "benzodiazepines".
Lexotan is used in adults to treat the following conditions:

Anxiety, emotional tension, and other anxiety-related manifestations;
Insomnia; only when it is severe, disabling, and causes significant distress in everyday life.
Please consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Lexotan

Do not take Lexotan

if you are allergic to bromazepam or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to benzodiazepines (a class of medicines to which bromazepam belongs);
if you suffer from myasthenia gravis (a serious disease affecting the muscles, characterized by weakness and fatigue);
if you suffer from severe respiratory insufficiency (severe reduction in respiratory system activity);
if you suffer from severe liver problems (severe hepatic impairment);
if you suffer from sleep apnoea syndrome (temporary cessation of breathing during sleep);
if you suffer from narrow-angle glaucoma (an eye disease caused by increased pressure of the fluid inside the eye);
if you are consuming excessive amounts of alcohol (acute alcohol intoxication);
if you are consuming excessive amounts of medicines:
hypnotics (calming medicines and sleep inducers);
analgesics (medicines for the treatment of acute or chronic severe pain);
psychotropics (medicines used for mental disorders and/or depression).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lexotan.
In particular, consult your doctor or pharmacist before taking Lexotan if you think any of the following conditions apply to you:

you suffer from depression or anxiety associated with depression, because Lexotan may worsen your condition and may lead to the emergence of suicidal thoughts (attempting to kill yourself);
you have previously had problems with drug or alcohol abuse;
you are alcohol-dependent or use opioids (medicines used for pain);
you have previously experienced a severe allergic reaction after administration of a benzodiazepine (anaphylactic/anaphylactoid reaction);
you suffer from chronic respiratory insufficiency (reduced activity of the respiratory system);
you suffer from renal insufficiency (reduced kidney function);
you suffer from severe hepatic insufficiency (severe reduction in liver function);
you suffer from cardiac insufficiency (reduced heart function);
you suffer from low blood pressure;
you suffer from a mental disorder causing altered perception of reality, thought disturbances, or mental confusion (psychosis).

Development of tolerance
Prolonged and repeated use of this medicine may lead to a decrease in its effectiveness (tolerance).

Development of dependence
Using high doses and/or prolonged treatment with bromazepam may lead to physical and psychological dependence. The risk is higher if you have previously abused medicines, drugs, or alcohol (especially in polydrug abusers). The risk of dependence is reduced if you use Lexotan at the appropriate dose as prescribed by your doctor and for a short treatment duration (see section 3 “How to take Lexotan”).

If you are elderly
Take Lexotan with caution and under medical supervision if you are elderly. This medicine may increase the risk of falls and fractures due to adverse effects such as ataxia (reduced motor coordination and gait instability), muscle weakness, dizziness, drowsiness, fatigue, and tiredness.

Children and adolescents
Benzodiazepines must not be administered to patients under 18 years of age.

Other medicines and Lexotan
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
Inform your doctor or pharmacist if you are taking any of the following medicines:

medicines used for certain mental illnesses (antipsychotics/neuroleptics);
calming and sleep-inducing medicines (hypnotics);
medicines causing physical and mental dullness (anxiolytics/sedatives);
medicines for the treatment of depression (antidepressants, such as fluvoxamine);
medicines for the treatment of acute or chronic severe pain (narcotic analgesics);
medicines for the treatment of epilepsy (antiepileptics);
anaesthetics;
medicines to counter allergic reactions (sedating antihistamines);
medicines used for cough (antitussive opioids);
cimetidine (a medicine used in case of stomach ulcer);
theophyllines or aminophyllines (medicines used for bronchial asthma);
antifungals (medicines used for fungal infections), protease inhibitors (medicines used in HIV therapy), macrolides (a type of antibiotic);
propranolol (a medicine used to treat various heart conditions).

The concomitant use of Lexotan and opioids (strong painkillers, opioid replacement therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are available. However, if your doctor prescribes Lexotan together with opioids, they will limit the dose and duration of concomitant treatment. Inform your doctor about all opioid-containing medicines you are taking and carefully follow their recommendations regarding dosage. It may be helpful to inform friends or family members so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor immediately.

Lexotan and alcohol
Do not drink alcohol while taking Lexotan, as the sedative effect may be enhanced.
Consuming alcohol with Lexotan may impair your ability to drive or operate machinery (see section “Driving and use of machines”).

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
The safety of bromazepam use during pregnancy has not yet been established. In some studies, an increased risk of congenital malformations has been observed following the use of other benzodiazepines or similar substances during the first trimester of pregnancy. Treatment with high-dose benzodiazepines during the second and/or third trimester of pregnancy may cause reduced fetal movements and altered heart rate in the fetus.

If you plan to become pregnant and are currently being treated with Lexotan, contact your doctor immediately. They will advise you on how to gradually discontinue this medicine.
If Lexotan is administered during the late stages of pregnancy or during labour, the newborn may experience hypothermia (reduced body temperature), hypotonia (reduced muscle tone), respiratory depression, or apnoea (absence of respiratory movements). Furthermore, newborns born to mothers who have chronically taken benzodiazepines during the later stages of pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period, such as hyperexcitability, agitation, and tremors, even several days after birth.

Breastfeeding
Do not take Lexotan if you are breastfeeding, as Lexotan passes into breast milk.

Driving and use of machines
Do not drive or operate machinery if you experience adverse effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or altered muscle function during treatment with Lexotan. These effects may be worsened if you consume alcohol together with Lexotan (see section “Lexotan and alcohol”).
Your alertness may be impaired, especially if your sleep duration has been insufficient after taking Lexotan.

Lexotan hard capsules and Lexotan tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Lexotan oral drops, solution contains:

glucose (contained in the blackberry flavour) If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
sodium This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.
alcohol (contained in the mixed fruit flavour) This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
propylene glycol This medicine contains 975 mg of propylene glycol per 1 ml. If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment. If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take Lexotan

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
Your doctor will determine the most appropriate dose and frequency for you in order to avoid taking an excessive dose of this medicine.
The recommended dose is 1.5 to 3 mg of bromazepam, up to three times a day:

3 mg capsules: 1 capsule, up to three times a day;
drops: 15–30 drops, up to three times a day;
1.5 mg tablets: 1 to 2 tablets, up to three times a day;
3 mg tablets: 1 tablet, up to three times a day.

If you are elderly, your doctor will assess whether to prescribe lower doses than those indicated above.
Children
Lexotan is not indicated for use in children.
Duration of treatment
Your doctor will prescribe the shortest possible duration of treatment. Depending on the condition for which your doctor has prescribed this medicine, the duration of treatment is as follows:

Anxiety: treatment should not exceed 8–12 weeks, including a gradual withdrawal period.
Insomnia: treatment duration ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.

In certain cases, after re-evaluating your health status, your doctor may decide to extend the treatment duration beyond that stated above. During the period of discontinuation of Lexotan treatment, your doctor will explain how to gradually reduce the dose of this medicine in order to minimize the risk of withdrawal and rebound symptoms (see sections “If you stop taking Lexotan” and “Possible side effects”).

If you take more Lexotan than you should
In case of accidental ingestion/overdose of Lexotan, contact your doctor immediately or go to the nearest hospital.
Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and gait), dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary eye movements).

Overdose of bromazepam rarely poses a life-threatening risk if taken alone, but may lead to dysarthria (slow and slurred speech), areflexia (absence of reflexes), apnea (cessation of breathing), hypotension (low blood pressure), cardiorespiratory depression (reduced heart and lung activity), and coma (loss of consciousness).

In mild cases, symptoms following accidental overdose of Lexotan may include:

drowsiness;
mental confusion;
lethargy (continuous sleepiness and reduced response to normal stimuli).

In more severe cases, symptoms may include:

ataxia (reduced motor coordination and gait);
hypotonia (reduced muscle tone);
hypotension (low blood pressure);
respiratory depression (reduced breathing);
coma (loss of consciousness);
death.

If you forget to take Lexotan
Do not take a double dose to make up for the missed dose.
If you stop taking Lexotan

Do not stop treatment with Lexotan without first consulting your doctor.
Your doctor will gradually reduce your dose during the discontinuation phase.
Abruptly stopping this medicine may cause:
withdrawal symptoms: headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
severe withdrawal symptoms: depersonalization (feeling detached from oneself), derealization (distorted perception of the external world), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities (hands and feet), hypersensitivity to light, noise, and physical touch, hallucinations (perception of things not present in reality), seizures.
other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (tingling sensations), perceptual disturbances (altered perceptions), abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (awareness of heartbeats), tachycardia (increased heart rate), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss (inability to recall recent events), hyperthermia (elevated body temperature).
rebound symptoms (when symptoms that led to treatment with bromazepam reappear in a more severe form after stopping treatment), such as mood changes, anxiety, restlessness, or sleep disturbances.

These symptoms occur especially if you have developed physical dependence on this medicine (see section “Warnings and precautions”). 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 will experience them.
Contact your doctor immediately if you experience any of the following serious side effects while taking Lexotan; your doctor will advise you on how to discontinue the medicine:

depression,
restlessness,
agitation,
irritability,
aggression,
distorted perception of reality (delusions),
anger,
nightmares and abnormal dreams,
perception of things that are not real (hallucinations),
changes in behaviour,
psychosis (a mental disorder causing altered perception of reality, disturbances in thinking, and mental confusion),
nervousness,
anxiety,
hyperactivity. These reactions may be more common in elderly patients. In addition, the following side effects may occur with unknown frequency (frequency cannot be determined from the available data):
allergic reaction (hypersensitivity),
severe allergic reaction (anaphylactic shock),
swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing (angioedema),
confusion,
disorientation,
emotional and mood disturbances,
changes in libido (sexual desire),
dependence,
misuse of the medicine,
withdrawal syndrome,
long-term memory problems (anterograde amnesia),
memory disturbances,
drowsiness,
headache (cephalalgia),
dizziness,
reduced alertness,
ataxia (reduced motor coordination and impaired gait),
blurred vision,
diplopia (double vision),
heart failure (reduced heart function), including cardiac arrest,
respiratory depression (reduced respiratory activity),
nausea,
vomiting,
constipation,
stomach and/or intestinal problems,
skin and subcutaneous tissue problems,
skin rash,
pruritus (itching),
urticaria (hives),
muscle weakness,
urinary retention,
fatigue,
falls,
fractures,
apnoea (temporary cessation of breathing),
worsening of pre-existing sleep apnoea. Other side effects reported with other medicines of the benzodiazepine class, such as Lexotan, include:
memory disturbances (amnesia and anterograde amnesia),
changes in behaviour,
worsening of pre-existing depression,
insomnia,
rebound anxiety (occurring after discontinuation of the medicine),
dependence,
jaundice (yellow or yellowish discoloration of the skin, mucous membranes, and whites of the eyes),
changes in certain blood tests (increased bilirubin, transaminases, and alkaline phosphatase),
thrombocytopenia (reduced platelet count),
agranulocytosis (reduced number of granulocytes, a type of white blood cell),
pancytopenia (reduction in all blood cell types),
syndrome of inappropriate antidiuretic hormone secretion (SIADH), causing water retention in the body and reduced sodium levels in the blood.

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: 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 Lexotan

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.
Hard capsules: Store below 30 °C.
Drops: No special storage conditions are required. After first opening of the bottle, use the medicine within 16 days. Do not use this medicine if you notice any obvious signs of damage or tampering with the bottle.
Tablets: No special storage conditions are required.
Do not dispose of medicines 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 Lexotan Contains
Lexotan 3 mg Hard Capsules

The active substance is: bromazepam 3 mg
Other components are: lactose monohydrate (see section “Lexotan capsules and Lexotan tablets contain lactose”), maize starch, talc, magnesium stearate, gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172).

Lexotan 2.5 mg/mL Oral Drops Solution

The active substance is: bromazepam (1 mL contains 2.5 mg bromazepam, equivalent to 25 drops)
Other components are: saccharin, sodium edetate, blackcurrant flavour (contains glucose), tutti-frutti flavour (contains alcohol), purified water, propylene glycol, sodium hydroxide (counterion and pH adjuster), glacial acetic acid (pH adjuster).

Lexotan 1.5 mg Tablets

The active substance is: bromazepam 1.5 mg
Other components are: microcrystalline cellulose, lactose monohydrate, talc, magnesium stearate.

Lexotan 3 mg Tablets

The active substance is: bromazepam 3 mg
Other components are: microcrystalline cellulose, lactose monohydrate, talc, magnesium stearate, red iron oxide (E172).

Description of the Appearance of Lexotan and Contents of the Pack
Hard Capsules
Presented as 3 mg hard capsules (composed of an opaque beige part and an opaque grey part, both marked with “ROCHE 3”), for oral use, packaged in blisters in a carton box containing 20 capsules.

Oral Drops
Presented as a clear solution contained in a 20 mL glass bottle fitted on the neck with a dropper dosing device.

Tablets
Presented as cylindrical, biconvex tablets of 1.5 mg (engraved on one side with “ROCHE/1.5” and a break line on the other side) or 3 mg (engraved on one side with “ROCHE/3” and a break line on the other side), for oral use, packaged in blisters in a carton box containing 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Delpharm Milano s.r.l.
Via Carnevale, 1
20090 Segrate (MI)
Italy
Roche S.p.A.
Viale G.B. Stucchi, 110
20900 Monza (MB)
Italy

Patient information leaflet

Lexotan 6 mg hard capsules

Bromazepam
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lexotan is and what it is used for

Lexotan contains the active substance bromazepam, which belongs to a class of medicines called "benzodiazepines".
Lexotan is used in adults to treat

anxiety, emotional tension, and other anxiety-related symptoms, but only when they are severe, disabling, and cause significant distress in normal daily life.
Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Lexotan

Do not take Lexotan

if you are allergic to bromazepam or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to benzodiazepines (a class of medicines to which bromazepam belongs);
if you suffer from myasthenia gravis (a serious disease affecting the muscles, characterized by weakness and fatigue);
if you suffer from severe respiratory insufficiency (severe reduction in respiratory system activity);
if you suffer from severe hepatic impairment (serious liver problems);
if you suffer from sleep apnoea syndrome (temporary cessation of breathing during sleep);
if you suffer from narrow-angle glaucoma (an eye disease caused by increased pressure of the fluid inside the eye);
if you are consuming excessive amounts of alcohol (acute alcohol intoxication);
if you are taking excessive amounts of medicines:
hypnotics (medicines with calming and sleep-inducing effects);
analgesics (medicines for treating acute or chronic severe pain);
psychotropics (medicines used for mental disorders and/or depression).

you suffer from depression or anxiety associated with depression, because Lexotan may worsen your condition and may lead to suicidal thoughts (attempting to kill yourself);
you have previously had problems with drug or alcohol abuse;
you are dependent on alcohol or use opioids (medicines used for pain relief);
you have previously experienced a severe allergic reaction after administration of a benzodiazepine (anaphylactic/anaphylactoid reaction);
you suffer from chronic respiratory insufficiency (reduced activity of the respiratory system);
you suffer from renal insufficiency (reduced kidney function);
you suffer from severe hepatic insufficiency (severe reduction in liver function);
you suffer from cardiac insufficiency (reduced heart function);
you suffer from hepatic insufficiency (reduced liver function);
you suffer from low blood pressure;
you suffer from a mental disorder causing altered perception of reality, thought disturbances, or mental confusion (psychosis).

Development of tolerance
Prolonged and repeated use of this medicine may lead to a decrease in its effectiveness (tolerance).

Development of dependence
Using high doses and/or taking bromazepam for prolonged periods may lead to physical and psychological dependence. The risk is higher if you have previously abused medicines, drugs, or alcohol (especially in polydrug abusers). The risk of dependence is reduced if you take Lexotan at the appropriate dose as prescribed by your doctor and for a short treatment duration (see section 3 “How to take Lexotan”).

If you are elderly
If you are elderly, take Lexotan with caution and under medical supervision. This medicine may increase the risk of falls and fractures due to side effects such as ataxia (reduced motor and gait coordination), muscle weakness, dizziness, drowsiness, fatigue, and tiredness.

Children and adolescents
Benzodiazepines must not be administered to patients under 18 years of age.

Other medicines and Lexotan
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

medicines used for certain mental illnesses (antipsychotics/neuroleptics);
calming and sleep-inducing medicines (hypnotics);
medicines causing physical and mental dullness (anxiolytics/sedatives);
medicines for treating depression (some antidepressants, such as fluvoxamine);
medicines for treating severe acute or chronic pain (narcotic analgesics, opioids);
medicines for treating epilepsy (antiepileptics);
anaesthetics;
medicines to counteract allergic reactions (sedating antihistamines);
medicines used for cough (antitussive opioids);
cimetidine (a medicine used in case of stomach ulcer);
theophyllines or aminophyllines (medicines used for bronchial asthma);
antifungals (medicines used for fungal infections), protease inhibitors (medicines used in HIV therapy), macrolides (a type of antibiotic);
propranolol (a medicine used to treat various heart conditions).

Concomitant use of Lexotan and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are available.
However, if your doctor prescribes Lexotan together with opioids, they will limit the dose and duration of concomitant treatment. Inform your doctor about all opioid-containing medicines you are taking and carefully follow their recommendations regarding dosage. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms listed above. If you experience these symptoms, contact your doctor immediately.

Lexotan and alcohol
Do not drink alcohol while taking Lexotan, as the sedative effect may be enhanced.
Consuming alcohol with Lexotan may impair your ability to drive vehicles or operate machinery (see section “Driving and use of machinery”).

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

Pregnancy
The safety of bromazepam use during pregnancy has not yet been established.
In some studies, an increased risk of malformations has been observed following the use of other benzodiazepines or similar substances during the first trimester of pregnancy. Treatment with benzodiazepines at high doses during the second and/or third trimester of pregnancy may lead to reduced fetal movements and altered heart rate.

If you plan to become pregnant and are currently being treated with Lexotan, contact your doctor immediately. They will advise you on how to gradually discontinue this medicine.
If Lexotan is administered during the late stages of pregnancy or during labour, the newborn may experience hypothermia (reduced body temperature), hypotonia (reduced muscle tone), and respiratory depression or apnoea (absence of breathing movements). Additionally, newborns born to mothers who have chronically taken benzodiazepines during the later stages of pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period, such as hyperexcitability, agitation, and tremors, even several days after birth.

Breastfeeding
Do not take Lexotan if you are breastfeeding, as Lexotan passes into breast milk.

Driving and use of machinery
Do not drive or operate machinery if, during treatment with Lexotan, you experience side effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or altered muscle function. Furthermore, these effects are worsened if you consume alcohol together with Lexotan (see section “Lexotan and alcohol”).
Your alertness may be impaired, especially if your sleep duration after taking Lexotan has been insufficient.

Lexotan hard capsules contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Lexotan

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
Your doctor will determine the most appropriate dose and frequency for you, in order to avoid
potentially taking an excessive dose of this medicine.
The recommended dose is 6–12 mg (equivalent to 1–2 capsules), 2–3 times daily.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not
be exceeded.
If you are elderly, your doctor will assess whether lower doses than those indicated above should be prescribed.
Children
Lexotan is not indicated in children.
Duration of treatment
Your doctor will prescribe the shortest possible duration of treatment.
The total duration of treatment should not exceed 8–12 weeks, including a period of gradual withdrawal.
In certain cases, after reassessing your health status, your doctor may decide to extend the duration of treatment beyond the period indicated above.
During the period of discontinuation of Lexotan treatment, your doctor will explain how to gradually reduce the dose of this medicine in order to minimize the risk of withdrawal and rebound symptoms (see sections “If you stop taking Lexotan” and “Possible side effects”).
If you take more Lexotan than you should
In case of accidental ingestion/overdose of Lexotan, contact your doctor immediately or go to the nearest hospital.
Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and gait instability), dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary eye movements).
Overdose of bromazepam rarely poses a life-threatening risk when the drug is taken alone, but may lead to dysarthria (slow and defective speech), areflexia (absence of reflexes), apnea (absence of breathing), hypotension (low blood pressure), cardiorespiratory depression (reduced heart and lung function), and coma (loss of consciousness).
In mild cases, symptoms following accidental ingestion/overdose of Lexotan may include:

drowsiness;
mental confusion;
lethargy (continuous sleep and reduced response to normal stimuli). In more severe cases, symptoms may include:
ataxia (reduced motor coordination and gait instability);
hypotonia (reduced muscle tone);
hypotension (low blood pressure);
respiratory depression (reduced breathing);
coma (loss of consciousness);
death.

If you forget to take Lexotan
Do not take a double dose to make up for the missed dose.
If you stop taking Lexotan

Do not stop treatment with Lexotan without first consulting your doctor.
Your doctor will gradually reduce your dose during the discontinuation phase.
Abruptly stopping this medicine may cause:
withdrawal symptoms such as headache, muscle pain, diarrhoea, extreme anxiety, tension, restlessness, confusion, and irritability;
severe withdrawal symptoms: depersonalization (feeling detached or estranged from oneself), derealization (distorted perception of the external world), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities (hands and feet), hypersensitivity to light, noise, and physical contact, hallucinations (perception of non-existent things), seizures;
other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (tingling sensation), perceptual disturbances (altered perceptions), abdominal and muscular cramps, tremor, myalgia (muscle pain), agitation, palpitations (awareness of increased heartbeat), tachycardia
(increased heart rate), panic attacks, dizziness, hyper-reflexia (exaggerated reflexes), short-term memory loss (inability to recall recent events), hyperthermia (elevated body temperature);
rebound symptoms (when symptoms that led to treatment with bromazepam reappear in a more severe form after stopping treatment), such as mood changes, anxiety, restlessness, or sleep disturbances.
These symptoms occur especially if you have developed physical dependence on this medicine (see section “Warnings and precautions”). If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately contact your doctor if, during treatment with Lexotan, you experience any of the following serious side effects; your doctor will advise you on how to discontinue use of the medicine:

depression,
restlessness,
agitation,
irritability,
aggressiveness,
distorted perception of reality (delusions),
anger,
nightmares and abnormal dreams,
perception of things that are not real (hallucinations),
changes in behaviour,
psychosis (a mental disorder causing altered perception of reality, disturbances in thinking, and mental confusion),
nervousness,
anxiety,
hyperactivity. These reactions may be more common in elderly patients. In addition, you may experience the following side effects with unknown frequency (frequency cannot be estimated from the available data):
allergic reaction (hypersensitivity),
severe allergic reaction (anaphylactic shock),
swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing (angioedema),
confusion,
disorientation,
emotional and mood disturbances,
altered libido (sexual desire),
dependence,
medicine abuse,
withdrawal syndrome,
long-term memory disturbances (anterograde amnesia),
memory disturbances,
drowsiness,
headache (cephalaea),
dizziness,
reduced alertness,
ataxia (reduced motor coordination and impaired gait),
blurred vision,
diplopia (double vision),
heart failure (reduced heart function), including cardiac arrest,
respiratory depression (reduced respiratory activity),
nausea,
vomiting,
constipation,
stomach and/or intestinal problems,
skin and subcutaneous tissue problems,
skin rash,
itching,
urticaria,
muscle weakness,
urinary retention,
fatigue,
falls,
fractures,
apnea (temporary cessation of breathing),
worsening of nocturnal apnea.

Other side effects reported with other medicines belonging to the benzodiazepine class, such as Lexotan:

memory disturbances (amnesia and anterograde amnesia),
changes in behaviour,
worsening of pre-existing depression,
insomnia,
rebound anxiety (occurring after discontinuation of the medicine),
dependence,
jaundice (yellow/yellowish discoloration of the skin, mucous membranes, and whites of the eyes),
changes in certain blood tests (increased bilirubin, transaminases, and alkaline phosphatase),
thrombocytopenia (reduced platelet count),
agranulocytosis (reduced number of granulocytes, a type of white blood cell),
pancytopenia (reduction in all blood cells),
syndrome of inappropriate antidiuretic hormone secretion (SIADH), causing water retention in the body and reduced sodium levels in the blood.

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: 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 Lexotan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date refers to the last day of that month.
Store below 30 C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package Contents and Other Information

What Lexotan Contains

The active substance is: bromazepam 6 mg
The other components are: lactose monohydrate, maize starch, talc, magnesium stearate, gelatin, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172).

Description of the Appearance of Lexotan and Package Contents
It is presented as 6 mg hard capsules (composed of an opaque red part and an opaque beige part, both marked with the inscription “ROCHE 6”) for oral use, packaged in blisters in a carton box containing 20 capsules.
Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Manufacturer
Delpharm Milano s.r.l.
Via Carnevale, 1
20090 Segrate (MI)
Roche S.p.A.
Viale G.B. Stucchi, 110
20900 Monza (MB)