LENDORMIN 0.25 mg Coated tablet

Зміст інструкції

1. Lendormin 0,25 mg tablets
   1. What is Lendormin and what is it used for
   2. What you need to know before taking Lendormin
   3. How to take Lendormin
   4. Possible side effects
   5. How to store Lendormin
   6. Contents of the pack and other information

Lendormin 0,25 mg tablets

Brotizolam

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lendormin and what is it used for

Lendormin contains the active substance brotizolam, which belongs to the class of medicines called
benzodiazepines, which induces sedation (physical and mental relaxation) and sleep.
Lendormin is used in the treatment for short periods of insomnia (difficulty falling asleep and/or
frequent or prolonged awakenings during the night) in adults aged 18 years and over.
Benzodiazepines are indicated only when insomnia is severe, disabling (i.e. that
compromises the ability to perform normal activities) and subjects the individual to severe discomfort.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Lendormin

Do not take Lendormin

• If you are allergic to brotizolam or any of the other ingredients of this medicine (listed in section 6) or to other benzodiazepines
• if you suffer from muscle weakness (myasthenia gravis)
• if you suffer from severe respiratory failure (severe respiratory disease that manifests rapidly and suddenly and involves inadequate oxygen and/or carbon dioxide levels in the blood)
• if you suffer from sleep apnea syndrome (when, during the night's sleep, apnea occurs multiple times, i.e., a temporary cessation of breathing, which can lead to considerable and unnatural drowsiness during the day)
• if you suffer from severe liver disease (severe hepatic insufficiency) (see section “Warnings and precautions”)
• if you are under 18 years of age as the tablets are only suitable for adults and studies in children are not available
• in case of rare hereditary conditions that may be incompatible with one of the components of this medicine (see also section “Lendormin contains lactose”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lendormin.

Warnings for specific population groups:

• If you are elderly or have reduced liver function If you are elderly or have reduced liver function, your doctor may reduce the dose of this medicine (see section 3 “How to take Lendormin"). Benzodiazepines are not indicated in patients with severe hepatic insufficiency, as these medicines can cause encephalopathy (a brain disease that causes confusion, disturbances in consciousness, personality disorders, memory loss, tremors and coma, due to the presence of toxic substances that accumulate in the blood due to a malfunction of the liver) (see section “Do not take Lendormin”).
• If you suffer from chronic respiratory disorders (chronic respiratory insufficiency) If you suffer from chronic respiratory insufficiency (a respiratory disease that lasts over time, and involves inadequate oxygen and/or carbon dioxide levels in the blood) accompanied by an increase in carbon dioxide in the blood (hypercapnia), your doctor may reduce the dose of this medicine, as it may increase the risk of reduced respiratory activity (respiratory depression), especially at night.
• If you suffer from mental disorders (psychoses) Lendormin is not recommended for the treatment of psychoses unless in association with other medicines.
• If you suffer from depression or anxiety associated with depression The use of this class of medicines may reveal an existing depression. Lendormin should not be used for the treatment of depression or anxiety associated with depression unless in combination with other medicines, as it may worsen behaviors against oneself, leading to death. Always follow your doctor's instructions.
• If you have a history of drug abuse This medicine should not be used if you have a history of drug abuse.
• If you have a history of alcohol abuse This medicine should not be used if you have a history of alcohol abuse (see section “Lendormin with alcohol”). ToleranceAfter repeated use for several weeks, some loss of the effects of benzodiazepines may occur.

Dependence

• The use of this class of medicines can lead to the development of physical and mental dependence. This risk increases with the dose and duration of treatment and is greater if you have previously abused alcohol or drugs: in this case, you should not take Lendormin.
• After discontinuation of treatment, a transient syndrome may occur consisting of the reappearance, in an aggravated form, of the symptoms that had led to the use of this medicine: this is one of the first symptoms of dependence and may be accompanied by other reactions such as mood changes, anxiety and restlessness or sleep disturbances.
• In cases where you have developed physical dependence, consult your doctor before stopping treatment with this medicine, as abrupt discontinuation of therapy will be accompanied by withdrawal symptoms of varying severity, from mild disturbances such as, for example, headache, muscle pain, to severe psychiatric symptoms such as anxiety and extreme tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: a feeling of perceiving the external world and reality in a distorted way (derealization), a feeling of detachment from the external world and from oneself (depersonalization), a disturbance of hearing that involves an increase in sensitivity and intolerance to sounds (hyperacusis), numbness and tingling in arms and legs, increased sensitivity to light, noise or physical contact, perception of things that do not exist in reality (hallucinations) or seizures. Please refer to sections “Possible side effects” and “If you stop taking Lendormin”. Furthermore, if you are taking a high dose of this medicine, withdrawal symptoms may also manifest in the interval between doses.

Amnesia (memory disorder)
Benzodiazepines can cause a memory disorder characterized by the inability to
memorize new information (anterograde amnesia) which may occur even at recommended dosages; the risk increases with higher dosages.
The effects related to anterograde amnesia may be associated with behavioral disturbances.
This condition occurs more often several hours after taking the medicine; therefore, to
reduce this risk, before taking this medicine, make sure you can have a sufficient period of uninterrupted sleep, generally 7-8 hours (see sections 4 "Possible side
effects" and 3 “How to take Lendormin”).

Psychiatric and paradoxical reactions (behavioral disorders)
During the use of benzodiazepines, restlessness, agitation, irritability, aggressiveness,
a state of mental confusion (delirium), anger, nightmares, perception of things that do not exist in
reality (hallucinations), mental disorders (psychoses), inappropriate behavior and other adverse
behavioral effects may occur. If this occurs, you should contact your doctor to stop using the
medicine (see section 4 “Possible side effects” and section “If you stop the
treatment with Lendormin”).

Children and adolescents
The tablets are only suitable for adults and studies in children are not available, therefore
Lendormin is contraindicated in children and adolescents under 18 years of age.

Other medicines and Lendormin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• The activity of Lendormin may be increased if it is prescribed together with other medicines that reduce the activity of the central nervous system, increasing their effects. The concomitant use of Lendormin and opioids (strong painkillers, medicines for addiction therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Lendormin 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 your doctor's recommendations on dosage. It may be helpful to inform friends or family members to pay attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms. This can happen with a variety of medicines including:
• antipsychotics (neuroleptics, medicines for mental disorders)
• hypnotics (sleeping pills)
• anxiolytics (medicines for anxiety)
• sedatives (medicines that cause physical and mental relaxation)
• antidepressants (medicines for depression)
• narcotic analgesics (medicines that reduce pain by acting on the central nervous system). In the case of narcotic analgesics, the increase in euphoria can lead to an increase in psychological dependence
• antiepileptics (medicines for epilepsy)
• anesthetics (medicines that cause temporary loss of sensitivity, pain, and in some cases also consciousness, associated with muscle relaxation)
• sedative antihistamines (medicines for allergies that also cause physical and mental relaxation on the central nervous system).
• The activity of Lendormin may be modified by medicines that influence liver metabolism (i.e. how the liver works):
• when Lendormin is administered together with medicines that stimulate liver metabolism such as rifampicin (antibiotic), the effect of Lendormin may decrease
• when Lendormin is administered together with medicines that reduce liver metabolism such as ketoconazole (medicine for fungal skin infections), the effect of Lendormin may increase and become harmful.

Lendormin with alcohol
When Lendormin is used simultaneously with alcohol, sedation
(physical and mental relaxation), fatigue and reduced concentration may increase, therefore concomitant
intake with alcohol is not recommended.
Furthermore, the increased sedative effect, when the medicine is taken simultaneously with alcohol,
affects the ability to drive vehicles or use machinery (see section “Driving and operating machinery”).
Taking an overdose of Lendormin together with alcohol can be a danger to
your life (see section “If you use more Lendormin than you should”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy and breastfeeding
There is insufficient data on Lendormin to assess the safety of the medicine during
pregnancy and breastfeeding. Therefore, the use of Lendormin is not recommended during
pregnancy and breastfeeding.
If you intend to become pregnant or suspect you are pregnant and are taking
this medicine, you should contact your doctor to stop using the medicine (see section
“If you stop taking Lendormin”).
Although not recommended, if your doctor prescribes this medicine in the late stages of
pregnancy or during labor, the newborn may have effects such as a decrease in body temperature
(hypothermia), a defect in muscle tone sometimes associated with muscle weakness (hypotonia) and
moderate respiratory depression (moderate respiratory depression), caused by the action of the
medicine.
Furthermore, children born to mothers who took benzodiazepines (i.e. medicines of the same class as
Lendormin) chronically during the last stages of pregnancy may develop physical
dependence and may have a certain risk of developing withdrawal symptoms in the postnatal period (see
section 4 “Possible side effects”).
Since benzodiazepines are excreted in breast milk, the use of this medicine is not
recommended for breastfeeding mothers.

Fertility
There is no data available on fertility for this medicine. Studies conducted with brotizolam, the
active ingredient of Lendormin, have not shown adverse effects on fertility.

Driving and operating machinery
Studies have not been conducted on the effect of the medicine on the ability to drive vehicles and use
machinery.
However, side effects such as sedation (physical and mental relaxation), memory impairment (amnesia), reduced mental and physical abilities (see
section “Possible side effects”) may occur during treatment.
Mental and physical impairment may increase the risk of falls and road accidents.
The concomitant intake of alcohol and/or medicines that reduce the activity of the central nervous
system may increase this impairment.
If you experience insufficient sleep, the probability of reduced alertness is increased.
Therefore, caution is recommended when driving vehicles and using machinery.
If you experience any of the above effects, you should avoid potentially dangerous activities such as driving
or using machinery.

Lendormin contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

3. How to take Lendormin

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

Adults aged 18 years or over

How much
The following dosages are recommended:
Adults: the recommended dose is 0.25 mg (1 tablet) in the evening before going to bed
Elderly: the recommended dose is 0.125 mg (half tablet) - 0.25 mg (1 tablet) in the evening
before going to bed
The tablets can be divided into two equal halves.
Treatment should be started at the lowest recommended dose.
The dose of 0.25 mg (1 tablet) should not be exceeded due to the increased risk
of developing undesirable effects on the central nervous system (see section 4 “Possible
undesirable effects”).
If your doctor prescribes a high dosage, withdrawal symptoms may occur
between doses (see section 4 “Possible undesirable effects”).
Since the risk of withdrawal or rebound symptoms is greater in case of abrupt discontinuation of
treatment, your doctor will gradually reduce the dosage before stopping it completely
(see section “If you stop taking Lendormin”).

How
The medicine should be taken with a moderate amount of liquid just before going to bed.
After taking this medicine, you should allow a period of 6-7 hours for rest or sleep.

If you have reduced liver function
If you have reduced liver function, the dose must be decreased as prescribed by
your doctor.

If you suffer from chronic respiratory disorders (chronic respiratory failure)
If you suffer from chronic respiratory failure (a long-lasting respiratory disease, which involves
inadequate oxygen and/or carbon dioxide levels in the blood) accompanied by an increase
in blood carbon dioxide (hypercapnia), your doctor may reduce the dose of this medicine,
as it may increase the risk of reduced respiratory activity (respiratory depression)
especially during the night.

If you have reduced kidney function
Available data show that dose adjustment is not necessary in case of reduced
kidney function. Take this medicine as prescribed by your doctor.

Duration of treatment
Treatment should be as short as possible. The duration of treatment ranges from a few days to a
maximum of 2 weeks. Your doctor will adjust the gradual dose reduction on an individual basis.
Therefore, at the beginning of treatment, your doctor will inform you that it will be of limited duration and will
explain exactly how you should progressively decrease the dosage.
In certain cases, your doctor, after a general reassessment of your condition, may decide
to extend the therapy beyond the maximum treatment period (i.e. beyond 2 weeks).

Use in children and adolescents
The tablets are only suitable for adults and there are no studies in children, therefore
Lendormin is contraindicated in children and adolescents under the age of 18 years.

If you use more Lendormin than you should
In case of accidental ingestion/intake of an excessive dose of Lendormin, immediately warn
your doctor or go to the nearest hospital.

Symptoms
In case of accidental ingestion/intake of an excessive dose of Lendormin, a reduction in the activity of the central nervous system of varying severity may usually
occur. In mild cases, symptoms include temporary loss of sensory and intellectual abilities associated with a sense
of disorientation (obnubilation), mental confusion and lethargy (a state of deep sleep with
reduced response to normal stimuli); in more severe cases, symptoms may include progressive loss
of muscle coordination (ataxia), muscle tone defect sometimes associated with muscle weakness (hypotonia), low blood pressure (hypotension), reduced respiratory activity
(respiratory depression), rarely coma and very rarely death.
As with other benzodiazepines, accidental ingestion/intake of an excessive dose should not
be life-threatening unless taken simultaneously
with other substances that reduce the activity of the central nervous system, including alcohol (see
section “Lendormin with alcohol”).

Treatment
In case of accidental ingestion/intake of an excessive dose of benzodiazepines for oral use, the
doctor, if you are conscious, will induce vomiting (within 1 hour of taking the excessive dose).
If you have lost consciousness, you will undergo gastric lavage (which will be performed in hospital by
specialized personnel).

If emptying the stomach (either through vomiting or gastric lavage) does not
lead to any benefit, the doctor will administer activated charcoal, a substance used to
reduce absorption. Heart and respiratory functions will be carefully monitored in
hospital in the intensive care unit.
If necessary, the doctor may use, as an antidote, flumazenil (a substance capable of blocking
the sedative effect of benzodiazepines, i.e. relaxation of the body and mind at the level of the
central nervous system).

If you forget to take Lendormin
Do not take a double dose to make up for a missed dose.

If you stop taking Lendormin

• If you have developed a physical dependence on this medicine (see section “Warnings and precautions”) consult your doctor before stopping treatment, as abrupt discontinuation of treatment may cause:
• withdrawal symptoms (such as headache, muscle pain, anxiety and extreme tension, restlessness, confusion or irritability)
• rebound symptoms (when the symptoms present at the beginning of treatment reappear in a more severe form and can cause other reactions including mood changes, anxiety and restlessness) Therefore, since the risk of withdrawal or rebound symptoms is greater in case of abrupt discontinuation of treatment, your doctor will gradually reduce the dosage.
• During the use of benzodiazepines, behavioral disorders may occur: restlessness, agitation, irritability, aggression, mental confusion (delirium), anger (rage), nightmares, perception of things that do not exist in reality (hallucinations), mental disorder (psychosis), inappropriate behavior and other undesirable behavioral effects (see section 4 “Possible undesirable effects”). If this occurs, you should immediately contact your doctor to stop using the medicine.
• If you intend to become pregnant or suspect you are pregnant, and you are taking this medicine, you should contact your doctor to stop using the medicine (see section “Pregnancy, breastfeeding and fertility”).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most of the side effects observed so far are related to the mechanism of action of the
medicine. These effects usually occur at the beginning of therapy and generally decrease
during treatment.
The risk of dependence increases with the duration of therapy with this medicine, which should not
exceed two weeks.
The symptoms of dependence may be:

• rebound effect (a condition that may occur if you have developed a physical dependence on the medicine and in which the symptoms present at the beginning of treatment appear more severely in case of abrupt discontinuation of therapy)
• mood changes
• anxiety
• restlessness

Common (may affect up to 1 in 10 people)

• drowsiness
• headache
• stomach and intestinal disorders (gastrointestinal disorders)

Uncommon (may affect up to 1 in 100 people)

• nightmares, drug dependence, depression, mood changes, anxiety, emotional disorders, behavioral disorders, agitation, decreased sexual desire (libido disorder)
• dizziness, physical and mental relaxation (sedation), progressive loss of muscle coordination (ataxia), memory impairment characterized by the inability to memorize new information (anterograde amnesia)
• dementia, mental disorders, reduction of mental and physical abilities; these side effects are characteristic of benzodiazepines
• double vision (diplopia), dry mouth, liver disorders, yellowing of the skin and whites of the eyes (jaundice), skin reactions, muscle weakness
• withdrawal syndrome (a condition that may occur if you have developed a physical dependence on the medicine and abruptly stop treatment). Symptoms include, for example: headache, muscle pain, anxiety and extreme tension, restlessness, confusion or irritability (see section “If you stop taking Lendormin”)
• rebound effects (a condition that may occur if you have developed a physical dependence on the medicine and in which the symptoms present at the beginning of treatment appear more severely in case of abrupt discontinuation of therapy). This condition can cause other reactions including mood changes, anxiety and restlessness (see section “If you stop taking Lendormin”)
• unexpected mental and behavioral disorders (paradoxical reactions), irritability, feeling of fatigue
• abnormalities in tests to evaluate liver function

Rare (may affect up to 1 in 1000)
Confusional state, restlessness, decreased level of consciousness

Other possible side effects with unknown frequency
Trauma
Road accidents, falls; these side effects are characteristic of benzodiazepines.
Dependence
Use (even at therapeutic doses) can lead to the development of physical dependence: discontinuation of
therapy may cause withdrawal or rebound phenomena (see sections “Warnings and precautions” and
“If you stop taking Lendormin”). Psychological dependence may occur. Cases of benzodiazepine abuse have been
reported.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 Lendormin

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in 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 Lendormin contains

• the active ingredient is: brotizolam 0.25 mg.
• the other ingredients are: lactose corn starch, sodium starch glycolate, microcrystalline cellulose, magnesium stearate.

Description of the appearance of Lendormin and contents of the pack
Lendormin 0.25 mg tablets is packaged in opaque blisters, in a carton containing 30 tablets.

Marketing Authorisation Holder
Boehringer Ingelheim Italia S.p.A.
Via Lorenzini, 8
20139 Milano

Manufacturer
Delpharm Reims S.A.S.
10 Rue Colonel Charbonneaux
51100 Reims (France)