BROMAZEPAM 1.5 mg Tablet

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1. BROMAZEPAM ACCORD 1,5 mg tablets, 3 mg tablets, 2,5 mg/ml oral drops, solution
   1. What is BROMAZEPAM ACCORD and what it is used for
   2. What you need to know before taking BROMAZEPAM ACCORD
   3. How to take BROMAZEPAM ACCORD
   4. Possible side effects
   5. How to store BROMAZEPAM ACCORD
   6. Contents of the pack and other information

BROMAZEPAM ACCORD 1,5 mg tablets, 3 mg tablets, 2,5 mg/ml oral drops, solution

Equivalent Medicinal Product
Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any undesirable effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BROMAZEPAM ACCORD and what it is used for

BROMAZEPAM ACCORD contains the active ingredient bromazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used to relieve severe states of anxiety, which subject the individual to severe
discomfort.
This medicine is used in adults for the treatment of the following conditions:

anxiety, states of emotional tension and other manifestations associated with anxiety;

insomnia(sleep disorders)
only when they are severe, disabling and cause significant discomfort in normal daily life.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking BROMAZEPAM ACCORD

Do not take BROMAZEPAM ACCORD

• if you are allergic to bromazepam, 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 serious illness that affects the muscles and manifests with fatigue and weakness)
• if you suffer from severe respiratory failure (a serious reduction in the activity of the respiratory system)
• if you have severe liver problems (severe hepatic impairment)
• if you suffer from temporary cessation of breathing during sleep (sleep apnea)
• if you suffer from narrow-angle glaucoma (an eye disease caused by an increase in the pressure of the fluid contained within the eye);
• if you are taking an excessive amount of alcohol or other medicines that depress the nervous system
• hypnotics (medicines that have a calming and sleep-inducing effect);
• analgesics (medicines for the treatment of acute or chronic pain of high intensity);
• psychotropic drugs (medicines used for mental disorders and/or depression).

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

• you suffer from depression or anxiety related to depression, because Lexotan may worsen your condition and may lead to the onset of suicidal thoughts (attempting to kill yourself);
• you have had problems with drug or alcohol abuse in the past;
• if you are addicted to alcohol or use opioids (medicines used for pain);
• if you have previously developed a severe allergic reaction after the administration of a benzodiazepine (anaphylactic/anaphylactoid reaction);
• you suffer from chronic respiratory failure (reduction in the activity of the respiratory system);
• you suffer from kidney failure (reduction of kidney function);
• you suffer from severe hepatic failure (severe reduction of liver function);
• you suffer from heart failure (reduced heart function);
• you suffer from low blood pressure;
• you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis). Development of toleranceAfter repeated use of this medicine for a prolonged period, a decrease in its effectiveness (tolerance) may occur. Development of dependenceThe use of high doses and/or for prolonged periods of bromazepam can cause physical and psychological dependence. This risk is higher if you have previously abused medicines, drugs or alcohol (especially in poly-substance abusers). The possibility of dependence is reduced if you use Bromazepam Accord at the appropriate dose, as prescribed by the doctor and with a short-term treatment (see section 3 “How to take Bromazepam Accord”). If you are elderlyIf you are elderly, take Bromazepam Accord 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 exhaustion.

Children and adolescents
Benzodiazepines should not be administered to patients under the age of 18.

Other medicines and BROMAZEPAM ACCORD
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor if you are taking the following medicines:

• medicines used for some mental illnesses (antipsychotics - neuroleptics)
• -medicines for the treatment of depression (antidepressants, such as fluvoxamine) medicines that have a calming and sleep-inducing effect (hypnotics)
• medicines that cause physical and mental torpor (anxiolytics/sedatives);
• medicines for the treatment of epilepsy (antiepileptics);
• medicines to counteract allergic manifestations (sedative antihistamines); anesthetics;
• medicines used for cough (opioid antitussives); theophylline and aminophylline, (medicines used against bronchial asthma);
• medicines that increase or decrease the metabolism of bromazepam (e.g. azoles, used to treat fungal infections, protease inhibitors, used for HIV therapy and a type of antibiotics, macrolides, used against bacterial infections)
• cimetidine (medicine used in case of stomach ulcer);
• medicines for the treatment of acute or chronic pain of high intensity (narcotic analgesics);
• medicines used for cough (opioid antitussives);
• propranolol (medicine used to treat various types of heart problems).

The concomitant use of BROMAZEPAM ACCORD and opioids (strong painkillers, medicines for substitution therapy for dependence and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes BROMAZEPAM ACCORD together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid-based medicines you are taking and carefully follow
their recommendations regarding the dose. It may be helpful to inform friends or relatives so that they are
aware of the above signs and symptoms. If you experience these symptoms, contact your doctor.

BROMAZEPAM ACCORD with alcohol
Do not drinkalcohol during treatment with this medicine, because the sedative effect may be increased.
Drinking alcohol with BROMAZEPAM ACCORD may impair the ability to drive vehicles and
operate machinery (see section “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice 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 benzodiazepines at high doses,
during the second and/or third trimester of pregnancy may determine in the fetus a decrease in
movements and alterations of the heartbeat.

• If you intend to become pregnant and are being treated with Bromazepam Accord, contact your doctor immediately who will tell you how to gradually stop using this medicine.
• If Bromazepam Accord is administered during the last period of pregnancy, or during labor, hypothermia (reduction of body temperature), hypotonia (reduction of muscle tone) and respiratory depression or apnea (absence of respiratory movements) may occur in the newborn. In addition, newborns born to mothers who have chronically taken benzodiazepines during the advanced stages of pregnancy may develop physical dependence and may present a certain risk of developing withdrawal symptoms in the postnatal period, such as hyperactivity, agitation and tremor even some days after birth.

Breastfeeding

Do nottake this medicine if you are breastfeeding, because bromazepam passes into
breast milk.

Driving and using machines
Do notdrive or operate machinery if you experience
side effects such as sedation (physical and mental relaxation), amnesia (memory disorders), alteration of
concentration and muscle function during treatment with Bromazepam Accord. These effects are also aggravated if you drink alcohol together
with Bromazepam Accord (see section “Bromazepam Accord and alcohol”).
Your vigilance may be altered, especially if you have not had enough sleep after taking
Bromazepam Accord.

BROMAZEPAM ACCORD tablets contains:
Lactose monohydrate:If your doctor has diagnosed you with an intolerance to certain sugars, consult
him/her before taking this medicine.

Sodium:This medicine contains less than 1 mmol (23mg) of sodiumper tablet, i.e. essentially
‘sodium-free’.

BROMAZEPAM ACCORD oral drops contains:
Propylene glycol:
This medicine contains 983.7 mg of propylene glycol per 1 ml (corresponding to 2.5 mg of
bromazepam). If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. Your doctor may perform further checks during therapy. If you suffer from liver or
kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor
may perform further checks during therapy.

Sodium:
This medicine contains less than 1 mmol (23mg) of sodiumper oral solution, i.e. essentially
‘sodium-free’.

3. How to take BROMAZEPAM ACCORD

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
doubts consult your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The doctor will establish the dose and frequency most suitable for you, in order to avoid the possible intake of an
excessive dose of this medicine.
The recommended dose is from 1.5 to 3 mg of bromazepam, up to 3 times a day:

• drops: 15-30 drops, up to 3 times a day;
• 1.5 mg tablets: from 1 to 2 tablets, up to 3 times a day;
• 3 mg tablets: 1 tablet, up to 3 times a day.

Treatment should be started with the lowest recommended dose.

Use in the elderly and people with kidney and liver problems
The dose will be carefully established by the doctor.
The doctor will assess whether to prescribe you lower doses than those indicated above.

Children
Bromazepam Accord is not indicated in children.

Duration of treatment
Your doctor will prescribe the shortest possible duration of treatment.
Depending on the indication for which your doctor has prescribed this medicine, the duration of treatment is the
following:

• anxiety: the duration of treatment should not exceed 8/12 weeks, including a period of gradual discontinuation
• insomnia: the duration of 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, the doctor, after re-evaluating your health condition, may decide to extend the treatment duration indicated above. During the period of discontinuation of treatment with Bromazepam Accord, the doctor will explain how to gradually reduce the dose of this medicine in order to reduce the risk of developing withdrawal and rebound symptoms (see paragraphs “If you stop taking Bromazepam Accord” and “Possible side effects”). Withdrawal symptoms may also appear when switching from a benzodiazepine with a long duration of action to one with a short duration of action. Therefore, carefully follow your doctor's recommendations.

If you take more BROMAZEPAM ACCORD than you should
In case of ingestion/accidental intake of an excessive dose of Bromazepam Accord, immediately
inform your doctor or go to the nearest hospital.

Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and
gait), dysarthria (speech disorder) and nystagmus (oscillatory, rhythmic and involuntary
eye movements).
Overdose of bromazepam can rarely determine a risk to life if the drug is taken by
alone, but can lead to dysarthria (words pronounced slowly and defectively), areflexia (absence of
reflexes), apnea (cessation of breathing), hypotension (low blood pressure), cardiorespiratory depression
(reduced activity of the heart and lungs) and coma (loss of consciousness).
In mild cases, the symptoms in case of ingestion/accidental intake of an excessive dose of Bromazepam
Accord may be:

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

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

If you stop taking BROMAZEPAM ACCORD
Donot stop treatment with BROMAZEPAM ACCORD without first consulting your doctor.
The doctor will gradually reduce the dose during the phase of suspension of therapy.

• Sudden discontinuation of this medicine can cause:
• withdrawal symptoms: headache, diarrhea, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
• severe withdrawal symptoms: derealization (sensation of perceiving the external world in a distorted way), depersonalization (sensation of detachment or estrangement from oneself), hyperacusis (excessive sensitivity to sounds), numbness and tingling of hands and feet, sensitivity to light, noise and physical contact, hallucinations (perception of things that do not exist in reality), seizures.
• other withdrawal symptoms are: depression, insomnia, sweating, persistent tinnitus (persistent ringing in the ear), involuntary movements, vomiting, paresthesia (sensation of tingling), altered perception, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, sensation of an increased heartbeat (palpitations), tachycardia (increased heart rate), panic attacks, dizziness, hyper-reflexia (exaggeration of reflexes), short-term memory loss (inability to remember recent events), hyperthermia (increased body temperature).
• rebound symptoms(when the symptoms that led to treatment with bromazepam reappear in a more severe form after discontinuation of treatment), such as anxiety, restlessness and sleep disturbances.

These symptoms occur especially if you have developed a physical dependence on this medicine (see
paragraph Warnings and precautions)
If you have any doubts about 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 everybody gets them.
Contact your doctor immediatelyif you experience any of the following serious side effectsduring treatment with Bromazepam Accord; your doctor will explain how to stopusing the medicine:

• depression,
• restlessness,
• agitation,
• irritability,
• aggression,
• distorted perception of reality (delusions),
• anger,
• nightmares and abnormal dreams,
• perception of things that do not exist in reality (hallucinations),
• behavioral changes,
• psychosis (a mental disorder that causes an altered perception of reality, thought disorders, mental confusion),
• nervousness,
• anxiety,
• hyperactivity. These reactions may be more frequent if you are elderly.

In addition, you may experience the following side effects with an unknown frequency (frequency cannot be established based on available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock),
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing (angioedema),
• confusional state,
• disorientation,
• emotional and mood disorders,
• altered libido (sexual desire),
• dependence,
• medicine abuse,
• withdrawal syndrome,
• long-term memory problems (anterograde amnesia),
• memory problems,
• drowsiness,
• headache,
• dizziness,
• reduced alertness,
• ataxia (reduced motor and gait coordination),
• blurred vision,
• diplopia (double vision),
• heart failure (reduced heart function), including cardiac arrest,
• respiratory depression (reduced breathing activity),
• nausea,
• vomiting,
• constipation,
• problems with the stomach and/or intestines,
• skin and subcutaneous tissue problems,
• skin rash,
• itching,
• urticaria (hives),
• muscle weakness,
• urinary retention,
• fatigue,
• falls,
• fractures,
• apnea (temporary cessation of breathing),
• worsening of sleep apnea.

Other side effects that have been reported with other medicines belonging to the benzodiazepine class, such as Bromazepam Accord:

• memory problems (amnesia and anterograde amnesia),
• behavioral changes,
• worsening of pre-existing depressive state,
• insomnia,
• rebound anxiety (which occurs after stopping the medicine),
• dependence,
• jaundice (yellowing/yellowish discoloration of the skin and mucous membranes and the whites of the eyes),
• alteration of some blood tests (increased bilirubin, transaminases and alkaline phosphatase),
• thrombocytopenia (reduction in the number of platelets),
• agranulocytosis (reduction in the number of granulocytes, a type of white blood cell),
• pancytopenia (reduction of all cells present in the blood),
• syndrome of inappropriate secretion of ADH (antidiuretic hormone) which causes water retention in the body and reduced levels of sodium in the blood.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency 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 BROMAZEPAM ACCORD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Oral drops must be used within 20 days of first opening the bottle. Excess product
must be discarded.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BROMAZEPAM ACCORD contains
BROMAZEPAM ACCORD 1.5 mg tablets

• The active ingredient is bromazepam. Each tablet contains 1.5 mg of bromazepam.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, talc.

BROMAZEPAM ACCORD 3 mg tablets

• The active ingredient is bromazepam. Each tablet contains 3 mg of bromazepam.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, talc, red iron oxide.

BROMAZEPAM ACCORD 2.5 mg/ml oral drops, solution

• The active ingredient is bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
• The other ingredients are: sodium saccharin, disodiumedetate, mixed fruit flavors, purified water, propylene glycol.

Description of the appearance of BROMAZEPAM ACCORD and contents of the pack
Pack containing 20 tablets of 1.5 mg.
Pack containing 20 tablets of 3 mg.
Pack containing 1 bottle of 20 ml of solution.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain

Manufacturers
Oral drops:
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
Tablets:
Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto Dè Stampi, Rozzano (MI)