Bromazepam Accord

Italy
Brand name Bromazepam Accord
Form tablets
Active substance / Dosage
BROMAZEPAM
Prescription type Prescription only
ATC code
N05BA08
Registration number 035647
Manufacturer ACCORD HEALTHCARE, S.L.U.
Bromazepam Accord tablets

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

BROMAZEPAM ACCORD 1.5 mg tablets, 3 mg tablets, 2.5 mg/ml oral drops, solution

Generic Medicine
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 others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, 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 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

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

BROMAZEPAM ACCORD contains the active substance bromazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress to the individual.
This medicine is used in adults to treat the following conditions:
anxiety, emotional tension and other symptoms associated with anxiety;
insomnia (sleep disturbances)
only when they are severe, disabling and cause significant distress in everyday life.
Talk to your doctor if you do not feel better or if you feel worse.

2. What you should 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 disease affecting muscles, characterized by fatigue and weakness)
  • if you suffer from severe respiratory insufficiency (severe reduction in respiratory system activity)
  • if you have severe liver problems (severe hepatic impairment)
  • if you suffer from temporary cessation of breathing during sleep (sleep apnea)
  • if you have narrow-angle glaucoma (an eye disease caused by increased pressure of the fluid inside the eye)
  • if you consume excessive amounts of alcohol or other medicines that depress the central nervous system, such as:
    • hypnotics (calming medicines and sleep inducers)
    • analgesics (medicines for treating 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 BROMAZEPAM ACCORD.
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, as 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)
  • you previously experienced a severe allergic reaction after taking a benzodiazepine (anaphylactic/anaphylactoid reaction)
  • you suffer from chronic respiratory insufficiency (reduced respiratory system activity)
  • you suffer from renal insufficiency (reduced kidney function)
  • you suffer from severe hepatic insufficiency (severe reduction in liver function)
  • you suffer from heart failure (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)

Tolerance development
Repeated use of this medicine over a prolonged period may lead to reduced effectiveness (tolerance).

Dependence development
Taking high doses and/or using bromazepam for prolonged periods may lead to physical and psychological dependence. This 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 Bromazepam Accord at the appropriate dose as prescribed by your doctor and for a short duration (see section 3 “How to take Bromazepam Accord”).

If you are elderly
Take Bromazepam Accord 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 BROMAZEPAM ACCORD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking the following medicines:

  • medicines used for certain mental illnesses (antipsychotics/neuroleptics)
  • medicines for treating depression (antidepressants, such as fluvoxamine)
  • calming and sleep-inducing medicines (hypnotics)
  • medicines causing physical and mental sedation (anxiolytics/sedatives)
  • medicines for treating epilepsy (antiepileptics)
  • medicines used to treat allergic reactions (sedating antihistamines)
  • anesthetics
  • medicines used for cough (opioid antitussives)
  • theophylline and aminophylline (medicines used for bronchial asthma)
  • medicines that increase or decrease bromazepam metabolism (e.g. azoles, used to treat fungal infections; protease inhibitors, used in HIV therapy; and macrolides, a type of antibiotic used for bacterial infections)
  • cimetidine (a medicine used for stomach ulcers)
  • medicines for treating severe acute or chronic pain (narcotic analgesics)
  • medicines used for cough (opioid antitussives)
  • propranolol (a medicine used to treat various heart conditions)

Concomitant use of BROMAZEPAM ACCORD and opioids (strong analgesics, medicines for opioid dependence replacement 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 BROMAZEPAM ACCORD together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid-containing medicines you are taking and carefully follow their recommendations regarding dosage. It may be helpful to inform family members or friends so they are aware of the signs and symptoms listed above.
If you experience these symptoms, contact your doctor.

BROMAZEPAM ACCORD and alcohol
Do not drink alcohol during treatment with this medicine, as the sedative effect may be enhanced.
Consuming alcohol with BROMAZEPAM ACCORD 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The safety of bromazepam use during pregnancy has not yet been established. Some studies have shown an increased risk of congenital malformations 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 heart rate abnormalities in the fetus.

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

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

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

BROMAZEPAM ACCORD tablets contain:
Lactose monohydrate: If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

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

3. How to take BROMAZEPAM ACCORD

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.
Your doctor will determine the most appropriate dose and frequency for you in order to avoid the possible
intake of an excessive dose of this medicine.
The recommended dose is 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: 1 to 2 tablets, up to 3 times a day;
  • 3 mg tablets: 1 tablet, up to 3 times a day.

Treatment should be initiated with the lowest recommended dose.
Use in elderly patients and patients with kidney or liver problems
Your doctor will carefully determine your dose.
Your doctor will assess whether to prescribe lower doses than those indicated above.
Children
Bromazepam Accord 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 duration should not exceed 8–12 weeks, including a period of gradual discontinuation.
  • Insomnia: treatment duration ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation. In certain cases, after re-evaluating your health status, your doctor may decide to extend the duration of treatment beyond the above limits. During the discontinuation period of Bromazepam Accord treatment, your doctor will explain how to gradually reduce the dose of this medicine in order to reduce the risk of withdrawal and rebound symptoms (see sections “If you stop taking Bromazepam Accord” and “Possible side effects”). Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, follow your doctor’s advice carefully.

If you take more BROMAZEPAM ACCORD than you should
In case of accidental ingestion/overdose of Bromazepam Accord, contact your doctor immediately or go to the nearest hospital.
Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor and gait coordination), dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary eye movements).
Overdose of bromazepam rarely poses a life-threatening risk if the drug is taken alone, but may lead to dysarthria (slow and slurred speech), areflexia (absence of reflexes), apnea (absence 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 Bromazepam Accord may include:

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

If you forget to take BROMAZEPAM ACCORD
Do not take a double dose to make up for the missed dose.
If you stop taking BROMAZEPAM ACCORD
Do not stop taking BROMAZEPAM ACCORD without first consulting your doctor.
Your doctor will gradually reduce your dose during the discontinuation phase.

  • Sudden discontinuation of this medicine may cause:
    • Withdrawal symptoms: headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
    • Severe withdrawal symptoms: derealization (distorted perception of the external world), depersonalization (feeling 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 non-existent things), seizures.
    • Other withdrawal symptoms include: depression, insomnia, sweating, persistent tinnitus (persistent ringing in the ears), involuntary movements, vomiting, paresthesia (tingling sensations), altered perception, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, sensation of increased heartbeat (palpitations), 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 anxiety, restlessness, and 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 how to use 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.
Immediately contact your doctor if you experience any of the following serious side effects while taking Bromazepam Accord; your doctor will explain how to stop taking 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),
  • behavioural changes,
  • psychosis (mental disorder causing altered perception of reality, thought disturbances, mental confusion),
  • nervousness,
  • anxiety,
  • hyperactivity. These reactions may be more frequent in elderly patients.

Additionally, the following side effects may occur 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,
  • changes in libido (sexual desire),
  • dependence,
  • misuse of the medicine,
  • withdrawal syndrome,
  • long-term memory disturbances (anterograde amnesia),
  • memory disturbances,
  • drowsiness,
  • headache (cephalalgia),
  • dizziness,
  • reduced alertness,
  • ataxia (reduced motor coordination and gait instability),
  • 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,
  • rash,
  • itching,
  • urticaria,
  • 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 belonging to the benzodiazepine class, such as Bromazepam Accord:

  • memory disturbances (amnesia and anterograde amnesia),
  • behavioural changes,
  • worsening of pre-existing depressive state,
  • 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 (decreased platelet count),
  • agranulocytosis (decreased number of granulocytes, a type of white blood cell),
  • pancytopenia (reduction in all blood cell types),
  • syndrome of inappropriate antidiuretic hormone (ADH) secretion, 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 Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps 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 stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, stored correctly.
Oral drops must be used within 20 days after first opening the bottle. Any remaining product
should be discarded.
This medicine does not require any special storage conditions.
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 BROMAZEPAM ACCORD contains
BROMAZEPAM ACCORD 1.5 mg tablets

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

BROMAZEPAM ACCORD 3 mg tablets

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

BROMAZEPAM ACCORD 2.5 mg/ml oral drops, solution

  • The active substance is bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
  • The other components are: sodium saccharin, disodium edetate, mixed fruit flavours, 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 solution.

Marketing Authorization 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)