Bromazepam Zentiva

Package leaflet: Information for the patient

Bromazepam Zentiva 1.5 mg tablets, 3 mg tablets, 2.5 mg/ml oral drops, solution

Generic Medicine
Please read all of this leaflet carefully before you take 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bromazepam Zentiva is and what it is used for

Bromazepam Zentiva 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 patient.
This medicine is indicated for the treatment of:

• anxiety, tension, and other anxiety-related disorders
• sleep disorders (insomnia).

2. What you need to know before taking Bromazepam Zentiva

Do not take Bromazepam Zentiva

• 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 disease causing muscle weakness and fatigue
• if you suffer from severe respiratory insufficiency
• if you have serious liver problems (severe hepatic insufficiency)
• if you have breathing difficulties during sleep (sleep apnea)
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”)
• if you have a narrow-angle glaucoma eye condition
• if you have acute intoxication from alcohol or other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bromazepam Zentiva.
The use of this medicine or other similar medicines (benzodiazepines) may cause severe allergic reactions (anaphylactic/anaphylactoid reactions), including swelling of the tongue, larynx, and throat, which can lead to breathing and swallowing difficulties (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting. This may result in airway obstruction, which could be fatal.
These reactions may occur after taking the first dose or subsequent doses.
If you experience such symptoms, stop taking the medicine immediately and contact your doctor.
If benzodiazepines have caused angioedema, these medicines must no longer be taken.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly. In this case, your doctor will prescribe an appropriate dose to avoid side effects such as movement disorders (ataxia), muscle weakness, dizziness, drowsiness, fatigue, and exhaustion, which may increase the risk of falls (your doctor may decide to reduce the dose)
• if you have respiratory problems (chronic respiratory insufficiency). In this case, your doctor may decide to reduce the dose due to the risk of respiratory depression
• if you have kidney problems (renal insufficiency)
• if you have low blood pressure or heart problems (cardiac insufficiency). In this case, you should undergo regular check-ups as prescribed by your doctor
• if you suffer from depression or have previously abused alcohol or drugs.

Tolerance: If after several weeks you feel the medicine is less effective, consult your doctor.
Dependence: When taking this medicine, there is a risk of dependence, meaning a need to continue taking the medicine. The risk increases with higher doses and longer treatment duration, but may also occur at therapeutic doses. The risk is greater if you have previously suffered from psychiatric disorders or have abused drugs or alcohol. If dependence develops, abrupt discontinuation or rapid dose reduction must be avoided, as withdrawal symptoms may occur (see next section).
Discontinuation and withdrawal: When stopping treatment with Bromazepam Zentiva, a temporary condition may occur in which the symptoms that led to benzodiazepine treatment reappear in a worsened form (rebound syndrome). Other symptoms may also occur, such as mood changes, anxiety, restlessness, and sleep disturbances. If dependence has developed during treatment (see above), abrupt discontinuation will be accompanied by withdrawal symptoms, which may include: headache (cephalalgia), diarrhea, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: thought and behavioral disturbances such as derealization (feeling that things are unreal) and depersonalization (feeling of detachment from the surrounding environment), hearing disturbances (hyperacusis), numbness and tingling in hands and feet, excessive sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that do not exist), epileptic seizures (sudden, uncontrollable movements). Other symptoms related to treatment discontinuation may include: depression, insomnia, sweating, persistent perception of noise (tinnitus), involuntary movements, vomiting, altered skin sensation (paresthesia), altered sensations, abdominal and muscle cramps, tremor, muscle pain (myalgia), agitation, irregular or rapid heartbeat (palpitations, tachycardia), panic attacks, dizziness, increased nerve reflexes (hyperreflexia), loss of recent memory, increased body temperature (hyperthermia).
Withdrawal symptoms may appear within the first few days after stopping treatment. To minimize these symptoms, your doctor will gradually reduce the dose (see section “If you stop taking Bromazepam Zentiva”).
Treatment should be discontinued gradually, as directed by your doctor; otherwise, the conditions for which you were being treated may reappear, even more intensely than before (rebound syndrome). The risk of developing these symptoms is higher if you stop taking Bromazepam Zentiva abruptly.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a shorter-acting one. Therefore, such substitution is not recommended.
Amnesia: This medicine (especially at higher doses) may cause amnesia (memory loss) associated with abnormal behavior, particularly several hours after intake. To reduce the risk of amnesia, it is advisable to have uninterrupted sleep of 7–8 hours.
Behavioral reactions (psychiatric and paradoxical reactions): If you experience behavioral disturbances such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, inappropriate behavior, or psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), stop taking the medicine immediately and contact your doctor (see section 4 “Possible side effects”). These reactions are more frequent in children, elderly patients, and individuals with various brain disorders (organic brain syndrome).
For the treatment of mental illnesses (psychotic disorders) and depression or anxiety associated with depression, your doctor will not prescribe benzodiazepines alone, as suicidal thoughts may occur in these cases.
Children and adolescents
In children and adolescents under 18 years of age, Bromazepam Zentiva should only be used after careful evaluation by a doctor, only when absolutely necessary, and for the shortest possible duration.
Other medicines and Bromazepam Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics) and antidepressants, used to treat mental disorders
• hypnotics, medicines used to promote sleep
• anxiolytics and sedatives, used to treat anxiety and agitation
• certain strong painkillers or certain cough medicines (narcotic analgesics, opioids), which when taken with Bromazepam Zentiva may lead to dependence (i.e., increase your desire to continue taking these medicines)
• antiepileptics, used for epilepsy
• antihistamines with sedative effects, used to treat allergies
• anesthetics, used during surgery
• theophylline and aminophylline, used to treat asthma or other respiratory diseases
• medicines that increase or decrease bromazepam metabolism (e.g., azoles, used to treat fungal infections; protease inhibitors, used to treat AIDS; macrolide antibiotics, used for bacterial infections)
• cimetidine, used to treat heartburn and stomach lesions.

Concomitant use of Bromazepam Zentiva and opioids (strong painkillers, medicines for addiction therapy, and certain cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other therapeutic alternatives are possible.
However, if your doctor prescribes Bromazepam Zentiva together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Bromazepam Zentiva and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may impair breathing and increase the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Bromazepam Zentiva during pregnancy.
Rarely, cleft lip may occur if the medicine is taken during the first trimester.
If your doctor considers it necessary for you to take this medicine in the late stages of pregnancy, your baby may develop the “floppy infant syndrome,” characterized by low body temperature, loss of muscle tone, feeding difficulties (sucking problems), poor weight gain, and breathing difficulties.
If Bromazepam Zentiva has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms. If Bromazepam Zentiva has been taken at high doses, your baby may experience breathing problems, low body temperature (hypothermia), reduced movement, and heart rhythm disturbances.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.
Driving and using machines
Taking Bromazepam Zentiva may affect your ability to drive vehicles and operate machinery, as you may have difficulty concentrating, feel forgetful, drowsy, or experience muscle tone problems.
These effects are worsened if you have not had sufficient sleep. If this occurs, avoid driving or operating machinery.
Consuming alcohol during treatment with this medicine worsens these effects and therefore negatively affects your ability to drive and operate machinery.
Bromazepam Zentiva tablets contain lactose monohydrate.
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Bromazepam Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose according to your individual needs.
Tablets: The recommended average dose is 1 to 2 tablets of 1.5 mg, taken 2–3 times daily, or 1 tablet of 3 mg, 2–3 times daily.
Oral drops: The recommended average dose is 15 to 30 drops, taken 2–3 times daily.
Take Bromazepam Zentiva oral drops as follows:

• To open the bottle: press down on the cap and unscrew it at the same time (Fig. 1).
• Let the drops fall into a glass, holding the bottle vertically with the opening facing downwards. The drops should be diluted with a small amount of water (Fig. 2).
• To close the bottle: screw the cap back on until it is tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
Treatment of anxiety
Treatment duration should be as short as possible. Generally, treatment should not exceed 8–12 weeks, including a period of gradual discontinuation.
In certain cases, your doctor may decide to extend the treatment, but only after evaluating your health condition.
Treatment of insomnia
Treatment duration should be as short as possible. Generally, treatment lasts from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation. In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition from the start of treatment and may reduce the dose or frequency of administration if necessary.
Use in elderly patients and patients with kidney problems or respiratory disorders (chronic respiratory insufficiency)
In elderly patients and in patients with these conditions, your doctor may prescribe a reduced dose.
If you take more Bromazepam Zentiva than you should
If you (or someone else) have taken an excessive dose of Bromazepam Zentiva, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
An overdose may cause drowsiness, speech disorders (dysarthria), involuntary eye movements (nystagmus). It may also cause severe depression of the central nervous system, with symptoms such as drowsiness, confusion, lethargy, speech difficulties (slurred speech), loss of reflexes (areflexia), progressive loss of muscle coordination (ataxia), reduced muscle tone (hypotonia), breathing difficulties (apnea, respiratory depression), low blood pressure (hypotension), cardiac depression, coma, and death.
Take this leaflet and the remaining medicine in its original packaging with you to the hospital or doctor, so that they know which medicine has been taken.
If you forget to take Bromazepam Zentiva
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.
If you stop taking Bromazepam Zentiva
Do not stop treatment with Bromazepam Zentiva suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, your dose will be gradually reduced to minimize withdrawal symptoms (see section 2, "Warnings and precautions – Discontinuation of treatment and withdrawal").
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 everybody experiences them.
Contact your doctor immediately if you experience:
Behavioural reactions including:
Depression and behavioural changes such as restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), changes in behaviour. If you experience any of these side effects, stop treatment immediately and contact your doctor. These reactions are more likely to occur in children, elderly people and individuals with brain disorders (see section “Warnings and precautions”).

The following side effects may also occur (see also sections “Warnings and precautions” and “If you stop taking Bromazepam Zentiva”):
Frequency not known (frequency cannot be estimated from the available data):

• altered sexual desire
• medicine dependence, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Bromazepam Zentiva”),
• depression
• memory loss that does not affect past memories (anterograde amnesia) (see section “Warnings and precautions”),
• memory disturbances
• blurred vision
• double vision
• constipation
• urinary problems (urinary retention)
• hives
• skin irritation
• itching
• increased risk of falls and fractures, especially in elderly patients and patients taking sedatives or alcohol concomitantly
• muscle weakness
• fatigue
• breathing problems, even during the night (respiratory depression, apnoea, nocturnal apnoea)
• heart problems (heart failure, cardiac arrest)
• allergic reactions (hypersensitivity and anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema)
• nausea
• vomiting
• headache
• reduced alertness
• loss of muscle coordination (ataxia)
• drowsiness
• dizziness
• emotional disturbances

In addition, the following side effects have been reported with the use of benzodiazepines:

• jaundice (yellowing of the skin and whites of the eyes)
• increase in certain liver blood tests (transaminases, bilirubin, alkaline phosphatase)
• decrease in platelets (thrombocytopenia), decrease in certain white blood cells (agranulocytosis), decrease in all blood cells (pancytopenia), disturbance in the secretion of antidiuretic hormone (SIADH)

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 Bromazepam Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, stored correctly.
This medicine does not require any special storage conditions.
Bromazepam Zentiva 2.5 mg/ml oral drops, solution.
Shelf-life after first opening of the bottle: 12 weeks. After this period, any remaining product must be discarded.
Do not dispose of medicines 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 Zentiva contains
Bromazepam Zentiva 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, talc, magnesium stearate.

Bromazepam Zentiva 3 mg tablets

• The active substance is bromazepam. Each tablet contains 3 mg of bromazepam.
• The other components are: microcrystalline cellulose, lactose monohydrate, talc, magnesium stearate, red iron oxide (E172).

Bromazepam Zentiva 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 Zentiva and contents of the pack
Bromazepam Zentiva 1.5 mg:
Blister pack containing 20 tablets.
Bromazepam Zentiva 3 mg:
Blister pack containing 20 tablets.
Bromazepam Zentiva 2.5 mg/ml oral drops, solution:
Bottle containing 20 ml of oral solution.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale Bodio, 37/B – 20158 Milano
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 De’ Stampi, Rozzano (MI)