BROMAZEPAM 1.5 MG Tablets

Зміст інструкції

1. Bromazepam Zentiva 1,5 mg tablets, 3 mg tablets, 2,5 mg/ml oral drops, solution
   1. What is Bromazepam Zentiva and what is it used for?
   2. What you need to know before you take 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

Bromazepam Zentiva 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 for you only. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, 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 you take 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 is Bromazepam Zentiva and what is it used for?

Bromazepam Zentiva 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 indicated for the treatment of:

• anxiety, tension and other disorders associated with anxiety
• sleep disorders (insomnia).

2. What you need to know before you take 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 that causes muscle weakness and fatigue
• if you suffer from severe respiratory failure
• if you have severe liver problems (severe hepatic insufficiency)
• if you have problems breathing during sleep (sleep apnea)
• if you are pregnant or if you are breastfeeding (see section “Pregnancy and breastfeeding”)
• if you have an eye disease called narrow-angle glaucoma
• if you have an acute intoxication from alcohol or other medicines that depress the 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) can cause severe allergic reactions
( anaphylactic/anaphylactoid reactions) with swelling of the tongue, larynx and throat that can cause
difficulty in breathing and swallowing (angioedema), shortness of breath (dyspnea), closure of the throat, nausea
and vomiting. Airway obstruction may occur, which could also lead to death.
These reactions can occur after the first dose or subsequent doses.
If these disorders occur, stop taking the medicine immediately and contact your doctor.
If benzodiazepine use has caused angioedema, these medicines should no longer be taken.
Take this medicine with cautionand always under the supervision of your doctor in the following cases:

• if you are elderly. In this case, your doctor will prescribe an appropriate dose to avoid unwanted effects such as movement disorders (ataxia), muscle weakness, dizziness, drowsiness, fatigue, exhaustion, which can increase the risk of falls (the doctor may decide to reduce the dose)
• if you have breathing 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 (heart failure). In this case, you will need to undergo regular checks prescribed by your doctor
• if you suffer from depression or if you have abused alcohol or drugs in the past.

Tolerance:If after a few weeks you feel that the medicine is working less, consult your doctor.

Dependence:When you take this medicine, there is a risk of dependence, that is, the need to
continue taking the medicine. The risk increases with increasing dose and duration of treatment,
but can also occur at therapeutic doses. It is greater if you have suffered from psychiatric disorders in the past
or have abused drugs or alcohol. If dependence develops, abrupt discontinuation of treatment or a rapid
reduction in dose should be avoided as withdrawal symptoms may occur (see
the following paragraph).

Discontinuation of treatment and withdrawal: When you stop taking Bromazepam Zentiva, you may
experience a temporary situation in which the disorders that led to treatment with
benzodiazepines reappear in an aggravated form (rebound syndrome). Other
disorders such as mood changes, anxiety, restlessness and sleep disturbances may occur. If dependence has developed during treatment
(see above), abrupt discontinuation of treatment will be
accompanied by withdrawal symptoms, which may consist of: headache, diarrhea, muscle pain,
severe anxiety, tension, restlessness, confusion and irritability. In severe cases, they may manifest:
thought and behavioral disorders such as derealization (feeling that things are not real) and
depersonalization (feeling of detachment from the surrounding environment), auditory disturbances (hyperacusis),
numbness and tingling of hands and feet, excessive sensitivity to light, noise and physical contact,
hallucinations (seeing and hearing things that do not exist), seizures (sudden and
uncontrollable movements). Other symptoms related to discontinuation of treatment may be: depression, insomnia,
sweating, persistent perception of noises (tinnitus), involuntary movements, vomiting, altered
skin sensitivity (paresthesia), altered sensations, abdominal and muscle cramps, tremor,
muscle pain (myalgia), agitation, altered or accelerated heartbeat (palpitations, tachycardia),
panic attacks, dizziness, increased nerve reflexes (hyperreflexia), recent memory loss,
increased temperature (hyperthermia).
Withdrawal symptoms can appear within the first few days after stopping treatment. To
minimize these symptoms, your doctor will gradually reduce the dose (see paragraph “If
you stop taking Bromazepam Zentiva”).
Treatment should be discontinued gradually, according to your doctor's instructions, otherwise the disorders for
which you were being treated may reappear even more intensely than before (rebound syndrome). The risk of
developing these symptoms is greater when you stop taking Bromazepam Zentiva
suddenly.
Withdrawal symptoms can 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) can cause amnesia (memory loss)
associated with abnormal behavior, especially several hours after taking it. To reduce the
risk of amnesia, it is advisable to have an uninterrupted sleep of 7-8 hours.

Behavioral (psychiatric and paradoxical) reactions: If you experience behavioral disturbances such as
restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, behaviors
inappropriate, psychosis (a serious condition of the mind in which a person loses contact 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, the elderly and individuals with various brain disorders (organic cerebral syndrome).
For the treatment of mental (psychotic) illnesses and depression or anxiety associated with depression, the
doctor will not prescribe benzodiazepines alone because suicidal thoughts can occur in these cases.

Children and adolescents
In children and adolescents under the age of 18, Bromazepam Zentiva should only be used after
appropriate evaluation by a doctor, in cases of absolute necessity and the duration of treatment should
be as short as possible.

Other medicines and Bromazepam Zentiva
Tell 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
• some strong painkillers or certain medicines used for cough (narcotic analgesics, opioids), which when taken with Bromazepam Zentiva can cause dependence (i.e. increase your desire to continue taking these medicines)
• antiepileptics, used for epilepsy
• antihistamines with sedative effect, used to treat allergies
• anesthetics, used during a surgical operation
• theophylline and aminophylline, used to treat asthma or other respiratory diseases
• medicines that increase or decrease the metabolism of bromazepam (e.g. azoles, used to treat fungal infections, protease inhibitors, used to treat AIDS and macrolide antibiotics (against bacterial infections)
• cimetidine, used to treat heartburn and stomach lesions.

The concomitant use of Bromazepam Zentiva and opioids (strong painkillers, medicines for addiction therapy 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 therapeutic alternatives are not possible.
However, if your doctor prescribes Bromazepam Zentiva 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 to be aware of the
signs and symptoms listed above.
Contact your doctor if you experience these symptoms.

Bromazepam Zentiva with alcohol
Avoid drinking alcohol during treatment with this medicine, as it can alter breathing and
increase the sedative effect of the medicine. This negatively affects the ability to drive vehicles and
use machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Bromazepam Zentiva during pregnancy.
Rarely, the occurrence of cleft lip may occur if the medicine is taken in the first trimester.
If your doctor believes you should take this medicine in the later stages of pregnancy, your
baby may develop “floppy baby syndrome” characterized by low body temperature,
loss of muscle tone and difficulty feeding (difficulty sucking) with poor weight gain and
difficulty breathing.
If Bromazepam Zentiva has been taken regularly during the later stages of pregnancy, your baby
may develop withdrawal symptoms; if Bromazepam Zentiva has been taken at high doses, symptoms may appear in the baby
such as breathing disorders, low body temperature (hypothermia), decreased movements,
heartbeat disturbances.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.

Driving and using machines
The use of Bromazepam Zentiva can affect your ability to drive vehicles and use machinery because
you may have difficulty concentrating, feel forgetful, drowsy, or have problems with muscle tone.
These effects are increased if you have not had enough sleep. If this happens to you, avoid driving
vehicles or using machinery.
Drinking alcohol while taking this medicine exacerbates these effects and therefore negatively affects
the ability to drive vehicles and use machinery.

Bromazepam Zentiva tablets contain lactose monohydrate.
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to some
sugars, consult him before taking this medicine.

3. How to take Bromazepam Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
The doctor will establish the dose based on your needs.
Tablets: the average recommended dose is from 1 to 2 tablets of 1.5 mg, 2-3 times a day or 1
tablet of 3 mg, 2-3 times a day.
Oral drops: the average recommended dose is from 15 drops to 30 drops, 2-3 times a day.

Administer the drops of Bromazepam Zentiva as follows:

• To open the bottle: press on the cap and unscrew simultaneously (Fig. 1).
• Let the drops fall into a glass, holding the bottle in a vertical position with the opening facing downwards. The drops must be diluted with a little water (Fig. 2).
• To close the bottle: screw the cap on tightly until it is sealed (Fig. 3).

Fig. 1Fig. 2Fig. 3
Treatment of anxiety
The duration of treatment should be as short as possible. The duration of treatment, generally, should not
exceed 8-12 weeks, including a period of gradual discontinuation.
In certain cases, the doctor may decide to prolong the treatment, but only after evaluating your
health conditions.

Treatment of insomnia
The duration of treatment should be as short as possible. The duration of treatment, generally, 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 may decide to prolong the treatment, after evaluating your
health conditions.
The treatment must be started with the lowest recommended dose. The maximum dose must not be
exceeded.
The doctor will regularly monitor your condition from the start of treatment to decrease, if necessary,
the dose or frequency of intake.

Use in the elderly and in people with kidney problems or with breathing problems (chronic
respiratory failure)
In the elderly and in patients with these disorders, the 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 think a child
may have taken this medicine, immediately notify your doctor or go to the Emergency Room
of the nearest hospital.
An overdose can cause drowsiness, speech disorders (dysarthria), involuntary eye movements (nystagmus). It can also cause severe depression of the nervous system with disorders such as
drowsiness, mental confusion, lethargy, speech disorders (slurred speech), loss of reflexes
(areflexia), progressive loss of muscle coordination (ataxia), decreased muscle tone
(hypotonia), breathing problems (apnea, respiratory depression), lowering of blood pressure
(hypotension), heart depression, coma and death.
Bring this leaflet and the remaining packaging with the medicine to the hospital or doctor
so they know which medicine was taken.

If you forget to take Bromazepam Zentiva
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost
time to take the 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 agreeing
with your doctor, because withdrawal symptomsmay occur.
If the doctor has decided to stop the treatment, they will gradually reduce the dose to minimize
withdrawal symptoms (see paragraph 2, “Warnings and precautions – Discontinuation of treatment and
withdrawal”).
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.
Seek immediate medical attention if you experience:
Behavioural changes including:
Depression and behavioural reactions, such as restlessness, agitation, irritability, aggression, delirium,
anger, nightmares, hallucinations (seeing or 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 any of these side effects occur, stop treatment and
contact your doctor immediately. These reactions are more common in children, the elderly and
people with brain diseases (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(the frequency cannot be estimated from the available data):

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

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

• jaundice (yellowing of the skin and whites of the eyes)
• increased levels of certain liver enzymes (transaminases, bilirubin, alkaline phosphatase)
• decreased platelets (thrombocytopenia), decreased white blood cells (agranulocytosis), decreased all blood cells (pancytopenia) alteration of the secretion of the antidiuretic hormone (SIADH) Reporting ofside effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 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.
This medicine does not require any particular storage conditions.
Bromazepam Zentiva 2.5 mg/ml oral drops, solution.
Period of validity after first opening of the bottle: 12 weeks. After this period, any excess product
must be discarded.
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 Zentiva contains
Bromazepam Zentiva 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, talc, magnesium stearate.

Bromazepam Zentiva 3 mg tablets

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

Bromazepam Zentiva 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, disodium edetate, mixed fruit flavors, purified water, propylene glycol.

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

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale Bodio, 37/B – 20158 Milan

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)