BROMAZEPAM 1.5 mg Tablet

Зміст інструкції

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

BROMAZEPAM ALMUS 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 pass it on to others, even if they have the same symptoms as you, as it may 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 ALMUS is and what it is used for
• 2. What you need to know before you take BROMAZEPAM ALMUS
• 3. How to take BROMAZEPAM ALMUS
• 4. Possible side effects
• 5. How to store BROMAZEPAM ALMUS
• 6. Contents of the pack and other information

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

BROMAZEPAM ALMUS 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 serious 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 taking BROMAZEPAM ALMUS

Do not take BROMAZEPAM ALMUS

• 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 serious liver problems (hepatic insufficiency)
• if you have problems breathing during sleep (sleep apnea)
• if you have an eye disease called narrow-angle glaucoma
• if you have an intoxication from alcohol or other medicines that depress the nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)

Warnings and precautions
Consult your doctor or pharmacist before taking BROMAZEPAM ALMUS.
Be careful when using the medicine because it can cause serious allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling involving the tongue, larynx and throat that
can cause difficulty in breathing and swallowing (angioedema), shortness of breath (dyspnea),
constriction of the throat, nausea and vomiting. The doctor will continuously assess the need to continue
therapy and, in case of angioedema, will tell you not to resume treatment.
Take this medicine with cautionand always under the supervision of your doctor in the following cases:

• if you are elderly. In this case, the doctor may decide to reduce the dose to avoid undesirable effects such as loss of muscle coordination (ataxia), muscle weakness, dizziness, drowsiness, fatigue, and exhaustion which can increase the risk of falls
• if you have respiratory problems (respiratory failure). In this case, the doctor may decide to reduce the dose
• if you have serious liver problems (hepatic insufficiency)
• if you have kidney problems (renal insufficiency)
• if you have low blood pressure or heart problems (heart failure). In this case, the doctor may decide to subject you to regular checks
• 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 not working as well as
at the beginning of treatment, consult your doctor.

Dependence:When you take this medicine, there is a risk of physical and
psychic dependence, that is, the need to continue taking the medicine. The risk increases with the dose
and duration of treatment. It is greater if you have suffered from psychiatric disorders in the past or have
abused drugs or alcohol.

Withdrawal:When you stop taking BROMAZEPAM ALMUS, you may experience withdrawal or rebound symptoms (such as headache, diarrhea, muscle pain, severe anxiety, tension,
restlessness, confusion and irritability), even if you have taken the medicine at the recommended doses and
for a short period of time (see section “If you stop taking BROMAZEPAM ALMUS”). To minimize these symptoms, it is recommended to gradually reduce the
dose.
Withdrawal symptoms may also appear when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such a substitution is not
recommended.

Duration of treatment:The duration of treatment should be as short as possible and should not
exceed 4 weeks for the treatment of insomnia and 8-12 weeks for the treatment of
anxiety, including a period of gradual discontinuation.
Amnesia: Benzodiazepines can induce amnesia (memory loss). This happens more often
several hours after taking the drug. To reduce the risk, ensure uninterrupted sleep
of 7-8 hours.
Behavioralreactions: If you experience reactions such as restlessness, agitation, irritability,
aggression, delirium, anger, nightmares, hallucinations, psychosis, altered behavior and other
adverse effects related to behavior, consult your doctor immediately because taking
the medicine should be discontinued. These reactions are more common in children and the elderly.
Benzodiazepines should not be used alone to treat depression or insomnia
associated with depression, as suicidal thoughts may occur in these patients.

Children and adolescents
In patients under the age of 18, BROMAZEPAM ALMUS should only be used in cases of
absolute necessity and the duration of treatment should be as short as possible.

Other medicines and BROMAZEPAM ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Be particularly careful and tell 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, tranquilizers and sedatives, used to treat anxiety
• some strong painkillers (opioids), which can cause an increased sense of well-being when taken with BROMAZEPAM ALMUS. This can increase your desire to continue taking these medicines (dependence)
• antiepileptics, used for epilepsy
• antihistamines with a 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
• cimetidine, used to treat heartburn and stomach lesions.

The concomitant use of BROMAZEPAM ALMUS and opioids (strong painkillers, medicines for
addiction therapy and some medicines for cough) increases the risk of drowsiness, difficulty in
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 ALMUS together with opioids, the dose and duration
of concomitant treatment must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow
your doctor's recommendations on dosage.
It may be helpful to inform friends or relatives to pay
attention to the signs and symptoms listed above.
Contact your doctor if you experience these symptoms.

BROMAZEPAM ALMUS with alcohol
Avoid drinking alcohol during treatment with this medicine, as it can 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 are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take BROMAZEPAM ALMUS during pregnancy unless absolutely necessary.
If your doctor believes you should take this medicine in the late stages of pregnancy, your
baby may develop floppy baby syndrome, characterized by low
body temperature, loss of muscle tone, low blood pressure, difficulty in
sucking and breathing.
If BROMAZEPAM ALMUS has been taken regularly during the late stages of pregnancy, your
baby may develop physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into
breast milk.

Driving and using machines
The use of BROMAZEPAM ALMUS can affect your ability to drive vehicles and use
machinery because you may feel confused, forgetful, drowsy, with muscle tone problems.
These effects are increased if you have not slept enough. If this happens to you, avoid
driving vehicles or using machinery.
Drinking alcohol during treatment with this medicine negatively affects the
ability to drive vehicles and use machinery.

BROMAZEPAM ALMUS tablets contain lactose.
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking
this medicine.

3. How to take BROMAZEPAM ALMUS

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The doctor will adjust the dose according to your needs.
The average recommended dose ranges from 1.5 mg (1 tablet of 1.5 mg or 15 drops) to 3 mg (2
tablets of 1.5 mg or 1 tablet of 3 mg or 30 drops), 2-3 times a day.

Treatment of anxiety, tension and other disorders associated with 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, after assessing your
health conditions.

Treatment of insomnia
The duration of treatment should be as short as possible. The duration of treatment,
generally, ranges 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 assessing your
health conditions.
Treatment should be started with the lowest recommended dose. The maximum dose should not
be exceeded.
The doctor will regularly check your condition at the beginning of treatment to reduce, if
necessary, the dose or frequency of intake.

Use in the elderly and people with kidney and liver problems
In the elderly and debilitated patients, a reduced dose should be administered.

If you take more BROMAZEPAM ALMUS than you should
If you (or someone else) have taken an excessive dose of BROMAZEPAM ALMUS or if you think a
child may have taken this medicine, immediately inform your doctor or go to the
Emergency Room of the nearest hospital.
An overdose can cause depression of the nervous system with symptoms ranging from
drowsiness to coma. Mild poisoning manifests with symptoms such as drowsiness
(nystagmus), mental confusion, severe fatigue (lethargy). In more severe cases, symptoms may
include progressive loss of muscle coordination (ataxia), decreased muscle tone (hypotonia), difficulty breathing (respiratory depression), low blood pressure (hypotension), rarely coma and very rarely death.
Bring this leaflet and the packaging to the hospital or doctor so they know which
medicine was taken.

If you forget to take BROMAZEPAM ALMUS
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 ALMUS
Do not stop treatment with BROMAZEPAM ALMUS suddenly or without first having
agreed 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, such as:

• headache, muscle pain, tension
• severe anxiety, confusion, restlessness, irritability
• in severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet, hypersensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures may occur. Other symptoms are: depression, insomnia, sweating, persistent ringing in the ear (tinnitus), involuntary movements, vomiting, altered sensitivity of hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, feeling of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia).

Treatment should be discontinued gradually otherwise the symptoms for which you were being treated
may reappear even more intensely than before (rebound insomnia and anxiety). The risk of
developing these symptoms is greater when you suddenly stop taking BROMAZEPAM ALMUS.
You may also experience mood changes, anxiety, restlessness and
sleep disturbances.
If you have any doubts about using 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:

• Depression and behavioral reactions, such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (a serious mental condition in which a person loses contact with reality and the ability to think and judge clearly), behavioral changes. If any of these side effects occur, treatment should be discontinued. These reactions are more likely to occur in children and the elderly (see section Warnings and precautions).

The following side effects may occur at the beginning of therapy, but disappear with
subsequent administrations:

• drowsiness, dizziness
• confusion, reduced emotional capacity, decreased alertness
• fatigue, decreased muscle tone
• loss of muscle coordination (ataxia)
• headache, double vision (diplopia).

The following side effects may also occur:

Frequency not known(frequency cannot be estimated based on available data):

• heart problems (heart failure, cardiac arrest)
• blurred vision
• nausea, dry mouth, constipation
• urinary problems (urinary retention)
• sudden, potentially life-threatening allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema)
• increased risk of falls and fractures, especially in the elderly
• decreased sexual desire
• dependence on the medicine, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking BROMAZEPAM ALMUS”)
• loss of memory that does not impair past memories (anterograde amnesia) (see section “Warnings and precautions”), memory disorders
• respiratory depression (dose-dependent, greater at higher doses), apnea, breathing problems during the night (sleep apnea)
• urticaria, rash, itching.

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

Rare(may affect up to 1 in 1,000 patients):

• increased levels of liver enzymes (transaminases), increased bilirubin, increased alkaline phosphatase;
• jaundice, a disease characterized by a yellowish discoloration of the skin and whites of the eyes;
• decreased platelets (thrombocytopenia), decreased white blood cells (agranulocytosis), decreased of all blood cells (pancytopenia);
• alteration of the secretion of the antidiuretic hormone (SIADH).

Reporting ofside effects
If 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
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 ALMUS

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.
BROMAZEPAM ALMUS 2.5 mg/ml oral drops, solution must be used within 12 weeks
from the first opening of 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 medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BROMAZEPAM ALMUS contains
BROMAZEPAM ALMUS 1.5 mg tablets

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

BROMAZEPAM ALMUS 3 mg tablets

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

BROMAZEPAM ALMUS 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: saccharin, disodium edetate, mixed fruit flavors, purified water, propylene glycol.

Description of the appearance of BROMAZEPAM ALMUS 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
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa

Manufacturers
Oral drops:
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe 1 - 29016 Cortemaggiore (PC)
1.5 mg and 3 mg tablets:
Doppel Farmaceutici S.r.l. - Via Volturno 48 - 20089 Quinto Dè Stampi, Rozzano (MI)