BROMAZEPAM 1.5 mg Таблетки

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

Bromazepam Alter 1,5 mg tablets, 3 mg tablets, 2,5 mg/ml oral drops, solution

Bromazepam

Generic medicine
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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bromazepam Alter 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 Alter

Do not take Bromazepam Alter

• 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 trouble 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 intoxication from alcohol or other medicines that act on the nervous system (hypnotics, analgesics, antidepressants, lithium).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bromazepam Alter.
Be careful when using this medicine because it can cause serious allergic reactions (anaphylactic reactions) with swelling that affects the tongue, larynx and throat, which can cause difficulty in
breathing and swallowing (angioedema), shortness of breath (dyspnea), closure of the throat, nausea and vomiting. Your
doctor will regularly assess the need to continue therapy.
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 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 it seems to you that the medicine no longer works as well as at the beginning of
treatment, 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 the dose and duration of treatment. It is
higher if you have suffered from psychiatric disorders in the past or have abused drugs or alcohol.

Withdrawal:when you stop taking Bromazepam Alter you may experience withdrawal symptoms or
rebound (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 Alter”). To minimize these symptoms it is
recommended to gradually reduce the dose.
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, such 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: to reduce the risk of amnesia (memory loss), make sure you have an uninterrupted sleep of 7-8 hours.

Behavioral reactions: if you experience behavioral disturbances, immediately stop
taking the medicine (see section 4. “Possible side effects”). 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 children and adolescents under the age of 18, Bromazepam Alter should only be used in cases of
absolute necessity and the duration of treatment should be as short as possible.

Other medicines and Bromazepam Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention 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 and sedatives, used to treat anxiety
• some strong painkillers (opioids), which can cause an increased sense of well-being when taken with Bromazepam Alter. This may 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 Alter and opioids (strong painkillers, medicines for the therapy of
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 Alter together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell 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 members to watch out for
the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take Bromazepam Alter during pregnancy unless absolutely necessary.
If your doctor believes you should take this medicine in the late stages of pregnancy or during
labor, your baby may develop floppy baby syndrome characterized by low
body temperature, loss of muscle tone, difficulty breathing.
If Bromazepam Alter has been taken regularly during the late stages of pregnancy, your baby
may develop physical dependence and withdrawal symptoms.
If you start treatment with Bromazepam Alter in your childbearing years, consult your doctor, whether you intend to start a
pregnancy or suspect you are pregnant, because the administration of the
medicine will need to be stopped.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.

Driving and using machines
The use of Bromazepam Alter can affect your ability to drive vehicles and operate machinery because
you may feel confused, forgetful, drowsy, with muscle tone problems. These effects increase if
you haven't slept enough. If this happens to you, avoid driving vehicles or operating machinery.
Drinking alcohol while taking this medicine negatively affects your ability to
drive vehicles and operate machinery.

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

Bromazepam Alter drops contains propylene glycol
This medicine contains 1013 mg of propylene glycol per 1 ml.

3. How to take Bromazepam Alter

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
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 is from 1.5 mg to 3 mg, 2-3 times a day:
1-2 tablets of 1.5 mg 2-3 times a day, or 1 tablet of 3 mg 2-3 times a day, or 15-
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 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.
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 decrease, 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 Alter than you should
If you (or someone else) have taken an overdose of Bromazepam Alter 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 severe depression of the nervous system with symptoms such as drowsiness,
progressive loss of muscle coordination (ataxia), difficulty in articulating words, visual disturbances,
loss of reflexes, breathing problems (respiratory depression), lowering of blood pressure
(hypotension), depression of the nervous system that can worsen up to coma and very rarely
to death.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine has been taken.

If you forget to take Bromazepam Alter
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 a missed dose.

If you stop taking Bromazepam Alter
Do not stop treatment with Bromazepam Alter 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, 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, sensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures may appear. 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 Alter. 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.
Contact your doctor immediately if you experience:

• depression and behavioral 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 behavior. If 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 alertness
• reduced emotional capacity
• fatigue, decreased muscle tone, muscle weakness, tiredness
• loss of muscle coordination (ataxia)
• headache, double vision
• nausea, vomiting.

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
• constipation
• urination disorders (urinary retention)
• sudden, potentially life-threatening allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat that may cause difficulty breathing and swallowing (angioedema)
• jaundice, a disease characterized by a yellowish discoloration of the skin and whites of the eyes
• increased levels of liver enzymes (transaminases), increased bilirubin, increased alkaline phosphatase
• decreased platelets (thrombocytopenia), decreased white blood cells (agranulocytosis), decreased of all blood cells (pancytopenia)
• alteration of the secretion of the antidiuretic hormone (SIADH)
• increased risk of falls and fractures, especially in the elderly and patients taking sedatives and alcohol concurrently
• decreased libido
• dependence on the medicine, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Bromazepam Alter”)
• loss of memory that does not impair past memories (anterograde amnesia) (see section “Warnings and precautions”), memory disorders
• respiratory depression, apnea, breathing problems during the night (sleep apnea)
• urticaria, skin rash, itching.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://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 Alter

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 9 months 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 Alter contains
Bromazepam Alter 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 Alter 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 Alter 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 Alter and contents of the pack
Pack containing 20 tablets of 1.5 mg in blisters.
Pack containing 20 tablets of 3 mg in blisters.
Pack containing 1 bottle of 20 ml of solution.

Marketing Authorisation Holder
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milan

Manufacturers
Oral drops:

• Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
• ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO) Tablets of 1.5 mg and 3 mg:
• Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto Dè Stampi, Rozzano (MI)