BROMAZEPAM 1.5 mg Tablet

Зміст інструкції

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

Bromazepam Mylan Generics Italia 1,5 mg tablets, 3 mg tablets, 2,5 mg/ml oral drops, solution

bromazepam

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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Bromazepam Mylan Generics Italia and what is it used for

Bromazepam Mylan Generics Italia contains the active ingredient bromazepam, which belongs to a group of
medicines called benzodiazepines.
Bromazepam Mylan Generics Italia is used in adultsfor the treatment of:

• anxiety, states of emotional tension and other manifestations associated with anxiety;
• insomnia; only when it is severe, disabling and causes significant distress in normal daily life.

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Bromazepam Mylan Generics Italia

Do not take Bromazepam Mylan Generics Italia

• if you are allergic to bromazepam or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (benzodiazepines);
• if you suffer from myasthenia gravis, a severe muscle disease that causes weakness and fatigue;
• if you suffer from severe respiratory failure (severe reduction of the activity of the respiratory system);
• if you have serious liver problems (severe hepatic insufficiency);
• if you have problems breathing during sleep (sleep apnea);
• if you have an eye disease caused by an increase in the pressure of the fluid contained within the eye, called narrow-angle glaucoma;
• if you have consumed an excessive amount of alcohol (acute alcohol intoxication);
• if you have consumed an excessive amount of other medicines:
• hypnotics (medicines that calm and promote sleep);
• analgesics (medicines for the treatment of 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 Mylan Generics Italia.
In particular, talk to your doctor or pharmacist beforetaking Bromazepam Mylan Generics Italia if
you think that any of the following conditions apply to you:

• you suffer from depression or anxiety related to depression, because Bromazepam Mylan Generics Italia may worsen your condition and may lead to the onset of suicidal thoughts (attempting to kill yourself);
• you have had problems with drug or alcohol abuse in the past;
• if you are addicted to alcohol or use opioids (medicines used for pain);
• if you have previously developed a severe allergic reaction after the administration of a benzodiazepine (anaphylactic/anaphylactoid reaction);
• you suffer from chronic respiratory failure (reduction of the activity of the respiratory system);
• you suffer from renal insufficiency (reduced kidney function);
• you suffer from severe hepatic insufficiency (severe reduction of liver function);
• you suffer from heart failure (reduced heart function);
• you suffer from low blood pressure;
• you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis).

Tolerance
Following repeated use of this medicine for a prolonged period, a
decrease in efficacy (tolerance) may occur. Talk to your doctor.

Dependence
When you take this medicine at high doses and/or for prolonged periods, there is a risk of physical and psychological dependence, that is, the need to continue taking the medicine. This risk is higher if
you have suffered from psychiatric disorders in the past, have abused medicines, drugs or alcohol (especially in
poly-abusers).
The possibility of dependence is reduced if you use Bromazepam Mylan Generics Italia at the
appropriate dose, as prescribed by your doctor and with a short-term treatment (see section 3 “How
to take Bromazepam Mylan Generics Italia”).

Elderly
If you are elderly, take Bromazepam Mylan Generics Italia with caution and under your doctor's supervision.
This medicine may increase the risk of falls and fractures due to undesirable effects such as ataxia
(reduced motor and gait coordination), muscle weakness, dizziness, drowsiness, fatigue,
tiredness.

Children and adolescents
Benzodiazepines should not be administered to patients under the age of 18.
It may be administered under the direct supervision of a doctor, if absolutely necessary and the duration of
treatment will be as short as possible.

Other medicines and Bromazepam Mylan Generics Italia
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 or pharmacist if you are taking the following medicines:

• medicines used for some mental disorders (antipsychotics/neuroleptics);
• calming and sleep-inducing medicines (hypnotics);
• medicines that cause physical and mental torpor (anxiolytics and sedatives);
• medicines for the treatment of depression (antidepressants, such as fluvoxamine);
• medicines for the treatment of acute or chronic severe pain (narcotic-opioid analgesics), which can increase the dependence on these medicines;
• medicines used for epilepsy (antiepileptics);
• medicines used to treat allergies (sedating antihistamines);
• anaesthetics;
• medicines used for cough (opioid antitussives);
• theophylline and aminophylline, used to treat asthma or other respiratory diseases;
• medicines used to treat fungal infections (antimycotics), protease inhibitors (used for HIV therapy) and macrolide antibiotics;
• cimetidine, used to treat heartburn and stomach lesions;
• propranolol (used for various types of heart problems).

The concomitant use of Bromazepam Mylan Generics Italia and opioids (strong painkillers, medicines for
substitute 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 be considered only when other treatment options are not possible.
However, if your doctor prescribes Bromazepam Mylan Generics Italia 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 dosage recommendations. 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 Mylan Generics Italia and alcohol
Donot drink alcohol while taking Bromazepam Mylan Generics Italia because the sedative effect may
be increased.
Taking alcohol with Bromazepam Mylan Generics Italia may impair your ability to drive
vehicles and operate machinery (see section “Driving and using machines”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of bromazepam use during pregnancy has not yet been established. In some studies, an increased risk of congenital malformations has been observed following the use of other benzodiazepines or
similar substances during the first trimester of pregnancy. Treatment with benzodiazepines at high doses,
during the second and/or third trimester of pregnancy may cause a decrease in fetal movements
and alterations in fetal heart rate.

• If you intend to become pregnant and are being treated with Bromazepam Mylan Generics Italia, contact your doctor immediately who will tell you how to gradually stop using this medicine.
• If Bromazepam Mylan Generics Italia is administered during the last period of pregnancy, or during labor, hypothermia (reduction of body temperature), hypotonia (reduction of muscle tone) and respiratory depression or apnea (absence of respiratory movements) may occur in the newborn. In addition, newborns born to mothers who have chronically taken benzodiazepines during the advanced stages of pregnancy may develop physical dependence and may present a certain risk of developing withdrawal symptoms in the postnatal period, including hyperactivity, agitation and tremor, even several days after birth.

Breastfeeding

Donot take this medicine if you are breastfeeding, because bromazepam passes into breast milk.

Driving and using machines
Do not drive or operate machinery if you experience
undesirable effects such as sedation (physical and mental relaxation), amnesia (memory disorders), alteration
of concentration and muscle function during treatment with Bromazepam Mylan Generics Italia. These effects are also worsened if you take alcohol
together with Bromazepam Mylan Generics Italia (see section “Bromazepam Mylan Generics Italia and
alcohol”).
Your vigilance may be altered especially if your sleep duration has been insufficient after taking
Bromazepam Mylan Generics Italia.

Bromazepam Mylan Generics Italia tablets contains lactose
If your doctor has diagnosed you with lactose intolerance, contact him before taking this
medicine.

Bromazepam Mylan Generics Italia oral drops, solution contains propylene glycol
This medicine contains 1144.36 mg of propylene glycol per 30-drop dose.
If the child is under 5 years of age, talk to your doctor or pharmacist before giving this
medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding or suffer from liver or kidney disease, do not take this medicine unless
otherwise recommended by your doctor. The doctor may perform further checks during therapy.
The oral solution contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Bromazepam Mylan Generics Italia

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Adults
The doctor will establish the dose and frequency most suitable for you, in order to avoid the possible intake of an
excessive dose of this medicine.
The recommended dose ranges from 1.5 mg to 3 mg, 2-3 times a day:

• 1.5 mg tablets: 1-2 tablets 2-3 times a day
• 3 mg tablets: 1 tablet 2-3 times a day
• drops: 15-30 drops 2-3 times a day

Treatment should be started with the lowest recommended dose, gradually increasing it to the
optimal level. The maximum dose should not be exceeded.
Take the drops of Bromazepam Mylan Generics Italia 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 down (Fig. 2).
• To close the bottle: screw the cap on tightly (Fig. 3).

Fig. 1Fig. 2Fig. 3
Duration of treatment
The doctor will prescribe the shortest possible duration of treatment.
Depending on the indication for which the doctor has prescribed this medicine, the duration of treatment is as
follows:

• anxiety: the duration of treatment should not exceed 8/12 weeks, including a period of gradual discontinuation
• insomnia: the duration of treatment 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, after evaluating your state of health, may decide to prolong the treatment. During the period of discontinuation of treatment with Bromazepam Mylan Generics Italia, the doctor will explain how to gradually reduce the dose of this medicine in order to reduce the risk of withdrawal and rebound symptoms (see paragraphs “If you stop taking Bromazepam Mylan Generics Italia” and “Possible side effects”).

Use in children and adolescents
The use of bromazepam is not indicated in children and adolescents.

Use in the elderly
The dose is carefully established by the doctor, who will assess the need to reduce dosages.

If you take more Bromazepam Mylan Generics Italia than you should
If you (or someone else) have taken an excessive dose of Bromazepam Mylan Generics Italia 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.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine was taken.

Symptoms
A benzodiazepine overdose commonly causes drowsiness, ataxia (reduced motor and
gait coordination), dysarthria (difficulty speaking) and nystagmus (oscillatory, rhythmic and involuntary
eye movements).
Overdose of bromazepam can rarely pose a life risk if the drug is taken by
alone, but can lead to dysarthria (words pronounced slowly and defectively), areflexia (absence of
reflexes), apnea (breathing problems), hypotension (low blood pressure), cardiorespiratory depression (reduced
heart and lung activity) and coma (loss of consciousness).
In mild cases, the symptoms in case of accidental ingestion/intake of an excessive dose of Bromazepam
Mylan Generics Italia may be:

• drowsiness;
• mental confusion;
• lethargy (continuous sleep and reduced response to normal stimuli). In more severe cases, the symptoms may be:
• 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 Mylan Generics Italia
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 Mylan Generics Italia
Donot suddenly stop treatment with Bromazepam Mylan Generics Italia or without first
agreeing with your doctor, as withdrawal symptoms may occur.
The doctor will gradually reduce the dose during the phase of discontinuation of therapy.
Abrupt discontinuation of this medicine can cause:

• withdrawal symptoms: headache, diarrhea, muscle pain, tension, extreme anxiety, confusion, restlessness and irritability.
• severe withdrawal symptoms: derealization (feeling that things are not real), depersonalization (feeling of detachment or alienation from oneself), increased sensitivity 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), seizures.
• other withdrawal symptoms:depression, insomnia, sweating, persistent ringing in the ear (tinnitus), involuntary movements, vomiting, altered sensitivity of hands and feet (paresthesia), altered perception, abdominal and muscle cramps, tremor, muscle inflammation with pain (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).
• rebound symptoms:(when the symptoms that led to treatment with bromazepam reappear in a more severe form after discontinuation of treatment) such as mood changes, anxiety, restlessness or sleep disturbances.

These symptoms occur especially if you have developed physical dependence on this medicine (see
paragraph “Warnings and precautions”).
If you have any questions 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.
Contact your doctor immediatelyif you experience any of the following seriousside effects; your doctor will
explain how to stopusing the medicine:

• depression
• restlessness
• agitation
• irritability
• aggression
• nervousness
• anxiety
• psychomotor hyperactivity
• delirium (distorted perception of reality)
• rage
• nightmares and abnormal dreams
• 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)
• behavioral changes. These reactions are more likely to occur in children or if you are elderly (see section “Warnings and precautions”).

The following side effects may also occur with an unknown frequency (frequency cannot
be estimated based on available data):

• allergic reaction (hypersensitivity)
• severe allergic reaction (anaphylactic shock)
• swelling of the face or mouth causing difficulty in breathing (angioedema)
• confusional state
• disorientation
• emotional and mood disorders
• decreased sexual desire (libido)
• dependence
• medicine abuse
• withdrawal syndrome
• long-term memory loss (anterograde amnesia)
• memory problems
• drowsiness
• dizziness
• headache
• double vision (diplopia)
• decreased level of consciousness
• loss of muscle coordination and gait (ataxia)
• blurred vision
• nausea
• vomiting
• constipation
• skin rash
• itching
• urticaria
• muscle weakness
• urination disorders (urinary retention)
• fatigue
• falls*
• fractures*
• difficulty breathing (respiratory depression)
• temporary cessation of breathing (apnea)
• breathing problems during the night (worsening of sleep apnea)
• heart problems (heart failure), including cardiac arrest
• jaundice (yellowing of the skin and whites of the eyes)
• alteration of some blood tests (increased transaminases, bilirubin and 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) which causes water retention in the body and reduced levels of sodium in the blood. *especially in the elderly and patients taking sedatives and alcohol concurrently

Other side effects that have been reported with other medicines belonging to the
benzodiazepine class, such as Bromazepam Mylan Generics Italia:

• memory problems (amnesia and anterograde amnesia)
• behavioral changes
• depression (worsening of pre-existing depressive state)
• restlessness
• agitation
• irritability
• aggression
• delirium
• rage
• nightmares
• hallucinations
• psychosis
• insomnia
• rebound anxiety (which occurs after stopping the medicine)
• dependence on the medicine

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 Mylan Generics Italia

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 pack 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
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 contains Bromazepam Mylan Generics Italia

Bromazepam Mylan Generics Italia 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 Mylan Generics Italia 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 Mylan Generics Italia 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 Mylan Generics Italia and contents of the pack
Tablets: pack containing 20 tablets.
Oral drops, solution: pack containing a 20 ml bottle of solution.

Marketing Authorisation Holder
Mylan S.p.A., via Vittor Pisani 20, 20124 Milano

Manufacturers
Oral drops, solution:
Doppel Farmaceutici S.r.l., via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 Località San Bernardo, Ivrea (TO)
1.5 mg and 3 mg tablets:
Doppel Farmaceutici S.r.l., via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI)
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 Località San Bernardo, Ivrea (TO)