Bromazepam Mylan Generics Italia

Italy
Brand name Bromazepam Mylan Generics Italia
Form tablets
Active substance / Dosage
BROMAZEPAM
Prescription type Prescription only
ATC code
N05BA08
Registration number 036034
Manufacturer MYLAN S.P.A.

Table of Contents

Patient Information Leaflet

Bromazepam Mylan Generics Italia 1.5 mg tablets, 3 mg tablets, 2.5 mg/ml oral drops, solution

bromazepam
Generic Medicine
Please read this leaflet carefully before taking 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

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

2. What you should 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 serious muscle disease causing weakness and fatigue;
  • if you have severe respiratory insufficiency (severe reduction in respiratory system activity);
  • if you have severe liver problems (severe hepatic insufficiency);
  • if you have breathing difficulties during sleep (sleep apnoea);
  • if you have a condition of the eye caused by increased pressure of the fluid inside the eye, known as narrow-angle glaucoma;
  • if you have consumed excessive amounts of alcohol (acute alcohol intoxication);
  • if you have taken excessive amounts of other medicines:
    • hypnotics (calming and sleep-inducing medicines);
    • 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 before taking Bromazepam Mylan Generics Italia if
you think any of the following conditions apply to you:

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

Tolerance
Following repeated use of this medicine over a prolonged period, a reduction in effectiveness (tolerance) may occur. Consult your doctor.
Dependence
When taking this medicine at high doses and/or for prolonged periods, there is a risk of physical and psychological dependence, i.e. the need to continue taking the medicine. This risk is higher if you have previously suffered from psychiatric disorders, or have abused medicines, drugs, or alcohol (especially in polydrug abusers).
The risk of dependence is reduced if you use Bromazepam Mylan Generics Italia at the appropriate dose, as prescribed by your doctor, and for the shortest possible duration (see section 3 “How to take Bromazepam Mylan Generics Italia”).
Elderly patients
If you are elderly, take Bromazepam Mylan Generics Italia with caution and under medical supervision.
This medicine may increase the risk of falls and fractures due to adverse effects such as ataxia (reduced motor coordination and gait), muscle weakness, dizziness, drowsiness, fatigue, and tiredness.
Children and adolescents
Benzodiazepines must not be administered to patients under 18 years of age.
Administration may be considered under direct medical supervision if strictly necessary, and the duration of treatment should 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 special attention and inform your doctor or pharmacist if you are taking the following medicines:

  • medicines used for certain mental disorders (antipsychotics/neuroleptics);
  • calming and sleep-inducing medicines (hypnotics);
  • medicines causing physical and mental dullness (anxiolytics and sedatives);
  • medicines for the treatment of depression (antidepressants, such as fluvoxamine);
  • medicines for the treatment of severe acute or chronic pain (narcotic analgesics/opioids), which may increase dependence on these medicines;
  • medicines used for epilepsy (antiepileptics);
  • medicines used to treat allergies (antihistamines with sedative effect);
  • anaesthetics;
  • medicines used for cough (antitussive opioids);
  • theophylline and aminophylline, used to treat asthma or other respiratory diseases;
  • medicines used to treat fungal infections (antifungals), protease inhibitors (used in HIV therapy), and macrolide antibiotics;
  • cimetidine, used to treat stomach burning and lesions;
  • propranolol (used for various heart conditions).

Concomitant use of Bromazepam Mylan Generics Italia and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Bromazepam Mylan Generics Italia together with opioids, the dose and duration of concomitant treatment must be strictly limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. 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 any of these symptoms.
Bromazepam Mylan Generics Italia and alcohol
Do not drink alcohol while taking Bromazepam Mylan Generics Italia, as the sedative effect may be enhanced.
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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of using bromazepam 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 reduced fetal movements and changes in heart rate.

  • If you plan to become pregnant and are currently being treated with Bromazepam Mylan Generics Italia, contact your doctor immediately. Your doctor will advise you on how to gradually discontinue this medicine.
  • If Bromazepam Mylan Generics Italia is administered during late pregnancy or during labour, the newborn may experience hypothermia (reduced body temperature), hypotonia (reduced muscle tone), respiratory depression, or apnoea (absence of respiratory movements). Furthermore, newborns born to mothers who have chronically taken benzodiazepines during the later stages of pregnancy may develop physical dependence and may be at risk of experiencing withdrawal symptoms in the postnatal period, such as hyperexcitability, agitation, and tremors, even several days after birth.

Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.
Driving and using machines
Do not drive or operate machinery if, during treatment with Bromazepam Mylan Generics Italia, you experience adverse effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or altered muscle function. These effects may be worsened if you consume alcohol together with Bromazepam Mylan Generics Italia (see section “Bromazepam Mylan Generics Italia and alcohol”).
Your alertness may be impaired, especially if your sleep duration has been insufficient after taking Bromazepam Mylan Generics Italia.
Bromazepam Mylan Generics Italia tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor 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, speak with your doctor or pharmacist before administering 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. Your doctor may perform additional monitoring during treatment.
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 instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
Your doctor will determine the most suitable dose and frequency 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 daily:

  • 1.5 mg tablets: 1–2 tablets 2–3 times daily
  • 3 mg tablets: 1 tablet 2–3 times daily
  • drops: 15–30 drops 2–3 times daily

Treatment should be initiated with the lowest recommended dose, gradually increasing it until the optimal level is reached. The maximum dose must not be exceeded.
Take Bromazepam Mylan Generics Italia drops as follows:

  • To open the bottle: press down on the cap and simultaneously unscrew it (Fig. 1).
  • Let the drops fall into a glass, holding the bottle in an upright position with the opening facing downward (Fig. 2).
  • To close the bottle: screw the cap back on until tightly sealed (Fig. 3).
Schematic drawing of a bottle with a screw cap and two arrows indicating the downward movement for closing or opening

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

  • Anxiety: treatment duration should not exceed 8–12 weeks, including a period of gradual discontinuation.
  • Insomnia: treatment duration ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation. In certain cases, after assessing your health status, your doctor may decide to extend the treatment. During the discontinuation period of Bromazepam Mylan Generics Italia treatment, your doctor will explain how to gradually reduce the dose of this medicine in order to minimize the risk of withdrawal and rebound symptoms (see sections “If you stop taking Bromazepam Mylan Generics Italia” and “Possible side effects”).

Use in children and adolescents
The use of bromazepam is not recommended in children and adolescents.
Use in elderly patients
The dose will be carefully determined by the doctor, who will evaluate whether dosage reduction is necessary.
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 suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
Bring this leaflet, the bottle, and its container with you to the hospital or doctor so they know which medicine has been taken.
Symptoms
Overdose with benzodiazepines commonly causes drowsiness, ataxia (reduced motor coordination and gait), dysarthria (difficulty speaking), and nystagmus (oscillating, rhythmic, involuntary eye movements).
Bromazepam overdose rarely poses a life-threatening risk when taken alone, but may lead to dysarthria (slow and slurred speech), areflexia (absence of reflexes), apnea (breathing difficulties), hypotension (low blood pressure), cardiorespiratory depression (reduced heart and lung activity), and coma (loss of consciousness).
In mild cases, symptoms following accidental ingestion/overdose of Bromazepam Mylan Generics Italia may include:

  • drowsiness;
  • mental confusion;
  • lethargy (continuous sleepiness and reduced response to normal stimuli).

In more severe cases, symptoms may include:

  • ataxia (reduced motor coordination and gait);
  • 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, 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 Mylan Generics Italia
Do not stop treatment with Bromazepam Mylan Generics Italia suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
Your doctor will gradually reduce your dose during the discontinuation phase.
Sudden discontinuation of this medicine may cause:

  • Withdrawal symptoms: headache (cephalaea), diarrhoea, muscle pain, tension, extreme anxiety, confusion, restlessness, and irritability.
  • Severe withdrawal symptoms: derealization (feeling that things are not real), depersonalization (feeling of detachment or estrangement from oneself), increased sensitivity to sound (hyperacusis), numbness and tingling in hands and feet, hypersensitivity to light, noise, and physical contact, hallucinations (seeing and hearing things that are not real), epileptic seizures.
  • Other withdrawal symptoms: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscular cramps, tremor, muscle inflammation with pain (myalgia), agitation, sensation 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 symptoms that led to treatment with bromazepam reappear in a more severe form after stopping treatment), such as mood changes, anxiety, restlessness, or sleep disturbances.

These symptoms occur especially if you have developed physical dependence on this medicine (see section “Warnings and precautions”).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately contact your doctor if you experience any of the following serious side effects; your doctor will advise you how to discontinue use of the medicine:

  • depression
  • restlessness
  • agitation
  • irritability
  • aggression
  • nervousness
  • anxiety
  • psychomotor hyperactivity
  • delirium (distorted perception of reality)
  • anger
  • nightmares and abnormal dreams
  • hallucinations (seeing or hearing things that do not exist)
  • psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly)
  • behavioural changes. These reactions are more likely to occur in children or in elderly patients (see section “Warnings and precautions”).

The following side effects may also occur with unknown frequency (the frequency cannot be determined from the available data):

  • allergic reaction (hypersensitivity)
  • severe allergic reaction (anaphylactic shock)
  • swelling of the face or mouth causing breathing difficulties (angioedema)
  • confusion
  • disorientation
  • disturbances in emotional state and mood
  • changes in sexual desire (libido)
  • dependence
  • misuse of the medicine
  • withdrawal syndrome
  • long-term memory loss (anterograde amnesia)
  • memory disturbances
  • drowsiness
  • dizziness
  • headache
  • double vision (diplopia)
  • reduced level of consciousness
  • loss of muscle coordination and gait (ataxia)
  • blurred vision
  • nausea
  • vomiting
  • constipation
  • skin rash
  • itching
  • hives (urticaria)
  • muscle weakness
  • urinary problems (urinary retention)
  • fatigue
  • falls*
  • fractures*
  • difficulty breathing (respiratory depression)
  • temporary interruption of breathing (apnoea)
  • breathing problems during the night (worsening of nocturnal apnoea)
  • heart problems (heart failure), including cardiac arrest
  • jaundice (yellowing of the skin and whites of the eyes)
  • changes in certain blood tests (increased transaminases, bilirubin, and alkaline phosphatase)
  • decrease in platelets (thrombocytopenia)
  • decrease in white blood cells (agranulocytosis)
  • decrease in all blood cells (pancytopenia)
  • disturbance in the secretion of antidiuretic hormone (SIADH), leading to water retention in the body and reduced sodium levels in the blood.
    *particularly in the elderly and in patients concurrently taking sedatives and alcohol

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

  • memory disturbances (amnesia and anterograde amnesia)
  • behavioural changes
  • depression (worsening of pre-existing depression)
  • restlessness
  • agitation
  • irritability
  • aggression
  • delirium
  • anger
  • nightmares
  • hallucinations
  • psychosis
  • insomnia
  • rebound anxiety (occurring after discontinuation of the medicine)
  • dependence on the medicine

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 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, undamaged packaging, stored correctly.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Mylan Generics Italia contains
Bromazepam Mylan Generics Italia 1.5 mg tablets

  • The active substance 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 substance 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 substance is bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
  • The other ingredients are: sodium saccharin, disodium edetate, mixed fruit flavours, 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 one 20 ml bottle of solution.

Marketing Authorization 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)