Bromazepam Aurobindo Italia

Patient Information Leaflet: Information for the Patient

Bromazepam Aurobindo Italia 2.5 mg/ml oral drops, solution

Equivalent medicine
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bromazepam Aurobindo Italia is and what it is used for

Bromazepam Aurobindo Italia contains the active substance bromazepam, which belongs to a group of
medicines called benzodiazepines.
Bromazepam Aurobindo Italia is used in adults to treat the following conditions:

• anxiety, emotional tension, and other manifestations associated with anxiety;
• insomnia; only when it is severe, disabling, and causes severe distress in normal daily life.
  Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Bromazepam Aurobindo Italia

Do not take Bromazepam Aurobindo 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 benzodiazepines (a class of medicines to which bromazepam belongs);
• if you suffer from myasthenia gravis, a serious disease affecting the muscles, characterized by weakness and fatigue;
• if you suffer from severe respiratory insufficiency (severe reduction in respiratory system activity);
• if you suffer from severe liver problems (severe hepatic impairment);
• if you suffer from sleep apnoea syndrome (temporary cessation of breathing during sleep);
• if you suffer from narrow-angle glaucoma (an eye disease caused by increased pressure of the fluid inside the eye);
• if you consume excessive amounts of alcohol (acute alcohol intoxication);
• if you consume excessive amounts of medicines:
• hypnotics (calming medicines and those promoting sleep);
• analgesics (medicines used to treat acute or chronic pain of high intensity);
• psychotropics (medicines used for mental disorders and/or depression).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bromazepam Aurobindo Italia.
In particular, consult your doctor or pharmacist before taking Bromazepam Aurobindo Italia if you think
any of the following conditions apply to you:

• you suffer from depression or anxiety associated with depression, because Bromazepam Aurobindo Italia may worsen your condition and may lead to suicidal thoughts (attempting to kill yourself);
• you have previously had problems with drug or alcohol abuse;
• you are dependent on alcohol 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 activity of the respiratory system);
• you suffer from renal insufficiency (reduced kidney function);
• you suffer from hepatic insufficiency (severe reduction in liver function);
• you suffer from cardiac insufficiency (reduced heart function);
• you suffer from low blood pressure;
• you suffer from a mental disorder causing altered perception of reality, thought disturbances, and mental confusion (psychosis).

Development of tolerance
Following repeated use of this medicine over a prolonged period, its effectiveness may decrease (tolerance).
Development of dependence
Using high doses and/or using bromazepam for prolonged periods may lead to physical and psychological dependence.
This risk increases if you have previously abused medicines, drugs, or alcohol (especially in polydrug abusers).
The risk of dependence is reduced if you use Bromazepam Aurobindo Italia at the appropriate dose, as prescribed by your doctor, and for a short-term treatment (see section 3 “How to take Bromazepam Aurobindo Italia”).
Elderly
If you are elderly, take Bromazepam Aurobindo 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.
Other medicines and Bromazepam Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines used for certain mental illnesses (antipsychotics/neuroleptics);
• calming and sleep-promoting medicines (hypnotics);
• medicines causing physical and mental dullness (anxiolytics/sedatives);
• medicines used to treat depression (antidepressants, such as fluvoxamine);
• medicines used to treat severe acute or chronic pain (narcotic analgesics);
• medicines used to treat epilepsy (antiepileptics);
• anaesthetics;
• medicines used to counter allergic reactions (sedating antihistamines);
• cough medicines (antitussive opioids);
• cimetidine (a medicine used in case of stomach ulcers);
• theophyllines or aminophyllines (medicines used for bronchial asthma);
• antifungals (medicines used to treat fungal infections), protease inhibitors (medicines used in HIV therapy), macrolides (a type of antibiotic);
• propranolol (a medicine used to treat various heart conditions).

The concomitant use of Bromazepam Aurobindo Italia and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may potentially be life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are available.
However, if your doctor prescribes Bromazepam Aurobindo Italia together with opioids, they will limit the dose and duration of concomitant treatment. Inform your doctor about all opioid medicines you are taking and carefully follow their recommendations regarding dosage. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above.
If you experience these symptoms, contact your doctor.
Bromazepam Aurobindo Italia and alcohol
Do not drink alcohol while taking Bromazepam Aurobindo Italia, as it may increase the sedative effect of the medicine. Consuming alcohol with Bromazepam Aurobindo Italia may impair your ability to drive or operate machinery (see section “Driving and use of machines”).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, 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 heart rate abnormalities in the fetus.

• If you plan to become pregnant and are currently being treated with Bromazepam Aurobindo Italia, contact your doctor immediately. They will advise you on how to gradually discontinue this medicine.
• If Bromazepam Aurobindo Italia is administered during the late stages of pregnancy or during labour, the newborn may experience hypothermia (reduced body temperature), hypotonia (reduced muscle tone), sucking difficulties leading to poor weight gain, and 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, because bromazepam passes into breast milk.
Driving and use of machinery
Do not drive or operate machinery if, during treatment with Bromazepam Aurobindo Italia, you experience adverse effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or impaired muscle function. These effects may be worsened if you consume alcohol together with Bromazepam Aurobindo Italia (see section “Bromazepam Aurobindo Italia and alcohol”).
Your alertness may be impaired, especially if your sleep duration has been insufficient after taking Bromazepam Aurobindo Italia.
This medicine contains less than 1 mmol (23 mg) of sodium per unit of volume, i.e. essentially ‘sodium-free’.

3. How to take Bromazepam Aurobindo Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
Your doctor will determine the most appropriate dose and frequency for you in order to avoid the possible
intake of an excessive dose of this medicine.
The recommended dose ranges from 15 to 30 drops, up to 3 times daily.
If you are elderly, your doctor will evaluate whether to prescribe lower doses than those indicated above.
Children
Bromazepam Aurobindo Italia is not indicated in children.
Take Bromazepam Aurobindo 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. The drops should be diluted with a small amount of water or another beverage (Fig. 2).
• To close the bottle, screw the cap back on until tightly sealed (Fig. 3).

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 should not exceed 8–12 weeks, including a gradual discontinuation period.
• Insomnia: treatment duration ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual discontinuation period. In certain cases, after reassessing your health status, your doctor may decide to extend the treatment duration beyond the above limits.

During the discontinuation period of Bromazepam Aurobindo 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 Aurobindo Italia” and “Possible side effects”).
If you take more Bromazepam Aurobindo Italia than you should
In case of accidental ingestion/overdose of Bromazepam Aurobindo Italia, contact your doctor immediately or go to the nearest hospital Emergency Department.
Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and gait), dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary eye movements).
Overdose with bromazepam rarely poses a life-threatening risk if the drug is taken alone, but may lead to dysarthria (slow and slurred speech), areflexia (absence of reflexes), apnea (absence of breathing), hypotension (low blood pressure), cardiorespiratory depression (reduced heart and lung function), and coma (loss of consciousness).
In mild cases, symptoms following accidental ingestion/overdose of Bromazepam Aurobindo Italia may include:

• drowsiness;
• mental confusion;
• lethargy (continuous drowsiness 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 Aurobindo Italia
Do not take a double dose to make up for the missed dose.
If you stop taking Bromazepam Aurobindo Italia
Do not stop treatment with Bromazepam Aurobindo Italia without first consulting your doctor.
Your doctor will gradually reduce your dose during the discontinuation phase.
Abruptly stopping this medicine may cause:

• Withdrawal symptoms: headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
• Severe withdrawal symptoms: depersonalization (feeling of detachment or estrangement from oneself), derealization (feeling of perceiving the surrounding environment in a distorted way), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities (hands and feet), hypersensitivity to light, noise, and physical touch, hallucinations (seeing and hearing things that do not exist), epileptic seizures.
• Other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (tingling sensation), perceptual disturbances (altered perceptions), abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (increased heart rate), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss (inability to remember recent events), hyperthermia (elevated body temperature).
• Rebound symptoms: when the symptoms that led to treatment with bromazepam reappear in a more severe form after discontinuation, 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 everyone will experience them.
Contact your doctor immediately if you experience any of the following serious side effects while taking Bromazepam Aurobindo Italia. Your doctor will advise you on how to discontinue use of the medicine:

• allergic reaction (hypersensitivity);
• severe allergic reaction (anaphylactic shock);
• swelling, sometimes of the face or mouth, causing breathing difficulties (angioedema);
• depression;
• restlessness;
• agitation;
• irritability;
• aggression;
• distorted perception of reality (delusions);
• anger;
• nightmares and abnormal dreams;
• hallucinations (seeing or hearing things that do not exist);
• behavioural changes;
• psychosis (mental disorder causing altered perception of reality, thought disturbances, mental confusion);
• nervousness;
• anxiety;
• hyperactivity. These reactions may be more frequent in elderly patients.

In addition, the following side effects may occur with unknown frequency (frequency cannot be determined from the available data):

• confusion;
• disorientation;
• emotional and mood disturbances;
• changes in libido (sexual desire);
• dependence;
• misuse of the medicine;
• withdrawal syndrome;
• long-term memory disturbances (anterograde amnesia);
• memory disturbances;
• drowsiness;
• headache (cephalalgia);
• dizziness;
• reduced alertness;
• ataxia (reduced motor coordination and gait instability);
• blurred vision;
• diplopia (double vision);
• heart failure (reduced heart function), including cardiac arrest;
• respiratory depression (reduced respiratory activity);
• nausea;
• vomiting;
• constipation;
• stomach and/or intestinal problems;
• skin and subcutaneous tissue disorders;
• skin rash;
• pruritus (itching);
• urticaria;
• muscle weakness;
• urinary retention;
• fatigue;
• falls;
• fractures;
• apnoea (temporary cessation of breathing);
• worsening of nocturnal apnoea.

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

• memory disturbances (amnesia and anterograde amnesia);
• behavioural changes;
• worsening of pre-existing depression;
• insomnia;
• rebound anxiety (occurring after discontinuation of the medicine);
• dependence;
• jaundice (yellow/yellowish discoloration of the skin, mucous membranes, and whites of the eyes);
• changes in certain blood tests (increased bilirubin, transaminases, and alkaline phosphatase);
• thrombocytopenia (reduced platelet count);
• agranulocytosis (reduced number of granulocytes, a type of white blood cell);
• pancytopenia (reduction in all blood cell types);
• syndrome of inappropriate antidiuretic hormone (ADH) secretion, causing water retention in the body and reduced sodium levels in the blood.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Aurobindo 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 packaging after EXP. The expiry date refers to the last day of that month.
The medicine should be used within 3 months of first opening the bottle. Any remaining medicine should be discarded.
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 Aurobindo Italia contains

• The active substance is bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
• The other ingredients are: saccharin, disodium edetate, mixed fruit flavours, purified water, propylene glycol.

Description of the appearance of Bromazepam Aurobindo Italia and contents of the pack
Pack containing 1 bottle of 20 ml solution.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)
Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 (TO) – Ivrea – Italy