Bromazepam Hexal

Package leaflet: Information for the patient

Bromazepam Hexal 1.5 mg tablets, 3 mg tablets, 2.5 mg/ml oral drops, solution

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

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

Bromazepam Hexal contains the active substance bromazepam, which belongs to a group of medicines
called benzodiazepines.
This medicine is indicated for the treatment of:

• anxiety, tension, and other anxiety-related disorders;
• sleep disorders (insomnia).

Benzodiazepines are used only when symptoms are severe, cause significant distress to the patient,
and limit normal daily activities. Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Bromazepam Hexal

Do not take Bromazepam Hexal

• 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 severe myasthenia gravis (a serious disease affecting the muscles, characterized by weakness and fatigue);
• if you suffer from severe respiratory insufficiency;
• if you have severe liver problems (hepatic insufficiency), as this may cause mental confusion (hepatic encephalopathy);
• if you have breathing difficulties during sleep (sleep apnea);
• if you have narrow-angle glaucoma (an eye condition caused by increased pressure of the fluid inside the eye);
• if you have consumed excessive amounts of alcohol (acute alcohol intoxication);
• if you have taken excessive amounts of medicines, such as:
• hypnotics (medicines with calming and sleep-inducing effects);
• 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 Hexal.
In particular, consult your doctor or pharmacist before taking Bromazepam Hexal if you think any
of the following conditions apply to you:

• you suffer from depression or anxiety associated with depression, because Bromazepam Hexal 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 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).

Development of tolerance: Following repeated use of this medicine over a prolonged period, a reduction in its effectiveness (tolerance) may occur.
Development of dependence: The use of high doses and/or prolonged treatment with bromazepam may lead to physical and psychological dependence. The risk is higher if you have previously abused medicines, drugs, or alcohol (especially in polydrug abusers). The risk of dependence is reduced if you take Bromazepam Hexal at the appropriate dose as prescribed by your doctor and for a short duration (see section 3 “How to take Bromazepam Hexal”).

If you are elderly
If you are elderly, take Bromazepam Hexal with caution and under medical supervision.
This medicine may increase the risk of falls and fractures due to side effects such as ataxia (reduced motor coordination and gait instability), 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 Hexal
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 if you are taking the following medicines:

• medicines used for certain mental illnesses (antipsychotics/neuroleptics);
• calming and sleep-inducing medicines (hypnotics);
• medicines causing physical and mental drowsiness (anxiolytics/sedatives);
• medicines for the treatment of depression (antidepressants, such as fluvoxamine);
• medicines for the treatment of severe acute or chronic pain (narcotic analgesics);
• medicines for the treatment of epilepsy (antiepileptics);
• anesthetics;
• medicines used to treat allergic reactions (sedating antihistamines);
• medicines used for cough (antitussive opioids);
• cimetidine (a medicine used in stomach ulcers);
• theophyllines or aminophyllines (medicines used for bronchial asthma);
• antifungals (medicines used for 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 Hexal and opioids (strong analgesics, medicines used in addiction therapy, 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 Hexal together with opioids, the dose and duration of concomitant treatment must be 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 family members or friends to watch for the symptoms listed above.
Contact your doctor immediately if you experience any of these symptoms.

Bromazepam Hexal and alcohol
Do not drink alcohol while taking Bromazepam Hexal, as the sedative effect may be increased.
Consuming alcohol with Bromazepam Hexal may impair your ability to drive vehicles or operate machinery (see section “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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 high-dose benzodiazepines during the second and/or third trimester of pregnancy may cause reduced fetal movements and changes in heart rate.

• If you are planning a pregnancy and are currently being treated with Bromazepam Hexal, contact your doctor immediately. The doctor will advise you on how to gradually discontinue this medicine.
• If Bromazepam Hexal is administered during the late stages of pregnancy or during labor, the newborn may experience hypothermia (lowered body temperature), hypotonia (reduced muscle tone), respiratory depression, or apnea (absence of breathing 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 you experience side effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or altered muscle function during treatment with Bromazepam Hexal. These effects may be worsened if you consume alcohol together with Bromazepam Hexal (see section “Bromazepam Hexal and alcohol”).
Your alertness may be impaired, especially if your sleep duration after taking Bromazepam Hexal has been insufficient.

Bromazepam Hexal tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Bromazepam Hexal 2.5 mg/ml oral drops contain:
913.6 mg of propylene glycol in 25 drops, equivalent to 1 ml of Bromazepam Hexal.
If the child is under 5 years of age, talk to 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, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
If you 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.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Bromazepam Hexal

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you otherwise.

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 average 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), taken 2–3 times daily.
If you are elderly, your doctor will assess whether a lower dose than those indicated above should be prescribed.

Children
Bromazepam Hexal is not indicated for use in children.

Duration of treatment
Your doctor will prescribe the shortest possible duration of treatment.
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 gradual withdrawal period.
• Insomnia: treatment duration ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.

In certain cases, after reassessing your health status, your doctor may decide to extend the treatment duration beyond the periods indicated above.
During the period of discontinuation of Bromazepam Hexal 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 Hexal” and “Possible side effects”).

Use in elderly patients and patients with liver problems
A reduced dose must be administered in elderly patients and in patients with liver impairment.

If you take more Bromazepam Hexal than you should
If you (or someone else) have taken an excessive dose of Bromazepam Hexal, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and gait instability), dysarthria (speech disorder), and nystagmus (rhythmic, involuntary, oscillating eye movements).
Overdose with bromazepam rarely poses a life-threatening risk when the drug is taken alone, but may lead to dysarthria (slow and defective speech), areflexia (absence of reflexes), apnea (absence of breathing), 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 Hexal 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 instability);
• hypotonia (reduced muscle tone);
• hypotension (low blood pressure);
• respiratory depression (reduced breathing);
• coma (loss of consciousness);
• death.

If you forget to take Bromazepam Hexal
If you forget to take a dose of the medicine, 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 Hexal
Do not stop treatment with Bromazepam Hexal suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize withdrawal symptoms.

Abrupt discontinuation of 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 (distorted perception of the external world), hyperacusis (increased sensitivity to sounds), numbness and tingling in the extremities (hands and feet), increased sensitivity to light, noise, and physical contact, hallucinations (perception of non-existent things), seizures.
• other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (tingling sensations), perceptual disturbances (altered perceptions), abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (awareness of rapid heartbeat), tachycardia (increased heart rate), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss (inability to recall recent events), hyperthermia (elevated body temperature).
• 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 are especially likely 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 will experience them.
Contact your doctor immediately if you experience any of the following serious side effects while taking Bromazepam Hexal; your doctor will explain how to discontinue use of the medicine:
• depression,
• restlessness,
• agitation,
• irritability,
• aggression,
• distorted perception of reality (delirium),
• anger,
• nightmares and abnormal dreams,
• perception of non-existent things (hallucinations),
• 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 estimated from the available data):
• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock),
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing,
• confusional state,
• disorientation,
• emotional and mood disturbances,
• altered libido (sexual desire),
• dependence,
• medicine abuse,
• 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 problems,
• rash,
• pruritus (itching),
• urticaria (hives),
• 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 Hexal:
• 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 and mucous membranes and the 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 secretion (SIADH), 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, talk to your doctor or pharmacist.
You can 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 Hexal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 Hexal contains
Bromazepam Hexal 1.5 mg tablets

• The active substance is: bromazepam. Each tablet contains 1.5 mg of bromazepam.
• The other components are: microcrystalline cellulose, lactose, talc, magnesium stearate. Bromazepam Hexal 3 mg tablets
• The active substance is: bromazepam. Each tablet contains 3 mg of bromazepam.
• The other components are: microcrystalline cellulose, lactose, talc, magnesium stearate, red iron oxide (E172). Bromazepam Hexal 2.5 mg/ml oral drops:
• The active substance is: bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
• The other components are: saccharin sodium, sodium edetate, mixed fruit flavours, purified water, propylene glycol.

Description of the appearance of Bromazepam Hexal and package contents
Pack containing 20 tablets of 1.5 mg.
Pack containing 20 tablets of 3 mg.
Pack consisting of one glass bottle containing 20 ml of solution, with a PE dropper.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturers
Tablets of 1.5 mg and 3 mg:

• Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto Dè Stampi, Rozzano (MI)

Oral drops:

• Doppel Farmaceutici s.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
• Mipharm Spa - Via B. Quaranta 12 - 20141 Milan
• ICE S.p.A., Canton Moretti 29, Località San Bernardo, 10015 Ivrea (TO)