Bromazepam Sandoz

Patient Information Leaflet

Bromazepam Sandoz 2.5 mg/ml oral drops, solution

Generic 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, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What you need to know before taking Bromazepam Sandoz

3. How to take Bromazepam Sandoz

4. Possible side effects

5. How to store Bromazepam Sandoz

6. Contents of the pack and other information

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

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

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

2. What you should know before taking Bromazepam Sandoz

Do not take Bromazepam Sandoz

• if you are allergic to the active substance, 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 causing muscle weakness and fatigue;
• if you suffer from severe respiratory insufficiency;
• if you have severe liver problems (hepatic insufficiency), as it may cause mental confusion (hepatic encephalopathy);
• 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 are consuming excessive amounts of alcohol (acute alcohol intoxication);
• • if you are taking excessive amounts of medicines:
• • hypnotics (calming and sleep-inducing medicines);
• • analgesics (medicines for treating 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 Sandoz.

Be cautious when using this medicine, as it may cause severe allergic reactions (anaphylactic reactions) with swelling of the tongue, larynx, and throat, which may lead to breathing and swallowing difficulties (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting. Your doctor will continuously assess the need to continue treatment.
In particular, consult your doctor or pharmacist before taking Bromazepam Sandoz if you think any of the following conditions apply to you:

• you suffer from depression or anxiety associated with depression, as Bromazepam Sandoz 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 alcohol-dependent or use opioids (medicines used for pain relief);
• you have previously experienced a severe allergic reaction after administration of 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 cardiac insufficiency (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
Prolonged repeated use of this medicine may lead to reduced effectiveness (tolerance).

Development of dependence
Taking high doses and/or prolonged use of bromazepam may lead to physical and psychological dependence. This risk is higher if you have previously abused medicines, drugs, or alcohol (especially in polydrug abusers). The risk of dependence is reduced if you use Bromazepam Sandoz at the appropriate dose as prescribed by your doctor and for a short duration (see section 3 “How to take Bromazepam Sandoz”).

If you are elderly
Take Bromazepam Sandoz with caution and under medical supervision if you are elderly. This medicine may increase the risk of falls and fractures due to side effects such as ataxia (reduced motor and gait coordination), 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 Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• medicines used for certain mental illnesses (antipsychotics/neuroleptics);
• • hypnotics (calming and sleep-inducing medicines);
• • medicines causing physical and mental drowsiness (anxiolytics/sedatives);
• • medicines for treating depression (antidepressants, such as fluvoxamine);
• • medicines for treating severe acute or chronic pain (narcotic analgesics);
• • medicines for treating epilepsy (antiepileptics);
• • anaesthetics;
• • medicines used to treat allergic reactions (sedating antihistamines);
• • medicines used for cough (antitussive opioids);
• • cimetidine (a medicine used in stomach ulcer);
• • 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).

Concomitant use of Bromazepam Sandoz and opioids (strong analgesics, medicines for addiction treatment, 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 Sandoz 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 dose recommendations carefully. It may be helpful to inform family members or friends to watch for the signs and symptoms listed above. Contact your doctor immediately if you experience such symptoms.

Bromazepam Sandoz and alcohol
Do not drink alcohol while taking Bromazepam Sandoz, as the sedative effect may be enhanced.
Consuming alcohol with Bromazepam Sandoz may impair your ability to drive or operate machinery (see section “Driving and use of machinery”).

Bromazepam Sandoz oral drops, solution contains:
Propylene glycol
This medicine contains 568.278 mg of propylene glycol per dose corresponding to 15 drops equivalent to 0.6 ml, i.e., 1.5 mg of bromazepam.
This medicine contains 18,942.6 mg of propylene glycol per dose corresponding to 30 drops equivalent to 1.2 ml, i.e., 3 mg of bromazepam.
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.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium (from sodium saccharin and sodium edetate) per dose (15 drops) equivalent to 0.6 ml, i.e., 1.5 mg of bromazepam. This is essentially ‘sodium-free’.
This medicine contains less than 1 mmol (23 mg) of sodium (from sodium saccharin and sodium edetate) per dose (30 drops) equivalent to 1.2 ml, i.e., 3 mg of bromazepam. This is essentially ‘sodium-free’.

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 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 high-dose benzodiazepines during the second and/or third trimester of pregnancy may cause reduced fetal movements and altered heart rate in the fetus.

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

Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.

Driving and use of machinery
Do not drive or operate machinery if, during treatment with Bromazepam Sandoz, you experience side 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 Sandoz (see section “Bromazepam Sandoz and alcohol”).
Your alertness may be impaired, especially if your sleep duration was insufficient after taking Bromazepam Sandoz.

3. How to take Bromazepam Sandoz

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 for as long as your doctor tells you to.

Adults
Your doctor will adjust the dose according to your needs.
The recommended average dose ranges from 1.5 mg (15 drops) to 3 mg (30 drops), 2–3 times daily.
If you are elderly, your doctor will assess whether lower doses than those indicated above should be prescribed.

Children
Bromazepam Sandoz 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 re-evaluating your health status, your doctor may decide to extend the duration of treatment beyond the periods indicated above.
During the period of discontinuation of Bromazepam Sandoz, 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 Sandoz” and “Possible side effects”).

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

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

Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and impaired gait), dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary 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 Sandoz may include:

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

In more severe cases, symptoms may include:

• ataxia (reduced motor coordination and impaired gait);
• hypotonia (reduced muscle tone);
• hypotension (low blood pressure);
• respiratory depression (reduced breathing);
• coma (loss of consciousness);
• death.

If you forget to take Bromazepam Sandoz
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 Sandoz
Do not stop treatment with Bromazepam Sandoz suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
Sudden discontinuation of this medicine may cause:

• withdrawal symptoms: headache, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
• severe withdrawal symptoms: depersonalization (feeling detached or estranged from oneself), derealization (distorted perception of the external world), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities (hands and feet), hypersensitivity to light, noise, and physical touch, hallucinations (perception of things not present in reality), seizures.
• other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paraesthesia (tingling sensations), perceptual disturbances (altered perceptions), abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (awareness of increased 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 doubts about how to use 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.
Contact your doctor immediately if, during treatment with Bromazepam Sandoz, you experience any of the following serious side effects; your doctor will explain how to stop taking the medicine:

• depression,
• restlessness,
• agitation,
• irritability,
• aggression,
• distorted perception of reality (delusions),
• anger,
• nightmares and abnormal dreams,
• perception of things that do not exist in reality (hallucinations),
• behavioural changes,
• psychosis (mental disorder causing altered perception of reality, disturbances in thinking, mental confusion),
• nervousness,
• anxiety,
• hyperactivity. These reactions may be more frequent in elderly patients.

In addition, you may experience the following side effects with unknown frequency (frequency cannot be established from the available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock),
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing,
• confusion,
• 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),
• 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,
• skin rash,
• itching,
• urticaria,
• muscle weakness,
• urinary retention,
• fatigue,
• falls,
• fractures,
• apnoea (temporary cessation of breathing),
• worsening of nocturnal apnoea.

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

• 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 cells),
• syndrome of inappropriate antidiuretic hormone secretion (ADH), 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 the following website:
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 Sandoz

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, correctly stored.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bromazepam Sandoz contains

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

Description of the appearance of Bromazepam Sandoz and contents of the pack
Pack containing 1 bottle of 20 ml solution with dropper.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy
Manufacturers
ABC Farmaceutici S.p.A. - Canton Moretti, 29 - Località San Bernardo - 10015 Ivrea (TO)
Mipharm SpA – Via B. Quaranta, 12 – 20141 Milan