Bromazepam EG

Package leaflet: Information for the patient

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

Equivalent medicine
Please read all of this leaflet carefully before you start 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, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BROMAZEPAM EG is and what it is used for

BROMAZEPAM EG contains the active substance bromazepam, which belongs to a group of medicines
called benzodiazepines.
Benzodiazepines are used to relieve anxiety states only when these are severe and cause significant distress to the individual.
This medicine is indicated for the treatment of:

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

2. What you should know before taking BROMAZEPAM EG

Do not take BROMAZEPAM EG

• if you are allergic to bromazepam, 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 have severe respiratory insufficiency;
• if you have severe liver problems (hepatic insufficiency);
• if you have breathing difficulties during sleep (sleep apnea).

Warnings and precautions
Talk to your doctor or pharmacist before taking BROMAZEPAM EG.
Take this medicine with caution and always under medical supervision in the following cases:

• if you are elderly. In this case, your doctor may decide to reduce the dose;
• if you have respiratory problems (respiratory insufficiency). In this case, your doctor may decide to reduce the dose;
• if you suffer from depression or have previously abused alcohol or drugs.

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: Taking this medicine may lead to dependence, meaning a need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously suffered from psychiatric disorders or have abused drugs or alcohol.
Withdrawal: When you stop taking BROMAZEPAM EG, you may experience withdrawal symptoms or rebound effects (such as headache, diarrhoea, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability, sleep disturbances), even if you have taken the medicine at the recommended doses and for a short period of time (see section “If you stop treatment with BROMAZEPAM EG”). In severe cases, the following symptoms may also occur:
derealization (distorted perception of reality), depersonalization (feeling detached from oneself), hypersensitivity to sounds, numbness and tingling in hands and feet, hypersensitivity to light, noise, and physical touch, hallucinations, or epileptic seizures.
To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Anterograde amnesia (severe limitation or complete inability to memorize new information):
BROMAZEPAM EG (like all benzodiazepines) may cause anterograde amnesia; therefore, to reduce the risk, ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances (such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, or changes in behaviour), stop taking the medicine immediately (see section 4. “Possible side effects”).
Such reactions are more frequent in children and elderly patients.
Benzodiazepines should not be used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such patients.
Children and adolescents
In children, BROMAZEPAM EG should only be used when absolutely necessary, and the duration of treatment should be as short as possible.
Other medicines and BROMAZEPAM EG
Tell 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:

• antipsychotics (neuroleptics) and antidepressants, used to treat psychiatric disorders;
• hypnotics, medicines used to promote sleep;
• anxiolytics, tranquillizers, and sedatives, used to treat anxiety;
• certain strong painkillers (narcotic analgesics such as opioids), which may cause increased feelings of well-being when taken with BROMAZEPAM EG. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy;
• antihistamines with sedative effects, used to treat allergies;
• anaesthetics, used during surgery;
• medicines that increase or decrease the metabolism of bromazepam.

The concomitant use of BROMAZEPAM EG and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are possible.
However, if your doctor prescribes BROMAZEPAM EG together with opioids, the dose and duration of concomitant therapy must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and follow the doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives about the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
BROMAZEPAM EG and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may enhance the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will assess whether to prescribe Bromazepam EG during pregnancy: it is important that you strictly follow the prescribed instructions and dosage.
Some studies on benzodiazepines have shown that their use during the first trimester of pregnancy may increase the likelihood of the unborn child having a congenital malformation of the palate and lip called “cleft lip/palate”.
If your doctor considers it necessary for you to take this medicine in the late stages of pregnancy or during labour, your baby may experience low body temperature (hypothermia), loss of muscle tone (hypotonia), and breathing difficulties.
If BROMAZEPAM EG has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence, withdrawal symptoms (such as hyperexcitability, tremors, restlessness), and/or floppy infant syndrome (loss of muscle tone in the newborn). Therefore, your doctor will need to monitor your baby regularly.
Inform your doctor if you intend to become pregnant or suspect you are pregnant during treatment, as treatment must be discontinued.
Breastfeeding
BROMAZEPAM EG is not recommended if you are breastfeeding, as the medicine passes into breast milk.
Driving and using machines
The use of BROMAZEPAM EG negatively affects your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are worse if you have not slept enough. If this occurs, avoid driving or operating machinery.
BROMAZEPAM EG tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
BROMAZEPAM EG oral drops contain sodium and propylene glycol (E1520).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
This medicine contains 953.63 mg of propylene glycol per ml.
If you are pregnant or breastfeeding, or suffer from liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take BROMAZEPAM EG

Take this medicine exactly as instructed by your doctor. 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 do so.
Your doctor will adjust the dose according to your individual needs.
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.

Treatment of anxiety, tension, and other anxiety-related disorders
Treatment duration should be as short as possible. Generally, treatment should not exceed 8–12 weeks, including a gradual withdrawal period. However, your doctor should regularly assess your health status and the ongoing need for continued treatment with Bromazepam EG. In certain cases, your doctor may decide to extend the treatment, but only after carefully evaluating your health condition.

Treatment of insomnia
Treatment duration should be as short as possible. Generally, treatment lasts from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period. However, your doctor should regularly assess your health status and the ongoing need for continued treatment with BROMAZEPAM EG.
In certain cases, your doctor may decide to extend the treatment, but only after carefully evaluating your health condition.

Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the dose or frequency of administration if necessary.

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 EG than you should
If you (or someone else) have taken an excessive dose of BROMAZEPAM EG, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
As with other benzodiazepines, an overdose is unlikely to be life-threatening unless other central nervous system (CNS) depressants (including alcohol) are taken concomitantly.
An overdose may cause marked depression of the central nervous system, with symptoms such as rhythmic, involuntary, oscillating eye movements (nystagmus), progressive loss of muscle coordination (ataxia), difficulty speaking (dysarthria), absence of reflexes (areflexia), breathing difficulties (apnea, respiratory depression), low blood pressure (hypotension), cardiorespiratory depression, and CNS depression that may progress to coma.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know which medicine has been taken.

If you forget to take BROMAZEPAM EG
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 a forgotten dose.

If you stop taking BROMAZEPAM EG
Do not stop treatment with BROMAZEPAM EG suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, your dose will be gradually reduced to minimize withdrawal symptoms (see section “Warnings and precautions”).
Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear and be even more intense than before (rebound insomnia and rebound anxiety). The risk of developing such symptoms is greater if you stop taking BROMAZEPAM EG abruptly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.

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 everyone gets them.
Contact your doctor immediately if you experience:

• Depression and behavioural reactions such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, 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), behavioural changes. If any of these side effects occur, treatment must be discontinued. These reactions are more frequent in children and elderly patients (see section “Warnings and precautions”).

At the beginning of treatment, the following side effects may occur, which usually disappear with continued administration:

• drowsiness, dizziness;
• confusion, reduced alertness;
• reduced emotional responsiveness;
• fatigue, decreased muscle tone;
• loss of muscular coordination (ataxia);
• headache, double vision;
• constipation, nausea, vomiting.

The following additional side effects may also occur:
Frequency not known (frequency cannot be estimated from the available data):

• heart problems (heart failure, cardiac arrest);
• urinary disorders (urinary retention);
• sudden potentially life-threatening allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause breathing or swallowing difficulties (angioedema);
• increased risk of falls and fractures, particularly in elderly patients and in patients taking sedatives or alcohol concomitantly;
• skin reactions: urticaria, skin rash, itching;
• altered sexual desire;
• medicine dependence (physical and psychological), drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking BROMAZEPAM EG”);
• memory loss that does not affect past memories (anterograde amnesia) (see section “Warnings and precautions”), memory disturbances;
• respiratory depression.

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 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 EG

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, correctly stored.
Shelf life after first opening of the bottle: 30 days.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What BROMAZEPAM EG contains
Bromazepam EG 1.5 mg tablets

• The active substance is bromazepam. Each tablet contains 1.5 mg of bromazepam.
• The other components are: microcrystalline cellulose, monohydrate lactose, talc, magnesium stearate.

Bromazepam EG 3 mg tablets

• The active substance is bromazepam. Each tablet contains 3 mg of bromazepam.
• The other components are: microcrystalline cellulose, monohydrate lactose, talc, magnesium stearate, E172.

Bromazepam EG 2.5 mg/ml oral drops, solution

• The active substance is bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
• The other components are: saccharin, disodium edetate, mixed fruit flavours, purified water, propylene glycol (E1520).

Description of the appearance of BROMAZEPAM EG and contents of the pack
Pack containing 20 tablets of 1.5 mg.
Pack containing 20 tablets of 3 mg.
Pack containing 1 bottle of 20 ml solution.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturers
Oral drops:

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

Tablets 1.5 mg and 3 mg:

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