Bromazepam Almus: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

BROMAZEPAM ALMUS 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BROMAZEPAM ALMUS is and what it is used for
What you need to know before taking BROMAZEPAM ALMUS
How to take BROMAZEPAM ALMUS
Possible side effects
How to store BROMAZEPAM ALMUS
Contents of the pack and other information

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

BROMAZEPAM ALMUS contains the active substance bromazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that 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 ALMUS

Do not take BROMAZEPAM ALMUS

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 serious liver problems (hepatic insufficiency)
if you have breathing problems during sleep (sleep apnea)
if you have a type of eye disease called narrow-angle glaucoma
if you have alcohol intoxication or intoxication from other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)

Warnings and precautions
Talk to your doctor or pharmacist before taking BROMAZEPAM ALMUS.
Be cautious when using this medicine, as it may cause severe allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling of the tongue, larynx, and throat, which may cause difficulty in breathing and swallowing (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting. Your doctor will continuously assess the need to continue treatment and, in case of angioedema, will advise you not to restart the treatment.
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 to avoid undesirable effects such as loss of muscle coordination (ataxia), muscle weakness, dizziness, drowsiness, tiredness, fatigue, which may increase the risk of falls
if you have respiratory problems (respiratory insufficiency). In this case, your doctor may decide to reduce the dose
if you have serious liver problems (hepatic insufficiency)
if you have kidney problems (renal insufficiency)
if you have low blood pressure or heart problems (cardiac insufficiency). In this case, your doctor may decide to perform regular check-ups
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: When taking this medicine, there is a risk of developing physical and psychological dependence, i.e., the 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 stopping treatment with BROMAZEPAM ALMUS, you may experience withdrawal or rebound symptoms (such as headache, diarrhoea, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability), even if you have taken the medicine at the recommended doses and for a short period of time (see section “If you stop taking BROMAZEPAM ALMUS”). 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.
Duration of treatment: Treatment duration should be as short as possible and should not exceed 4 weeks for insomnia and 8–12 weeks for anxiety, including a gradual tapering-off period.
Amnesia: Benzodiazepines may cause amnesia (memory loss). This is more likely to occur several hours after taking the medicine. To reduce the risk, ensure uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience reactions such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, changes in behaviour, or other adverse behavioural effects, contact your doctor immediately, as treatment should be discontinued. These 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 patients under 18 years of age, BROMAZEPAM ALMUS should be used only when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and BROMAZEPAM ALMUS
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:

antipsychotics (neuroleptics) and antidepressants, used to treat psychiatric disorders
hypnotics, medicines used to promote sleep
anxiolytics, tranquillisers, and sedatives, used to treat anxiety
certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with BROMAZEPAM ALMUS. 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 surgical procedures
theophylline and aminophylline, used to treat asthma or other respiratory diseases
medicines that increase or decrease bromazepam metabolism
cimetidine, used to treat stomach burning and lesions.

Concomitant use of BROMAZEPAM ALMUS and opioids (strong analgesics, medicines for addiction 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 treatment options are possible.
However, if your doctor prescribes BROMAZEPAM ALMUS together with opioids, the dose and duration of concomitant treatment must be strictly limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s dosing recommendations. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
BROMAZEPAM ALMUS 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take BROMAZEPAM ALMUS during pregnancy unless absolutely necessary.
If your doctor considers it necessary for you to take this medicine during the late stages of pregnancy, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, low blood pressure, and difficulties with sucking and breathing.
If BROMAZEPAM ALMUS has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.
Driving and using machines
Taking BROMAZEPAM ALMUS may affect your ability to drive vehicles or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems.
These effects are more pronounced if you have not slept enough. If this occurs, avoid driving or operating machinery.
Consuming alcohol during treatment with this medicine negatively affects your ability to drive and operate machinery.
BROMAZEPAM ALMUS tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take BROMAZEPAM ALMUS

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 do so.
Your doctor will adjust the dose according to your individual needs.
The recommended daily 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.
In certain cases, your doctor may decide to extend the treatment after 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.
In certain cases, your doctor may decide to extend the treatment after 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 kidney or liver problems
A reduced dose should be administered in elderly and debilitated patients.

If you take more BROMAZEPAM ALMUS than you should
If you (or someone else) have taken an excessive dose of BROMAZEPAM ALMUS, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Overdose can cause depression of the central nervous system, with symptoms ranging from drowsiness to coma. Mild intoxication may present with symptoms such as drowsiness (nystagmus), mental confusion, and severe fatigue (lethargy). In more severe cases, symptoms may include progressive loss of muscle coordination (ataxia), reduced muscle tone (hypotonia), breathing difficulties (respiratory depression), low blood pressure (hypotension), rarely coma, and very rarely death.
Bring this leaflet and the medicine packaging with you to the hospital or doctor so they know which medicine has been taken.

If you forget to take BROMAZEPAM ALMUS
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 ALMUS
Do not stop treatment with BROMAZEPAM ALMUS 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, such as:

headache, muscle pain, tension
severe anxiety, confusion, restlessness, irritability
in severe cases of withdrawal: derealization (feeling that things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, hypersensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that are not real), or epileptic seizures. Other symptoms may include: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (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).

Treatment must be discontinued gradually; otherwise, the symptoms for which you were being treated may return more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking BROMAZEPAM ALMUS abruptly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.
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 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), changes in behaviour. If any of these side effects occur, treatment must be discontinued. These reactions are more common in children and elderly patients (see section "Warnings and precautions").

The following side effects may occur at the beginning of treatment and usually disappear with continued administration:

drowsiness, dizziness
confusion, reduced emotional responsiveness, decreased alertness
fatigue, reduced muscle tone
loss of muscle coordination (ataxia)
headache, double vision (diplopia)

Additionally, the following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

heart problems (heart failure, cardiac arrest)
blurred vision
nausea, dry mouth, constipation
urinary problems (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 difficulty in breathing or swallowing (angioedema)
increased risk of falls and fractures, particularly in the elderly
changes in sexual desire
medicine dependence, drug abuse, withdrawal symptoms (see sections "Warnings and precautions" and "If you stop taking BROMAZEPAM ALMUS")
memory loss that does not affect past memories (anterograde amnesia) (see section "Warnings and precautions"), memory disturbances
respiratory depression (dose-dependent, greater at higher doses), apnoea, breathing difficulties during sleep (sleep apnoea)
urticaria, skin rash, itching

In addition, the following side effects have been reported with benzodiazepines:
Rare (may affect up to 1 in 1,000 patients):

increased levels of liver enzymes (transaminases), increased bilirubin, increased alkaline phosphatase;
jaundice, a condition characterised by yellowing of the skin and whites of the eyes;
decreased platelet count (thrombocytopenia), decreased white blood cell count (agranulocytosis), decreased counts of all blood cells (pancytopenia);
disturbance in the secretion of antidiuretic hormone (SIADH).

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 ALMUS

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 refers to the product in its original, unopened packaging, correctly stored.
BROMAZEPAM ALMUS 2.5 mg/ml oral drops, solution should be used within 12 weeks after first opening the bottle.
Any excess product must be discarded.
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 no longer used. This will help protect the environment.

6. Package contents and other information

What BROMAZEPAM ALMUS contains
BROMAZEPAM ALMUS 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 ALMUS 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 ALMUS 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.

Description of the appearance of BROMAZEPAM ALMUS 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
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa

Manufacturers
Oral drops:
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe 1 - 29016 Cortemaggiore (PC)

Tablets 1.5 mg and 3 mg:
Doppel Farmaceutici S.r.l. - Via Volturno 48 - 20089 Quinto Dè Stampi, Rozzano (MI)