BROMAZEPAM ALTER

PATIENT INFORMATION LEAFLET

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

Bromazepam
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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

Do not take Bromazepam Alter

• 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 suffer from severe respiratory insufficiency
• if you have severe liver problems (hepatic insufficiency)
• if you have breathing difficulties during sleep (sleep apnea)
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding")
• if you have a condition of the eye called narrow-angle glaucoma
• if you have alcohol intoxication or intoxication from other medicines acting on the central nervous system (hypnotics, analgesics, antidepressants, lithium).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bromazepam Alter.
Be careful when using this medicine, as it may cause severe allergic reactions (anaphylactic reactions) with swelling of the tongue, larynx, and throat, which may cause difficulty breathing and swallowing (angioedema), shortness of breath (dyspnea), throat closure, nausea, and vomiting. Your doctor will regularly assess whether continued treatment is necessary.
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 muscle weakness, dizziness, drowsiness, fatigue, and tiredness, 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 severe 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 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 Bromazepam Alter, you may experience withdrawal or rebound symptoms (such as headache, diarrhea, 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 Alter"). 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 discontinuation period.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances, stop taking the medicine immediately (see section 4. "Possible side effects"). These reactions are more common 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 and adolescents under 18 years of age, Bromazepam Alter should be used only when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and Bromazepam Alter
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 and sedatives, used to treat anxiety
• certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with Bromazepam Alter. This may increase your desire to continue taking these medicines (dependence)
• antiepileptics, used for epilepsy
• antihistamines with sedative effect, used to treat allergies
• anaesthetics, used during surgery
• theophylline and aminophylline, used to treat asthma or other respiratory diseases
• medicines that increase or decrease bromazepam metabolism
• cimetidine, used to treat heartburn and stomach lesions.

Concomitant use of Bromazepam Alter 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. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Bromazepam Alter 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 carefully follow the doctor's recommendations regarding dosage. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
Bromazepam Alter and alcohol
Avoid alcohol while taking this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy and breastfeeding
Pregnancy
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.
Do not take Bromazepam Alter during pregnancy unless absolutely necessary.
If your doctor considers it necessary for you to take this medicine during the last stages of pregnancy or during labour, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
If Bromazepam Alter has been taken regularly during the last stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
If you start treatment with Bromazepam Alter and are of childbearing age, consult your doctor both if you intend to become pregnant and if you suspect you are pregnant, as it will be necessary to discontinue the medicine.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into breast milk.
Driving and using machines
Taking Bromazepam Alter may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are worse if you have not slept enough. If this happens, avoid driving or operating machinery.
Consuming alcohol during treatment with this medicine negatively affects your ability to drive and use machinery.
Bromazepam Alter tablets contain lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Bromazepam Alter drops contain propylene glycol
This medicine contains 1013 mg of propylene glycol per 1 ml.

3. How to take Bromazepam Alter

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 to stop.
Your doctor will adjust the dose according to your individual needs.
The recommended average dose ranges from 1.5 mg to 3 mg, taken 2–3 times daily:
1–2 tablets of 1.5 mg 2–3 times daily, or 1 tablet of 3 mg 2–3 times daily, or 15–
30 drops 2–3 times daily.

Treatment of anxiety, tension, and other anxiety-related disorders
The duration of treatment should be as short as possible. Generally, treatment should not exceed 8–12 weeks, including a period of gradual discontinuation.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.

Treatment of insomnia
The duration of treatment 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 period of gradual discontinuation.
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 Alter than you should
If you (or someone else) have taken an excessive dose of Bromazepam Alter, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause marked depression of the central nervous system, with symptoms such as drowsiness, progressive loss of muscle coordination (ataxia), difficulty speaking, visual disturbances, absence of reflexes, breathing difficulties (respiratory depression), low blood pressure (hypotension), depression of the nervous system which may worsen to coma, and very rarely, death.
Bring this leaflet, the bottle, and its container with you to the hospital or doctor so they know which medicine has been taken.

If you forget to take Bromazepam Alter
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 Alter
Do not stop treatment with Bromazepam Alter 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), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that are not real), or epileptic seizures. Other symptoms 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, elevated body temperature (hyperthermia).

Treatment must be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is greater if you stop taking Bromazepam Alter 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 everybody will experience 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 are not real), 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 common 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, muscle weakness, tiredness
• loss of muscle coordination (ataxia)
• headache, double vision
• nausea, vomiting.

Other side effects that may occur include:
Frequency not known (frequency cannot be estimated from the available data):

• heart problems (heart failure, cardiac arrest)
• blurred vision
• 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)
• jaundice, a condition characterised by yellowing of the skin and whites of the eyes
• increased liver enzyme levels (transaminases), increased bilirubin, increased alkaline phosphatase
• decreased platelet count (thrombocytopenia), decreased white blood cell count (agranulocytosis), decreased counts of all blood cells (pancytopenia)
• disturbance in antidiuretic hormone secretion (SIADH)
• increased risk of falls and fractures, particularly in elderly patients and in patients taking sedatives or alcohol concurrently
• changes in sexual desire
• medicine dependence, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Bromazepam Alter”)
• memory loss that does not affect past memories (anterograde amnesia) (see section “Warnings and precautions”), memory disturbances
• respiratory depression, apnoea, breathing difficulties during sleep (nocturnal apnoea)
• urticaria, skin rash, itching.

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bromazepam Alter

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, unopened packaging, stored correctly.
Oral drops should be used within 9 months after first opening the bottle. Any remaining product should be discarded.
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 in use. This will help protect the environment.

6. Package contents and other information

What Bromazepam Alter contains
Bromazepam Alter 1.5 mg tablets

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

Bromazepam Alter 3 mg tablets

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

Bromazepam Alter 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: sodium saccharin, disodium edetate, mixed fruit flavours, purified water, propylene glycol.

Description of the appearance of Bromazepam Alter and the contents of the pack
Pack containing 20 tablets of 1.5 mg in blister packs.
Pack containing 20 tablets of 3 mg in blister packs.
Pack containing 1 bottle of 20 ml solution.
Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milan
Manufacturers
Oral drops:

• Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
• ICE S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO) Tablets 1.5 mg and 3 mg:
• Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto Dè Stampi, Rozzano (MI)

January 2026