Bromazepam PensA

Italy
Brand name Bromazepam PensA
Form tablets
Active substance / Dosage
BROMAZEPAM
Prescription type Prescription only
ATC code
N05BA08
Registration number 035954
Manufacturer TOWA PHARMACEUTICAL S.P.A.
Bromazepam PensA tablets

Table of Contents

Package leaflet: Information for the user

BROMAZEPAM PENSA 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, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT BROMAZEPAM PENSA IS AND WHAT IT IS USED FOR:

BROMAZEPAM PENSA contains bromazepam, which belongs to a class of medicines called
"benzodiazepines" with anxiolytic action.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress to the patient.
This medicine is used to treat:

  • anxiety, tension, and other conditions associated with anxiety
  • sleep disorders (insomnia)

Benzodiazepines are indicated only when the condition is severe, disabling, and causes significant distress to the patient.

2. WHAT YOU NEED TO KNOW BEFORE TAKING BROMAZEPAM PENSA

Do not take BROMAZEPAM PENSA:

  • 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 are allergic to benzodiazepines (a class of medicines to which bromazepam belongs)
  • if you suffer from severe myasthenia gravis (a serious disease affecting muscles, characterized by weakness and fatigue)
  • if you suffer from severe respiratory insufficiency (severe reduction in respiratory system activity)
  • if you suffer from severe liver problems (severe hepatic insufficiency)
  • 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 consuming excessive amounts of medicines:
    • Hypnotics (calming medicines and those promoting sleep)
    • Analgesics (medicines used to treat acute or chronic pain of high intensity)
    • Psychotropic medicines (medicines used for mental disorders and/or depression)

Warnings and precautions
Talk to your doctor or pharmacist before taking BROMAZEPAM PENSA.
In particular, talk to your doctor or pharmacist before taking Lexotan if you think any of the following conditions apply to you:

  • you suffer from depression or anxiety associated with depression, because Lexotan 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 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: After repeated use of this medicine over a prolonged period, its effectiveness may decrease (tolerance).
Development of dependence: Using high doses and/or prolonged treatment with BROMAZEPAM PENSA may lead to physical and psychological dependence. This risk is higher if you have previously abused medicines, drugs, or alcohol (especially in polyabusers). The likelihood of dependence is reduced if you use BROMAZEPAM PENSA at the appropriate dose as prescribed by your doctor and for a short-term treatment (see section 3 “How to take BROMAZEPAM PENSA”).

If you are elderly
If you are elderly, take BROMAZEPAM PENSA with caution and under medical supervision.
This medicine may increase the risk of falls and fractures due to adverse 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 Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

  • medicines used for certain mental illnesses (antipsychotics/neuroleptics)
  • medicines used to treat depression (antidepressants, such as fluvoxamine)
  • calming and sleep-inducing medicines (hypnotics)
  • medicines causing physical and mental drowsiness (anxiolytics/sedatives)
  • medicines used to treat severe acute or chronic pain (narcotic analgesics)
  • medicines used for cough (antitussive opioids)
  • medicines used to treat epilepsy (antiepileptics)
  • medicines used to counteract allergic reactions (sedating antihistamines)
  • anaesthetics
  • 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 with alcohol and/or CNS depressant medicines must be avoided.
Concomitant use may enhance the clinical effects of bromazepam, including profound sedation, respiratory depression and/or clinically relevant cardiovascular depression.
Concomitant use of BROMAZEPAM PENSA and opioids (strong painkillers, medicines for opioid dependence substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are available.
However, if your doctor prescribes BROMAZEPAM PENSA together with opioids, the dose and duration of concomitant treatment must be strictly limited by your doctor.
Inform your doctor about all opioid-containing medicines you are taking and carefully follow their dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above.
Contact your doctor if you experience any of these symptoms.

BROMAZEPAM PENSA with food, drinks and alcohol:
Do not drink alcohol while taking this medicine, as the sedative effect of the medicine may be increased.

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
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 benzodiazepines at high doses during the second and/or third trimester of pregnancy may cause reduced fetal movements and heart rate abnormalities in the fetus.
If you plan to become pregnant while being treated with Bromazepam Pensa, contact your doctor immediately. The doctor will advise you on how to gradually discontinue this medicine.
If Bromazepam Pensa is administered during late pregnancy or during labour, the newborn may experience hypothermia (reduced body temperature), hypotonia (reduced muscle tone), and respiratory depression or apnoea (absence of respiratory movements).
Moreover, newborns born to mothers who have chronically taken benzodiazepines during advanced stages of pregnancy may develop physical dependence and may be at risk of developing 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, during treatment with BROMAZEPAM PENSA, you experience adverse effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or altered muscle function. These effects may worsen if you consume alcohol together with BROMAZEPAM PENSA (see section “BROMAZEPAM PENSA and alcohol”).
Your alertness may be impaired, especially if your sleep duration has been insufficient after taking BROMAZEPAM PENSA.

BROMAZEPAM PENSA tablets contain lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

BROMAZEPAM PENSA drops contain propylene glycol:
This medicine contains 962 mg of propylene glycol per 1 ml.
Talk to your doctor or pharmacist before administering this medicine, especially if you are 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.

3. HOW TO TAKE BROMAZEPAM PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
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 dose is:

  • tablets: 1–2 tablets of 1.5 mg two to three times daily, or 1 tablet of 3 mg two to three times daily,
  • drops: 15–30 drops two to three times daily.

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 duration of
treatment is as follows:
Anxiety
The duration of treatment should not exceed 8–12 weeks, including a period of gradual withdrawal.
Insomnia
The duration of treatment varies from a few days to two weeks, up to a maximum of four
weeks, including a period of gradual withdrawal. In certain cases, after reassessing your health status, your doctor may decide to extend the duration of treatment beyond the above limits.
During the period of discontinuation of BROMAZEPAM PENSA 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 PENSA” and “POSSIBLE SIDE EFFECTS”.
If you take more BROMAZEPAM PENSA than you should:
In case of accidental ingestion/overdose of BROMAZEPAM PENSA,
contact your doctor immediately or go to the nearest hospital.
Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor coordination and gait),
dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary eye movements).
Overdose of bromazepam rarely poses a life-threatening risk if 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 PENSA may include:

  • drowsiness;
  • mental confusion;
  • lethargy (continuous sleep and reduced response to normal stimuli). In more severe cases, symptoms may include:
  • ataxia (reduced motor coordination and gait);
  • hypotonia (reduced muscle tone);
  • hypotension (low blood pressure);
  • respiratory depression (reduced breathing);
  • coma (loss of consciousness);
  • death.

If you forget to take BROMAZEPAM PENSA
Do not take a double dose to make up for the missed dose.
If you stop taking BROMAZEPAM PENSA
Do not stop taking BROMAZEPAM PENSA without first consulting your doctor.
Your doctor will gradually reduce the dose during the discontinuation phase.
Abruptly stopping this medicine may cause:

  • withdrawal symptoms: headache, diarrhoea, muscle pain, tension, severe anxiety, confusion, restlessness, irritability.
  • severe withdrawal symptoms: derealization (distorted perception of the external world), depersonalization (feeling of detachment or estrangement from oneself), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities (hands and feet), hypersensitivity to light, noise and physical contact, hallucinations (perception of non-existent things), or seizures.
  • other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (tingling sensation), perceptual disturbances (altered perceptions), abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (sensation of increased heartbeat), tachycardia (increased heart rate), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss (difficulty remembering recent events), hyperthermia (increased 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 occur especially 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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately if, during treatment with BROMAZEPAM PENSA, you experience any of the following serious adverse reactions. Your doctor will advise you on how to discontinue the use of the medicine:

  • Depression
  • Restlessness
  • Agitation
  • Irritability
  • Aggressiveness
  • Distorted perception of reality (delirium)
  • Anger
  • Nightmares and abnormal dreams
  • Perception of things that are not present in reality (hallucinations)
  • Behavioral changes
  • Psychosis (mental disorder causing altered perception of reality, disturbances in thinking, confusion)
  • Nervousness
  • Anxiety
  • Hyperactivity

These reactions may be more frequent in elderly patients.

Additionally, the following adverse reactions may occur with unknown frequency (frequency cannot be determined from available data):

  • Allergic reaction (hypersensitivity)
  • Severe allergic reaction (anaphylactic shock)
  • Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing (angioedema)
  • Confusional state
  • Disorientation
  • Emotional and mood disturbances
  • Changes in libido (sexual desire)
  • Dependence
  • Medicinal product 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)
  • Nausea
  • Vomiting
  • Constipation
  • Stomach and/or intestinal problems
  • Skin rash
  • Itching, urticaria
  • Muscle weakness
  • Urinary retention
  • Fatigue
  • Falls
  • Fractures
  • Respiratory depression (reduced respiratory activity)
  • Apnea (temporary cessation of breathing)
  • Worsening of nocturnal apnea
  • Heart failure (reduced heart function), including cardiac arrest
  • 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 ADH secretion (antidiuretic hormone) leading to water retention in the body and reduced sodium levels in the blood

Other adverse reactions reported with other medicines belonging to the benzodiazepine class, such as BROMAZEPAM PENSA:

  • Memory disturbances (amnesia and anterograde amnesia)
  • Depression
  • Insomnia
  • Rebound anxiety (occurring after discontinuation of the medicine)
  • Dependence

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BROMAZEPAM PENSA

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 and to the product in its original packaging,
properly stored.
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. PACK CONTENTS AND OTHER INFORMATION

What Bromazepam Pensa contains
BROMAZEPAM PENSA 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 PENSA 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, E172.

BROMAZEPAM PENSA 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 (Sequestrene Na2), mixed fruit flavours, purified water, propylene glycol.

Description of the appearance of Bromazepam Pensa and pack contents
BROMAZEPAM PENSA 1.5 mg tablets – Blister pack containing 20 tablets of 1.5 mg.
BROMAZEPAM PENSA 3 mg tablets – Blister pack containing 20 tablets of 3 mg.
BROMAZEPAM PENSA 2.5 mg/ml oral drops – Bottle containing 20 ml of solution at 2.5 mg/ml.
BROMAZEPAM PENSA 2.5 mg/ml oral drops – Bottle containing 30 ml of solution at 2.5 mg/ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturers
Tablets:
ICE S.p.A. – Cantone Moretti, 29 – 10015 Ivrea (TO)
DOPPEL FARMACEUTICI S.p.A. – Via Volturno, 48 – Quinto de’ Stampi – 20089 Rozzano (MI)

Oral drops:
ICE S.p.A. – Cantone Moretti, 29 – 10015 Ivrea (TO)
DOPPEL FARMACEUTICI S.p.A. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

This leaflet was last approved in January 2026