Bromazepam Ratiopharm

Patient Information Leaflet

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

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

Bromazepam ratiopharm contains bromazepam, a substance that belongs to a group of
medicines called benzodiazepines, which are used to relieve severe emotional and
psychological distress that causes significant discomfort and sometimes interferes with normal daily activities.
This medicine is therefore indicated for the treatment of:

• anxiety, feelings of tension, and other disorders associated with anxiety (somatic or psychiatric);
• sleep disorders (insomnia).

Benzodiazepines are indicated only when the disorder is severe, disabling, and causes significant distress in everyday life.
Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Bromazepam ratiopharm

Do not take Bromazepam ratiopharm

• if you are allergic to bromazepam, to other similar medicines (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease causing muscle weakness and fatigue (myasthenia gravis);
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have severe liver problems (severe hepatic impairment);
• if you have breathing difficulties during sleep (sleep apnea);
• if you suffer from a type of eye disease called narrow-angle glaucoma, characterized by altered ocular pressure;
• if you consume excessive amounts of alcohol (acute alcohol intoxication);
• if you are taking excessive amounts of medicines:
  • hypnotics (calming and sleep-inducing medicines);
  • analgesics (medicines for the treatment of 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 ratiopharm.
In particular, consult your doctor or pharmacist before taking Bromazepam ratiopharm if:

• you suffer from depression or anxiety associated with depression, because Bromazepam ratiopharm 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 concurrently taking medicines with central nervous system depressant activity;
• 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 have lung problems (chronic respiratory insufficiency);
• you have kidney problems (renal insufficiency);
• you have severe liver impairment (severe reduction in liver function);
• you have heart problems or suffer from blood pressure disorders (heart failure and low blood pressure);
• you suffer from a mental disorder causing altered perception of reality, thought disturbances, or mental confusion (psychosis).

Tolerance development
If, after a prolonged period of treatment with this medicine, you feel that the medicine no longer has an effect on your symptoms, consult your doctor.
Dependence development
When taking high doses and/or for prolonged periods of bromazepam, there may be a risk of developing physical and psychological dependence. This is more likely if you have previously abused drugs or alcohol, especially in polydrug abusers.
The risk of dependence is reduced if you use Bromazepam ratiopharm at the appropriate dose, as prescribed by your doctor, and for a short duration (see section 3 “How to take Bromazepam ratiopharm”).
If you are elderly
If you are elderly, take Bromazepam ratiopharm 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), muscle weakness, dizziness, drowsiness, fatigue, and tiredness.
Children and adolescents
The use of benzodiazepines in children is not recommended unless the doctor considers it strictly necessary. In such cases, treatment duration should be as short as possible.
Amnesia
Benzodiazepines may cause anterograde amnesia (loss of memory that does not affect past memories but greatly impairs the individual’s ability to store new information).
This phenomenon occurs more frequently several hours after taking the medicine, especially when high doses have been taken. Therefore, to reduce the risk of this occurring, ensure you can sleep uninterrupted for several hours after taking Bromazepam ratiopharm.
Amnesia may manifest with behavioral changes.
Other medicines and Bromazepam ratiopharm
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 or pharmacist if you are taking any of the following medicines:

• antipsychotics ( neuroleptics ) and certain antidepressants used to treat mental disorders;
• hypnotics used to promote sleep;
• anxiolytics/sedatives used to treat anxiety;
• certain strong painkillers ( narcotic analgesics );
• antiepileptics used for epilepsy;
• anaesthetics ;
• antihistamines with sedative effect used to treat allergies;
• opioid antitussives used to treat cough;
• cimetidine, a medicine used in stomach ulcer;
• theophyllines or aminophyllines , used to treat asthma;
• antifungals, medicines used for fungal infections, or 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 ratiopharm and opioids (strong analgesics, substitution therapy drugs, or cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, potentially endangering the patient’s life. Therefore, concomitant use should only be considered when no alternative therapies are available.
However, if your doctor prescribes Bromazepam ratiopharm together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s dosage recommendations. 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 these symptoms.
Bromazepam ratiopharm and alcohol
DO NOT consume alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine and negatively affect your ability to drive vehicles and operate machinery (see section “Driving and use of machines”).
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, 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 high-dose benzodiazepines during the second and/or third trimester of pregnancy may cause reduced fetal movements and altered heart rate.
If you plan to become pregnant while being treated with Bromazepam ratiopharm, contact your doctor immediately; they will advise you on how to gradually discontinue this medicine.
If you take Bromazepam ratiopharm as directed by your doctor during the late stages of pregnancy or during labor, the newborn may experience hypothermia (reduced body temperature), hypotonia (reduced muscle tone), respiratory depression, or apnea (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, because bromazepam passes into breast milk.
Driving and use of machines
Bromazepam ratiopharm may impair your ability to drive vehicles and operate machinery, as adverse effects such as amnesia (memory disturbances), sedation (physical and mental relaxation), impaired concentration, and altered muscle function may occur during treatment.
Furthermore, alcohol consumption during treatment with this medicine may enhance these effects (see section “Bromazepam ratiopharm and alcohol”).
Additionally, if you have not rested sufficiently, the risk of impaired attention is higher.
Bromazepam ratiopharm tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Bromazepam ratiopharm oral solution contains propylene glycol:
this medicine contains approximately 1.2 g of propylene glycol per 1.5 mg dose of bromazepam (15 drops). If you suffer from liver or kidney disease, or 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.
Bromazepam ratiopharm oral drops, solution contains sodium:
this medicine contains less than 1 mmol (23 mg) of sodium per maximum dose of 3 mg (30 drops), i.e., essentially “sodium-free”.

3. How to take Bromazepam ratiopharm

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

Adult patients
The recommended dose may range from 1.5 mg to 3 mg, up to three times daily.
Never exceed the dose prescribed by your doctor.
If you are elderly, your doctor will assess whether lower doses than those indicated above should be prescribed.

Use in children
This medicine is not indicated for use in children.

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

Insomnia
Treatment duration should be as short as possible and generally ranges 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 re-evaluating your health condition.

During the discontinuation period of Bromazepam ratiopharm 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 ratiopharm” and “Possible side effects”).

If you take more Bromazepam ratiopharm than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital immediately.

Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor and gait coordination), dysarthria (speech disorder), and nystagmus (oscillating, rhythmic, involuntary eye movements).
Overdose with 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 activity of the heart and lungs), and coma (loss of consciousness).

In mild cases, symptoms following accidental ingestion/overdose of Bromazepam ratiopharm may include:

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

In more severe cases, symptoms may include:

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

If you forget to take Bromazepam ratiopharm
Do not take a double dose to make up for the missed dose.

If you stop taking Bromazepam ratiopharm
Do not stop treatment with Bromazepam ratiopharm suddenly or without first discussing it with your doctor. Your doctor will gradually reduce your dose during the discontinuation phase.

Sudden discontinuation of this medicine may cause:

• withdrawal symptoms such as 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), increased sensitivity to light, noise, and physical touch, hallucinations (perception of non-existent things), 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 (awareness of rapid 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 bromazepam treatment reappear in a more severe form after discontinuation), 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 will experience them.
Stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:

• depression and mental disorders, such as
• restlessness,
• agitation,
• irritability,
• aggression,
• confusion (delirium),
• anger,
• nightmares and abnormal dreams,
• hallucinations (seeing or hearing things that are not real),
• changes in behaviour,
• psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly),
• nervousness,
• anxiety,
• hyperactivity.

These reactions are more frequent in elderly patients.

Additionally, the following side effects may occur with unknown frequency (cannot be estimated from the available data):

• allergic reaction (hypersensitivity);
• severe allergic reaction (anaphylactic shock);
• swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema);
• confusion;
• disorientation;
• emotional disturbances;
• changes in sexual desire;
• physical and psychological dependence, leading to excessive and uncontrolled use (abuse) of the medicine;
• withdrawal symptoms or rebound phenomena upon discontinuation of treatment;
• long-term memory loss (anterograde amnesia);
• memory impairment;
• Drowsiness;
• headache;
• dizziness;
• reduced alertness;
• fatigue, muscle weakness, difficulty controlling movements (ataxia);
• double or blurred vision;
• changes in heart function (cardiac insufficiency, including cardiac arrest);
• breathing difficulties (respiratory depression);
• nausea;
• vomiting;
• constipation;
• stomach and/or intestinal problems;
• skin and subcutaneous tissue disorders;
• rash, itching, hives;
• muscle weakness;
• difficulty urinating (urinary retention);
• fatigue;
• increased risk of falls and fractures;
• involuntary cessation of breathing, even during sleep (apnoea);
• worsening of pre-existing sleep apnoea.

Other side effects reported with other medicines belonging to the benzodiazepine class, such as Bromazepam ratiopharm:

• 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 or yellowish discoloration of the skin, mucous membranes, and whites of the eyes);
• abnormalities in certain blood tests (increased bilirubin, transaminases, and alkaline phosphatase);
• thrombocytopenia (reduced number of platelets);
• 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: 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 ratiopharm

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 ratiopharm contains
Bromazepam ratiopharm 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 ratiopharm 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, red iron oxides (E 172).

Bromazepam ratiopharm 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 ratiopharm and contents of the pack
Bromazepam ratiopharm 1.5 mg tablets are supplied in a box containing 20 tablets in blister packs.
Bromazepam ratiopharm 3 mg tablets are supplied in a box containing 20 tablets in blister packs.
Bromazepam ratiopharm 2.5 mg/ml oral drops, solution are supplied in a box containing a 20 ml bottle of solution with a dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - Ulm (Germany)
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy