Bromazepam Tecnigen

Patient Information Leaflet: Information for the User

BROMAZEPAM TECNIGEN 2.5 mg/ml oral drops, solution

Bromazepam
Generic medicine
Please read all of this leaflet carefully before you start using 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What you need to know before you use BROMAZEPAM TECNIGEN

3. How to use BROMAZEPAM TECNIGEN

4. Possible side effects

5. How to store BROMAZEPAM TECNIGEN

6. Contents of the pack and other information

7. What BROMAZEPAM TECNIGEN is and what it is used for

BROMAZEPAM TECNIGEN contains the active substance Bromazepam, which belongs to a group of medicines called "anxiolytics", used in the treatment of anxiety, tension, and other somatic (bodily) or psychiatric symptoms associated with anxiety disorders and sleep disturbances (insomnia).
This medicine is indicated only in cases where the condition is severe, disabling, and causes the individual severe distress.

2. What you should know before using BROMAZEPAM TECNIGEN

Do not use BROMAZEPAM TECNIGEN

• if you are allergic to the active substance bromazepam, to other similar medicines (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 suffer from severe respiratory insufficiency;
• if you have serious liver problems (severe hepatic insufficiency);
• if you have breathing difficulties during sleep (sleep apnoea syndrome);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

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

• if you are elderly. In this case, the doctor may decide to reduce the dose;
• if you have respiratory problems (chronic respiratory insufficiency) due to the risk of respiratory depression. In this case, the doctor may decide to reduce the dose;
• if you suffer from liver problems (severe hepatic insufficiency), as a brain disorder called “hepatic encephalopathy” may occur;
• if you suffer from depression or have previously abused alcohol or drugs.

Tolerance:
Contact your doctor if, after a few weeks, you feel the medicine is not working as well as at the beginning of treatment.
Dependence:
While taking this medicine, there is a risk of dependence, i.e. the need to continue taking the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol.
Withdrawal:
When stopping BROMAZEPAM TECNIGEN, you may experience withdrawal or rebound symptoms, 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 TECNIGEN”). To minimize these symptoms, gradual dose reduction is recommended.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
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 frequent in children and elderly patients.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
Other medicines and BROMAZEPAM TECNIGEN
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Pay particular attention and inform your doctor if you are taking the following medicines:

• antipsychotics and antidepressants;
• hypnotics, medicines that promote sleep;
• anxiolytics/tranquillisers/sedatives, medicines used to treat anxiety;
• antiepileptics, used for epilepsy;
• anaesthetics, used during surgical procedures;
• opioids, anticonvulsants;
• sedating antihistamines, medicines used to treat allergies;
• narcotic analgesics, strong painkillers that may increase euphoria leading to increased psychological dependence;
• cytochrome P450 inhibitors, a group of specialized proteins called “enzymes” that may increase the activity of BROMAZEPAM TECNIGEN.

The concomitant use of BROMAZEPAM TECNIGEN and opioids (strong painkillers, substitution therapy medicines, 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 TECNIGEN 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 carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or family members so they can recognize the signs and symptoms listed above. Contact your doctor if such symptoms occur.
BROMAZEPAM TECNIGEN and alcohol
Avoid consuming alcohol during treatment with this medicine.
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
Do not take BROMAZEPAM TECNIGEN during pregnancy.
If your doctor considers it necessary for you to take BROMAZEPAM TECNIGEN in the late stages of pregnancy or during labour, your baby may experience low body temperature, loss of muscle tone, low blood pressure, and difficulties with sucking and breathing.
If BROMAZEPAM TECNIGEN has been taken regularly during the late stages of pregnancy, your baby may experience withdrawal symptoms.
If you start treatment with BROMAZEPAM TECNIGEN and are of childbearing age, consult your doctor whether you are planning a pregnancy or 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
The use of BROMAZEPAM TECNIGEN may affect your ability to drive vehicles or operate machinery, as you may feel confused, experience memory problems, feel drowsy, or have muscle tone problems. These effects are increased if you have not slept enough. If this happens, avoid driving or using machinery.

3. How to take BROMAZEPAM TECNIGEN

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Due to individual differences in response, the dose should be adjusted on a case-by-case basis; the average dose is 1.5–3 mg 2–3 times daily (15–30 drops 2–3 times daily).
Anxiety
Treatment should be as short as possible. The total duration of treatment should generally not exceed 8–12 weeks, including a gradual withdrawal period.
In certain cases, after re-evaluation of your condition, your doctor may consider it necessary to extend treatment beyond this maximum period.
Insomnia
Treatment should be as short as possible. The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period.
In certain cases, after re-evaluation of your condition, your doctor may consider it necessary to extend treatment beyond this maximum period.
Treatment should be initiated with the lowest recommended dose.
The maximum dose should not be exceeded.
Use in children and adolescents
This medicine should only be used when absolutely necessary, and the duration of treatment should be as short as possible.
Use in the elderly
In elderly patients, the recommended dose should be carefully determined by the doctor, who may consider reducing the doses indicated above.
Use in patients with liver problems
In patients with impaired liver function, the recommended dose should be carefully determined by the doctor, who may consider reducing the doses indicated above.
If you take more BROMAZEPAM TECNIGEN than you should
If you have taken an excessive dose of BROMAZEPAM TECNIGEN, contact your doctor immediately or go to the nearest hospital.
Overdose may cause severe depression of the central nervous system, with symptoms such as drowsiness, fatigue, confusion, visual disturbances, deep sleep progressing to unconsciousness, progressive loss of muscle coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, temporary loss of sensory and intellectual functions (obnubilation), which may worsen to coma and, very rarely, death.
If you forget to take BROMAZEPAM TECNIGEN
Do not take a double dose to make up for the forgotten dose.
If you stop taking BROMAZEPAM TECNIGEN
Do not stop treatment with BROMAZEPAM TECNIGEN 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, diarrhoea;
• severe anxiety, confusion, restlessness, irritability;
• in severe withdrawal cases, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not real), or epileptic seizures.
  Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may return more intensely than before (rebound insomnia and anxiety).
  If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
At the beginning of treatment, daytime drowsiness, emotional disturbances, unconsciousness, confusion, fatigue, headache (cephalalgia), dizziness, muscle weakness, progressive loss of muscle coordination (ataxia), or double vision (diplopia) may occur. These reactions usually disappear with continued treatment.
Other adverse reactions have been occasionally reported, including: gastrointestinal
disturbances, urinary retention, decreased sexual desire, and skin reactions.
Contact your doctor immediately if you experience:

• depression and mental disorders such as restlessness, agitation, irritability, aggressiveness, 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.

Reporting of side effects
If you get any side effects, 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 the website
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 TECNIGEN

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 product must be used within 20 days of first opening the bottle.
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. Package contents and other information

What BROMAZEPAM TECNIGEN contains
1 ml of solution contains:

• The active substance: Bromazepam 2.5 mg.
• The other components are: Sodium saccharin, tutti frutti flavour, Sodium edetate, Purified water, Propylene glycol.

Description of the appearance of BROMAZEPAM TECNIGEN and contents of the pack
Pack containing one 20 ml bottle of solution.
Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
This leaflet was last updated on
January 2016