BROMAZEPAM 0.25% Krople doustne, roztwór

Treść ulotki

1. What you need to know before using BROMAZEPAM TECNIGEN
2. Possible side effects
3. How to store BROMAZEPAM TECNIGEN
4. Contents of the pack and other information

BROMAZEPAM TECNIGEN 2.5 mg/ml oral drops, solution
Bromazepam

Equivalent medicine
Read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is BROMAZEPAM TECNIGEN and what it is used for
• 2. What you need to know before using 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
• 1. What is BROMAZEPAM TECNIGEN and what it is used for

BROMAZEPAN TECNIGEN contains the active ingredient Bromazepam which belongs to a
group of medicines called “anxiolytics”, used for the therapy of anxiety, tension and other
somatic (body) or psychiatric manifestations associated with anxiety syndrome and
sleep disorders (insomnia).
This medicine is indicated only in cases where the disorder is severe, disabling and
subjects people to severe distress.

2. What you need to know before using BROMAZEPAM TECNIGEN

Do not use BROMAZEPAM TECNIGEN

• if you are allergic to the active ingredient 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 that causes muscle weakness and fatigue (myasthenia gravis);
• if you suffer from severe respiratory failure;
• if you have serious liver problems (severe hepatic insufficiency);
• if you have problems breathing during sleep (sleep apnea syndrome);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

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

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

Tolerance:
Consult your doctor if after a few weeks it seems that the medicine is not working
as well as it did at the beginning of treatment.

Dependence:
During the intake of this medicine, the risk of dependence may arise, that is
the need to continue taking the medicine. The risk increases with the dose and the
duration of treatment. It is greater if you have previously abused drugs and alcohol.

Withdrawal:
When you stop taking 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, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also appear 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 uninterrupted sleep of
7-8 hours.

Behavioral reactions:
If you experience behavioral disturbances, immediately stop taking the
medicine (see section 4. “Possible side effects”). These reactions are more
common in children and the elderly.
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
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 and antidepressants;
• hypnotics, medicines that promote sleep;
• anxiolytics/tranquilizers/sedatives, medicines used to treat anxiety;
• antiepileptics, used for epilepsy;
• anesthetics, used during surgical operations;
• opioids, anticonvulsants;
• sedating antihistamines, medicines used to treat allergies;
• narcotic analgesics, strong painkillers that can cause an increase in euphoria leading to increased psychological dependence;
• cytochrome P450 inhibitors, a group of specialized proteins called “enzymes” that can increase the activity of BROMAZEPAM TECNIGEN.

The concomitant use of BROMAZEPAM TECNIGEN and opioids (strong painkillers,
medicines for substitution therapy and some cough medicines) increases the risk of
drowsiness, difficulty breathing (respiratory depression), coma and can be
life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes BROMAZEPAM TECNIGEN together with opioids, the dose
and duration of concomitant therapy must be limited by your doctor.
Tell your doctor all the opioid medicines you are taking and carefully follow
your doctor's recommendations on dosage. It may be helpful to
inform friends or family members to be able to recognize the signs and symptoms mentioned above. Consult your doctor when these symptoms occur.

BROMAZEPAM TECNIGEN with alcohol
Avoid drinking alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
Do not take BROMAZEPAM TECNIGEN during pregnancy.
If your doctor believes you should take BROMAZEPAM TECNIGEN, in the late stages
of pregnancy or during labor, your baby may experience low
body temperature, loss of muscle tone, low blood pressure, difficulty
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 while of childbearing potential, consult your doctor,
whether you intend to become pregnant or suspect you are pregnant, because
it will be necessary to stop taking the medicine.
Breastfeeding
Do not take this medicine if you are breastfeeding, as bromazepam passes into
breast milk.

Driving and operating machinery
The use of BROMAZEPAM TECNIGEN may affect your ability to drive vehicles and
operate machinery because you may feel confused, experience memory problems,
feel sleepy, experience problems with muscle tone. These effects are increased if
you have not had enough sleep. If this happens to you, avoid driving vehicles or
operating machinery.

• 3. How to take BROMAZEPAM TECNIGEN

Take this medicine following exactly the instructions of your doctor or
pharmacist. If you have doubts, consult your doctor or pharmacist.
Due to the different individual responses, the dose should be adjusted on a case-by-case basis, on average 1.5-3 mg 2-
3 times a day (15-30 drops 2-3 times a day).
Anxiety
Treatment should be as short as possible. The total duration of
treatment generally should not exceed 8-12 weeks, including a
period of gradual discontinuation.
In certain cases, after reassessment of your condition, your doctor may
consider extending beyond the maximum treatment 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 period of gradual discontinuation.
In certain cases, after reassessment of your condition, your doctor may
consider extending beyond the maximum treatment period.
Treatment should be started with the lowest recommended dose.
The maximum dose should not be exceeded.

Use in children and adolescents
This medicine should only be used in cases of absolute necessity and the duration
of treatment should be as short as possible.

Use in the elderly
In the elderly, the recommended dose must be carefully established by the doctor who
will have to assess a possible reduction of the above dosages.

Use in people with liver problems
In patients with reduced liver function, the recommended dose must be
carefully established by the doctor who will have to assess a possible reduction of the dosages
above.

If you take more BROMAZEPAM TECNIGEN than you should
If you have taken an excessive dose of BROMAZEPAM TECNIGEN, immediately warn
your doctor or go to the nearest hospital.
An overdose can cause severe depression of the nervous system with symptoms
such as drowsiness, fatigue, confusion, visual disturbances, deep sleep up to
unconsciousness, progressive loss of muscle coordination (ataxia), reduction of
muscle tone (hypotonia), lowering of blood pressure (hypotension),
respiratory depression, temporary loss of sensory and intellectual abilities
(obnubilation) which can worsen to coma and, very rarely, death.

If you forget to take BROMAZEPAM TECNIGEN
Do not take a double dose to make up for a missed dose.

If you stop taking BROMAZAPEM TECNIGEN
Do not stop treatment with BROMAZAPEM TECNIGEN suddenly or without
having first agreed with your doctor, as withdrawal symptoms may occur.
If your doctor has decided to stop treatment, they will gradually reduce your dose to
minimize withdrawal symptoms, such as:

• headache, muscle pain, tension, diarrhea.
• severe anxiety, confusion, restlessness, irritability.
• in severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures may occur. Treatment must be discontinued gradually otherwise the symptoms for which you were being treated may reappear even 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 everyone will experience them.
At the beginning of treatment, drowsiness during the day, emotional disturbances, state of unconsciousness, confusion, fatigue, headache, dizziness,
muscle weakness, progressive loss of muscle coordination (ataxia) or
double vision (diplopia) may occur. These reactions generally disappear with the continuation
of treatment.
Other adverse reactions have been reported occasionally, including: gastrointestinal
disorders, urinary retention, decreased sexual desire and skin reactions.
Contact your doctor immediately if you experience:

• depression and mental disorders, such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses contact with reality and the ability to think and judge clearly), changes in behavior. Treatment should be discontinued when these side effects occur. These reactions are more likely to occur in children and the elderly.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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 in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What BROMAZEPAM TECNIGEN contains
1 ml of solution contains:

• The active ingredient: Bromazepam 2.5 mg.
• The other ingredients are: Sodium saccharin, All fruit flavour, Sodium edetate, Purified water, Propylene glycol.

Description of the appearance of BROMAZEPAM TECNIGEN and contents of the pack
Pack containing a 20 ml bottle of solution.

Marketing Authorisation 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 in
January 2016