Bromazepam Biogaran tablet Uses, Dosage, Side Effects, Precautions & Warnings
Active ingredients: Bromazepam
- 1 what is Bromazepam Biogaran used for and indication?
- 2 Bromazepam Biogaran Dosage
- 3 Bromazepam Biogaran Contraindications
- 4 How To Take Bromazepam Biogaran ?
- 5 how does Bromazepam Biogaran work?
- 6 How To Store Bromazepam Biogaran ?
- 7 Bromazepam Biogaran Side Effects
- 8 Bromazepam Biogaran Interactions
- 9 Effects on ability to Drive and use machines
- 10 Warnings and Precautions
- 11 PREGNANCY & BREAST-FEEDING & FERTILITY
- 12 What happens if I overdose from Bromazepam Biogaran ?
- 13 What should I do if I miss a dose?
- 14 What happens if you stop taking Bromazepam Biogaran ?
- 15 What is Forms and Composition ?
what is Bromazepam Biogaran used for and indication?
- Symptomatic treatment of severe anxiety symptoms and / or disabling.
- Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.
PRESENTATION (S) AVAILABLE FOR BROMAZEPAM BIOGARAN 6 MG
polypropylene tube (s) of 30 tablet (s)
|Active substance (s)||for one tablet: bromazepam (6 mg)|
|Pharmaceutical form||quadrisis tablet|
|Route (s) of administration||oral|
|Social security reimbursement rate||65%|
|Conditions of issue||available by simple prescription|
Bromazepam Biogaran Dosage
- Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
- The dosage is strictly individual and it is not possible to define a usual dose.
Bromazepam Biogaran Contraindications
This medication should never be used in the following situations:
- ·Hypersensitivity to benzodiazepines, the active substance or to any of the excipients listed in section A composition;
- ·Severe respiratory failure;
- ·Severe hepatic insufficiency, acute or chronic (risk of developing hepatic encephalopathy);
- ·Sleep apnea syndrome.
How To Take Bromazepam Biogaran ?
- Oral route.
- Swallow this medicine with a glass of water.
Duration of the treatment
- The duration of treatment should be as short as possible and should not exceed 8 to 12 weeks.
how does Bromazepam Biogaran work?
Pharmacotherapeutic group: Benzodiazepine derivatives, ATC code: N05BA.
Bromazepam belongs to the class of 1-4 benzodiazepines and has pharmacodynamic activity qualitatively similar to that of other compounds in this class:
- Muscle relaxant,
These effects are linked to a specific agonist action on a central receptor forming part of the “GABA-OMEGA macromolecular receptors” complex, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.
How To Store Bromazepam Biogaran ?
- Keep this medication out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month .
- This medication does not require any special storage conditions.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
Bromazepam Biogaran Side Effects
Like all medicines, BROMAZEPAM BIOGARAN 6 mg, four-scored tablet can cause side effects, although not everybody gets them.
They are related to the dose ingested and the individual sensitivity of the patient.
Neuro-psychiatric adverse effects .
- memory impairment (memory loss ), which can occur with therapeutic doses, the risk increasing in proportion to the dose,
- behavioral disturbances, changes in consciousness, irritability, aggressiveness, agitation,
- physical and psychological dependence, even at therapeutic doses with withdrawal or rebound syndrome upon discontinuation of treatment,
- feelings of intoxication, headaches, difficulty coordinating certain movements,
- confusion, decreased alertness or even drowsiness (particularly in the elderly), insomnia, nightmares, tension,
- changes in libido.
Skin side effects
- rashes, with or without itching.
General side effects
- muscle weakness, fatigue.
Ocular side effects
- double vision.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Bromazepam Biogaran Interactions
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Effects on ability to Drive and use machines
- Attention is drawn to drowsiness and decreased alertness associated with the use of this medication.
- The combination with other sedative or hypnotic drugs, and of course with alcohol, is not recommended when driving a car or using machines.
- If the duration of sleep is insufficient, the risk of impaired vigilance is further increased.
Warnings and Precautions
If loss of effectiveness occurs with repeated use of the drug, do not increase the dose.
Risk of DEPENDENCE: this treatment can lead, especially in the event of prolonged use, to a state of physical and psychological dependence. Various factors seem to favor the onset of dependence:
- duration of treatment,
- history of other drug dependence or not, including alcoholic.
Addiction can occur even in the absence of these contributing factors.
For more information, talk to your doctor or pharmacist.
- Abruptly stopping this treatment may cause the appearance of a WITHDRAWAL phenomenon. This is characterized by the appearance, in a few hours or a few days, of signs such as severe anxiety, insomnia, muscle pain, but one can also observe restlessness, irritability, headaches, numbness or tingling of the extremities, abnormal sensitivity to noise, light or physical contact, etc., etc.
The modalities for stopping treatment should be defined with your doctor.
- The very PROGRESSIVE reduction of the doses and the spacing of the doses represent the best prevention of this phenomenon of withdrawal. This period will be longer as the treatment has been prolonged.
- Despite the gradual decrease in doses, a mild REBOUND phenomenon may occur, with TRANSITIONAL reappearance of symptoms (anxiety) which had justified the initiation of treatment.
- Memory problems as well as alterations in psychomotor functions are likely to appear within hours of taking the drug.
- In some subjects, this medication may cause reactions contrary to the desired effect: insomnia, nightmares, restlessness, nervousness, euphoria or irritability, tension, changes in consciousness, or even potentially dangerous behavior (aggression towards oneself or those around them , as well as behavioral disorders and automatic acts).
If one or more of these reactions occur, contact your doctor as soon as possible.
- Benzodiazepines and related products should be used with caution in the elderly, because of the risk of drowsiness and / or muscle relaxation which can promote falls, with often serious consequences in this population.
- Due to the presence of lactose, this medicine should not be used in case of galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
Precautions for use
- This drug treatment alone cannot resolve the difficulties associated with anxiety.
- You should seek advice from your doctor. He will show you the behaviors that can help in the fight against anxiety.
Taking this medication requires reinforced medical monitoring, especially in cases of renal failure, chronic liver disease, alcoholism and respiratory failure.
- This medicine does not treat depression. In the subject presenting a depression, it should not be used alone because it would allow the depression to evolve on its own account with persistence or increase of the suicidal risk.
- Alcohol intake is strictly discouraged during the treatment.
- IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
PREGNANCY & BREAST-FEEDING & FERTILITY
- This medicine will only be used during pregnancy on the advice of your doctor.
- If you discover that you are pregnant, consult your doctor, he alone can judge the need for continued treatment.
Feeding with milk
- This drug passes into breast milk: therefore, breast-feeding is not recommended.
- Ask your doctor or pharmacist for advice before taking any medicine.
What happens if I overdose from Bromazepam Biogaran ?
- Immediately consult your doctor or pharmacist.
What should I do if I miss a dose?
- Take the next dose at the usual time. Do not take a double dose to make up for the dose you forgot to take.
What happens if you stop taking Bromazepam Biogaran ?
- Withdrawal and rebound phenomena (see “Special warnings”).
- If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.
What is Forms and Composition ?
Appearance and shape
- Quadrisis tablet.
- 30 tablets in tube (polypropylene) with cap (LDPE) with compartment and tab).
Active ingredient Quadrisis tablet
Bromazepam 6 mg ** per unit dose
Active ingredients: Bromazepam
Excipients with known effects ? : Lactose monohydrate
Other excipients: Microcrystalline cellulose, Talc, Magnesium stearate
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