Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BROMAZEPAM
DKSH MALAYSIA SDN BHD
BROMAZEPAM
100Tablet Tablets
Delpharm Milano s.r.l
LEXOTAN ® Bromazepam (1.5 mg tablet) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Lexotan is used for 2. How Lexotan works 3. Before you use Lexotan 4. How to use Lexotan 5. While you are using Lexotan 6. Side effects 7. Storage and disposal of Lexotan 8. Product Description 9. Manufacturer and Product Registration Holder 1. WHAT LEXOTAN IS USED FOR _ _ Lexotan contains the active ingredient bromazepam. Lexotan is used to treat the following: • _Emotional _ _disturbances._ Acute tension and anxiety states. Difficulties in interpersonal contact. Agitation, insomnia. Anxious, agitated depressive reactions. • _Functional _ _disturbances _ _in _ _the _ _heart _ _and _ _lung _ _systems _ (pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea, hyperventilation) • _In _ _the _ _gastrointestinal _ _system_ (irritable bowel syndrome, epigastric pain, spasm, bloating diarrhea, etc.) • _ In _ _the _ _genitourinary _ _system _ (frequency, irritable bladder; dysmenorrhea). • _Psychosomatic _ _disorders._ Headache or skin problems caused by mental disturbances. Asthma. Gastric and duodenal ulcer, ulcerative colitis • _Emotional reactions to chronic _ _organic disease._ Your doctor, however, may have prescribed Lexotan for another purpose. Ask your doctor if you have any questions why Lexotan has been prescribed for you. This medicine may be addictive. This medicine is available only with a doctor’s prescription. 2. HOW LEXOTAN WORKS _ _ Lexotan belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. 3. BEFORE YOU USE LEXOTAN _ _ _-_ _ _ _When you must not use it_ 1. YOU HAVE HAD AN ALLERGIC REACTION TO LEXOTAN, OTHER BENZODIAZEPINES OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include: • Shortness of breath • Wheezing or difficulty breathing • Swelling of the face, lips, tongue or other parts of the body • Rash, i Leggi il documento completo
Leaflet 1,5 mg Lexotan MY DRAFT (DATE) 17.12.2019 [12:50 uhr] (4) COLOURS Pantone Black linework DIMENSIONS 150+150x304,5 mm MATERIAL NUMBER 90002931/10 FONT SIZE 9 pt PRODUCT CODE Delpharm Milano 86067044 MY-CP Lexotan ® Bromazepam 1. DESCRIPTION 1.1 Therapeutic / Pharmacologic Class of Drug Anxiolytic ATC code: N05BA08 1.2 Type of Dosage Form Tablets 1.3 Route of Administration Oral 1.4 Qualitative and Quantitative Composition Active ingredient: bromazepam Tablets 1.5 mg The tablets are of a slightly yellowish colour. Excipients: Lexotan tablets contain lactose. For warning related to lactose, see section 2.4.1 General (Warnings and Precautions). 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) Emotional disturbances. Acute tension and anxiety states. Difficulties in interpersonal contact. Agitation, insomnia. Anxious, agitated depressive reactions. Functional disturbances in the vascular and respiratory systems (pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea, hyperventilation); in the gastrointestinal system (irritable bowel syndro - me, epigastric pain, spasm, bloating diarrhea, etc); in the genitourinary system (frequency, irritable bladder; dysmenorrhea). Psychosomatic disorders. Psychogenic heada - che. Psychogenic dermatosis. Asthma. Gastric and duodenal ulcer, ulcerative colitis. Emotional reactions to chronic organic disease. Adjuvant to psychotherapy in psychoneurosis. 2.2 Dosage and Administration Standard dosage Average dosing for outpatient therapy: 1.5-3 mg up to three times daily. Severe cases, especially in hospital: 6-12 mg two or three times daily. These amounts are general recommendations, and dosage should be individually determined. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level. Duration of treatment The duration of treatment should be as short as possible. The patient should be reassessed regu - larly and the need for continued treatment should be evaluated, especially in case the patient is s Leggi il documento completo