Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DIAZEPAM 10 mg/stuk
Neogen Developments N.V. Square Marie Curie 50 1070 ANDERLECHT (BELGIË)
N05BA01
DIAZEPAM 10 mg/stuk
Tablet
LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD,
Oraal gebruik
Diazepam
Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD;
1900-01-01
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DALPAM 2 MG TABLETTEN DALPAM 5 MG TABLETTEN DALPAM 10 MG TABLETTEN diazepam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dalpam is and what it is used for 2. What you need to know before you take Dalpam 3. How to take Dalpam 4. Possible side effects 5. How to store Dalpam 6. Contents of the pack and further information 1. WHAT DALPAM IS AND WHAT IT IS USED FOR Dalpam contain the active substance diazepam which belongs to a group of medicines called benzodiazepines. Dalpam has anxiolytic, sedative and muscle relaxant effect. Dalpam is used: - in the treatment of anxiety. - in the treatment of muscle spasms, including those caused by cerebral spasticity (originates in the brain). - for symptoms of alcohol withdrawal. - to provide sedation before operations (premedication). Your doctor may prescribe Dalpam for other uses. Please follow your doctor’s instructions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALPAM DO NOT TAKE DALPAM - if you are ALLERGIC to diazepam or any of the other ingredients of this medicine (listed in section 6). - if you have a condition called MYASTHENIA GRAVIS which causes muscles to weaken and tire easily. - if you suffer from SLEEP APNOEA (a sleep disorder where you have abnormal pauses in breathing during sleep). - if you have SEVERE LIVER disorders. - if you have ACUTE RESPIRATORY DEPRESSION (slow and/or shallow breathing). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Dalpam 3 - if you have a Læs hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dalpam 2 mg tabletten Dalpam 5 mg tabletten Dalpam 10 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg diazepam. Each tablet contains 5 mg diazepam. Each tablet contains 10 mg diazepam. Excipient(s) with known effect: Each Dalpam 2 mg tablet contains 168.1 mg lactose monohydrate. Each Dalpam 5 mg tablet contains 165.1mg lactose monohydrate. Each Dalpam 10 mg tablet contains 160.1 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Dalpam 2 mg: white to almost white round, flat, 8 mm in diameter with “2” on one side and a break line on the other side. Dalpam 5 mg: Tablet is white to almost white round, flat, 8 mm in diameter with “5” on one side and a break line on the other side. Dalpam 10 mg: Tablet is white to almost white round, flat, 8 mm in diameter with “10” on one side and a break line on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Anxiety. - Adjunct in the control of skeletal muscle spasm, including spasticity caused by upper motor neuron disorders (such as cerebral palsy). - Alcohol withdrawal symptoms. - Premedication before general anaesthesia or for sedation during minor surgical or investigative procedures. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Standard dosage 3 For optimal effect, the dosage should be carefully individualised. Treatment should begin at the lowest effective dose appropriate to the particular condition. Duration of treatment The duration of treatment should be as short as possible (see section 4.4). The patient should be re- evaluated after a period of no more than 4 weeks and then regularly thereafter in order to assess the need for continued treatment, especially in case the patient is symptom free. In general, treatment mu Læs hele dokumentet