Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAMADOL HYDROCHLORIDE
IMEKS PHARMA SDN. BHD.
TRAMADOL HYDROCHLORIDE
50Capsule Capsules; 100Capsule Capsules; 10Capsule Capsules; 30Capsule Capsules
Salutas pharma GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ TRAMADOLOR ® 50 CAPSULES Tramadol HCl (50 mg) _ _ 1 WHAT IS IN THE LEAFLET 1. What TRAMADOLOR ® is used for 2. How TRAMADOLOR ® works 3. Before you use TRAMADOLOR ® 4. How to use TRAMADOLOR ® 5. While you are using it 6. Side effects 7. Storage and Disposal of TRAMADOLOR ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT TRAMADOLOR ® IS USED FOR TRAMADOLOR ® contains the active ingredient Tramadol hydrochloride. It is used to treat moderate to severe pain. HOW TRAMADOLOR ® WORKS TRAMADOLOR ® is classified as a pain reliever medicine. It works by blocking a chemical messenger from reaching the brain to interpret pain. The chemical messenger called prostaglandin is secreted by injured or damaged cell. BEFORE YOU USE TRAMADOLOR ® _ _ _- _ _When you must not use it_ Do not take TRAMADOLOR ® if you: • Have allergic reaction to the active ingredient Tramadol hydrochloride or to any other ingredients in this product. • Recently take large amount of alcohol. • Taking any other pain killers. • Taking any medicines that may affect your alertness or mood including medicines for psychiatry problems. • Taking monoamine oxidase (MAO) inhibitors or within two weeks of their withdrawal • In acute poisoning with alcohol, hypnotics, centrally analgesics, opioids, or psychotropic medicinal products • Are less than 12 years old • Have slow or shallow breathing, or other breathing problems. • Are pregnant • Are breastfeeding. _If you are not sure whether you should start _ _taking this medicine, consult your doctor._ - _Before you start to use it _ Tell your doctor if you: • Have thyroid hormone deficiency. • Have adrenal insufficiency (adrenal gland not producing enough of its hormone) • Have history of head injury or increase pressure inside the skull. • Have history with seizure. • Have respiratory problem. • Have opioids dependency. • Have abdominal problems. • Have liver and kidney pro Lestu allt skjalið
Directions for Use Please Read Carefully! Tramadolor ® 50 Capsules Tramadolor 50 Capsule (Active Ingredient: Tramadol HCI 50mg) DESCRIPTION Snap-fit, green cap and yellow body, hard gelatine capsule (size 3), containing a white odourless powder. CLINICAL PARTICULARS Indications Management of moderate to severe pain. Mode of Administration Oral Recommended Dosage Unless otherwise prescribed, the following dosage guidelines apply: Tramadol should not in any circumstances be used longer than therapeutically absolutely necessary. If the nature and severity of the disease makes more prolonged analgesic treatment with tramadol necessary, a regular, careful and frequent check should be carried out (possibly by the use of treatment-free intervals) to determine whether and to what extent a medical requirement still exists. Tramadol should be adjusted to the severity of pain and the patient’s individual sensitivity. For moderately severe pain, tramadol should be given at the following dosage: Adults and adolescents (12 years and older) Tramadolor ® 50 is not approved for use in patients below 12 years old. 1-2 capsules Tramadolor ® 50, equivalent to 50-100mg tramadol hydrochloride. Single oral dose of tramadol hydrochloride ranging from 50 – 200mg have provided relief of postoperative pain in patients who have undergo various types of surgery. If a dose of 1 capsule of Tramadolor ® 50 is not followed by adequate pain relief within 30-60 minutes, a single second dose of 1 capsule of Tramadolor ® 50 may be given. In severe pain, if clinical experience suggests that a higher analgesic dose is likely to be required, the initial dose may be 2 capsules Tramadolor ® 50. Not suitable for children weighing less than 25kg and cannot usually dosed individually for children under 14 years. An oral solution and an injectable solution are available for this purpose. The duration of action of tramadol hydrochloride is an average of 4-8 hours, depending on the severity of pain, when therapeutic doses are given. Daily doses of up Lestu allt skjalið