País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Acetaminophen; TRAMADOL HYDROCHLORIDE
JOHNSON & JOHNSON SDN BHD
Acetaminophen; TRAMADOL HYDROCHLORIDE
10Tablet Tablets; 30Tablet Tablets
JANSSEN CILAG SPA
ULTRACET TABLET ® Tramadol hydrochloride / acetominophen (37.5mg/325mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ULTRACET ® is used for 2. How ULTRACET ® works 3. Before you use ULTRACET ® 4. How to use ULTRACET ® 5. While you are using it 6. Side effects 7. Storage and disposal of ULTRACET ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT ULTRACET ® IS USED FOR ULTRACET ® is used to treat moderate pain to severe pain. HOW ULTRACET ® WORKS ULTRACET ® tablets have a combination of two pain relievers – tramadol hydrochloride (an opioid analgesic) and acetaminophen (same as paracetamol). BEFORE YOU USE ULTRACET ® - _When you must not use it _ • You are less than 12 years old; • You have slow or shallow breathing, or other breathing problems; • You are pregnant; • You are breastfeeding. You must not take ULTRACET ® if you have previously had an allergic reaction (hypersensitivity) to tramadol hydrochloride or acetaminophen, or to any other opioid pain relievers. Please tell your doctor if this applies to you. Hypersensitivity can be recognized for instance by skin rash, itching, shortness of breath or swollen face. If any of these occur, contact your doctor right away. Do not give ULTRACET ® to a child under 18 years of age that has just an operation to remove their tonsils or adenoids. Do not take ULTRACET ® if you are taking: • Sleeping pills e.g. hypnotics; • Medicines that affect your mood or emotions e.g. narcotics and psychotropic drugs; • Pain relievers that affect your central nervous system e.g. centrally acting analgesics and opioids; • Antidepressants such as Monoamine Oxidase Inhibitors (MAO inhibitors) currently or within the last 14 days. _ _ _Pregnancy and lactation _ If you are, or think you may be, pregnant, you should inform your doctor, who will decide if you can take ULTRACET ® . Opioid medicines can slow the breathing of a newborn child. Prolonged use of ULTRACET ® during Leer el documento completo
PRODUCT NAME ULTRACET ® (tramadol and paracetamol) DOSAGE FORMS AND STRENGTHS Light yellow, film-coated capsule-shaped tablet debossed: “J-C” on one side and “T/P” on the other side. Each tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS ULTRACET is indicated for the management of moderate to severe pain. DOSAGE AND ADMINISTRATION DOSAGE ADULTS AND CHILDREN 16 YEARS OF AGE AND OVER_ _ The maximum single dose of ULTRACET is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. The lowest effective dose should be used for the shortest period of time. ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) ULTRACET is not approved for use in patients below 12 years old. PAEDIATRIC POPULATION The safety and efficacy of ULTRACET has not been studied in the paediatric population. Therefore, use of ULTRACET is not recommended in patients under 12 years of age. TREATMENT WITHDRAWAL Do not stop use of ULTRACET abruptly. Withdrawal symptoms may be relieved by tapering the medication (see _Warnings and Precautions – Treatment withdrawal_ ). SPECIAL POPULATIONS _CHILDREN BELOW 16 YEARS OF AGE _ The use of ULTRACET is contraindicated in children below 12 years of age (see _Contraindications_ ). _ _ The safety and effectiveness of ULTRACET in children aged 12 to below 16 years of age has not been established(see _Contraindications and Warnings and Precautions - Other risk factors for life-_ _threatening respiratory depression in children_ ). _ELDERLY (65 YEARS OF AGE AND OLDER) _ No overall differences with regard to safety or pharmacokinetics were noted between subjects ≥65 years of age and younger subjects. However, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, of concomitant disease and multiple drug therapy. _RENAL IMPAIRMENT _ In patients with creatinine clearances of less than 30 mL/min, i Leer el documento completo