Страна: Израел
Език: английски
Източник: Ministry of Health
OXYCODONE HYDROCHLORIDE
RAFA LABORATORIES LTD
N02AA05
TABLETS CONTROLLED RELEASE
OXYCODONE HYDROCHLORIDE 10 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
OXYCODONE
OXYCODONE
For the relief of moderate to severe chronic pain.
2021-03-31
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only OXYCONTIN 10, 20, 40, 80 CONTROLLED-RELEASE TABLETS ACTIVE INGREDIENT: Each tablet of OXYCONTIN 10 contains: 10 mg oxycodone hydrochloride. Each tablet of OXYCONTIN 20 contains: 20 mg oxycodone hydrochloride. Each tablet of OXYCONTIN 40 contains: 40 mg oxycodone hydrochloride. Each tablet of OXYCONTIN 80 contains: 80 mg oxycodone hydrochloride. For the list of the additional ingredients, see section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to the doctor or pharmacist. This medicine was prescribed to treat your condition. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. Medicines of the opioids group may cause addiction, especially with prolonged use, and they have a potential for misuse and overdose. A reaction to an overdose may be manifested in slow breathing and may even cause death. Make sure you know the name of the medicine, the dosage that you take, how often you take it, the duration of treatment, potential side effects and risks. Additional information regarding the risk of dependence and addiction can be found at the following link: https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf Taking this medicine along with medicines from the benzodiazepines group, other medicines that depress the central nervous system (including drugs) or alcohol may cause a feeling of profound drowsiness, breathing difficulties (respiratory depression), coma and death. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the relief of long-term moderate to severe pain. THERAPEUTIC GROUP: Opioid analgesics This medicine has been prescribed for you only and should not be given to anyone else. Opioids may cause addiction, and you may experience withdrawal Прочетете целия документ
DL-OxyContin-SPC-Aug 2023-08 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _OXYCONTIN_ 10, 20, 40, 80 CONTROLLED RELEASE TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _OXYCONTIN 10_ contains 10 mg of oxycodone hydrochloride. _OXYCONTIN 20_ contains 20 mg of oxycodone hydrochloride. _OXYCONTIN 40_ contains 40 mg of oxycodone hydrochloride. _OXYCONTIN 80_ contains 80 mg of oxycodone hydrochloride. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Controlled release tablets. The 10 mg tablets are white. The 20 mg tablets are pink. The 40 mg tablets are yellow. The 80 mg tablets are green. 4. CLINICAL PARTICULARS WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see 'Drug Interactions']. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. 4.1 THERAPEUTIC INDICATIONS For the relief of moderate to severe chronic pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _OXYCONTIN _tablets must be swallowed whole, and not broken, chewed or crushed. _OXYCONTIN _tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth. (see also section 4.4). _Adults over 18 years:_ _ _ _OXYCONTIN _tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements. 2 Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with oxycodone in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). _OXY Прочетете целия документ