País: Israel
Língua: inglês
Origem: Ministry of Health
NALOXONE HYDROCHLORIDE (AS DIHYDRATE); OXYCODONE HYDROCHLORIDE
RAFA LABORATORIES LTD
V03AB15
TABLETS PROLONGED RELEASE
OXYCODONE HYDROCHLORIDE 10 MG; NALOXONE HYDROCHLORIDE (AS DIHYDRATE) 5 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
NALOXONE
NALOXONE
Targin is indicated for the relief of moderate to severe pain.The oxycodone component is indicated for the relief of moderate to severe pain in adults who require continuous around-the-clock opioid analgesia for several days or more. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.
2023-12-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only TARGIN 5, TARGIN 10, TARGIN 20, TARGIN 30, TARGIN 40 PROLONGED RELEASE TABLETS ACTIVE INGREDIENTS: PRODUCT Oxycodone hydrochloride (Oxycodone HCl) Naloxone hydrochloride (Naloxone HCl) TARGIN 5 5 mg 2.5 mg TARGIN 10 10 mg 5 mg TARGIN 20 20 mg 10 mg TARGIN 30 30 mg 15 mg TARGIN 40 40 mg 20 mg For the list of additional ingredients, see section 6. See also ‘Important information about some of the medicine’s ingredients’ in section 2. 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 your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that 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 by 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 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 which 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? Targin is intended for the relief of moderate to severe pain. Targin has two active ingredients, oxycodone and naloxone. The oxycodone is intended for the relief of moderate to severe pain in adults who need opioid pain relief throughout the en Leia o documento completo
1 DL-Targin -SPC-21-September- 2023- 08 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _Targin 5_, _Targin 10, Targin 20, Targin 30_, _Targin 40 _ _ _ Prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Targin 5 _ Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg oxycodone, and 2.73 mg of naloxone hydrochloride dihydrate equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone. _Targin 10 _ Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride equivalent to 9 mg oxycodone, and 5.45 mg of naloxone hydrochloride dihydrate equivalent to 5 mg naloxone hydrochloride and 4.5 mg naloxone. _Targin 20 _ Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride equivalent to 18 mg oxycodone, and 10.9 mg of naloxone hydrochloride dihydrate equivalent to 10 mg naloxone hydrochloride and 9 mg naloxone. _Targin 30 _ Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride equivalent to 27 mg oxycodone, and 16.48 mg of naloxone hydrochloride dihydrate equivalent to 15 mg naloxone hydrochloride and 13.5 mg naloxone. _ _ _Targin 40 _ Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36 mg oxycodone, and 21.8 mg of naloxone hydrochloride dihydrate equivalent to 20 mg naloxone hydrochloride and 18 mg naloxone. Excipient with known effect: Each tablet of _Targin 5_ contains 71.75 mg lactose monohydrate. Each tablet of _Targin 10_ contains 64.25 mg lactose monohydrate. Each tablet of _Targin 20_ contains 54.5 mg lactose monohydrate. Each tablet of _Targin 30_ contains 38.42 mg lactose monohydrate. Each tablet of _Targin 40_ contains 109 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablets. _ _ _Targin 5_ are oblong, blue film-coated tablets, unscored and marked “OXN” on one side and “5” on the other side. _Targin 10_ are oblong, white film-coated tablets, unscored and marked “OXN” on Leia o documento completo