Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 174.72 mg (equivalent: tapentadol, qty 150 mg) - tablet, modified release - excipient ingredients: propylene glycol; magnesium stearate; iron oxide red; hypromellose; lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; macrogol 6000; purified talc; iron oxide yellow - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 29.12 mg (equivalent: tapentadol, qty 25 mg) - tablet, modified release - excipient ingredients: hypromellose; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; lactose monohydrate; purified talc; macrogol 6000; macrogol 400; titanium dioxide; iron oxide yellow; iron oxide red - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 291.2 mg (equivalent: tapentadol, qty 250 mg) - tablet, modified release - excipient ingredients: iron oxide red; iron oxide yellow; microcrystalline cellulose; propylene glycol; macrogol 6000; lactose monohydrate; hypromellose; magnesium stearate; purified talc; iron oxide black; titanium dioxide; colloidal anhydrous silica - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 232.96 mg (equivalent: tapentadol, qty 200 mg) - tablet, modified release - excipient ingredients: iron oxide yellow; hypromellose; magnesium stearate; colloidal anhydrous silica; iron oxide red; lactose monohydrate; titanium dioxide; purified talc; microcrystalline cellulose; macrogol 6000; propylene glycol - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 116.48 mg (equivalent: tapentadol, qty 100 mg) - tablet, modified release - excipient ingredients: magnesium stearate; microcrystalline cellulose; purified talc; titanium dioxide; macrogol 6000; hypromellose; colloidal anhydrous silica; propylene glycol; iron oxide yellow; lactose monohydrate - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 58.24 mg (equivalent: tapentadol, qty 50 mg) - tablet, modified release - excipient ingredients: titanium dioxide; lactose monohydrate; propylene glycol; hypromellose; purified talc; colloidal anhydrous silica; macrogol 6000; microcrystalline cellulose; magnesium stearate - palexia sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. palexia sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. palexia sr is not indicated as an as-needed (prn) analgesia.

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - tapentadol 100 mg - like other drugs with mu-opioid agonist activity, nucynta® is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. nucynta® is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment [see warnings and precautions (5.1)] . like drugs with mu-opioid agonist activity, nucynta® is contraindicated in any patient who has or is suspected of having paralytic ileus. nucynta® is contraindicated in patients who are receiving monoamine oxidase (mao) inhibitors or who have taken them within the last 14 days due to potential additive effects on norepinephrine levels which may result in adverse cardiovascular events [see drug interactions (7.4)] . pregnancy category c. tapentadol hcl was evaluated for teratogenic effects in pregnant rats and rabbits following intravenous and subcutaneous exposure during the period of embryofetal organogenesis. w

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 116.48 mg (equivalent: tapentadol, qty 100 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; lactose monohydrate; iron oxide yellow; purified talc; povidone; titanium dioxide; iron oxide red; polyvinyl alcohol; microcrystalline cellulose; macrogol 3350; iron oxide black - palexia ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 87.36 mg (equivalent: tapentadol, qty 75 mg) - tablet, film coated - excipient ingredients: macrogol 3350; polyvinyl alcohol; iron oxide red; croscarmellose sodium; purified talc; lactose monohydrate; titanium dioxide; microcrystalline cellulose; povidone; magnesium stearate; iron oxide yellow - palexia ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tapentadol hydrochloride, quantity: 58.24 mg (equivalent: tapentadol, qty 50 mg) - tablet, film coated - excipient ingredients: purified talc; titanium dioxide; croscarmellose sodium; polyvinyl alcohol; lactose monohydrate; macrogol 3350; microcrystalline cellulose; povidone; magnesium stearate - palexia ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.