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SPC, UK: PALEXIA SR Prolonged-release tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

PALEXIA SR 50 mg prolonged-release tablets. PALEXIA SR 100 mg prolonged-release tablets. PALEXIA SR 150 mg prolonged-release tablets. PALEXIA SR 200 mg prolonged-release tablets. PALEXIA SR 250 mg prolonged-release ...

Qualitative and quantitative composition

Each prolonged-release tablet contains 50 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 100 mg tapentadol (as hydrochloride). Each prolonged-release tablet contains 150 mg tapentadol ...

Pharmaceutical form

Prolonged-release tablet. 50 mg: White film-coated oblong shaped tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H1” on the other side. 100 mg: Pale yellow film-coated oblong shaped ...

Therapeutic indications

PALEXIA SR is indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics.

Posology and method of administration

Posology The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient. PALEXIA SR should be taken ...

Contraindications

PALEXIA SR is contraindicated: in patients with hypersensitivity to tapentadol or to any of the excipients listed in section 6.1. in situations where active substances with mu-opioid receptor agonist activity ...

Special warnings and precautions for use

Potential for Abuse and Addiction/ Dependence Syndrome PALEXIA SR has a potential for abuse and addiction. This should be considered when prescribing or dispensing PALEXIA SR in situations where there ...

Interaction with other medicinal products and other forms of interaction

Sedative medicines such as benzodiazepines or related drugs The concomitant use of PALEXIA SR with sedating medicinal products such as benzodiazepines or other respiratory or CNS depressants (other opioids, ...

Fertility, pregnancy and lactation

Pregnancy There is very limited amount of data from the use in pregnant women. Studies in animals have not shown teratogenic effects. However, delayed development and embryotoxicity were observed at doses ...

Effects on ability to drive and use machines

PALEXIA SR may have major influence on the ability to drive and use machines, because it may adversely affect central nervous system functions (see section 4.8). This has to be expected especially at the ...

Undesirable effects

The adverse drug reactions that were experienced by patients in the placebo controlled trials performed with PALEXIA were predominantly of mild and moderate severity. The most frequent adverse drug reactions ...

Overdose

Symptoms Human experience with overdose of tapentadol is very limited. Preclinical data suggest that symptoms similar to those of other centrally acting analgesics with mu-opioid receptor agonist activity ...

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics; opioids; other opioids ATC code: N02AX06 Tapentadol is a strong analgesic with µ-agonistic opioid and additional noradrenaline reuptake inhibition properties. Tapentadol ...

Pharmacokinetic properties

Absorption Mean absolute bioavailability after single-dose administration (fasting) of Palexia SR is approximately 32% due to extensive first-pass metabolism. Maximum serum concentrations of tapentadol ...

Preclinical safety data

Tapentadol was not genotoxic in bacteria in the Ames test. Equivocal findings were observed in an in vitro chromosomal aberration test, but when the test was repeated the results were clearly negative. ...

List of excipients

Tablet core (all doses): Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate Tablet coat: Hypromellose Lactose monohydrate Talc Macrogol 6000 Propylene glycol Titanium ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PVDC-aluminium/paper/PET blisters: Packs with 7, 10, 14, 20, 24, 28, 30, 40, 50, 54, 56, 60, 90, 100 prolonged-release tablets. PVC/PVDC aluminium/paper/PET perforated unit-dose blisters: Packs with ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom

Marketing authorization number(s)

PALEXIA SR 50 mg prolonged-release tablets: PL 21727/0041 PALEXIA SR 100 mg prolonged-release tablets: PL 21727/0042 PALEXIA SR 150 mg prolonged-release tablets: PL 21727/0043 PALEXIA SR 200 mg prolonged-release ...

Date of first authorization / renewal of the authorization

04 February 2011

Date of revision of the text

28 October 2019

Πηγαίο έγγραφο

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