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SPC, UK: PALEXIA Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

PALEXIA 50 mg film-coated tablets. PALEXIA 75 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg tapentadol (as hydrochloride). Each film-coated tablet contains 75 mg tapentadol (as hydrochloride). Excipient(s) with known effect: PALEXIA 50 mg contains 24.74 ...

Pharmaceutical form

Film-coated tablet (tablet). 50mg: White round shaped film-coated tablets of 7 mm diameter, marked with Grünenthal logo on one side and H6 on the other side. 75mg: Pale yellow round shaped film-coated ...

Therapeutic indications

PALEXIA is indicated for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics.

Posology and method of administration

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. Patients should start treatment with ...

Contraindications

PALEXIA 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 has a potential for abuse and addiction. This should be considered when prescribing or dispensing PALEXIA in situations where there is concern ...

Interaction with other medicinal products and other forms of interaction

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

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 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 Tapentadol is rapidly and completely absorbed after oral administration of PALEXIA. Mean absolute bioavailability after single-dose administration (fasting) is approximately 32% due to extensive ...

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): Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Povidone K30 Magnesium stearate Tablet coat (All doses): Polyvinylalcohol Titanium dioxide (E171) Macrogol ...

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 blisters: Packs with 5, 10, 14, 20, 24, 28, 30, 40, 50, 54, 56, 60, 90, 100 film-coated tablets. PVC/PVDC aluminium perforated unit-dose blisters: Packs with 10x1, 14x1, 20x1, 28x1, ...

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 50 mg film-coated tablets: PL 21727/0032 PALEXIA 75 mg film-coated tablets: PL 21727/0033

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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