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SPC, UK: PALEXIA Oral solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

PALEXIA 20 mg/ml oral solution.

Qualitative and quantitative composition

1 ml oral solution contains 20 mg tapentadol (as hydrochloride). Excipients with known effect: PALEXIA 20 mg/ml oral solution contains propylene glycol and sodium. See section 4.4. For the full list of ...

Pharmaceutical form

Oral solution. Clear, colourless solution. pH 3.5 to 4.5

Therapeutic indications

PALEXIA is indicated for the relief of moderate to severe acute pain in children from 2 years of age with a body weight of more than 16 kg and in adults, which can be adequately managed only with opioid ...

Posology and method of administration

The use of PALEXIA in children is restricted to hospital use where appropriate equipment to enable respiratory support is available. The dosing regimen should be individualised according to the severity ...

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

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

The bioavailability as assessed by C<sub>max</sub> and AUC and all other pharmacokinetic parameters determined for tapentadol after administration of 100 mg tapentadol as oral solution were similar compared ...

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

Citric acid monohydrate Sucralose (E955) Raspberry flavor, containing propylene glycol (E1520) Sodium hydroxide (for pH adjustment) Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years. After first opening of the bottle, the solution should not be used for longer than six weeks.

Special precautions for storage

Unopened: This medicinal product does not require any special storage conditions. After first opening: Store in an upright position.

Nature and contents of container

High density polyethylene (HDPE)-bottles sealed with aluminium foil liner and closed with a high density polyethylene (HDPE)/polypropylene (PP) child-resistant cap. Each bottle of the oral solution is ...

Special precautions for disposal and other handling

No special requirements for disposal. For other handling see section 4.2

Marketing authorization holder

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

Marketing authorization number(s)

PL 21727/0054

Date of first authorization / renewal of the authorization

05/12/2012

Date of revision of the text

28 October 2019

Πηγαίο έγγραφο

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