Palexia 20mg/ml oral solution

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Tapentadol hydrochloride

Disponible des:

Grunenthal Ltd

Codi ATC:

N02AX06

Designació comuna internacional (DCI):

Tapentadol hydrochloride

Dosis:

20mg/1ml

formulario farmacéutico:

Oral solution

Vía de administración:

Oral

clase:

Schedule 2 (CD)

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04070200; GTIN: 4032129047143 4032129045453

Informació per a l'usuari

1. WHAT PALEXIA IS AND WHAT IT IS USED FOR
The full name of your medicine is ‘PALEXIA 20 mg/ml oral
solution’. It is
referred to as ‘PALEXIA’ in the rest of this leaflet.
Tapentadol - the active substance in PALEXIA - is a strong painkiller
which belongs to the class of opioids. PALEXIA is used in adults for
the
treatment of moderate to severe pain of recent onset that can only be
adequately managed with an opioid painkiller.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA DO NOT TAKE PALEXIA
• if you are allergic to tapentadol or any of the other ingredients
of this
medicine (listed in section 6)
• if you have asthma or if your breathing is dangerously slow or
shallow
(respiratory depression, hypercapnia)
• if you have no bowel movement as shown by severe constipation and
bloating which may be accompanied by pain or discomfort in the lower
stomach
• if you have poisoning with alcohol, sleeping pills, pain relievers
or
medicines that affect mood and emotions (see ‘other medicines and
PALEXIA’)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking PALEXIA if you:
• have slow or shallow breathing
• suffer from increased pressure in the brain or are not fully
conscious
• have had a head injury or brain tumors
• have had an epileptic fit or if you are at risk of having
epileptic fits
• suffer from liver or kidney problems (see “How to take
PALEXIA”)
• suffer
from
a
pancreatic
disease
including
inflammation
of
the
pancreas
(pancreatitis)
or
disease
of
the
bile
duct
(biliary
tract
disease)
• are taking medicines referred to as mixed opioid
agonist/antagonists
(e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g.
buprenorphine)
• have a tendency to abuse medicines or if you are dependent on
medicines, as PALEXIA may lead to addiction. In this case, you should
only take this medicine for short periods of time and under strict
medical supervision.
OTHER MEDICINES AND PALEXIA
Tell your doctor or pharmacist if you are taking, have recently taken
or
mi

Fitxa tècnica

OBJECT 1
PALEXIA ORAL SOLUTION 20 MG/ML
Summary of Product Characteristics Updated 29-Aug-2017 | Grunenthal
Ltd
1. Name of the medicinal product
PALEXIA
®
20 mg/ml oral solution
2. Qualitative and quantitative composition
1 ml oral solution contains 20 mg tapentadol (as hydrochloride)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
Clear, colourless solution
pH 3.5 to 4.5
4. Clinical particulars
4.1 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.
4.2 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 single doses of 50 mg tapentadol
as oral solution administered every 4
to 6 hours. Higher starting doses may be necessary depending on the
pain intensity and the patient's
previous history of analgesic requirements.
On the first day of dosing, an additional dose may be taken as soon as
one hour after the initial dose, if
pain control is not achieved. The dose should then be titrated
individually to a level that provides
adequate analgesia and minimises undesirable effects under the close
supervision of the prescribing
physician.
Daily doses greater than 700 mg tapentadol on the first day of
treatment and maintenance daily doses
greater than 600 mg tapentadol have not been studied and are therefore
not recommended.
_Duration of treatment_
The oral solution is intended for acute pain situations. If longer
term treatment is anticipated or becomes
necessary and effective pain relief in the absence of intolerable
adverse events was achieved with
PALEXIA, the possibility of switching the patient to therapy with
PALEXIA prolonged release tablets
should be considered. As with all symptomatic treatments, the
continued use of tapentadol must be
evaluated on an ongoing basis.
Calculatio