Palgotal 75mg/650mg film-coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

PARACETAMOL, TRAMADOL HYDROCHLORIDE

Saatavilla:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC-koodi:

N02AJ13

INN (Kansainvälinen yleisnimi):

PARACETAMOL 650 mg TRAMADOL HYDROCHLORIDE 75 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

PARACETAMOL 650 mg TRAMADOL HYDROCHLORIDE 75 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANALGESICS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2014-05-12

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PALGOTAL 75 MG / 650 MG FILM-COATED TABLETS
tramadol hydrochloride / paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Palgotal is and what it is used for
2. What you need to know before you take Palgotal
3. How to take Palgotal
4. Possible side effects
5. How to store Palgotal
6. Contents of the pack and other information
1.
WHAT PALGOTAL IS AND WHAT IT IS USED FOR
Palgotal contains two pain relieving active substances: tramadol and
paracetamol. Palgotal is used to
treat moderate to severe pain when your doctor recommends that a
combination of tramadol and
paracetamol is needed.
Palgotal is intended for adults and adolescents over 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALGOTAL
DO NOT TAKE PALGOTAL

if you are
ALLERGIC
to tramadol, paracetamol or any of the other ingredients of this
medicine (listed
in section 6).

in cases of
ACUTE POISONING
with alcohol, sleeping pills, pain relievers or psychotropic drugs
(that
affect mood, emotions and state of mind).

if you are also taking medicines called
MONOAMINE OXIDASE INHIBITORS
(MAOIs) or have taken
MAOIs
IN
THE LAST 14 DAYS
before treatment with Palgotal. MAOIs are used in the treatment of
depression or Parkinson’s disease.

if you have a
SEVERE LIVER DISORDER
.

if you have
EPILEPSY
that is not adequately controlled by your current medicine.
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WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Palgotal>

i

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Palgotal 75 mg / 650 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg tramadol hydrochloride and 650 mg
paracetamol.
Excipient with known effect: Each tablet contains 1.9 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Slightly yellowish brown, oblong, biconvex film-coated tablets,
half-scored on both sides with
dimensions 18×9 mm, radius 8 mm. The tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palgotal is indicated for the symptomatic treatment of moderate to
severe pain in adults and
adolescents over the age of 12 years.
The use of Palgotal should be restricted to patients whose moderate to
severe pain is considered to
require a combination of tramadol and paracetamol (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents (12 years and older) _
The use of Palgotal should be restricted to patients whose moderate to
severe pain is considered to
require a combination of tramadol and paracetamol.
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient.
The lowest effective dose for analgesia should generally be selected.
An initial dose of one tablet of Palgotal is recommended. Additional
doses can be taken as needed,
not exceeding 4 tablets (equivalent to 300 mg tramadol and 2,600 mg
paracetamol) per day.
The dosing interval should not be less than six hours.
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Palgotal should under no circumstances be administered for longer than
is strictly necessary (see
section 4.4). If repeated use or long term treatment with Palgotal is
required as a result of the nature
and severity of the illness, then careful, regular monitoring should
take place (with breaks in the
treatment, where possible), to assess whether continuation of the
treatment is necessary.
_Paediatric population _
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