Tramadol Hydrochloride/Paracetamol Amneal 37,5 mg/325 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

PARACETAMOL ; TRAMADOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; TRAMADOL

Beschikbaar vanaf:

Amneal Pharma Europe Limited

ATC-code:

N02AJ13

INN (Algemene Internationale Benaming):

PARACETAMOL ; TRAMADOLHYDROCHLORIDE COMPOSITION corresponding to ; TRAMADOL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171), CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tramadol and paracetamol

Autorisatie datum:

2018-08-28

Bijsluiter

Paracetamol 325 mg and Tramadol hydrochloride 37.5 mg Tablets
1.3.1-package-leaflet
12-September-2017
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMADOL HYDROCHLORIDE/PARACETAMOL AMNEAL 37,5 MG/325 MG, FILMOMHULDE
TABLETTEN
(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
Tramadol Hydrochloride/Paracetamol Amneal
is and what it is used for
2. What you need to know before you take Tramadol
Hydrochloride/Paracetamol Amneal
3. How to takeTramadol Hydrochloride/Paracetamol Amneal
4. Possible side effects
5. How to store
Tramadol Hydrochloride/Paracetamol Amneal
6. Contents of the pack and other information
1.
WHAT TRAMADOL HYDROCHLORIDE/PARACETAMOL AMNEAL IS AND WHAT IT IS USED
FOR
This medicine is a combination of two analgesics, tramadol and
paracetamol, which act
together to relieve your pain.
This medicine is intended for use in the treatment of moderate to
severe pain when your doctor
recommends that a combination of tramadol hydrochloride and
paracetamol is needed.
This medicine should only be taken by adults and adolescents over 12
years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL
HYDROCHLORIDE/PARACETAMOL
AMNEAL
DO NOT TAKE TRAMADOL HYDROCHLORIDE/PARACETAMOL AMNEAL

if you have had an allergic reaction (for instance skin rash, swelling
of the face, wheezing or
difficulty breathing) after taking tramadol or paracetamol or any of
the other ingredients of
this medicine (listed in section 6);

in acute poisoning with alcohol, sleeping p

Productkenmerken

Paracetamol 325 mg and Tramadol hydrochloride 37.5 mg Tablets
1.3.1-Summary-of-Product-Characteristics
28-July-2017
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS:
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol Hydrochloride/Paracetamol Amneal 37,5 mg/325 mg, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325
mg paracetamol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, film coated, capsule shaped tablets about 15.98 X 7.14
mm, engraved “AN506” on
one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tramadol Hydrochloride/Paracetamol Amneal 37.5mg/325mg are indicated
for the symptomatic
treatment of moderate to severe pain.
The use of Tramadol Hydrochloride/Paracetamol Amneal 37.5mg/325mg
should be restricted to
patients whose moderate to severe pain is considered to require a
combination of tramadol and
paracetamol (see also Section 5.1
).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_ _
The use of Tramadol Hydrochloride/Paracetamol Amneal 37.5mg/325mg
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 intensity of pain and the sensitivity
of the individual patient.
The
lowest effective dose for analgesia should generally be selected. The
total dose of 8 tablets
(equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol)
per day should not be
exceeded. The dosing interval should not be less than six hours.
Adults and adolescents (12 years and older)
An initial dose of two tablets of is recommended.
Additional doses can be taken
as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and
2600 mg paracetamol) per
day.
Paracetamol 325 mg and Tramadol hydrochloride 37.5 mg Tablets
1.3.1-Summary-of-Product-Characteristics
28-July-2017
Page 2 of 15
The dosing interval should not be less