Tramadol 37.5mg / Paracetamol 325mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Paracetamol; Tramadol hydrochloride

Disponible des:

Krka UK Ltd

Codi ATC:

N02AJ13

Designació comuna internacional (DCI):

Paracetamol; Tramadol hydrochloride

Dosis:

325mg ; 37.5mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

Schedule 3 (CD No Register Exempt Safe Custody)

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04070200; GTIN: 5391512451950

Informació per a l'usuari

1. WHAT TrAmAdol/PArAceTAmol IS ANd WHAT IT IS USed For
Tramadol/Paracetamol is a combination of two analgesics (pain killers)
tramadol and paracetamol that
act together to relieve your pain.
Tramadol/Paracetamol is intended for use in the treatment of moderate
to severe pain when your
doctor recommends that a combination of tramadol and paracetamol is
needed.
2. WHAT yoU Need To kNoW beFore yoU TAke TrAmAdol/PArAceTAmol
do not take Tramadol/Paracetamol if you:
•
are allergic to paracetamol, tramadol or any of the other ingredients
of this medicine (listed in section 6)
•
drink alcohol
•
take any medicine that can make you sleepy or less alert; these
include opioids containing pain relievers
such as morphine and codeine
•
are also taking MAO inhibitors (certain medicines used for treatment
of depression or Parkinson’s
disease) or have taken them in the last 14 days before treatment with
Tramadol/Paracetamol
•
suffer from severe liver problems
•
have epilepsy that is not adequately controlled on your current
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol/Paracetamol.
Take special care with Tramadol/Paracetamol if you:
•
have kidney problems
•
have liver problems or alcoholic liver disease or you have noticed
your eyes and skin turning yellow,
which may suggest jaundice or problems with bile ducts
•
have difficulty breathing, for example, asthma or lung problems
•
are dependent on any other medicines used to relieve moderate to
severe pain, for example, morphine
•
are epileptic or if have you experienced fits or seizures
•
have suffered from a head injury, shock or severe headaches which may
or may not be associated with
vomiting
•
take other medicines containing paracetamol or tramadol.
other medicines and Tramadol/Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
•
Important: This medicine contains paracetamol and tramadol. Tell your
doctor if you are
taking any other medic

Fitxa tècnica

OBJECT 1
TRAMADOL HYDROCHLORIDE/PARACETAMOL
37.5MG/325MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 20-Nov-2017 | Consilient
Health Ltd
1. Name of the medicinal product
Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 37.5 mg tramadol hydrochloride
equivalent to 32.94 mg tramadol and
325 mg paracetamol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Tablets are yellow-brown, oval, slightly biconvex.
4. Clinical particulars
4.1 Therapeutic indications
Tramadol hydrochloride/Paracetamol tablets are indicated for the
symptomatic treatment of moderate to
severe pain.
The use of Tramadol hydrochloride/Paracetamol 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
_Adults and adolescents (12 years and older) _
The use of Tramadol hydrochloride/Paracetamol should be restricted to
patients whose moderate to severe
pain is considered to require a combination of tramadol and
paracetamol.
The dose should be individually adjusted according to 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 two tablets of Tramadol hydrochloride/Paracetamol
is recommended. Additional doses
can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg
tramadol hydrochloride and 2600
mg paracetamol) per day.
The dosing interval should not be less than six hours.
Tramadol hydrochloride/Paracetamol should under no circumstances be
administered for longer than is
strictly necessary (see also section 4.4.). If repeated use or long
term treatment with Tramadol
hydrochloride/Paracetamol is required as a result of the nature and
severity of the illness, then careful,
regular monitoring should take place (with breaks in the t