Tramadol 50mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Tramadol hydrochloride

Saatavilla:

Sandoz Ltd

ATC-koodi:

N02AX02

INN (Kansainvälinen yleisnimi):

Tramadol hydrochloride

Annos:

50mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04070200

Pakkausseloste

TRAMADOL 50 MG CAPSULES
Tramadol hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 50 mg Capsules are and what they are
used for
2. What you need to know before you take Tramadol 50 mg
Capsules
3. How to take Tramadol 50 mg Capsules
4. Possible side effects
5. How to store Tramadol 50 mg Capsules
6. Contents of the pack and other information
1. WHAT TRAMADOL 50 MG CAPSULES ARE AND
WHAT THEY ARE USED FOR
Tramadol 50 mg Capsules are 'analgesics' which act on the
central nervous system (the brain and the spinal cord).
Analgesics are often called 'pain killers' or 'pain relievers'.
Tramadol 50 mg Capsules relieve pain and can also be taken
to prevent pain.
Pain is a symptom not an illness. There are many types of
pain with many different causes, for example back-ache,
toothache, pain after an operation or pain from broken
bones.
Tramadol 50 mg Capsules help your body's system for
relieving pain. It does this in two ways:
- Acts directly on parts of your brain and spinal cord to
reduce the amount of pain you feel
- Reduces the size of the pain message passed from one
nerve to another.
Tramadol 50 mg Capsules should only be taken by adults
or children over 12 years.
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL 50 MG CAPSULES
DO NOT TAKE TRAMADOL 50 MG CAPSULES
•
If you are allergic to tramadol or any of the other
ingredients in Tramadol 50 mg Capsules listed in section 6
•
If you are pregnant or if you are breast-feeding
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Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tramadol Hydrochloride 50mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg tramadol hydrochloride (equivalent to 43.9
mg of
tramadol base)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tramadol capsules are indicated for the management (treatment and
prevention) of
moderate to severe pain.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
As with all analgesic drugs, 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. A total daily oral dose of 400 mg should not be exceeded,
except in special
circumstances.
Unless otherwise prescribed, tramadol should be administered as
follows:
Adults and children aged 12 years and over
_Acute pain: _
An initial dose of 100 mg is usually necessary. This can be followed
by doses of 50 or 100
mg at 4 – 6 hourly, intervals, and the duration of treatment should
be matched to clinical
need (see section 5.1).
_Pain associated with Chronic Conditions: _
An initial dose of 50 mg is advised and then titrate dose according to
pain severity. The need
for continued treatment should be assessed at regular intervals as
withdrawal symptoms and
dependence have been reported (see section 4.4).
Paediatric population
Tramadol capsules are not suitable for children below the age of 12
years.
Older people
A dose adjustment is not usually necessary in patients up to 75 years
without clinically
manifest hepatic or renal insufficiency. In elderly patients over 75
years elimination may be
prolonged. Therefore, if necessary the dosage interval is to be
extended according to the
patient’s requirement.
_Renal insufficiency/dialysis and hepatic impairment _
In patients with renal and/or hepatic insufficiency the elimination of
tramadol is delayed. In
these patients prolongation of the dosage int