Tramake 100mg Tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Tramadol hydrochloride

থেকে পাওয়া:

Galen Limited

এটিসি কোড:

N02AX; N02AX02

INN (আন্তর্জাতিক নাম):

Tramadol hydrochloride

ডোজ:

100 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

থেরাপিউটিক এলাকা:

Other opioids; tramadol

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2000-02-04

তথ্য লিফলেট

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KAPAKE 30MG/500MG TABLETS
(Codeine Phosphate and 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kapake 30mg/500mg Tablets are and what they are used for
2.
What you need to know before you take Kapake 30mg/500mg Tablets
3.
How to take Kapake 30mg/500mg Tablets
4.
Possible side effects
5.
How to store Kapake 30mg/500mg Tablets
6.
Contents of the pack and other information
1.
WHAT KAPAKE 30MG/500MG TABLETS ARE AND WHAT THEY ARE USED FOR
Kapake 30mg/500mg Tablets contain codeine, an opioid analgesic, in
combination with
paracetamol. Kapake 30mg/500mg Tablets are one of a group of medicines
called analgesics or
painkillers. They are used to relieve severe pain in adults.
Codeine can be used in children over 12 years of age for the
short-term relief of moderate pain
that is not relieved by other painkillers such as paracetamol or
ibuprofen alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KAPAKE 30MG/500MG TABLETS
DO NOT TAKE KAPAKE 30MG/500MG TABLETS:
-
if you are allergic to codeine phosphate, paracetamol or any of the
other ingredients of this
medicine (listed in section 6).
-
if you have suffered a head injury or have raised pressure in the
skull (may cause painful
eyes, changes in vision or headache behind the eyes).
-
if you have been told by your doctor that you have a severe breathing
difficulty called
respiratory depression.
-
if you are having (or have recently had) a severe but short-lasting
asthma

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramake 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Tramadol hydrochloride 100 mg.
Excipient(s) with known effect:
contains 100mg of lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White uncoated tablets marked “TRAMAKE 100” on one side and the
other side is plain and unmarked.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramake 100mg Tablets are indicated in adults and adolescents aged 12
years and over for the treatment and prevention
of severe pain.
Tramadol has been found to be of benefit in both acute and chronic
pain states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Tramake 100mg Tablets should not be used in children aged 0 to 12
years.
Older children (aged 12 years and over) and adults: 50-100mg every 4-6
hours.
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.
For acute pain a starting dose of 100mg is most often required.
Chronic conditions usually respond to 50mg starting
dose.
Treatment periods should be short and intermittent as dependence can
occur with tramadol.
The benefits of continued
use should be reviewed in order to ensure that they outweigh the risks
of dependence (see sections 4.4 and 4.8).
No more than 400mg orally is usually necessary for pain management in
any 24 hour period.
Elderly patients
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 requirements.
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 intervals shoul