Temgesic 200 microgram Sublingual Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Buprenorphine hydrochloride

זמין מ:

Indivior Europe Limited

קוד ATC:

N02AE; N02AE01

INN (שם בינלאומי):

Buprenorphine hydrochloride

כמות:

0.2 Base Milligrams

טופס פרצבטיות:

Sublingual tablet

סוג מרשם:

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

איזור תרפויטי:

Oripavine derivatives; buprenorphine

מצב אישור:

Not marketed

תאריך אישור:

2019-02-01

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
Temgesic 200 microgram
Sublingual Tablets
Buprenorphine hydrochloride
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 side effects
not listed in this leaflet, See section 4.
What is in this leaflet:
1. What Temgesic is and what it is used for
2. What you need to know before you take Temgesic 200 microgram
Sublingual Tablets
3. How to take Temgesic 200 microgram Sublingual Tablets
4. Possible side effects
5. How to store Temgesic 200 microgram Sublingual Tablets
6. Contents of the pack and other information
1. WHAT TEMGESIC IS AND WHAT IT IS USED FOR
Temgesic 200 microgram Sublingual Tablets are strong pain killers that
help lessen moderate
or severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMGESIC 200
MICROGRAM SUBLINGUAL TABLETS
DO NOT TAKE TEMGESIC

if you are allergic (hypersensitive) to buprenorphine (the active
ingredient in Temgesic) or
to other opiates or to any other component of the product (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Temgesic if you have:

asthma or other breathing problems or are taking medicines which may
make your
breathing slower or weaker,

an addiction or have ever been addicted to medicines or substances,

problems with your liver, such as hepatitis,

any kidney disease,

low blood pressure,

recently suffered from head injury or brain disease,

thyroid problems,

adrenocortical disorder such as Addison’s disease,

a urinary disorder such as an enlarged prostate or narrowing of the
urethra.

prostatic disease,

ar

מאפייני מוצר

Health Products Regulatory Authority
13 August 2021
CRN00CF4X
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Temgesic 200 microgram Sublingual Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 micrograms of buprenorphine (as
hydrochloride).
Excipient(s) with known effect: Lactose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sublingual tablet.
White to creamy white circular biconvex sublingual tablet engraved
with the letter ‘L’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a strong analgesic for the relief of moderate to severe pain such
as occurs after surgery, with myocardial infarction or in
patients with terminal or intractable disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 weighing over 50 kg
1-2 tablets (200-400 micrograms) to be dissolved under the tongue
every 6-8 hours or as required. The recommended starting
dose for moderate to severe pain of the type typically presenting in
general practice is 1 to 2 tablets, 8 hourly.
_ _
Children over 37.5 kg:
Children weighing more than 37.5 kg and who are able to use a
sublingual tablet, treatment can be started with one Temgesic
200 microgram sublingual tablets. The dose can be repeated every 6 to
8 hours.
The tablets should lie under the tongue until dissolved, which occurs
in 5 to 10 minutes. They should not be chewed or
swallowed. The dose may be repeated every 6-8. hours. Temgesic 400
microgram sublingual tablets should not be used in
children.
Temgesic sublingual tablets should be not used for children weighing
less than 37.5 kg.
Fixed intervals or daily doses should not be prescribed until an
appropriate dosing interval is determined by clinical
observation of the child.
_Special populations_
_ _
_Hepatic impairment_
As buprenorphine pharmacokinetics may be altered in patients with
hepatic impairment, lower initial doses and careful dose
titration in patients with hepatic impairment may be required (See
section 4.4). _Bup