Temgesic 200microgram sublingual tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Buprenorphine hydrochloride

Saadav alates:

Eumedica Pharmaceuticals AG

ATC kood:

N02AE01

INN (Rahvusvaheline Nimetus):

Buprenorphine hydrochloride

Annus:

200microgram

Ravimvorm:

Sublingual tablet

Manustamisviis:

Sublingual

Klass:

Schedule 3 (CD No Register)

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04070200; GTIN: 5054792000378

Infovoldik

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMGESIC 200 MICROGRAM
Buprenorphine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE .
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Temgesic Sublingual Tablets are and what they are used for
2.
Before you take Temgesic Sublingual Tablets
3.
How to take Temgesic Sublingual Tablets
4.
Possible side effects
5.
How to store Temgesic Sublingual Tablets
6.
Further information
1.
WHAT TEMGESIC SUBLINGUAL TABLETS ARE AND WHAT THEY ARE USED
FOR
Temgesic Sublingual Tablets are strong pain killers that help lessen
moderate or severe pain.
2.
BEFORE YOU TAKE TEMGESIC SUBLINGUAL TABLETS
DO NOT TAKE TEMGESIC
If you are allergic (hypersensitive) to buprenorphine, to any of the
other ingredients of
Temgesic Sublingual Tablets (see section 6 ‘Further Information’)
or to other opiates
(drugs which are morphine – like in their action).
TAKE SPECIAL CARE WITH TEMGESIC SUBLINGUAL TABLETS
Before starting treatment with Temgesic, contact your doctor if you:

Are or have ever been addicted to medicines or substances;

Have problems with you liver;

Have breathing problems or are taking medicines with may make your
breathing slower or
weaker.
Athletes must be aware that this medicine may cause a postive reaction
to ‘anti-doping’tests.
TAKING OTHER MEDICINES
TEMGESIC SHOULD NOT BE TAKEN WITH:

Medicines containing gestodene (a hormone)
;

Antibiotic medicines (troleandomycin, rifampicin);

Medicines to treat fungal infections (ketoconazole);

Medicines for depression (norfluoxetine);

Medicines for HIV infection (protease inhibitors:

Toote omadused

OBJECT 1
TEMGESIC 200 MICROGRAM SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 31-May-2016 | Indivior UK
Limited
1. Name of the medicinal product
Temgesic 200 microgram Sublingual Tablets
2. Qualitative and quantitative composition
Buprenorphine hydrochloride 216 µg/tablet, equivalent to 200 µg
buprenorphine base.
3. Pharmaceutical form
Sublingual tablet
White to creamy white, circular, biconvex tablets, embossed on one
side with “L“.
4. Clinical particulars
4.1 Therapeutic indications
As a strong analgesic for the relief of moderate to severe pain.
4.2 Posology and method of administration
Administration by the sublingual route.
Adults and children over 12:
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.
Elderly:
There is no evidence that dosage needs to be modified for the elderly.
Children under 12 years:
Temgesic Sublingual is suitable for use in children under 12 as
follows:
16-25 kg (35-55 lb) ½ tablet
25-37.5 kg (55-82.5 lb) ½ - 1 tablet
37.5-50 kg (82.5-110 lb) 1-1 ½ tablets
The recommended dose should be administered every 6-8 hours.
Sublingual administration is not suitable for children under the age
of six years.
Temgesic sublingual may be used in balanced anaesthetic techniques at
a dose of 400 micrograms.
Special populations
_Hepatic impairment_
The effects of hepatic impairment on the pharmacokinetics of
buprenorphine were evaluated in a
postmarketing study. Buprenorphine is extensively metabolized in the
liver, and plasma levels were found
to be higher for buprenorphine in patients with moderate and severe
hepatic impairment compared to
healthy subjects. Patients should be monitored for signs and symptoms
of toxicity or overdose caused by
increased levels of buprenorphine. Temgesic should be used with
caution in patients with moderate to
severe hepatic impairment (See section 5.2).
4.3 Cont