Temgesic 400microgram sublingual tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Buprenorphine hydrochloride

Commercializzato da:

Eumedica Pharmaceuticals AG

Codice ATC:

N02AE01

INN (Nome Internazionale):

Buprenorphine hydrochloride

Dosaggio:

400microgram

Forma farmaceutica:

Sublingual tablet

Via di somministrazione:

Sublingual

Classe:

Schedule 3 (CD No Register)

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04070200; GTIN: 5054792000385

Foglio illustrativo

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMGESIC 400 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: ritonavir

Scheda tecnica

OBJECT 1
TEMGESIC 400 MICROGRAM SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 31-May-2016 | Indivior UK
Limited
1. Name of the medicinal product
Temgesic 400 microgram Sublingual Tablets
2. Qualitative and quantitative composition
Buprenorphine hydrochloride 432 µg/tablet, equivalent to 400 µg
buprenorphine base.
3. Pharmaceutical form
Sublingual tablet
White to creamy white, circular, biconvex tablets, embossed on one
side with “H“.
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:
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 200 to 400
microgram tablets, 8 hourly. The tablet should not be chewed or
swallowed whole as this will reduce
efficacy.
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)
100 micrograms
25-37.5 kg (55-82.5 lb)
100-200 micrograms
37.5-50 kg (82.5-110 lb)
200-300 micrograms
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