Espranor 2mg oral lyophilisates

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Buprenorphine hydrochloride

Fáanlegur frá:

Martindale Pharmaceuticals Ltd

ATC númer:

N07BC01

INN (Alþjóðlegt nafn):

Buprenorphine hydrochloride

Skammtar:

2mg

Lyfjaform:

Oral lyophilisate

Stjórnsýsluleið:

Oromucosal

Tegund:

Schedule 3 (CD No Register)

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04100300; GTIN: 5026468198122 5026468198825

Upplýsingar fylgiseðill

3. Remove the wafer carefully from the foil and take
out from the packaging immediately.
4. Place the wafer on the tongue and close your
mouth. Allow it to remain there for a few seconds
until it has dissolved. Try to avoid swallowing during
the first 2 minutes.
Do not eat or drink for at least 5 minutes.
IF YOU TAKE MORE ESPRANOR THAN YOU SHOULD
Tell your doctor immediately or contact your nearest
hospital casualty department. Remember to take the
pack and any remaining wafers with you.
IF YOU FORGET TO TAKE ESPRANOR
You should tell your doctor and follow their
instructions. Do not take a double dose to make up for
the missed dose, unless your doctor tells you to.
IF YOU STOP TAKING ESPRANOR
Do not suddenly stop taking the wafers unless told
to do so by your doctor, as this may cause withdrawal
symptoms.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
LIKE ALL MEDICINES, THIS MEDICINE CAN CAUSE SIDE
EFFECTS, ALTHOUGH NOT EVERYONE GETS THEM.
For the first 24 hours of treatment, you may feel
uncomfortable with some mild opiate withdrawal
symptoms.
TELL YOUR DOCTOR IMMEDIATELY OR SEEK URGENT
MEDICAL ATTENTION if you experience uncommon side
effects, such as:
• swelling of the face, lips, tongue or throat which
may cause difficulty in swallowing or breathing,
severe hives/nettle rash. These may be signs of a
life-threatening allergic reaction.
• feeling sleepy and uncoordinated, have blurred
vision, have slurred speech, cannot think well or
clearly, or your breathing gets much slower than is
normal for you.
ALSO TELL YOUR DOCTOR IMMEDIATELY if you experience
uncommon side effects such as:
• severe tiredness, itching with yellowing of skin or
eyes. These may be symptoms of liver damage.
• seeing of hearing things that are not there
(hallucination)
Very common side effects (may effect more than 1 in
10 people) include:
Insomnia (inability to sleep), constipation, feeling
or being sick (nausea), sweating, headache, drug
withdrawal syndrome.
C

Vara einkenni

OBJECT 1
ESPRANOR 2 MG ORAL LYOPHILISATE.
Summary of Product Characteristics Updated 21-Nov-2017 | Martindale
Pharma
1. Name of the medicinal product
Espranor 2 mg oral lyophilisate.
2. Qualitative and quantitative composition
Each oral lyophilisate contains 2 mg of buprenorphine (as
hydrochloride).
Each oral lyophilisate contains 0.50 mg aspartame.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral lyophilisate.
White to off-white circular oral lyophilisate with a diameter of 10.3
mm, debossed with 'M2' on one side.
4. Clinical particulars
4.1 Therapeutic indications
Substitution treatment for opioid drug dependence, within a framework
of medical, social and
psychological treatment.
Treatment with Espranor oral lyophilisate is intended for use in
adults and adolescents aged 15 years or
over who have agreed to be treated for addiction.
4.2 Posology and method of administration
TREATMENT SHOULD BE UNDER THE SUPERVISION OF A CLINICIAN EXPERIENCED
IN THE MANAGEMENT OF OPIATE
DEPENDENCE/ADDICTION.
Espranor is NOT INTERCHANGEABLE WITH OTHER BUPRENORPHINE PRODUCTS.
Different buprenorphine products
have different bioavailability. Therefore, the dose in mg can differ
between products. Once the appropriate
dose has been identified for a patient with a certain product (brand),
the product cannot readily be
exchanged with another product.
The route of administration for Espranor is ON THE TONGUE, not under
it.
Administration is oromucosal. The oral lyophilisate should be taken
from the blister unit with dry fingers,
and placed whole on the tongue until dispersed, which usually occurs
within 15 seconds, and then
absorbed through the oromucosa. Swallowing should be avoided for 2
minutes. The oral lyophilisate
should be taken immediately after opening the blister. Patients should
not consume food or drink for 5
minutes after administration.
Physicians must advise patients that the oromucosal route of
administration is the only effective and safe
route of administration for this medicinal product. If