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ESPRANOR 2 MG ORAL LYOPHILISATE

Active substance(s): BUPRENORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

D02813

Rare side effects (may effect up to 1 in 1000 people)
are:
Slow or difficult breathing, liver injury with or
without jaundice, swelling of face and throat or life
threatening allergic reactions.

Espranor® 2 mg and 8 mg Oral Lyophilisate
(Buprenorphine)
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.
2.
3.
4.
5.
6.

What Espranor is and what it is used for
What you need to know before you take Espranor
How to take Espranor
Possible side effects
How to store Espranor
Contents of the pack and other information

1. What Espranor Oral Lyophilisate is
and what it is used for
Espranor oral lyophilisate is a freeze-dried wafer
which dissolves rapidly on the tongue.
Espranor is used in adults and adolescent over
15 years of age, as part of a medical, social and
psychological treatment programme for addiction.
Espranor contains buprenorphine, an opioid
(narcotic) analgesic. When it is used for the treatment
of patients addicted to opiate (narcotic) drugs, such
as morphine or heroin, it acts as a substitute for these
drugs and therefore aids the patient in withdrawing
from them over a period of time.
If treatment is stopped abruptly, withdrawal
symptoms can occur.

2. What you need to know before you
take Espranor
Espranor is not interchangeable with other oral
buprenorphine products and the dose of Espranor
may differ from the dose of other buprenorphine
products
Do not take Espranor if:
• You have severe breathing problems
• You have severe liver problems
• You are alcohol dependent or suffer from acute
alcoholism including ‘the shakes’ or hallucinations
• You are pregnant (unless your doctor tells you to
take it)
• You are allergic (hypersensitive) to buprenorphine
or any of the other ingredients in Espranor (see
section 6)
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before
taking Espranor:
• If you suffer breathing problems e.g. asthma
• If you have kidney problems
• If you have liver problems
• If you are breastfeeding a baby
If any of the above applies to you, please tell your
doctor before taking Espranor as your doctor may
need to reduce your dose of Espranor or you may
need additional treatment to control it.
Espranor should not be given to children or
adolescents under 15 years old.
Other medicines and Espranor
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
The following medicines have sedative effects (make
you feel sleepy/drowsy). These effects are increased
if these medicines are taken while you are being
treated with Espranor:
• Benzodiazepines (medicines used to treat anxiety
or sleep disorders) e.g. diazepam (valium). Your
doctor will prescribe the correct dose for you.
Taking the wrong dose of benzodiazepines may
cause death due to respiratory failure (inability to
breathe).
• Barbiturates e.g. phenobarbital
• Other opioids or opioid derivatives e.g. morphine,
strong pain killers or cough medicines
• Certain antidepressants e.g. fluoxetine (Prozac)
• Monoamine oxidase inhibitors (MAOI) (medicines
used to treat severe depression) e.g. phenelzine
• Medicines that cause drowsiness such as
antihistamines or sedatives
• Certain drugs used to treat high blood pressure
• Antipsychotic drugs (medicines used to treat
certain mental disorders)

Espranor with food, drink and alcohol
Espranor should not be taken at the same time as
food or drink.
You should not drink alcohol or take any medicines
that contain alcohol while taking Espranor as this will
increase the risk of drowsiness, respiratory depression
and fatal overdose.
Pregnancy, breast-feeding and fertility
Before taking Espranor, tell your doctor if you are
pregnant or trying to become pregnant. If you
become pregnant during treatment with Espranor,
tell your doctor straight away.
Since Espranor is passed into breast milk, you should
not breast feed while taking this medicine.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
This medicine can cause drowsiness, which may
be made worse if you also drink alcohol or take
tranquilizers or anti-anxiety drugs. If you are drowsy,
do not drive or operate machinery.
This medicine can affect your ability to drive.
Do not drive whilst taking this medicine until you
know how this medicine affects you.
It may be an offence to drive if your ability to drive
safely is affected.
There is further information for patients who are
intending to drive in Great Britain – go to https://
www.gov.uk/drug-driving-law.
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine
Important information about some of the
ingredients of Espranor
Espranor contains aspartame. Aspartame contains
a source of phenylalanine. This may be harmful for
people with phenylketonuria.
3. How to take Espranor
Always take Espranor exactly as your doctor or
pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure.
When to start taking Espranor
Starting Espranor treatment if you are dependent
on heroin or a short acting opioid – your first dose of
Espranor should be taken at least 6 hours after you
last used the opioid or when signs of withdrawal
appear.
Starting Espranor treatment if you are dependent on
methadone or a long acting opioid – you will not start
treatment with this medicine until your daily dose of
methadone is 30 mg a day or less. The first dose of
Espranor should be taken when signs of withdrawal
appear, but not less than 24 hours after you last used
methadone.
For the first 24 hours of treatment, you may feel
uncomfortable with some mild opiate withdrawal
symptoms e.g. sweating, feeling sick (see section 4
Possible side effects).
How much to take
Your doctor will decide what dose you need to start
treatment with.
During treatment your doctor will adjust your dose
depending upon your response. The maximum dose
is 18 mg daily. After a period of successful treatment,
your doctor may gradually reduce your dose and
depending on your condition, may stop it altogether.
Do not suddenly stop taking Espranor as this may
lead to withdrawal symptoms.
Instructions for use
Take Espranor by placing ON your tongue, not
under your tongue.
Espranor is sensitive to moisture. Make sure your
hands are dry before handling the wafer. Take the
wafer by following the instructions below:

1. Tear a square off the blister pack along the
perforated lines.

If you are taking any of the following medicines,
your doctor may need to prescribe a lower dose of
Espranor:
• Ketoconazole (medicine used to treat a fungal
infection which can increase the levels of Espranor
in your blood if both are taken at the same time)
• Gestodene (found in some contraceptive pills)
• Drugs used to treat HIV e.g. ritonavir, indinavir and
saquinavir
• Phenprocoumon (a blood thinning medicine)
If you are taking any of the following medicines,
your doctor may need to prescribe a higher dose of
Espranor:
• Enzyme inducers e.g. phenobarbital,
carbamazepine, phenytoin and rifampicin
Naltrexone may prevent the therapeutic effects of
Espranor. If currently taking this medicine followed
by concomitant use of naltrexone, you may
experience a sudden onset of prolonged and intense
withdrawal.

2. The foil is easily peelable. Do not force the wafer
through the foil as it is fragile and can easily break.
Instead, fold back the foil and then peel it off.
Continued overleaf

Side effects with unknown frequency (frequency
cannot be estimated from the available data) include:
Sudden withdrawal syndrome caused by taking
Espranor too soon after use of illicit opioids, drug
withdrawal syndrome in newborn.
3. Remove the wafer carefully from the foil and take
out from the packaging immediately.

If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
If you are not sure what the side effects listed are, ask
your doctor to explain them to you.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
Website: http//www.mhra.gov.uk/yellowcard.
By reporting the side effects you can help provide
more information on the safety of this medicine.

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.

5. How to store Espranor
Keep this medicine out of the sight and reach of
children
Do not use Espranor after the expiry date, which is
stated on the carton after EXP. The expiry date refers
to the last day of that month.
Store your medicine in the original packaging to
protect from light and moisture.
Espranor does not require any special temperature
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6. Contents of the pack and other
information
What Espranor contains:
• The active substance is buprenorphine (as
buprenorphine hydrochloride). Each wafer
contains 2 mg and 8 mg of buprenorphine.
• The other ingredients are gelatin, mannitol,
aspartame, mint flavour and citric acid.
What Espranor looks like and the contents of the
pack
Espranor 2 mg oral lyophilisate is a white to off-white
circular wafer marked with “M2” on one side.
Espranor 8 mg oral lyophilisate is a white to off-white
circular wafer marked with “M8” on one side.
Your medicine is available in blisters containing 7 or
28 wafers in an outer carton.
Marketing Authorisation Holder and
Manufacturer:
Martindale Pharmaceuticals Ltd
(Trading as Martindale Pharma)
Bampton Road
Harold Hill
Romford, Essex
RM3 8UG
United Kingdom.
This leaflet was last updated in May 2015
Reference Number:
Espranor 2 mg Oral Lyophilisate: PL 00156/0364
Espranor 8 mg Oral Lyophilisate: PL 00156/0365

Common side effects (may effect up to 1 in 10
people) are:
Weight loss, swelling (hands and feet), tiredness,
drowsiness, anxiety, nervousness, tingling,
depression, decreased sexual drive, increase in
muscle tension, abnormal thinking, increased
tearing (watering eyes) or other tearing disorder,
blurred vision, flushing, increased blood pressure,
palpitations, widening of blood vessel, migraines,
runny nose, sore throat and painful swallowing,
increased cough, upset stomach or other stomach
discomfort, diarrhoea, abnormal liver function,
flatulence, vomiting, numbness of the tongue or
mouth, rash, itching, hives, pain, joint pain, muscle
pain, leg cramps (muscle spasm), difficulty in
getting or keeping an erection, urine abnormality,
abdominal pain, back pain, weakness, infection,
chills, chest pain, fever, flu-like symptoms, feeling of
general discomfort, accidental injury caused by loss
of alertness or co-ordination, faintness and dizziness,
drop in blood pressure on changing position from
sitting or lying down to standing.
Uncommon side effects (may effect up to 1 in 100
people) are:
Swollen glands, agitation, tremor, abnormal
dream, excessive muscle activity. Not feeling like
yourself , medicine dependence, amnesia (memory
disturbance), loss of interest, exaggerated feeling of
well-being, convulsion (fits), speech disorder, small
pupil size, difficulty urinating, eye inflammation
or infection, rapid or slow heart beat, low blood
pressure, myocardial infarction (heart attack), chest
tightness, Shortness of breath, asthma, yawning,
pain and sores in mouth, tongue discolouration,
acne, skin nodule, hair loss, dry or scaling skin,
inflammation of joints, urinary tract infection,
abnormal blood tests, loss of appetite, blood in
urine, abnormal ejaculation, menstrual or vaginal
problems, kidney stone, sensitivity to heat or cold,
heat stroke, feelings of hostility.

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

D02813

100mm Measurement Verification Bar

2813-J

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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