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ESPRANOR 2 MG ORAL LYOPHILISATE

Active substance(s): BUPRENORPHINE HYDROCHLORIDE / BUPRENORPHINE HYDROCHLORIDE

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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

PACKAGE LEAFLET: INFORMATION FOR THE USER
Espranor 2 mg Oral Lyophilisate
Espranor 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. What Espranor is and what it is used for
2. What you need to know before you take Espranor
3. How to take Espranor
4. Possible side effects
5. How to store Espranor
6. 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
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

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)

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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

medicines, including medicines obtained without a prescription.
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
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

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.

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.

3. Remove the wafer carefully from the foil and take out from the packaging
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

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 lifethreatening 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:
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

Insomnia (inability to sleep), constipation, feeling or being sick (nausea), sweating,
headache, drug withdrawal syndrome.
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.
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.
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.
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 side effects you can help provide more information on the safety of this
medicine.
5. How to store Espranor
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

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 oral
lyophilisate (wafer) contains 2 mg or 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 oral lyophilisate
( wafer) marked with “M2” on one side.
Espranor 8 mg oral lyophilisate is a white to off-white circular oral lyophilisate
wafer marked with “M8” on one side.
Your medicine is available in blisters containing 7 or 28 wafers in an outer carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Martindale Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford, Essex
RM3 8UG
United Kingdom.
Manufacturer - Batch Release Site:
Macarthys Laboratories Limited
T/A Martindale Pharma
Bampton Road
Harold Hill
Romford,
Essex
RM3 8UG
United Kingdom
This medicinal product is authorised in the Member states of the EEA under the following
names:
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1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet

Espranor 2mg and 8mg Oral Lyophilisate

United Kingdom

Espranor 2 mg oral lyophilisate
Espranor 8 mg oral lyophilisate

Sweden

Espranor 2 mg frystorkad tablett
Espranor 8 mg frystorkad tablett

Malta

Espranor 2 mg oral lyophilisate
Espranor 8 mg oral lyophilisate

This leaflet was last updated in March 2017
Reference Number:
Espranor 2 mg Oral Lyophilisate: PL 00156/0364
Espranor 8 mg Oral Lyophilisate: PL 00156/0365

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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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