The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00156/0365.
Espranor 2mg and 8mg Oral Lyophilisate
Espranor 2 mg Oral Lyophilisate
Espranor 8 mg Oral Lyophilisate
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
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.
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:
Talk to your doctor, pharmacist or nurse before taking Espranor:
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.
You may be more closely monitored by your doctor if you are below the age of 18. Espranor should not be given to children or adolescents under 15 years old.
Misuse, abuse and diversion
This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft. Do not give this medicine to anyone else. It can cause death or otherwise harm them.
Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Sleep-related breathing disorders
Espranor can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
This product can cause dependence.
This product can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
This medicine can also cause withdrawal symptoms if you stop taking it abruptly.
Liver damage has been reported after taking this medicine, especially when the medicine is misused. This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver (see section 4). Regular blood tests may be conducted by your doctor to monitor the condition of your liver. Tell your doctor if you have any liver problems before you start treatment with Espranor.
This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
Diagnosis of unrelated medical conditions
This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. Do not forget to advise your doctor if you take this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may increase the side effects of Espranor and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Espranor without first talking to your doctor, especially:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
Tell your doctor if you are pregnant or intend to become pregnant.
When taken during pregnancy, particularly late pregnancy, medicines like Espranor may cause drug withdrawal symptoms including problems with breathing in your newborn baby. These symptoms may occur several days after birth.
Do not breast feed your baby whilst taking this medicine as Espranor passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
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/drugdriving-law.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine
This medicine contains 0.5 mg aspartame in each 2 mg Oral Lyophilisate
This medicine contains 2.0 mg aspartame in each 8 mg Oral Lyophilisate.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
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.
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).
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.
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 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.
Tell your doctor immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining wafers with you.
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.
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.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately and seek urgent medical attention if you experience any of the following serious effects, such as:
Other side effects may include:
Very common side effects (may affect more than 1 in 10 people) include: Insomnia (inability to sleep), feeling or being sick (nausea), hyperhidrosis (sweating), headache, drug withdrawal syndrome, pain.
Common side effects (may affect up to 1 in 10 people) are: Swollen arm or leg, tiredness, drowsiness, anxiety, nervousness, tingling, depression, abnormal thinking, increased tearing (watering eyes) or other tearing disorder, blurred vision, flushing, palpitations, widening of blood vessel, migraines, sore throat and painful swallowing, cough, upset stomach or other stomach discomfort, diarrhoea, flatulence, vomiting, rash, joint pain, muscle pain, muscle spasms, abdominal pain, back pain, infection, chills, chest pain, fever, feeling of general discomfort, faintness and dizziness, bone pain, bronchitis, constipation, decreased appetite, dry mouth, menstrual cramping/painful menstruation, dyspnoea, hostility, hypertonia (increase in muscle tension), influenza, swollen glands (lymph nodes), large pupil size, neck pain, paranoia, change of colour, appearance or texture of the skin, tooth disorder, tremor, yawning, agitation, gastrointestinal disorders.
Side effects with unknown frequency (frequency cannot be estimated from the available data) include:
Drug dependence, drug withdrawal syndrome neonatal, seeing or hearing things that are not there (hallucinations), drop in blood pressure on changing position from sitting or lying down to standing, whirling or spinning sensation, unable or inability to urinate, redness, pain or swelling at the point of application (e.g. injection site), liver injury with or without jaundice, abnormal liver functional test, inflammation of the inner layer of the heart.
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.
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package (blister) to protect from light and moisture.
This medicinal product 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 protect the environment.
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 x 1 oral lyophilisates or 28 x 1 oral lyophilisates in an outer carton.
Not all pack sizes may be marketed.
This medicinal product is authorised in the Member states of the EEA under the following names:
Ireland Espranor 2 mg Oral Lyophilisate
Espranor 8 mg 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
France OROBUPRE 2 mg lyophilisat oral
OROBUPRE 8 mg lyophilisat oral
This leaflet was last updated in September 2022
Espranor 2 mg Oral Lyophilisate: PL 00156/0364
Espranor 8 mg Oral Lyophilisate: PL 00156/0365