Espranor 8 mg oral lyophilisate

• 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.

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

Talk to your doctor, pharmacist or nurse before taking Espranor:

• If you suffer breathing problems e.g. asthma
• If you have liver problems
• If you have kidney problems
• If you have low blood pressure
• If you have a urinary disorder (especially linked to enlarged prostrate in men)
• If you have thyroid problems
• If you have adrenocortical disorder (e.g. Addison’s disease)
• If you have depression or other conditions that are treated with antidepressants. The use of these medicines together with Espranor can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and 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.

Additional monitoring

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.

Breathing problems

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.

Dependence

This product can cause dependence.

Withdrawal symptoms

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

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.

Blood pressure

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:

• Concomitant use of Espranor and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
  However if your doctor does prescribe Espranor together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• Anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Espranor and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions / seizures, pain. These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines. They may also cause central nervous system depression, which is very serious. Below is a list of examples of these types of medicines:
  • other opioid containing medicines such as methadone, certain pain killers and cough suppressants.
  • antidepressants (used to treat depression) such as isocarboxazide and valproate may increase the effects of this medicine.
  • sedative H1 receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine.
  • barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital.
  • tranquilisers (used to cause sleep or sedation) such as chloral hydrate.
• Naltrexone may prevent Espranor from working. If you take naltrexone whilst you are taking Espranor you may experience a sudden onset of prolonged and intense withdrawal symptoms.
• Clonidine used to treat high blood pressure) may extend the effects of this medicine.
• Anti-retrovirals (used to treat AIDS) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine.
• Some antifungal agents (used to treat fungal infections) such as ketoconazole and itraconazole and certain antibiotics (macrolide) may extend the effects of this medicine.
• Some medicines may decrease the effect of Espranor. These include medicines used to treat epilepsy (such as carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).

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.

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 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.

• The active substance is buprenorphine. Each oral lyophilisate (wafer) contains 2 mg or 8 mg of buprenorphine (as hydrochloride).
• The other ingredients are gelatine, mannitol, aspartame, mint flavour and citric acid.

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