BUPRENORPHINE 8 MG SUBLINGUAL TABLETS - patient leaflet, side effects, dosage

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 or pharmacist.

• – 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 or pharmacist. this includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Buprenorphine is and what it is used for

• 2. What you need to know before you take Buprenorphine

• 3. How to take Buprenorphine

• 4. Possible side effects

• 5. How to store Buprenorphine

• 6. Contents of pack and other information

1. what buprenorphine is and what it is used for

Buprenorphine is a medicinal product used in opioid dependence.

Buprenorphine is used as part of a medical, social and psychological treatment program for patients addicted to opiate (narcotic) drugs. Treatment with Buprenorphine is intended for use in adults and adolescents 16 or more years of age.

2. what you need to know before you take buprenorphine- are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)

• – have serious breathing problems

• – have serious problems with your liver, or if your doctor detects the development of such a problem during treatment

• – are intoxicated due to alcohol or have delirium tremens (the “shakes” and hallucinations)

• – are taking naltrexone or nalmefene (medicines used for the treatment of alcohol or opioid drug

dependence).

Buprenorphine sublingual tablets should not be used in children under the age of 16 years.

Talk to your doctor or pharmacist before taking Buprenorphine:

• – if you have asthma or other breathing problems

• – if you have kidney disease or other liver problems

• – if you have had a recent head injury or brain disease (such as increased pressure in the skull/head)

• – if you have low blood pressure or you know that you are prone to developing low blood pressure

• – if you have a blockage or obstruction in the tube which drains the bladder to the outside of the

body (urethra)

1.3.1.2 - Package Leaflet

• – if you are male and have any urinating problems (especially linked to an enlarged prostate)

• – if you have thyroid problems

• – if your adrenal glands do not produce sufficient steroid hormones (Addison’s disease)

• – if you are elderly or weak

• – if you have depression or other conditions that are treated with antidepressants.

The use of these medicines together with buprenorphine can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Buprenorphine”).

Misuse, especially by injection and at high dose is dangerous and could be fatal.

Serious cases of infections with potential fatal outcome may occur in context of misuse of buprenorphine, when taken by intravenous route

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 buprenorphine or took it in combination with other central nervous system depressants such as alcohol, benzodiazepines (medicines used to treat anxiety or sleep disorders) or other opioids.

Some people have damaged their liver when misusing opiates. The range of damage seen has been from mild forms to severe liver failure. Many of these people had viral infections (such as hepatitis B or C), a history of alcohol abuse, ongoing injecting of drugs or taken liver-damaging medicines (for example: antiretroviral nucleoside analogues, aspirin, amiodarone, isoniazid, valproate) which could have contributed to or caused the live damage. If you have symptoms of severe fatigue, no appetite, itching or if your skin or eyes look yellow, tell your doctor immediately, so that you can receive the proper treatment. Regular blood test may be conducted by your doctor to monitor the condition of your liver.

Sleep-related breathing disorders

Buprenorphine 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 medicine can cause:

• - withdrawal symptoms (anxiety, aching muscles, watery eyes, sweating or shivering, problems sleeping) if you take it less than six hours after you have taken a narcotic (morphine, heroin or other related products) or less than 24 hours after you have last taken methadone

• - drowsiness , which may be made worse if you also drink alcohol or have taken tranquillisers or

anti-anxiety drugs (including sedatives and hypnotics). If you are drowsy, do not drive or operate machinery.

• - a sudden drop in blood pressure , causing you to feel dizzy, especially if you get up too quickly from sitting or lying down

• - drug dependency

Talk to your doctor if you are taking this medicine, as this medicine may mask pain symptoms that could assist in the diagnosis of some diseases.

Other medicines and Buprenorphine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Before taking Buprenorphine, you must tell your doctor if you are taking any of the following:

– sedative medicines such as benzodiazepines or related drugs.

1.3.1.2 - Package Leaflet

• – other medicines that may make you feel sleepy which are used to treat illnesseses such as anxiety, sleeplessness. These types of medicines will reduce your alertness level making difficult for you to drive and use machines. Below is a list of examples of these types of medicines: sedating antihistamines (used to treat allergic reactions) such as diphenhydramine and chlorphenamine, barbiturates (used to cause sleep or sedation) such as phenobarbital and secobarbital, tranquilisers (used to cause sleep or sedation) such as chloral hydrate, certain antidepressants (used to treat depression) such as isocarboxazide, phenelzine, selegiline, tranylcypromine, and valproate may increase the effects of this medicine, and clonidine (a treatment for high blood pressure, migraine, menopausal flushing)

• – strong pain killers (opioid analgesics), cough medicines containing opioid-related substances and methadone

• – naltrexone or nalmefene (used primarily in the treatment of alcohol dependence and opioid dependence)

• – monoamine oxidase inhibitors (a type of antidepressant)

• – antipsychotic drugs

• – medicines to treat HIV / AIDS (protease inhibitors) including indinavir, ritonavir and nelfinavir.

• – anti-epileptic (anticonvulsant) medicines including phenobarbital, carbamazepine and phenytoin

• – antibiotic medicines including azithromycin, erythromycin, rifampicin

• – ketoconazole and itraconazole (a treatment for fungal infections)

• – anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with buprenorphine 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.

Concomitant use of Buprenorphine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Buprenorphine 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.

Buprenorphine with alcohol

Do not drink alcohol when you are being treated with Buprenorphine. Alcohol increases the sedative effects of buprenorphine, which can increase the risk of serious side effects developing.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The risks of using Buprenorphine in pregnant women are not known. Your doctor will help you decide if you should continue taking the medicine during pregnancy.

Using this medicine during late pregnancy may cause drug withdrawal symptoms including breathing problems in your new-born baby. This may happen from several hours to several days after birth.

Do not take Buprenorphine if you are breast-feeding as this medicine passes into breast milk.

Driving and using machines

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information

o provided with the medicine and

o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Buprenorphine may also cause drowsiness, impaired thinking, especially at the start or when changing the dose and dizziness, particularly when taken together with alcohol or central nervous system depressants. If you feel tired, do not drive or operate machinery.

Buprenorphine contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take buprenorphine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

The tablets are administered sublingually. This means that you must place the tablet under your tongue and allow it to dissolve, which may take 5 to 10 minutes. This is the only way the tablets should be taken. Do not chew or swallow them whole , as this will make them ineffective.

Dosage

Adults and adolescents over the age of 16 years : the initial dose is from 0.8 to 4 mg, administered once a day.

Patients who have not undergone withdrawal : Buprenorphine tablets should be taken at least 6 hours after the last use of the opioid (narcotic). If you take it less than 6 hours after you use a narcotic, you may get withdrawal symptoms.

Patients taking methadone : before beginning treatment, your doctor should reduce your dose of methadone to a maximum of 30 mg per day. Buprenorphine may cause withdrawal symptoms in patients who are dependent on methadone if used within 24 hours of the last dose of methadone.

During your treatment, your doctor may increase your dose of Buprenorphine to a maximum single daily dose of 32 mg, depending upon your response. After a period of successful treatment, your doctor may gradually reduce your dose. Depending on your condition, your dose may continue to be reduced under careful medical supervision, until it is stopped altogether.

Patients with liver or kidney problems: your doctor may recommend that you take lower amounts of this medicine or monitor you more carefully if you have, or develop during treatment liver or kidney problems.

If you take more Buprenorphine than you should

You must go or be taken immediately to an emergency centre or hospital for treatment.

If you forget to take Buprenorphine

Do not take a double dose to make up for a forgotten dose. Contact your doctor.

If you stop taking Buprenorphine

Stopping treatment may cause sudden or delayed withdrawal symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Buprenorphine immediately if you get any of the following effects and go straight away to hospital or seek medical advice from your doctor:

Common (may affect up to 1 in 10 people):

• a fast, irregular heartbeat, which you may feel as a thumping in the chest and can lead to dizziness and fainting (these may be signs that your heart is not beating properly)

Uncommon (may affect up to 1 in 100 people):

• difficulty in breathing which may be severe
• yellowing of your skin or whites of your eyes, dark urine, pale stools, loss of appetite, severe tiredness, fever, feeling sick, weakness, drowsiness and abdominal pain (these may be signs of problems with your liver)

Very rare (may affect up to 1 in 10,000):

• sudden swelling of the lips, tongue, face, throat or neck, possibly also hands and feet, difficulty swallowing or breathing or a red itchy rash (these are symptoms of an allergic reaction)

Not known (cannot be estimated from the available data):

• producing little or no urine, discomfort or possibly pain when urinating
• addiction to drugs or medicines (drug dependence)

Other side effects include:

problems sleeping (insomnia)

• headache
• nausea
• excessive sweating (hyperhidrosis)
• pain
• withdrawal syndrome (after your first dose of Buprenorphine, you may feel worse for a short time after. See section 2)

Common (may affect up to 1 in 10 people):

• cough, which may bring up yellow-grey mucus (bronchitis)
• infection
• flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills (influenza)
• sore throat and discomfort when swallowing (pharyngitis)
• swollen glands in the neck, armpit or groin (lymphadenopathy)
• decreased appetite
• fainting, dizziness
• unusual muscle stiffness causing poor control of movement (hypertonia)
• migraine
• a spinning sensation (vertigo)
• tingling or numbness of the hands or feet (paraesthesia)
• shaking or tremors
• agitation, anxiety, depression
• hostile behaviour
• nervousness
• mental illness causing suspiousness (paranoia)
• abnormal thinking,
• constipation, vomiting, diarrhoea, abdominal pain, dry mouth, indigestion (dyspepsia)
• excessive gas in stomach or bowel (flatulence)
• problems with your teeth
• watery eyes, dilation of the pupil of the eye (mydriasis)
• abnormal electrical activity of the heart that affects its rhythm (QT prolongation)
• runny or blocked nose, sneezing, facial pressure or pain (rhinitis)
• drowsiness
• drop in blood pressure on changing position from sitting or lying down to standing (you may feel light headed or faint)
• high blood pressure (hypertension)
• shortness of breath (dyspnoea)
• yawning
• rash
• joint pain, back pain, bone pain, neck pain
• muscle spasm
• muscle tenderness or weakness, not caused by exercise (myalgia)
• painfull menstrual periods (dysmenorrhoea)
• a general feeling of weakness (asthenia)
• chest pain
• chills
• generally feeling unwell (malaise)
• fever (pyrexia)

Uncommon (may affect up to 1 in 100 people):

• seeing, feeling or hearing things that are not there (hallucinations)

Not known (cannot be estimated from the available data):

• drug withdrawal syndrome in new born (e.g unusual muscle stiffness, shaking, restlessness and fit) including problems with breathing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme ator search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store buprenorphine

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.

[0.4 mg]: Do not store above 25°C.

[2 mg and 8 mg]: This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light and moisture.

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.

6. contents of the pack and other information- the active substance is buprenorphine (as buprenorphine hydrochloride). each tablet contains 0.4

mg, 2 mg or 8 mg of buprenorphine.

• – The other ingredients are lactose monohydrate; mannitol; maize starch; citric acid, anhydrous;

What Buprenorphine looks like and contents of the pack

Buprenorphine 0.4 mg sublingual tablets are white, round sublingual tablets marked with “^” on one side.

Buprenorphine 2 mg sublingual tablets are white, round sublingual tablets marked with “2” on one side and with “^” on the other side.

Buprenorphine 8 mg sublingua tablets are white, round sublingual tablets marked with “8” on one side and with “^” on the other side.

Your medicine is available in blisters packed in boxes of 7, 28, 30, 49 or 70 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Station Close, Potters Bar, Hertfordshire, EN6 ITL, UK

Manufacturer

Ethypharm

Chemin de la Poudriere-76120

Grand-Quevilly

France

Ethypharm

Z.I. de Saint-Arnoult

28170 Chateauneuf-en-Thymerais

France

Mylan B.V.

Dieselweg 25,

372 – LB Bunschoten

The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany UK	Buprenorphin dura 0.4 mg, 2 mg, and 8 mg Sublingualtabletten Buprenorphine 0.4 mg, 2 mg and 8 mg sublingual tablets
NL	Buprenorfine Mylan 0.4 mg, 2 mg, and 8 mg Tablet Voor Sublinguaal Gebruik

This leaflet was last revised in 12/2021

8/8