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Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet

Package leaflet: Information for the patient
Buprenorphine 0.4 mg sublingual tablets
Buprenorphine 2 mg sublingual tablets
Buprenorphine 8 mg sublingual tablets
(Buprenorphine hydrochloride)

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:


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

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.


What you need to know before you take Buprenorphine

Do not take Buprenorphine if you:
- are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section
- 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 breast-feeding
Buprenorphine sublingual tablets should not be used in children under the age of 16 years.
Warnings and precautions
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
- if you have low blood pressure or you know that you are prone to developing low blood

Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet


if you have a blockage or obstruction in the tube which drains the bladder to the outside of the
body (urethra)
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

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.
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
- 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:

benzodiazepines and other medicines used to treat anxiety or sleep disorders such as
diazepam, temazepam, alprazolam. Your doctor will prescribe the correct dose for you.
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
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

Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet


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 (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
anti-epileptic (anticonvulsant) medicines including phenobarbital, carbamazepine and
antibiotic medicines including azithromycin, erythromycin, rifampicin
ketoconazole and itraconazole (a treatment for fungal infections)

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.
Do not take Buprenorphine during pregnancy, unless your doctor tells you to do so.
Buprenorphine may cause withdrawal symptoms (e.g unusual muscle stiffness, shaking, restlessness
and fits) including problems with breathing in your new born baby. These symptoms may occur from
several hours to several days after birth.
Do not take Buprenorphine if you are breast-feeding as this medicine may be present in breast milk
and could afect the child. This medicine may also stop milk being produced.
Driving and using machines
Buprenorphine may cause drowsiness, impaired thinking, especially at the start or when changing the
dose and dizziness, particularly when taken together with alcohol or certain antidepressants. 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.


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

Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet

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
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.


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

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)

Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet

Other side effects include:
Very common (may affect more than 1 in 10 people):
• 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
• 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
• 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)
• 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)
• 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)

Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet

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: [to be completed nationally]. By reporting side effects
you can help provide more information on the safety of this medicine.


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.


Contents of the pack and other information

What Buprenorphine contains
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;
sodium citrate; povidone K30;sodium stearyl fumarate.
What Buprenorphine looks like and contents of the pack
Buprenorphine 0.4 mg sublingual tablets are white, roundsublingual tablets marked with “ →” on one
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 sublingual 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 or 70 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Chemin de la Poudriere-76120

Buprenorphine 0.4 mg – 2 mg – 8 mg, sublingual tablet

Z.I. de Saint-Arnoult
28170 Chateauneuf-en-Thymerais
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

Buprenorphin dura 0.4 mg, 2 mg, and 8 mg Sublingualtabletten


Buprenorfina Mylan Generics 0.4 mg, 2 mg, and 8 mg Compressa Sublinguale


Buprenorphine 0.4 mg, 2 mg and 8 mg sublingual tablets


Buprenorfine Mylan 0.4 mg, 2 mg, and 8 mg Tablet Voor Sublinguaal Gebruik

This leaflet was last revised in January 2017.

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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.