Patient leaflet - Buprenorphine 0.4 mg sublingual tablets
1. What Buprenorphine tablets are and what they are used for
Buprenorphine is used to treat dependence on opiate (narcotic) drugs, such as morphine and heroin in drug addicts who have agreed to be treated for their addiction.
Buprenorphine sublingual tablets is used in adults and adolescents over 16 years of age who are also receiving medical, social and psychological support.
It contains buprenorphine which belongs to a class of medicines called opioids, which are ‘pain relievers.
This medicine has been prescribed to you and should not be given to anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
2. What you need to know before you take Buprenorphine tablets
Do not take Buprenorphine tablets
- If you are a child under the age of 16 years.
If you are allergic (hypersensitive) to buprenorphine or to any
of the other ingredients of this
medicine (listed in section 6).
- If you have serious breathing problems.
- If you have serious problems with your liver.
If you are intoxicated due to alcohol or have trembling,
sweating, anxiety confusion or hallucinations
caused by alcohol.
If you are breast feeding a baby.
If you are taking naltrexone or nalmefene for the treatment of
alcohol or opioid dependence.
Warnings and precautions
Talk to your prescriber before taking this medicine if you:
- seizures, fits or convulsions
- asthma or other breathing problems
- any liver disease such as hepatitis
- low blood pressure
- recently suffered head injury or brain disease
a urinary disorder (especially linked to enlarged prostate
in men)
- any kidney disease
- thyroid problems
- adrenocortical disorder (e.g. Addison’s disease)
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 tablets’’).
are or have ever been addicted to opioids, alcohol,
prescription medicines, or illegal drugs.
have previously suffered from withdrawal symptoms such
as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
feel you need to take more of Buprenorphine Tablets to
get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it.
Speak to your prescriber who will discuss your treatment
and may change your dose or switch you to an alternative
pain reliever.
Tolerance, dependence, and addiction
This medicine contains buprenorphine which is an opioid medicine. Repeated use of opioids can result
in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of
Buprenorphine tablets can also lead to dependence, abuse, and addiction, which may result in life
threatening overdose.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you
need to take or how often you need to take it.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on
or addicted to buprenorphine if:
You or anyone in your family have ever abused or been
dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
- You are a smoker.
You have ever had problems with your mood (depression,
anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
If you notice any of the following signs whilst taking Buprenorphine tablets, it could be a sign that you have become dependent or addicted:
You need to take the medicine for longer than advised by
your doctor
- You need to take more than the recommended dose
You are using the medicine for reasons other than
prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
You have made repeated, unsuccessful attempts to quit
or control the use of the medicine
When you stop taking the medicine you feel unwell, and
you feel better once taking the medicine again (‘withdrawal effects’)
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Buprenorphine tablets.
Important things to be aware of:
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. Opioids should only be used by those they are prescribed for. Do not give this medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. 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. Addiction and withdrawal symptoms
Taking this medicine regularly, particularly for a long time, can lead
to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or
Colour Black
Size: 180x600 mm
Note: 2000XXXX Indicates provision for Rusan SAP code
8114170-7803
- 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.
Important information about some of the ingredients of Buprenorphine tablets Buprenorphine tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Buprenorphine 2 mg and Buprenorphine 8 mg sublingual tablets also contain the colouring agent sunset yellow (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Buprenorphine tablets
You must place the tablet under your tongue (sublingual) and allow it to dissolve which will take 5 to 10 minutes. This is the only way to take the tablets. Do not chew or swallow them whole, as they will not work.
Your prescriber should have discussed with you, how long the course of Buprenorphine tablets will last.
They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and
stop taking the medicine.
Your doctor will tell you how many tablets to take and you should always follow this advice.
To avoid sudden withdrawal symptoms, treatment with Buprenorphine tablets should be given when there are already clear signs of withdrawal symptoms.
Your prescriber should discuss your treatment and whether you need to continue taking tablets at regular intervals. If you and your prescriber decide to stop treatment, a plan will be put in place to gradually reduce the dose and stop taking the medicine to minimise the risk of withdrawal effects.
Adults and children over the age of 16 years: when beginning treatment the dose is between 0.8 to 4mg, taken once a day. For drug addicts who have not had any withdrawal treatment: one dose of Buprenorphine tablets should be taken at least 6 hours after the last use of the opioid (narcotic such as morphine or
heroin), or when the first signs of craving appear. If you take it less than six hours after you use a narcotic you may get withdrawal symptoms.
For patients taking methadone: before beginning treatment, your doctor should reduce your dose of methadone to not more than 30mg a day. Buprenorphine tablets 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 tablets, to a maximum single daily dose of 32mg, depending upon your response. Once you have been stable for a while, your doctor will gradually reduce your dose and it may be possible to stop it altogether. Do not suddenly stop taking the tablets, as this may cause withdrawal symptoms. If you take more Buprenorphine tablets than you should
If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital as overdose with Buprenorphine tablets may cause serious and life- threatening breathing problems.
If you forget to take Buprenorphine tablets
Tell your doctor as soon as possible if you miss a dose and follow his or her instructions. Do not take a double dose to make up for the forgotten dose.
If you stop taking Buprenorphine tablets
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
Pregnancy
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 everybody gets them.
Tell your doctor immediately or seek urgent medical attention if you experience side effects such as:
sudden wheezing, difficulty breathing, swelling of the eyelids,
face, tongue, lips, throat or hands;
rash or itching especially those covering your whole body.
These may be signs of a life-threatening
allergic reaction.
if you start to breathe more slowly or weakly than expected
(respiratory depression).
if you start to feel faint, as this may be a sign of low blood
pressure.
Also tell your doctor immediately if you experience side effects such as:
severe fatigue (tiredness), have no appetite or if your skin or
eyes look yellow. These may be symptoms of liver damage The frequency of possible side effects listed below is defined using the following convention:
- Very common (may affect more than 1 in 10 people)
- Common (may affect up to 1 in 10 people)
Not known (frequency cannot be estimated from the
available data).
Side effects reported with Buprenorphine tablets Very common
- drug withdrawal syndrome
- headache
- hyperhidrosis (sweating)
- insomnia (inability to sleep)
- nausea (feeling sick)
- pain
Common
- Abdominal pain
- agitation
- anxiety
- joint pain
- weakness
- back pain
- bone pain
- bronchitis
- chest pain
- chills
- constipation
- cough
- decreased appetite
- depression
- diarrhoea
- dizziness
- dry mouth
- painful period
- indigestion
- shortness of breath
- flatulence
- gastrointestinal disorder
- hostility
- increase in muscle tension
- infection
- influenza
- nervousness
- tearing (watery eyes) disorder
- swollen glands (lymph nodes)
- malaise
- a general feeling of discomfort
- migraine
- muscle spasms
- muscle pain
- dilation of the pupil
- neck pain
- palpitations
- paranoia
- burning or tingling in hands and feet
- swelling (hands and feet)
- runny or stuffy nose
- sore throat and painful swallowing
fever
- rash
- sleepiness
- syncope (fainting)
- thinking abnormal
- tooth disorder
- tremor
- flushing
- vomiting (being sick)
- yawning
Not known
- Dental caries
- Drug dependence
- drug withdrawal syndrome in newborn
- hallucinations (sensing things that are not real)
- drop in blood pressure on changing position from sitting or lying down to standing
- difficulty in urinating
- Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems
Drug Withdrawal
When you stop taking Buprenorphine Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. How do I know if I am addicted?
If you notice any of the following signs whilst taking Buprenorphine Tablets, it could be a sign that you have become addicted.
- You need to take the medicine for longer than advised by your prescriber
- You feel you need to use more than the recommended dose
- You are using the medicine for reasons other than prescribed
- When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these signs, it is important you talk to your prescriber
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or 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 tablets
Keep this medicine out of the sight and reach of children. Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them.
Do not use Buprenorphine tablets after the expiry date which is stated on the carton, blister and label after EXP. The expiry date refers to the last day of that month.
Blister packs:
Do not store above 25°C. Store in the original package in order to protect from moisture.
Tablet containers:
Do not store above 30°C. Keep the container tightly closed in order to protect from moisture.
Do not throw away 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 What Buprenorphine tablets contain
- The active substance is buprenorphine (as buprenorphine hydrochloride). Each tablet contains 0.4, 2 mg or 8 mg of buprenorphine.
- The other ingredients are magnesium stearate, sodium citrate, povidone, anhydrous citric acid, pregelatinised starch (maize), and lactose monohydrate. Buprenorphine 2 mg and Buprenorphine 8 mg sublingual tablets also contain crospovidone, mannitol and sunset yellow (E110). What Buprenorphine tablets look like and contents of the pack
Buprenorphine 0.4 mg sublingual tablets are uncoated, white or almost white, 6 mm round and flat with “B” on one side. Buprenorphine 2 mg sublingual tablets are uncoated, light orange, 5 × 8 mm oval and biconvex with “B” on one side. Buprenorphine 8 mg sublingual tablets are uncoated, light orange, 7.35 × 13.35 mm oval and biconvex with “B” on one side. Buprenorphine is available in tablet containers and blister packs in pack sizes of 1, 7, 20, 24, 28, 48 and 50 tablets. Not all pack sizes may be marketed
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Crawley West Sussex RH10 9BG United Kingdom Manufacturer Actavis hf ., Reykjavíkurvegi 78, IS-220 Hafnarfjörður Iceland