Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or pharmacist.
WARNINGS
Risk of Serious Harm or Death with Intravenous Administration
Hazardous and harmful use.
Life threatening respiratory depression
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants,
including alcohol
1. Why am I being given Buvidal Monthly?
Buvidal Monthly contains the active ingredient buprenorphine. Buprenorphine acts as
a substitute for opioids and helps withdrawal. Buvidal Monthly is used for maintenance
treatment of opioid dependence.
For more information, see Section
1. Why am I being given Buvidal Monthly? in the full CMI.
2. What should I know before I am given Buvidal Monthly?
Do not use if you have ever had an allergic reaction to Buvidal Monthly or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
Tell your doctor if you have or have had any of the following medical conditions: kidney disease, liver problems, problems with excess alcohol use, history of seizures
or breathing problems
For more information, see Section
2. What should I know before I am given Buvidal Monthly? in the full CMI.
3. What if I am taking other medicines?
4. How am I given Buvidal Monthly?
Your doctor will prescribe the correct starting dose of Buvidal Monthly for you. During
treatment with Buvidal Monthly, your doctor may decrease or increase the dose of Buvidal
Monthly according to your needs.
5. What should I know while being given Buvidal Monthly?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are being given Buvidal
Monthly.
|
|
Things you should not do
|
Do not stop treatment of this medicine suddenly, you should discuss stopping your
treatment with your doctor. Stopping treatment may cause withdrawal symptoms.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Buvidal Monthly affects
you. This medicine may cause dizziness and drowsiness in some people.
|
|
Drinking alcohol
|
If you drink alcohol with this medicine, the risk of breathing problems may be increased.
|
6. Are there any side effects?
Serious side effects that could occur while you are receiving Buvidal Monthly include
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.
|
WARNING: Risk of Serious Harm or Death with Intravenous Administration
Buvidal Monthly must not be injected into your veins as it could cause serious harm
or death by stopping your blood flow and the possible formation of clots in your veins
and lungs which could be life-threatening.
Hazardous and harmful use
Although Buvidal Monthly is indicated for the treatment of opioid dependence it still
poses risks of hazardous and harmful use which can lead to overdose and death. You
should be monitored for an ongoing risk of hazardous and harmful use regularly during
opioid substitution therapy with Buvidal Monthly.
Life threatening respiratory depression
Serious, life-threatening or fatal respiratory depression may occur with the use of
Buvidal Monthly. Be aware of situations which increase the risk of respiratory depression,
and monitor patients closely, especially on initiation or following a dose increase.
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants,
including alcohol
Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory depression, coma,
and death. Patients and their caregivers should be made aware of the symptoms of respiratory
depression. Patients and their caregivers should also be informed of the potential
harms of consuming alcohol while taking Buvidal Monthly.
|
Active ingredient(s): Buprenorphine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Buvidal Monthly. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Buvidal Monthly.
Where to find information in this leaflet:
1. Why am I being given Buvidal Monthly?
Buvidal Monthly contains the active ingredient buprenorphine.
Buvidal Monthly is Schedule 8 medicine classification, it contains buprenorphine which
acts as a substitute for opioids and it helps withdrawal from opioids over a period
of time. This medicine is available only with a doctor's prescription.
Buvidal Monthly is used for maintenance treatment of opioid dependence with prior
stabilisation on Buvidal Weekly or sublingual buprenorphine or buprenorphine/naloxone
within a framework of medical, social and psychological support.
2. What should I know before I am given Buvidal Monthly?
Warnings
Do not receive Buvidal Monthly if:
you are allergic to buprenorphine, or any of the ingredients listed at the end of
this leaflet. Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not receive Buvidal Monthly if you are under 16 years of age. Safety and effectiveness in children younger than 16 years has not been established.
Do not receive Buvidal Monthly if you have serious medical problems:
with your liver
with your breathing such as asthma
if you are intoxicated due to alcohol or have delirium tremens (the ‘shakes’ and hallucinations)
Check with your doctor if you:
Have any other medical conditions:
any kidney disease
liver problems such as hepatitis
low blood pressure
recently suffered a head injury or brain disease
a urinary disorder (especially linked to enlarged prostate in men)
thyroid problems
an adrenocortical disorder (eg Addison’s disease)
gall bladder problems
problems with excess alcohol use
history of seizures.
take any medicines for any other condition
If you have not told your doctor about any of the above, tell him/her before you receive
Buvidal Monthly.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
If you become pregnant while taking this medicine, tell your doctor immediately.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Buvidal Monthly and affect how it works.
Medicines that may
increase
the effect of Buvidal Monthly include:
certain medicines for treating anxiety and sleeping disorders such as benzodiazepines
gabapentinoids
alcohol
cannabis
medicines that may make you feel sleepy, which may be used for treating depression,
convulsion, pain and high blood pressure. These may include methadone, anti-cough
medications, anti-depressants, antihistamines, sedatives, barbiturates, some anxiolytics,
neuroleptics, clonidine, and monoamine oxidase inhibitors
strong pain killers such as morphine, methadone and fentanyl
certain medicines for treating HIV/AIDS such as ritonavir, nelfinavir or indinavir
certain medicines for treating fungal and bacterial infections such as ketoconazole,
itraconazole or macrolide antibiotics.
Medicines that may
reduce
the effect of Buvidal Monthly include:
naltrexone and nalmefene, which are used to treat dependence disorders
certain medicines used to treat epilepsy such as phenobarbital, carbamazepine and
phenytoin
certain medicines used to treat tuberculosis such as rifampicin
Medicines that may be affected by Buvidal (Monthly)
Medicines that may increase serotonin levels, such as escitalopram, duloxetine, venlafaxine,
tricyclic antidepressants, and phenelzine
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Buvidal Monthly.
4. How am I given Buvidal Monthly?
How much will I be given
Your doctor will determine the best dose for you. During your treatment, the doctor
may adjust the dose, depending on how you respond to the medicine.
You will receive treatment with Buvidal Monthly in a hospital, clinic or pharmacy.
Buvidal Monthly is given by a healthcare professional as an injection under the skin
(subcutaneously) in the buttock, thigh, abdomen or upper arm.
Starting treatment with Buvidal Monthly
Buvidal Monthly is for maintenance treatment only. Your doctor will prescribe the
correct starting dose of Buvidal Monthly for you.
Maintenance treatment and dose adjustment
During maintenance treatment with Buvidal Monthly, your doctor may decrease or increase
the dose of this medicine according to your needs. If required, you may receive one
8 mg dose of Buvidal Weekly on top of your regular monthly doses. The maximum dose
for Buvidal Monthly that can be received each month is 160 mg.
Changing between Monthly treatment and Weekly treatment
You may be changed from Monthly dosing to Weekly dosing or from Weekly dosing to Monthly
dosing. Your doctor will prescribe the correct dose when you change between dosing
intervals.
How long will it be given for
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition but does not cure it. It is important
to keep taking your medicine even if you feel well.
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.
If you forget your treatment with Buvidal Monthly
It is very important for you to keep all your appointments to receive Buvidal Monthly.
If you miss an appointment, ask your doctor when to schedule your next dose.
If you are given too much Buvidal Monthly
As Buvidal Monthly is given to you under the supervision of your doctor, it is very
unlikely that you will receive too much. Buvidal Monthly comes in a syringe pre-filled
with the dose your doctor has prescribed. However, if you feel you have been given
too much of Buvidal Monthly you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being given Buvidal Monthly?
Important things to be aware of while you are being given this medicine
Breathing problems
Some people have died from the reduced ability to breathe (respiratory depression)
because they took a similar medicine also containing buprenorphine, together with
central nervous system depressants such as benzodiazepines, gabapentinoids, alcohol
or other opioids.
Drowsiness
This medicine may cause drowsiness especially when taken with alcohol or other central
nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids
or hypnotics.
Dependence
This medicine can cause dependence.
Liver damage
Liver damage has been reported after taking buprenorphine, 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. Regular
blood tests may be conducted by your doctor
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.
Athletes
Athletes should be aware that this medicine may cause a positive reaction to "anti-doping"
tests.
Elderly
The safety and effectiveness in patients over 65 years of age has not been established.
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 are being given this medicine.
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Buvidal Monthly.
If you are going to have surgery, tell the surgeon or anesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine. It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests to check your liver function from time to time to make
sure the medicine is working and to prevent unwanted side effects.
Remind any doctor, dentist or pharmacist you visit that you are using Buvidal Monthly.
Things you should not do
Do not stop treatment with this medicine suddenly, you should discuss stopping your
treatment with your doctor. Stopping treatment may cause withdrawal symptoms.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Buvidal
Monthly affects you.
Buvidal Monthly may cause dizziness and drowsiness in some people. This is more likely
to happen at the start of treatment and when your dose is being changed. This effect
can be worse if you drink alcohol or take other sedative medicines. If you have any
of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may cause dizziness and risk of respiratory failure may be increased.
Looking after your medicine
The hospital, clinic. or pharmacy where you receive your treatment will store Buvidal
Monthly under the required conditions.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Effects on the body - General:
flushing
tremor
decreased appetite
pain when urinating
swelling of the legs and arms
Effect on the body - Nervous system related:
difficulty sleeping
headache
sleepiness
dizziness, feeling off balance
malaise, yawning
dizziness or fainting when standing up
headache-migraine
Effect on the body - Stomach related:
upset stomach including, nausea, vomiting and diarrhoea or constipation
upset stomach including stomach pain, wind, indigestion
dry mouth
Effect on the body - Skin related:
redness, soreness, swelling or itching at the Buvidal Monthly injection site
hives, rash, itching
Effects on the body - Eye related:
abnormal vision
Effects on the body - Infection related:
flu like symptoms, such as chills, fever, sore throat, coughing, runny nose, watery
eyes and sweating
respiratory infection
Effects on the body - Psychiatric related
depression, abnormal thinking, agitation, nervousness, anger, hallucinations
anxiety
Effect on the body - Pain related:
pain in the abdomen, back, and muscles, leg cramps, chest pain, neck pain, menstrual
pain, muscle weakness
pain in joints,
Effect on the body - Breathing related:
shortness of breath, enlarged or sore lymph nodes
Effects on the body - heart related:
strong or irregular heartbeat
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects such as liver problems can only be found when your doctor
does tests from time to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Buvidal Monthly contains
|
Active ingredient
(main ingredient)
|
buprenorphine
|
|
Other ingredients
(inactive ingredients)
|
phosphatidyl choline [soybean], glyceryl dioleate, N-methyl-2-pyrrolidone
|
|
Potential allergens
|
Contains soya bean products
|
Do not take this medicine if you are allergic to any of these ingredients.
What Buvidal Monthly looks like
Buvidal Monthly is a modified release solution for injection. Each pre-filled syringe
contains a yellowish to yellow clear liquid.
Pre-filled syringe containing 64 mg buprenorphine in 0.18 ml solution - AUST R 295045
Pre-filled syringe containing 96 mg buprenorphine in 0.27 ml solution - AUST R 295048
Pre-filled syringe containing 128 mg buprenorphine in 0.36 ml solution - AUST R 295051
Pre-filled syringe containing 160 mg buprenorphine in 0.45ml solution - AUST R 341073
Who distributes Buvidal Monthly?
Camurus Pty Ltd
223 Liverpool St
Darlinghurst, NSW, 2010
Phone Toll Free: 1800 142 038
® = Registered Trademark
This leaflet was prepared in March 2023.