NARBUP is a medicinal product used in opioid dependence. NARBUP is part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs. Treatment is prescribed and monitored by doctors who are specialists in the treatment of drug dependence. Treatment for NARBUP sublingual tablets is intended for use in adults and adolescents over 15 years of age.
1. What NARBUP is and what it is used for
2. What you need to know before you take NARBUP:
Do not take NARBUP
- If you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of NARBUP.
- If you have serious breathing problems,
- If you have serious problems with your liver,
- If you are intoxicated due to alcohol or have delirium tremens.
Warnings and precautions
Take special care with NARBUP:
Some people have died from respiratory failure (inability to breathe) because they misused buprenorphine or took it while in combination with other Central Nervous System depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids. NARBUP 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.
Cases of acute hepatic injury (liver problems) have been reported in a context of misuse, especially by intravenous route and at high dose. These injuries could be due to special conditions such as viral infections (chronic C hepatitis), alcohol abuse, anorexia, or medicines association (for example: antiretroviral nucleoside analogues, acetylsalicylic acid, amiodarone, isoniazid, valproate). If you have symptoms of severe fatigue, itching, or if your skin or eyes look yellow, tell your doctor immediately, so that you can receive the proper treatment.
This medicine can cause withdrawal symptoms if you take it less than six hours after you use a narcotic (e.g. morphine, heroin) or less than 24 hours after you use methadone. This medicine can cause sleepiness which may be increased by alcohol or anti-anxiety medicines. Advise your doctor in case of:
- recent head injury or brain disease,
- decrease of blood pressure,
- in men: urinary disorders (especially linked to enlarged prostate)
- depression or other conditions that are treated with antidepressants.
The use of these medicines together with NARBUP can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and NARBUP”). This medicine may mask pain reflecting some diseases. Do not forget to advise your doctor if you take this medicine. This medicine may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down. This medicine can cause dependence.
Athletes should be aware that this medicine, due to its active substance, may cause a positive reaction to "anti-doping tests". Advise your doctor in case of:
- asthma or other breathing problems
- kidney disease
- liver disease
3. How to take NARBUP
Do not share medicines prescribed for you with any other person. Always take NARBUP exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Sublingual route is the only efficacious administration route for this medicine. Do not swallow the tablets.
Keep the tablet dose under your tongue until it dissolves. This will take 5 – 10 minutes. Take the dose once a day. Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending on your response. To get the greatest benefit from taking NARBUP, you must tell your doctor about all the medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicine you are taking that had not been prescribed to you by your doctor.
Treatment duration
The length of treatment will be determined individually by your doctor. After a time of successful treatment, the doctor may reduce the dose gradually to a lower maintenance dose. Depending on your condition, the NARBUP dose may continue to be reduced under careful medical supervision, until eventually it may be stopped. Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. The effectiveness of this treatment depends:
- on the dose,
- in combination with the associated medical, psychological and social treatment.
If you have the impression that the effect of NARBUP is too strong or too weak, talk to your doctor or pharmacist. Your doctor will tell you how long your treatment with NARBUP will last. Do not stop treatment early, unless instructed to do so by your doctor.
If you take more NARBUP than you should
In case of overdose of buprenorphine, you must go or be taken immediately to an emergency centre or hospital for treatment. Immediately advise your doctor or pharmacist.
In the event of overdosage, contact the nearest hospital or poison control centre. If you forget to take NARBUP, contact your doctor. Do not take a double dose to make up for a missed dose. If you stop taking NARBUP, stopping treatment early may cause withdrawal symptoms. If you have any further questions on the use of this medicine ask your doctor or pharmacist.
4. Possible side effects
NARBUP can have side effects. Not all side effects reported for NARBUP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NARBUP, please consult your health care provider for advice.
After the first dose of NARBUP you may have some opiate withdrawal symptoms. Very common side effects (occurring in at least 1 in 10 patients) that may occur with NARBUP are: insomnia, constipation, nausea, sweating, headache, withdrawal syndrome.
Common side effects (occurring in at least 1 in 100 patients) that may occur during treatment with NARBUP are: weight loss, swelling (hands and feet), tiredness, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, muscle spasms, abnormal thinking, tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach, diarrhoea, abnormal liver function, loss of appetite, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps, impotence, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu syndrome, feeling of general discomfort, accidental injury, faintness and dizziness, drop in blood pressure on changing position from sitting or lying down to standing.
Uncommon side-effects (occurring in at least 1 in 1,000 patients) with NARBUP are: swollen glands (lymph nodes), blood abnormalities, agitation, tremor, abnormal dreams, excessive muscle activity, depersonalisation (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of wellbeing, convulsion (fits), speech disorder, small pupil size, problems with urination, conjunctivitis, rapid or slow heartbeat, low blood pressure, palpitations, myocardial infarction (heart attack), shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, sensitivity to heat or cold, allergic reactions, feelings of hostility.
Uncommon side-effects (frequency unknown) with NARBUP are: abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis). Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see Take special care with NARBUP). If any of the side-effects gets serious, or if you notice and side-effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NARBUP.
For reporting of side effects directly to the HCR, contact +27 11 635 0134 or email [email protected].
5. How to store NARBUP
Store at or below 30 °C in a dry place protected from light. Do not remove the tablets from the outer carton and blister pack until required for use. Keep out of reach of children. Do not use after the expiry date stated on the label. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).