Patient leaflet - Addnok 0.4 mg sublingual tablets
1. What Buprenorphine is and what it is used for
Buprenorphine is a medicinal product used in opioid (narcotic) dependence.
Buprenorphine are used as part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs.
Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence.
Treatment with Buprenorphine is intended for use in adults and adolescents over 15 years of age.
2. 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 6)
- suffer from serious breathing difficulties
- suffer from a seriously reduced liver function
suffer from alcoholism or delirium tremens (the “shakes” and hallucinations)
Warnings and precautions:
Talk to your doctor or pharmacist before taking Buprenorphine.
Tell your doctor if you have any of the following illnesses before treatment or develop them during treatment, as your doctor may need to reduce your dose of Buprenorphine or you may need extra treatment to control them:
- 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”)
- have taken morphine or heroin (opioids)less than 6 hours ago, as withdrawal symptoms can occur
- have taken methadone less than 24 hours ago, as withdrawal symptoms can occur (if you use methadone your dose may have to be adjusted before you take buprenorphine, see section 3)
- suffer from asthma or other breathing difficulties
- suffer from reduced function of the kidneys or the liver. If you suffer from serious liver insufficiency you must not take buprenorphine • low blood pressure
- difficulties passing urine (because of an enlarged prostate gland or urethral stricture)
head injuries and have an increased intracranial pressure or brain disease
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.
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 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, 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).
Misuse and abuse
Misuse, especially by injection and at a high dose is dangerous and could be fatal.
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.
Cases of acute hepatic injury (liver problems) have been reported in context of misuse, especially by intravenous route and at a high dose. These injuries could be due to special conditions such as viral infections (chronic C hepatitis), alcohol abuse, anorexia, or when taken with other medicines (for example:antiretroviral nucleoside analogues, acetylsalicylic acid (aspirin), amiodarone, isoniazid and valproate). If you have symptoms of severe tiredness, no appetite, 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 6 hours after you use a narcotic (morphine, heroin or other related products) or less than 24 hours after you use methadone
- drowsiness, which may be made worse if you also drink alcohol or take tranquillisers or anti-anxiety drugs. If you are drowsy, do not drive or operate machinery
- drug dependency
- sudden drop in blood pressure, causing you to feel dizzy and unwell if you get up too quickly from sitting or lying down
Buprenorphine may mask pain reflecting some diseases. Do not forget to inform your physician if you take this medicine.
The risk of serious side effects is greater if you use opioids, alcohol, sedatives and hypnotics especially benzodiazepines.
Discontinuation of treatment may lead to withdrawal syndrome.
Children and adolescents
Buprenorphine is not recommended for use in children and adolescents under the age of 15 years, due to insufficient data on safety and efficacy.
Other medicines and Buprenorphine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
Buprenorphine may influence the effect of other medicines and other medicines may influence the effect of buprenorphine. It is therefore important you tell your doctor if you use any of the following:
Medicines to treat depression 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.
- medicines used in the treatment of anxiety and disquiet and sleeping difficulties (benzodiazepines and anxiolytics other than benzodiazepines). If your physician prescribes benzodiazepines, you must not take more than the prescribed dose. Taking Buprenorphine with benzodiazepines may cause death due to respiratory failure.antifungal medicine used in the treatment of skin infection in the scalp (ketoconazole, itraconazole)
- antibiotic medicines used in the treatment of certain infections (rifampicin, erythromycin, troleandomycin)
- medicine used in the treatment of HIV/ AIDS (protease inhibitors including ritonavir, indinavir, nelfinavir and saquinavir)
- medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics)
- some types of medicine used in the treatment of depression (monoamine oxidase inhibitors)
- other medicines with sedative properties used in the treatment of migraine, high blood pressure, hot flushes and abstinences as a result of medicine abuse, (sedating antihistamines, certain antidepressants and clonidine)
- strong pain killers (opioid analgesics) and cough medicines containing opioid-related substances (methadone, dextropoxyphene, codeine, dextromethorphan, and noscapine)
- painkillers (morphine and morphine-like substances)
- medicine containing alcohol
- medicine used in the treatment of epilepsy (phenobarbital, phenytoin, carbamazepine)
- medicine used to treat psychiatric disorders(antipsychotics or neuroleptics)
- medicine used as sedatives and to relieve convulsions, sleep disorders and anxiety (barbiturates)
- medicines used for oral contraception (gestodene)
- muscle relaxants;
medicines used to treat Parkinson’s disease
Buprenorphine with food, drink and alcohol
You can take Buprenorphine independently of a meal.
Do not drink alcohol when you are being treated with Buprenorphine. Alcohol increases the sedative effect of buprenorphine, which can make driving and operating machinery dangerous.
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.
Pregnancy
You should not use buprenorphine during your pregnancyBut if your doctor finds it appropriate an exception can be made for the first 3 months of your pregnancy.
Breast-feeding
Do not take buprenorphine if you are breast-feeding.
Driving and using machines
Buprenorphine can be sedating, cause fainting and dizziness, and therefore it can reduce the ability to drive and use machines.
Do not drive or use machines if you feel dizzy or drowsy. This usually occurs at the beginning of treatment and when the dose is increased.
Buprenorphine contains lactose
Burpenorphine contains lactose (a type of sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Buprenorphine
Take the dose once a day, unless otherwise is prescribed by your doctor.
Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending upon your response. To get the greatest benefit from taking Buprenorphine, 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 have not been prescribed to you by your doctor.
After the first dose of Buprenorphine tablets, it is possible that you may have some opiate withdrawal symptoms, see section 4.
Reduced kidney or liver function:
If you have problems with your kidneys or liver your dose may have to be reduced. Talk to your doctor. If you suffer from serious liver insufficiency you must not take buprenorphine.
Concomitant methadone treatment
Your dose of methadone has to be reduced to a maximum of 30 mg daily before starting treatment with Buprenorphine. Contact your doctor if you experience withdrawal symptoms (sweating, disquiet or restlessness).
Use in children and adolescents (younger than 15 years):
Children and adolescents under the age of 15 must not use Subuphine, due to lack of data on safety and efficacy.
Method of Administration
Always take Buprenorphine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Buprenorphine, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking Buprenorphine.
The tablets are administered sublingually. This means that you must place the tablet under your tongue until it dissolves – normally it takes 5-10 minutes. This is the only way tablets should be taken. Do not swallow, crush or chew the tablet, as they will not work properly and you may get withdrawal symptoms.
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 lower a maintenance dose. Depending on your condition, the dose of Buprenorphine 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 Buprenorphine is too strong or too weak, talk to your doctor or pharmacist.
If you take more Buprenorphine 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 your pharmacist.
Symptoms of an overdose can include breathing difficulties, slowly breathing or heart symptoms.
Toxic poisoning has been observed after misuse (overdose or wrong administration) and in worst case it can result in stop of breathing, heart failure and/or liver damage.
If you forget to take Buprenorphine
Contact your doctor if you forget to take Buprenorphine. Do not take a double dose to make up for a forgotten dose unless your doctor instructs you to do so.
If you stop taking Buprenorphine
Do not stop the treatment yourself, but ask your doctor how to end the treatment.
A sudden interruption can cause withdrawal symptoms (sweating, disquiet and restlessness).
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.
If you develop symptoms of a severe allergic reactions (such as difficulty in breathing, wheezing and swelling of eyes, lips, throat, tongue or hands) seek medical help immediately.
Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems – see “Take care with Subuphine.
After the first dose of Buprenorphine, you may have some opiate withdrawal symptoms, see section 3 “How to take Subuphine”
Addiction to Buprenorphine
Please observe that Buprenorphine may cause dependence.
Very common: may affect more than 1 in 10 people:
Not being able to sleep, a general feeling of weakness, withdrawal syndrome
Common: may affect up to 1 in 10 people:
Headache, fainting, dizziness, constipation, nausea, vomiting, insomnia, drowsiness, feeling of weakness, drop in blood pressure on changing position from sitting or lying down to standing, sweating, anxiety, nervousness, diarrhoea, stomach pain, tearing disorder, runny nose, back pain, chills, abnormal electrocardiogram.
In long term use of buprenorphine, the common undesirable effects diminish successively. However constipation and sweating often remain.
Uncommon: may affect up to 1 in 100 people:
Hallucinations, severe difficulty in breathing (respiratory depression), liver problem with or without jaundice, death of the cells of the liver (necrosis of the liver).
Rare: may affect up to 1 in 1,000 people:
Hallucinations, respiratory depression, bronchial spasm, damage of the liver, hepatitis, anafylatic shock, angioneurotic oedema, urine retention.
Very rare: may affect up to 1 in 10,000 people:
hypersensitivity (allergic reactions have been reported. Symptoms may include skin rash, hives and itching.
Not known (cannot be estimated from the available data):
Dental caries
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 HPRA Pharmacovigilance Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie. 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 on the blister after Exp.The expiry date refers to the last day of that month.
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.
Does not require any special storage conditions.
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
What Buprenorphine contains
- The active substance is buprenorphine as buprenorphine hydrochloride. Each sublingual tablet contains 0.4 mg, 2 mg and 8 mg buprenorphine respectively.
- The other ingredients are lactose monohydrate, mannitol (E421), maize starch, citric acid (E330), sodium citrate (E331), povidone (E1201), magnesium stearate (E470b).
- The 0.4 mg sublingual tablets also contain: Talc (E553b) and colloidal anhydrous silica.
What Buprenorphinelooks like and contents of the pack
Buprenorphine 0.4 mg is a round, biconvex and white sublingual tablet.
Buprenorphine 2 mg is an oval, biconvex and white sublingual tablet with “2” embossed on one side.
Buprenorphine 8 mg is an oval, biconvex and white sublingual tablet with “8” embossed on one side.
Buprenorphine is packed in blister packs of 7, 14 and 28 sublingual tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Activase Pharmaceuticals Ltd, 11 Boumpoulinas St,
1060 Nicosia, Cyprus
Manufacturers
DDSA Pharmaceuticals Ltd 310 Old Brompton Road London SW5 9JQ
UK
Laboratorios Atral, S.A. Rua da Estacao no.42 Vala do Carregado Castanheira do Ribatejo 2600-726, Portugal