Buprenorphine 8 Mg Sublingual Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Buprenorphine 0.4 mg sublingual tablets Buprenorphine 2 mg sublingual tablets Buprenorphine 8 mg sublingual tablets
Read this entire leaflet carefully before you start taking this medicine because it contains important 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.
What is in this leaflet
1. What Buprenorphine tablets are and what they are used for
2. What you need to know before you take Buprenorphine tablets
3. How to take Buprenorphine tablets
4. Possible side effects
5. How to store Buprenorphine tablets
6. Contents of the pack and other information
1. What Buprenorphine tablets are and what they are used for
Buprenorphine is a medicinal product used in opioid (narcotic) dependence.
Buprenorphine sublingual tablets are used as a part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs. A sublingual tablet is a tablet that is placed under your tongue and allowed to dissolve.
Treatment is prescribed and monitored by physicians who are specialists in the treatment of drug dependence.
Treatment with Buprenorphine sublingual tablets is intended for use in adults and adolescents over 15 years of age.
2. What you need to know before you take Buprenorphine tablets Do not take Buprenorphine tablets
- if you are allergic (hypersensitive) to buprenorphine or any of the other ingredients of medicine (see section 6 for a list of ingredients).
- 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 (the “shakes” and hallucinations). Warnings and precautions
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 tablets or you may need extra treatment to control them:
- asthma or other breathing problems.
- liver or kidney problems. If you suffer from serious liver insufficiency you must not take buprenorphine.
- head injuries or brain disease.
- low blood pressure.
- enlarged prostate gland, which can make it difficult to pass water.
- difficulties passing water because of narrowing of the urethral (urethral stenosis).
Misuse and abuse
Misuse, especially by injection and at 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 a 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 certain 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 six 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 antianxiety drugs. If you are drowsy, do not drive or operate machinery.
- sudden drop in blood pressure, causing you to feel dizzy if you get up too quickly from sitting or lying down.
- drug dependency.
- a positive reaction to “anti-doping” tests (athletes should be aware).
Buprenorphine tablets 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.
Other medicines and Buprenorphine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Before taking Buprenorphine tablets, you must tell your doctor if you are taking any of the following medicines:
- benzodiazepines and other medicines used to treat anxiety or sleep disorders. If your physician prescribes benzodiazepines, you must not take more than the prescribed dose. Taking Buprenorphine tablets with benzodiazepines may cause death due to respiratory failure
- other medicines with sedative properties including sedating antihistamines, certain antidepressants and clonidine (a treatment for high blood pressure, migraine, menopausal flushing).
- strong pain killers (opioid analgesics) and cough medicines containing opioid-related substances such as methadone, dextropropoxyphene, codeine, dextromethorphan and noscapine.
- barbiturates and other medicines used for the treatment of sleep disorders, anxiety or relievment of convulsions.
- monoamine oxidase inhibitors (a type of antidepressant).
- antipsychotic drugs.
- gestodene (an oral contraception).
- medicines to treat HIV / AIDS (protease inhibitors) including indinavir, ritonavir, nelfinavir and saquinavir.
- anti-epileptic (anticonvulsant) medicines including phenobarbital, carbamazepine and phenytoin.
- antibiotic medicines including rifampicin, erythromycin and troleandomycin
- antifungal medicines including ketoconazole and itraconazole.
Buprenorphine tablets with food and drink
Do not drink alcohol when you are being treated with buprenorphine. Alcohol increases the sedative effects 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 any medicine.
Pregnancy
Before taking Buprenorphine tablets tell your doctor if you are pregnant or trying to become pregnant. If you become pregnant during treatment with Buprenorphine tablets tell your doctor straight away. Buprenorphine tabletsshould only be used in pregnancy if the benefits outweight the possible risks. Neonatal withdrawal symptoms, including respiratory suppression have been reported after treatment of mothers in the last part of the pregnancy. Your doctor will decide if you should be treated with Buprenorphine tablets.
Breast-feeding
Since this product will pass into your milk and may adversely affect the breast-fed child, you should discontinue breast-feeding while taking Buprenorphine tablets.
Driving and using machines
Buprenorphine may cause drowsiness. If you feel tired, do not drive or operate machinery. Buprenorphine tablets contain 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.
Buprenorphine 2 mg and Buprenorphine 8 mg sublingual tablets also contain the colouring agent sunset yellow (E110), which may cause allergic reactions.
3. How to take Buprenorphine tablets Method of administration
Always take Buprenorphine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets are administered sublingually. This means that you must place the tablet under your tongue and allow it to dissolve. This is the only way the tablets should be taken. Do not chew or crush the tablets or swallow them whole, as they will not work properly and you may get withdrawal symptoms.
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 ‘Possible side effects’.
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 tablets.
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 dose of Buprenorphine tablets 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 tablets is too strong or too weak, talk to your doctor or pharmacist.
Use in children and adolescents
Buprenorphine tablets should not be used in children and adolescents below the age of 15 years due to lack of data on safety and efficacy.
If you take more Buprenorphine tablets than you should
In case of overdose of Buprenorphine tablets, 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, slow 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 tablets
Contact your doctor if you forget to take Buprenorphine tablets. 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 tablets
Do not suddenly stop taking Buprenorphine tablets as this may cause withdrawal symptoms (sweating, disquiet and restlessness). Do not stop the treatment yourself, but ask your doctor how to end the treatment.
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 special care with Buprenorphine’.
After the first dose of Buprenorphine tablets, you may have some opiate withdrawal symptoms, see ‘Warnings and precautions’.
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 may affect up to 1 in 100 people
Uncommon:
Rare:
Very rare: Not known:
may affect up to 1 in 1000 people
may affect up to 1 in 10,000 people
frequency cannot be estimated from the available data
Very common side effects
- not being able to sleep
- a general feeling of weakness
- withdrawal syndrome
Common side effects
- headache
- fainting
- dizziness
- anxiety
- nervousness
- constipation
- nausea
- vomiting
- diarrhoea
- stomach pain
- tearing disorder
- runny nose
- drowsiness
- drop in blood pressure on changing position from sitting or lying down to standing
- sweating
- back pain
- chills
- abnormal electrocardiogram
Uncommon side effects
- hallucinations
- severe difficulty in breathing (respiratory depression)
- liver problem with or without jaundice
- death of the cells of the liver (necrosis of the liver)
Very rare side effects
- hypersensitivity (allergic) reactions have been reported. Symptoms may include skin rash, hives and itching.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
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.
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 x 8 mm oval and biconvex with “B” on one side.
Buprenorphine 8 mg sublingual tablets are uncoated, light orange, 7.35 x 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.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
Ealing, London
W5 5TL
Manufacturer
Actavis hf .,
Reykjavikurvegi 78,
IS-220 Hafnarfjordur Iceland
This leaflet was last revised in 09/2014