PACKAGE LEAFLET : INFORMATION FOR THE USER
Buprenorphine 0.4 mg, 2 mg and 8 mg Sublingual Tablets
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Buprenorphine Sublingual Tablets are and what they are used for
2. Before you take Buprenorphine Sublingual Tablets
3. How to take Buprenorphine Sublingual Tablets
4. Possible side effects
5. How to store Buprenorphine Sublingual Tablets
6. Further information
1. WHAT BUPRENORPHINE SUBLINGUAL TABLETS ARE AND WHAT THEY ARE USED FOR
Buprenorphine belongs to a group of medicines called opioid analgesics (also known as “opiates” or “narcotics”). Opioid analgesics, such as morphine or diamorphine (heroin), are often subject to abuse, which can lead to dependence (addiction). If you are addicted to these drugs, you need a regular dose to feel “normal”. Otherwise you will develop withdrawal symptoms within a day or so of the last dose. Withdrawal symptoms include sweating, feeling hot and cold, runny eyes and nose, feeling or being sick, diarrhoea, stomach cramps, poor sleep and just feeling awful.
Buprenorphine Sublingual Tablets are used as a substitution (replacement) treatment in patients who are addicted to opioid drugs such as heroin and morphine. The tablets prevent or reduce the unpleasant withdrawal symptoms experienced when addicts stop using opioid drugs.
Treatment with Buprenorphine Sublingual Tablets may form one aspect of a specialist support programme aimed at resolving opioid addiction.
The tablets are not to be used for pain relief purposes.
2. BEFORE YOU TAKE BUPRENORPHINE SUBLINGUAL
Do not take Buprenorphine Sublingual Tablets:
- if you are allergic (hypersensitive) to buprenorphine
- if you are allergic to any of the other ingredients in the tablets (these are listed in section 6, Further Information)
- if you have severe breathing problems
- if you have severe liver disease
- if you are an alcoholic or regularly drink large amounts of alcohol
- if you have delirium tremens (‘DTs’, ‘the shakes’ and hallucinations)
- if you are breast-feeding (see the section ‘Pregnancy and breast-feeding’ below for more information).
Buprenorphine Sublingual Tablets must not be used by children or adolescents under 16 years old.
Take special care with Buprenorphine Sublingual Tablets
Tell your doctor before taking these tablets:
- if you have asthma or any other breathing problems
- if you have any kidney problems
- if you have any liver problems.
Buprenorphine Sublingual Tablets contain buprenorphine which can become addictive if used continually for a long period of time. Drug dependence may occur as a result of taking this medicine.
Taking other medicines
Tell your doctor if you are taking or have recently taken any of the following medicines as they may interact with Buprenorphine Sublingual Tablets.
The following medicines have sedative effects (make you feel sleepy/drowsy). These effects are increased if these medicines are taken while you are being
treated with buprenorphine:
- benzodiazepines (used for treatment of anxiety or sleep disorders) e.g. diazepam and temazepam: you should not take these medicines while you are
taking buprenorphine, unless prescribed by your doctor because this combination can be fatal if the correct dose is not carefully determined
- barbiturates and other medicines used for the treatment of anxiety or sleep disorders
- other medicines containing opioid-related medicines e.g. codeine, dihydrocodeine and morphine (used as strong painkillers and in some cough medicines),
- medicines used for the treatment of depression, including medicines known as monoamine oxidase inhibitors (MAOIs) e.g. phenelzine
- antihistamine medicines (used for treatment of allergy and/or hay fever) e.g. promethazine and chlorphenamine
- medicines known as antipsychotics (used for the treatment of schizophrenia) e.g. chlorpromazine and haloperidol
- certain medicines for the treatment of high blood pressure (antihypertensives) e.g. clonidine.
If you are taking any of the following medicines, your doctor may need to prescribe a lower dose of buprenorphine:
- the antifungal medicine, ketoconazole
- medicines used to treat infections caused by viruses (antiviral agents) e.g. ritonavir, saquinavir and indinavir, which are used in the treatment of
- oral contraceptive medicines containing gestodene
- certain medicines called ‘macrolide antibiotics’ (used for the treatment of infections).
If you are taking any of the following medicines, your doctor may need to prescribe a higher dose of buprenorphine:
- medicines used for the treatment of epilepsy e.g. phenobarbital, carbamazepine and phenytoin
- the antibiotic medicine, rifampicin (used for the treatment of tuberculosis)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Buprenorphine Sublingual Tablets with food and drink
These tablets should not be taken at the same time as food or drink.
You should not drink alcohol or take any medicines that contain alcohol while taking buprenorphine sublingual tablets.
Pregnancy and breast-feeding
Before taking these tablets, tell your doctor if you are pregnant or trying to become pregnant. If you become pregnant during treatment with buprenorphine,
tell your doctor straight away.
Since buprenorphine is passed into breast milk, you must not breast feed while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel drowsy while being treated with this medicine, you should not drive or operate machinery.
Important information about some of the ingredients of Buprenorphine Sublingual Tablets
Buprenorphine Sublingual Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE BUPRENORPHINE SUBLINGUAL 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 doctor will tell you how many tablets to take and you should always follow this advice.
To avoid sudden withdrawal symptoms, treatment with Buprenorphine Sublingual Tablets should be given when there are already clear signs of withdrawal symptoms.
Adults and children over the age of 16 years: when beginning treatment the dose is between 0.8 to 4 mg, taken once a day.
For drug addicts who have not had any withdrawal treatment: one dose of Buprenorphine Sublingual Tablets should be taken at least 6 hours after the last use of the opioid (narcotic such as morphine or heroine), 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 30 mg a day. Buprenorphine Sublingual 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 Sublingual 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 Sublingual Tablets than you should
Tell your doctor immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining tablets with you.
If you forget to take Buprenorphine Sublingual Tablets
You should tell your doctor and follow their instructions. Do not take a double dose to make up for the missed dose, unless your doctor tells you to.
If you stop taking Buprenorphine Sublingual Tablets
Do not suddenly stop taking the tablets unless told to do so by your doctor, as this may cause withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Buprenorphine Sublingual Tablets can cause side effects, although not everyone gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:
Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat
Peeling and blistering of the skin, mouth, eyes and genitals
Rash affecting your whole body.
If you develop severe fatigue, loss of appetite or if your skin or eyes look yellow, tell your doctor immediately.
The following side effects have also been reported:
The most common side effects are: constipation, headache, difficulty in sleeping, weakness or lack of energy, drowsiness, nausea and vomiting (feeling and being sick), fainting and dizziness (especially when changing position from sitting or lying down to standing) and sweating.
After your first dose, you may suffer from opioid withdrawal symptoms. This is more likely if buprenorphine is taken less than six hours after using an opioid (e.g. heroin).
Rare side effects: severe difficulty in breathing, hallucinations.
- Athletes should be aware that this medicine may cause a positive reaction to ‘anti-doping tests’
- Drug dependence can occur as a result of taking this medicine.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE BUPRENORPHINE SUBLINGUAL TABLETS
Keep out of the reach and sight of children
Store your medicine in the original packaging to protect from light and moisture. The 0.4mg strength of Buprenorphine Sublingual Tablets should not be stored above 25°C. The 2mg and 8mg strengths of Buprenorphine Sublingual Tablets do not require any special temperature storage conditions.
Do not use Buprenorphine Sublingual Tablets after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Buprenorphine Sublingual Tablets contain:
- The active substance is buprenorphine (as buprenorphine hydrochloride). Each tablet contains 0.4 mg, 2 mg or 8 mg of buprenorphine.
- The other ingredients are lactose monohydrate, mannitol, maize starch, citric acid (anhydrous), sodium citrate, povidone (K30), magnesium stearate, talc and silica (colloidal anhydrous).
What Buprenorphine Sublingual Tablets look like and the contents of the pack
Buprenorphine 0.4 mg Sublingual Tablets are white, round tablets marked with “ ” on one side.
Buprenorphine 2 mg Sublingual Tablets are white, round tablets marked with “2” on one side and with “ ” on the other side.
Buprenorphine 8 mg Sublingual Tablets are white, round tablets marked with “8” on one side and with “ ” on the other side.
Your medicine is available in blisters containing 7 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Arrow Generics Limited
Chemin de la Poudrière
Z.I. de Saint-Arnoult
This leaflet was last approved in 12/2009.