Buprenorphine 0.4 Mg Sublingual Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPRENORPHINE
0.4 mg, 2 mg and 8 mg sublingual tablets Buprenorphine
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 gets 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
Medicinal product used in opioid dependence.
Buprenorphine sublingual tablets are used as part of a medical, social and psychological treatment program for patients addicted to opiate (narcotic) drugs. Treatment with Buprenorphine sublingual tablets is intended for use in adults and adolescents over 15 years of age.
2. BEFORE YOU TAKE BUPRENORPHINE SUBLINGUAL TABLETS Do not take Buprenorphine sublingual tablets if you:
- are allergic (hypersensitive) to buprenorphine or any of the other ingredients of Buprenorphine sublingual tablets
- have serious breathing problems
- have serious problems with your liver, or if your doctor detects the development of such a problem during treatment
- are intoxicated due to alcohol or have delirium tremens (the “shakes” and hallucinations)
- are breast-feeding
Buprenorphine sublingual tablets should not be used in children under the age of 15 years.
Take special care with Buprenorphine sublingual tablets
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:
- asthma or other breathing problems
- liver or kidney disease
- recent head injury or brain disease
- decrease of blood pressure
- in men: urinary disorders (especially linked to enlarged prostate)
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 severe acute liver injury have occurred in a context of misuse. These injuries could be due to special conditions as viral infections (chronic C hepatitis), alcohol abuse, anorexia or medicines association (for example: antiretroviral nucleoside analogues, aspirin, amiodarone, isoniazid, valproate). If you have symptoms of severe fatigue, 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)
- 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 (athlete’s should be aware)
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Before taking Buprenorphine sublingual tablets, you must tell your doctor if you are taking any of the following:
- benzodiazepines and other medicines used to treat anxiety or sleep disorders
- 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), cough medicines containing opioid-related substances and methadone
- monoamine oxidase inhibitors (a type of antidepressant)
- antipsychotic drugs
- gestodene (an oral contraception)
- medicines to treat HIV / AIDS (protease inhibitors) including indinavir, ritonavir and saquinavir.
- anti-epileptic (anticonvulsant) medicines including phenobarbital, carbamazepine and phenytoin
- antibiotic medicines including rifampicin, troleandomycin and ketoconazole (a treatment for fungal infections)
- phenprocoumon (a blood thinning drug)
Taking Buprenorphine sublingual 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 hazardous.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Buprenorphine during pregnancy, unless your doctor tells you to do so.
Do not take Buprenorphine if you are breast-feeding.
Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Buprenorphine may also cause drownsiness, particularly when taken together with alcohol or certain antidepressants. If you feel tired, do 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 intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE BUPRENORPHINE SUBLINGUAL TABLETS
Method of administration
Always take Buprenorphine sublingual 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, which will take 5 to 10 minutes. This is the only way the tablets should be taken. Do not chew or swallow them whole, as this will make them ineffective.
Dosage
The usual dose is:
Adults and adolescents over the age of 15 years: the initial dose is from 0.8 to 4 mg, administered once a day.
Patients who have not undergone withdrawal: one dose of Buprenorphine sublingual tablets tablets at least 6 hours after the last use of the opioid (narcotic), or when the first signs of craving appear.
Patients receiving methadone: before beginning treatment, your doctor should reduce your dose of methadone to a maximum of 30 mg a day. Buprenorphine may cause withdrawal symptoms in patients who are dependent on methadone.
During your treatment, your doctor may increase your dose of Buprenorphine to a maximum single daily dose of 24 mg, depending upon your response. 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, until it is stopped altogether.
If you take more Buprenorphine sublingual tablets than you should
You must go or be taken immediately to an emergency centre or hospital for treatment. Immediately advise your doctor or your pharmacist.
If you forget to take Buprenorphine sublingual tablets
Do not take a double dose to make up for a forgotten dose. Contact your doctor.
If you stop taking Buprenorphine sublingual tablets
Stopping treatment suddenly 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 can cause side effects, although not everybody gets them.
Very common side effects (affect more than 1 per 10 patients):
- insomnia
- a general feeling of weakness
- withdrawal syndrome
Common side effects (affect less than 1 per 10 but more than 1 per 100 patients):
- headache
- fainting
- dizziness
- anxiety
- nervousness
- constipation
- nausea
- vomiting
- diarrhoea,
- abdominal pain
- tearing disorder
- runny nose
- drowsiness
- drop in blood pressure on changing position from sitting or lying down to standing,
- sweating
- back pain
- chills
Uncommon side effects (affect less than 1 per 100 but more than 1 per 1000 patients):
- hallucinations
- respiratory depression (severe difficulty in breathing)
- liver problems with or without jaundice
- necrosis of the liver (death of the cells of the liver)
Very rare side effects (affect less than 1 per 10,000 patients):
- hypersensitivity (allergic) reactions have been reported. Symptoms may include skin rash, hives, and itching. If you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, swelling of the eyes, lips, throat, tongue or hands) seek medical help
If any of the side effects gets 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.
Do not use Buprenorphine sublingual tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Buprenorphine sublingual tablets 0.4 mg: Do not store above 25°C.
Buprenorphine sublingual tablets 2 mg and 8 mg: this medicinal product does not require any special temperature storage conditions.
Store in the original package to protect from light and moisture.
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 contains
- 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, sodium citrate, povidone K30, sodium stearyl fumarate.What Buprenorphine sublingual tablets looks like and contents of the pack
Buprenorphine 0.4 mg sublingual tablets are white, round sublingual tablets marked with “^” on one side.
Buprenorphine 2 mg sublingual tablets are white, round sublingual tablets marked with “2” on one side and with “^” on the other side.
Buprenorphine 8 mg sublingual tablets are white, round sublingual tablets marked with “8” on one side and with “^” on the other side.
Your medicine is available in blisters packed in boxes of 7 or 28, 30, 49 or 70 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
To be completed nationally.
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany
Italy
UK
NL
Buprenorphin dura 0,4 / 2 / 8 mg Sublingualtabletten Buprenorfina Mylan generics Buprenorphine 0.4 mg/2 mg/8 mg, sublingual tablets Buprenorfine Mylan 0,4 / 2 / 8 mg, tabletten voor sublinguaal gebruik
This leaflet was last approved in 11/2014
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