What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL30306/0327, PL30306/0376, PL30306/0328.

Buprenorphine 0.4mg, 2mg and 8mg Sublingual Tablets

PATIENT INFORMATION LEAFLET

Buprenorphine 0.4mg, 2mg and 8mg Sublingual Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information 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. See section 4.
  • The full name of this medicine is Buprenorphine 0.4mg, 2mg and 8mg Sublingual Tablets but within the leaflet it will be referred to as Buprenorphine tablets.

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 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 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 to buprenorphine or any of the other ingredients of this medicine (listed in section 6)
  • have serious breathing problems
  • have serious problems with your liver
  • 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, abuse and diversion

Misuse, especially by injection and at high dose is dangerous and could be fatal.

Serious cases of infections with potential fatal outcome may occur in a context of misuse of Burpenorphine tablets, when administered by the intravenous route.

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 anti-anxiety 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.

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.

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 alcohol

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 this 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 tablets should only be used in pregnancy if the benefits outweigh 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.

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:
    • The medicine has been prescribed to treat a medical or dental problem and
    • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
    • 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 tablets contains lactose and sunset yellow

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 2mg and Buprenorphine 8mg 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 this medicine exactly as your doctor has told you. 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 tablets, 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 are too strong or too weak, talk to your doctor or pharmacist.

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.

Tell your doctor immediately or seek urgent medical help if you experience very rare (may affect up to 1 in 10,000 people) allergic reactions, such as:

  • difficulty in breathing, wheezing and swelling of eyes, lips, throat, tongue or hands.
  • skin rash, hives and itching.

Also tell your doctor immediately if you experience uncommon side effects (may affect up to 1 in 10 people), such as:

  • severe fatigue, loss of appetite or yellowing of skin and eyes. These may be symptoms of liver damage such as death of the cells of the liver (necrosis of the liver).

Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems - see ‘Warnings and precautions’.

After the first dose of Buprenorphine tablets, you may have some opiate withdrawal symptoms, see section 3 ‘How to take’.

Very common side effects (may affect more than 1 in 10 people)

  • not being able to sleep
  • a general feeling of weakness
  • withdrawal syndrome.

Common side effects (may affect up to 1 in 10 people)

  • 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 (may affect up to 1 in 100 people)

  • hallucinations
  • severe difficulty in breathing (respiratory depression)

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 at: 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 this medicine 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.

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 tablets contain

  • The active substance is buprenorphine (as buprenorphine hydrochloride).
    Each tablet contains 0.4mg, 2mg or 8mg of buprenorphine.
  • The other ingredients are magnesium stearate, sodium citrate, povidone, anhydrous citric acid, pregelatinised starch (maize), and lactose monohydrate. Buprenorphine 2mg and Buprenorphine 8mg sublingual tablets also contain crospovidone, mannitol and sunset yellow (E110).

What Buprenorphine tablets look like and contents of the pack

Buprenorphine 0.4mg sublingual tablets are uncoated, white or almost white, 6mm round and flat with “B” on one side.

Buprenorphine 2mg sublingual tablets are uncoated, light orange, 5x8mm oval and biconvex with “B” on one side.

Buprenorphine 8mg sublingual tablets are uncoated, light orange, 7.35x13.35mm oval and biconvex with “B” on one side.

Pack size 7 tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörõur
Iceland

Manufacturer

Actavis hf.
Reykjavíkurvegur 78
IS-220 Hafnarfjörõur
Iceland

Actavis
Barnstaple
EX32 8NS
UK

This leaflet was last revised in April 2017

If you would like a leaflet with larger text, please contact 01271 385257.

Actavis
Barnstaple
EX32 8NS
UK

50929811 BBBA0656