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BUPRENORPHINE 8 MG SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

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Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets

PL 04416/0948-0950

PACKAGE LEAFLET: INFORMATION FOR THE USER
Buprenorphine, 0.4 mg, sublingual tablets
Buprenorphine, 2 mg, sublingual tablets
Buprenorphine, 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 is and what it is used for
2.
Before you take Buprenorphine
3.
How to take Buprenorphine
4.
Possible side effects
5.
How to store Buprenorphine
6.
Further information

1.
WHAT BUPRENORPHINE IS AND WHAT IT IS USED FOR
Buprenorphine is used to treat
• opioid dependence
Buprenorphine is part of a medical, social and psychological treatment programme for patients
addicted to opiate (narcotic) drugs. Treatment is prescribed and monitored by doctors who are
specialists in the treatment of drug dependence.
Treatment with Buprenorphine is intended for use in adults and adolescents aged 15 years and over.
2.
BEFORE YOU TAKE BUPRENORPHINE
Do not take Buprenorphine
if you are/have
• allergic (hypersensitive) to:
- buprenorphine or
- any of the other ingredients of this medicine
• serious breathing problems
• a serious liver disease
• intoxicated due to alcohol
• withdrawal symptoms, such as shakes and hallucinations
• under 15 years of age
Take special care with Buprenorphine
Inform your doctor if any of the following apply to you:
• reduced breathing function, such as asthma
You must not use Buprenorphine if you have serious breathing problems.
PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets







PL 04416/0948-0950

recent head injury or brain disease
reduced kidney function
reduced liver function
Acute liver problems have been reported which could be due to:
- misuse, especially through administration into a vein and at a high dose
- previous existing liver problems
- viral infections, such as hepatitis B or hepatitis C
- alcohol abuse
- anorexia
- liver damaging medicines
Inform your doctor immediately if you experience symptoms of liver problem such as severe
fatigue, itching and yellow skin or eyes. You can then receive the proper treatment.
However, you must not use Buprenorphine if you have a serious liver disease.
low blood pressure
in men: urinary disorders, especially due to enlarged prostate

In general, all patients have to undergo a liver test prior to Buprenorphine therapy. Regular
monitoring by the doctor is required if you have liver problems.
This medicinal product may mask pain of other diseases. Advise your doctor that you are taking this
medicine.
Misuse and abuse
Some users died from breathing failure after misusing buprenorphine or combining it with brain
acting substances, such as:
• alcohol
• medicines which calm, induce sleep or relax muscles with active substance names ending with
“azepam”, such as diazepam, temazepam
• other opioids
If it is not possible for you to stop misuse, please talk to your doctor, who will provide advice on
adequate treatment for problems like depression, anxiety or insomnia.
This product can cause withdrawal symptoms if you take it
• less than 6 hours after using a narcotic, such as morphine, heroin
• or less than 24 hours after you use methadone
You must not pass this medicine to others. This is forbidden and may be deadly - especially if one is
not used to opiates. A dose suitable for you may be deadly for another person.
Effects of misuse for doping
Using Buprenorphine can lead to positive results in doping tests. Abusing Buprenorphine for doping
purposes can endanger your health.
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.
The following medicines can affect or be affected by Buprenorphine:
• medicines which calm, induce sleep or relax muscles with active substance names ending with
“azepam”, such as diazepam, temazepam

PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets















PL 04416/0948-0950

This combination can be fatal. Therefore, the dose must be limited. Do not take these medicines
while taking Buprenorphine, where risk of misuse exists.
medicines to treat epilepsy or to sedate, with active substance names mostly ending with “tal”,
such as phenobarbital
other medicines used to treat anxiety or sleep disorders
other strong painkillers or medicines to treat cough, such as codeine, dihydrocodeine, morphine
methadone, a medicine to treat severe pain, or to counter addiction
naltrexone, a medicine to counter alcohol or opiate drug addiction
certain medicines to treat depression or Parkinson’s disease known as monoamine oxidase
inhibitors, such as moclobemide
other medicines to treat depression
medicines to treat allergies, sleep disturbances or cold; or prevent and treat nausea and
vomiting; such as doxylamine, diphenhydramine
medicines to treat mental or anxiety disorders, with sedative effects, such as chlorpromazine,
haloperidol
certain medicines to treat high blood pressure, such as clonidine
Your doctor may prescribe you a lower Buprenorphine dose if you take any of the following
medicines:
- ketoconazole, itraconazole: medicines to treat fungal infections
- medicines to treat HIV infections, such as ritonavir, nelfinavir, indinavir
Your doctor may supervise you closely if you take any of the following medicines:
- medicines to treat epilepsy, such as phenobarbital, carbamazepine, phenytoin
- rifampicin: a medicine to treat bacterial infections

If you need the help of a doctor or a hospital, you must provide information on your substitution
therapy and also be honest relating to your actual consumption of other pharmaceuticals or drugs.
This is necessary to avoid dangerous combinations.
Taking Buprenorphine with food and drink
Avoid drinking alcohol or taking any medicines that contain alcohol while taking Buprenorphine.
Pregnancy and breast-feeding
• Pregnancy
Buprenorphine is not recommended during pregnancy. Tell your doctor before taking
Buprenorphine if you are pregnant, trying or become pregnant during treatment.


Breast-feeding
Discontinue breast-feeding while taking Buprenorphine as it will pass into your milk and may
harm the breast-fed child.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you feel drowsy while being treated with this medicine.
Buprenorphine can impair alertness and the ability to react. Therefore, ask your doctor whether and
under what circumstances you can drive a vehicle, for example.
Important information about some of the ingredients of Buprenorphine
Buprenorphine contains lactose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets
3.

PL 04416/0948-0950

HOW TO TAKE BUPRENORPHINE

Always take Buprenorphine exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual dose is:
• Take the dose once a day unless otherwise 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.
If your craving for drugs is not suppressed completely, please inform your doctor.
The suitable dose is found, if you do not experience symptoms of withdrawal. However too high
doses will result in sedation or drowsiness.
Patients with reduced liver function
Your doctor will probably prescribe a lower dose than those described above. However, you must not
use Buprenorphine if you have serious liver diseases.
Method of use
The tablets are described as “sublingual”. This means that the tablet should be placed under the
tongue and kept there until fully dissolved. This usually takes 5 to 10 minutes.
This form of use is the only effective administration route for this product.
Do not suck, chew or swallow the tablets whole – the medicine will not work this way. Do not take
the tablets at the same time as food or drink.
Only sublingual application is allowed. Other forms of application (such as intravenous misuse) may
lead to life-threatening intoxications with buprenorphine. In addition, excipients of the tablet and
bacterial contamination may lead to health hazards such as hypersensitivity reactions, shock,
inflammation of the heart, thromboembolism and sepsis.
Duration of use
This will be decided by your doctor.
After a period of successful treatment, the doctor may gradually reduce the dose to a lower
maintenance dose. Depending on your condition, the Buprenorphine dose may be further reduced
under careful medical supervision, eventually it may be stopped.
Do not change the treatment in any way or stop treatment without the agreement of the attending
doctor.
The effectiveness of this treatment depends:
• upon the dose
• combined 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.

PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets

PL 04416/0948-0950

Instruction for use
Remove the sublingual tablets from the blister by pressing down on the whole
tablet, so you need the least effort and you prevent the tablets from being crushed.

If you take more Buprenorphine than you should
Tell your doctor immediately or contact your nearest hospital casualty department. Bring the pack and
any remaining tablets with you.
If you forget to take Buprenorphine
You should tell your doctor and follow his instructions. Do not take a double dose to make up a
forgotten tablet, unless your doctor tells you to do so.
If you stop taking Buprenorphine
Do not suddenly stop taking the tablets unless told 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 can cause side effects, although not everyone gets them.
Side effects can occur with the following frequencies:
Very common, affects more than 1 per 10 users
• sleeplessness
• weakness
• withdrawal symptoms
Common, affects 1 to 10 per 100 users
• anxiety
• nervousness
• drowsiness
• dizziness
• headache, backache, stomach ache
• flow of tears
• prolonged time of the heart ventricle activity, measured with electrodes
• fainting
• fall in blood pressure when standing up quickly
• runny nose
• constipation
• diarrhoea
• nausea, vomiting
• sweating
• shiver
Uncommon, affects 1 to 10 per 1,000 users
• hallucinations
• reduced breathing function
PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets


PL 04416/0948-0950

liver cell destruction and inflammation

Very rare, affects fewer than 1 per 10,000 users
• cramps of bronchial muscles
• life-threatening allergic shock reaction
• serious allergic reaction causing swelling of the face or throat
Contact your doctor immediately if you notice any of these very rare side effects.
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

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Buprenorphine after the expiry date, which is stated on the carton and plastic/aluminium
strip 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 contains:
The active substance is buprenorphine as buprenorphine hydrochloride.
Buprenorphine, 0.4 mg, sublingual tablets
Each tablet contains 0.4 mg buprenorphine.
Buprenorphine, 2 mg, sublingual tablets
Each tablet contains 2 mg buprenorphine.
Buprenorphine, 8 mg, sublingual tablets
Each tablet contains 8 mg buprenorphine.


The other ingredients are citric acid anhydrous, lactose monohydrate, mannitol, sodium citrate,
sodium stearyl fumarate, pregelatinised starch (maize).

What Buprenorphine looks like and contents of the pack
Buprenorphine, 0.4 mg, sublingual tablets
Buprenorphine 0.4 mg sublingual tablets are white to off-white, oval tablets (8.0 x 4.0 mm).

PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

Sandoz Limited
Buprenorphine 0.4mg, 2mg, 8mg Sublingual
Tablets

PL 04416/0948-0950

Buprenorphine, 2 mg, sublingual tablets
Buprenorphine 2 mg sublingual tablets are white to off-white, oval tablets with a breaking notch on
both sides (9.4 x 4.0 mm).
Buprenorphine, 8 mg, sublingual tablets
Buprenorphine 8 mg sublingual tablets are white to off-white, oval tablets with a breaking notch on
both sides (13.5 mm x 6.6 mm).
Your medicine is available in plastic/aluminium strips containing 7, 10, 20, 24, 28, 30, 48, 49, 50 or
70 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany

This leaflet was last revised in 12/2012

PIL.0951-0953.003d

07/12/12

V003: Update SPC & PIL to brand leader

PR

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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