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BUPRENORPHINE 200 MICROGRAM SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE HYDROCHLORIDE

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Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets

PL 04416/0958-9

PACKAGE LEAFLET: INFORMATION FOR THE USER
Buprenorphine 200 microgram Sublingual Tablets
Buprenorphine 400 microgram 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 a strong painkiller that belongs to a group of medicines called opioids.
It is used to treat:
• severe pain, such as pain following surgery or injury, in heart attacks and in cancer
Buprenorphine is not used to treat headache, toothache, migraine or other pains treatable with weaker
painkillers and/or medicines that relieve spasms.

2.

BEFORE YOU TAKE BUPRENORPHINE

Do not take Buprenorphine
if you are/have
• allergic (hypersensitive) to:
- buprenorphine or other painkillers acting in the brain or spinal cord
- any of the other ingredients of this medicine
• dependent on opioids or for withdrawal treatment from opioids
• serious breathing problems
• a serious liver disease
• treated or have been treated in the previous 2 weeks with medicines known as monoamine oxidase
inhibitors, such as moclobemide
These types of medicines are used to treat depression or Parkinson’s disease.
Take special care with Buprenorphine
Inform your doctor if any of the following apply to you:
- reduced breathing function such as:
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Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets

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- acute asthma
- disorders with narrowed lung airways
- enlarged right heart chamber due to continuing overload of the blood circulation through the
lung
- reduced oxygen supply
- increased levels of carbon dioxide in the blood
- shallow breathing
Your doctor will only prescribe you Buprenorphine under his/her close supervision if any of these
breathing difficulties apply to you. You must not use Buprenorphine if you have serious breathing
problems.
in the case of head or brain injuries or increased pressure inside the skull
Your doctor will only prescribe you Buprenorphine under his/her close supervision if any of these
cases apply to you.
a history of medicine abuse or emotional instability
disorder of the tube-like structures that carry bile
reduced kidney function
reduced function of the cortex of the two glands situated above the kidneys
underactive thyroid or accumulation of mucus and fluid in the fat tissues with swelling known as
myxoedema
psychosis due to medicines
central nervous depression or coma
enlarged prostate or narrowing of the urethra
acute alcoholism or alcohol delirium
deformity of the spinal column
have been treated recently with narcotic pain killers

Patients weighing less than 35 kg
Buprenorphine 200 microgram and 400 microgram are not recommended for these patients.
Patients weighing less than 45 kg
Buprenorphine 400 microgram is not is not recommended for these patients.
Elderly and weak patients
Buprenorphine should only be used in these patients with particular caution.
Effects of misuse for doping
Using of Buprenorphine can lead to positive results in doping tests. Abusing Buprenorphine for
doping purposes can endanger your health.
Using 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 that reduce the blood flow through the liver, such as halothane
• medicines which calm, induce sleep or relax muscles with active substance names ending with
“azepam”, such as diazepam, temazepam
Do not take these medicines while taking Buprenorphine, unless your doctor says it is absolutely
necessary. This combination can be fatal if the correct dose is not carefully determined.
• 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
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P001: Modification of deblister advice

MS

Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets










PL 04416/0958-9

certain medicines to treat depression or Parkinson’s disease known as monoamine oxidase
inhibitors, such as moclobemide
Do not take Buprenorphine while taking these medicines.
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: a medicine to treat fungal infections
- medicines to treat HIV infections, such as ritonavir, saquinavir, indinavir, atazanavir
- oral contraceptive medicines containing gestodene
- medicines to treat infections with active substance names ending in “mycin”, such as
erythromycin
Your doctor may prescribe you a higher Buprenorphine dose if you take any of the following
medicines:
- medicines to treat epilepsy, such as phenobarbital, carbamazepine, phenytoin
- rifampicin: a medicine to treat bacterial infections
phenprocoumon: a medicine to prevent normal blood coagulation
It is essential that you inform your doctor if you take this medicine. Your doctor will monitor you
very closely during Buprenorphine use and may need to adjust the Buprenorphine dose.

Taking Buprenorphine with food and drink
Avoid drinking alcohol or taking any medicines that contain alcohol while taking Buprenorphine.
Pregnany 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
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.

3.
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:
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P001: Modification of deblister advice

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Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets


PL 04416/0958-9

Patients weighing more than 45 kg
Buprenorphine 200 microgram
- 1 – 2 tablets as single dose
- If necessary, 1 – 2 further tablets can be taken every 6 – 8 hours.
Buprenorphine 400 microgram
- 1 tablet as single dose
- If necessary, 1 further tablets can be taken every 6 – 8 hours.



Patients weighing between 35 and 45 kg
Buprenorphine 200 microgram
- 1 tablet as single dose
- If necessary, 1 further tablet can be taken every 6 – 8 hours.
The dosage interval must be determined by the doctor, based upon observation of the individual
patient.



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.

The Buprenorphine effects onset within 30 minutes following administration and usually last for 6 – 8
hours. Please talk to your doctor or pharmacist if you feel that the effects are too strong or too weak.
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.
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.
In the presence of very dry oral mucosa, a few drops of liquid will accelerate the dissolution process.
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.
Patients who are not confined to bed should rest for 1 to 2 hours after taking Buprenorphine.
Duration of use
This depends on the nature and the severity of the pain and will be decided by the doctor.
Buprenorphine should only be used for as long as absolutely necessary. Where long-term pain
treatment is necessitated, reassessments at frequent, regular intervals, with administration pauses
where applicable, are required. These help in deciding if and with which dose Buprenorphine should
continue to be administered.
There is currently insufficient experience of long-term Buprenorphine use in children.
If you take more Buprenorphine than you should
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P001: Modification of deblister advice

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Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets

PL 04416/0958-9

Tell your doctor immediately or contact your nearest hospital casualty department. Bring the pack and
any remaining tablets with you.
Under all circumstances, you must avoid situations that require increased alertness, such as driving.
Somebody must keep the patient awake, give instructions to breathe and provide respiratory
assistance until a doctor arrives.
If you forget to take Buprenorphine
Continue with the treatment as recommended. Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Buprenorphine
Discuss it with your doctor before interrupting or stopping treatment.
Prolonged Buprenorphine use can result in development of physical dependence. Abrupt
discontinuation of the treatment will therefore be associated with withdrawal symptoms. These may
include headache, muscle pain, anxiety, states of tension, restlessness, confusion, irritability, recurrent
sleeplessness, mood swings, hallucinations and seizures.
The risk of withdrawal symptoms occurring is greater if the treatment is stopped abruptly. Your
doctor will gradually reduce the dosage when the treatment is discontinued.
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
• drowsiness
• tiredness
• sleep disturbances
Common, affects 1 to 10 per 100 users
• flushes
• dizziness
• headache
• narrowing of the pupils
• low blood pressure
• reduced breathing function
• nausea and vomiting
• sweating
Uncommon, affects 1 to 10 per 1,000 users
• generalized allergic reactions
• confusion, disorientation, nervousness, depression, psychosis, hallucinations, a feeling of loss of
personality, euphoria, depression, restlessness, exhaustion
• dry mouth, slurred speech
• coma
• shaking
• seizures
• lack of muscle coordination
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P001: Modification of deblister advice

MS

Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets













PL 04416/0958-9

seeing double, visual disturbances
inflammation causing red, watery and itchy eyes
ringing in the ears
high blood pressure
accelerated or slowed heart rhythm
bluish discoloration of the skin and particularly of the lips and fingernails as a result of oxygen
deficiency in the blood
disturbed heart conduction
breathing distress or arrest
constipation, indigestion, loss of appetite, diarrhoea
sensory disturbances of the skin
itching, skin rash, pale skin, hives
discomfort when emptying the bladder, inability to empty the bladder completely

Very rare, affects fewer than 1 per 10,000 users
• muscle seizures in the lung airways
• swelling of the skin and mucous membranes
• life-threatening allergic shock reaction
Frequency not known, according to the available data
• local irritation of the oral mucosa - in some cases with development of mouth ulcers and a
tendency to bleed
• disturbances in the regulation of circulation can occur immediately after use
• in opioid-dependent patients the first administration of Buprenorphine may induce withdrawal
symptoms
Other side effects observed in substitution therapy
• sleeplessness
• sleepiness
• fainting
• fall in blood pressure
• liver cell destruction
• liver inflammation
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

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:

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MS

Sandoz Limited
Buprenorphine 200 & 400 microgram Sublingual Tablets


PL 04416/0958-9

The active substance is buprenorphine as buprenorphine hydrochloride.

Buprenorphine 200 microgram Sublingual Tablets
Each tablet contains 200 microgram buprenorphine.
Buprenorphine 400 microgram Sublingual Tablets
Each tablet contains 400 microgram 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 200 microgram Sublingual Tablets
Buprenorphine 200 microgram Sublingual Tablets are white to off-white, round tablets.
Buprenorphine 400 microgram Sublingual Tablets
Buprenorphine 400 microgram Sublingual Tablets are white to off-white, oval tablets.
Your medicine is available in plastic/aluminium strips containing 7, 10, 20, 24, 28, 30, 48, 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 08/2013.

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P001: Modification of deblister advice

MS

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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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