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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-    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

-    underactive thyroid or accumulation of mucus and fluid 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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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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•    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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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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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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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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