TEPHINE 200 MICROGRAM SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Tephine 200 microgram Sublingual Tablets
Tephine 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 Tephine is and what it is used for
2. Before you take Tephine
3. How to take Tephine
4. Possible side effects
5. How to store Tephine
6. Further information

1

The following medicines can affect or be affected by
Tephine:
• 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 Tephine,
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
• certain medicines to treat depression or Parkinsonʼs
disease known as monoamine oxidase inhibitors,
such as moclobemide
Do not take Tephine 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 Tephine 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 Tephine 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 Tephine use and may need to adjust
the Tephine dose.

What Tephine is and what it is used for

Tephine 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.

Tephine 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 Tephine

Do not take Tephine
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 Parkinsonʼs disease.

Take special care with Tephine
Inform your doctor if any of the following apply to you:
• reduced breathing function such as:
- 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 Tephine under
his/her close supervision if any of these breathing
difficulties apply to you. You must not use Tephine 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 Tephine 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.

Taking Tephine with food and drink
Avoid drinking alcohol or taking any medicines that
contain alcohol while taking Tephine.

Pregnancy and breast-feeding
• Pregnancy
Tephine is not recommended during pregnancy. Tell
your doctor before taking Tephine if you are pregnant,
trying or become pregnant during treatment.

• Breast-feeding
Discontinue breast-feeding while taking Tephine 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.

Patients weighing less than 35 kg
Tephine 200 microgram and 400 microgram are not
recommended for these patients.

Tephine can impair alertness and the ability to react.
Therefore, ask your doctor whether and under what
circumstances you can drive a vehicle, for example.

Patients weighing less than 45 kg
Tephine 400 microgram is not recommended for these
patients.

Important information about some of the ingredients
of Tephine
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.

Elderly and weak patients
Tephine should only be used in these patients with
particular caution.

3

Effects of misuse for doping
Using of Tephine can lead to positive results in doping
tests. Abusing Tephine 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.

How to take Tephine

Always take Tephine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.

Continued on the next page >>

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The usual dose is:
• Patients weighing more than 45 kg
Tephine 200 microgram
- 1-2 tablets as single dose
- If necessary, 1-2 further tablets can be taken every
6-8 hours.






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
• seeing double, visual disturbances
• inflammation causing red, watery and itchy eyes
• ringing in the ears
• high blood pressure
• accelerated or slowed heart rhythm
• bluish discolouration 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.

Tephine 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
Tephine 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
Tephine if you have serious liver disease.

The Tephine 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.

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
Tephine may induce withdrawal symptoms.

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.

Other side effects observed in substitution therapy
• sleeplessness
• sleepiness
• fainting
• fall in blood pressure
• liver cell destruction
• liver inflammation.

Patients who are not confined to bed should rest for 1 to
2 hours after taking Tephine.
Duration of use
This depends on the nature and the severity of the pain
and will be decided by the doctor.

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

Tephine 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 Tephine should continue to be administered.

How to store Tephine

Keep out of the reach and sight of children.

There is currently insufficient experience of long-term
Tephine use in children.

This medicinal product does not require any special
storage conditions.

If you take more Tephine than you should
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.

Do not use Tephine 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

If you forget to take Tephine
Continue with the treatment as recommended. Do not
take a double dose to make up for a forgotten tablet.

If you stop taking Tephine
Discuss it with your doctor before interrupting or
stopping treatment.

Further information

What Tephine contains:
• The active substance is buprenorphine as
buprenorphine hydrochloride.

Tephine 200 microgram Sublingual Tablets
Each tablet contains 200 microgram buprenorphine.

Prolonged Tephine 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.

Tephine 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).

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.

What Tephine looks like and contents of the pack
Tephine 200 microgram Sublingual Tablets
Tephine 200 microgram Sublingual Tablets are white to
off-white, round tablets.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

low blood pressure
reduced breathing function
nausea and vomiting
sweating.

Tephine 400 microgram Sublingual Tablets
Tephine 400 microgram Sublingual Tablets are white to
off-white, oval tablets.

Possible side effects

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.

Like all medicines, Tephine can cause side effects,
although not everyone gets them.

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Side effects can occur with the following frequencies:
Very common, affects more than 1 per 10 users
• drowsiness
• tiredness
• sleep disturbances.

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany.

Common, affects 1 to 10 per 100 users
• flushes
• dizziness
• headache
• narrowing of the pupils

This leaflet was last revised in 08/2013.

Artwork Proof Box
Ref: P001 - Modification of deblister advice
Proof no.
002.0

Date prepared:
14/08/2013

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
8pt
Fonts:
Helvetica

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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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