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NATZON 0.4MG SUBLINGUAL TABLET

Active substance(s): BUPRENORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Natzon 0.4mg Sublingual Tablets
(Buprenorphine)
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.
What is in this leaflet:
1. What Natzon Sublingual Tablets are and
what they are used for
2. What you need to know before you take
Natzon Sublingual Tablets
3. How to take Natzon Sublingual Tablets
4. Possible side effects
5. How to store Natzon Sublingual Tablets
6. Contents of the pack and other information
1. What Natzon Sublingual Tablets are and
what they are used for
Natzon belongs to a group of medicines called
an opioid (also known as "opiates" or
"narcotics"). Opioids, such as morphine or
diamorphine (heroin), are often subject to
abuse, which can lead to dependence
(addiction). If you are addicted to these drugs,
you need a regular dose to feel "normal".
Otherwise you will develop withdrawal
symptoms within a day or so of the last dose.
Withdrawal symptoms include sweating,
feeling hot and cold, runny eyes and nose,
feeling or being sick, diarrhoea, stomach
cramps, poor sleep and just feeling awful.
Natzon Sublingual Tablets are used as a
substitution (replacement) treatment in patients
who are addicted to opioid drugs such as heroin
and morphine. The tablets prevent or reduce
the unpleasant withdrawal symptoms
experienced when addicts stop using opioid
drugs.
Treatment with Natzon Sublingual Tablets may
form one aspect of a specialist support
programme aimed at resolving opioid addiction.
The tablets are not to be used for pain relief
purposes.
2. What you need to know before you take
Natzon Sublingual Tablets
Do not take Natzon Sublingual Tablets:
! if you are allergic to buprenorphine or any of
the other ingredients of this medicine (listed
in section 6).
! if you have severe breathing problems.
! if you have severe liver disease.
! if you are an alcoholic or regularly drink
large amounts of alcohol.
! if you have delirium tremens ('DTs', 'the
shakes' and hallucinations).
! if you are breast-feeding (see the section
'Pregnancy and breast-feeding' below for
more information).
Natzon Sublingual Tablets must not be used by
children or adolescents under 16 years old.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Natzon Sublingual Tablets:
! if you have asthma or any other breathing
problems.
! if you have any kidney problems.
! if you have any liver problems.
Other medicines and Natzon Sublingual
Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicine.
The following medicines have sedative effects
(make you feel sleepy/drowsy). These effects
are increased if these medicines are taken
while you are being treated with buprenorphine:
! benzodiazepines (used for treatment of

!
!

!

!
!
!

anxiety or sleep disorders) e.g. diazepam
and temazepam: you should not take these
medicines while you are taking
buprenorphine, unless prescribed by your
doctor because this combination can be
fatal if the correct dose is not carefully
determined.
barbiturates and other medicines used for
the treatment of anxiety or sleep disorders.
other medicines containing opioid-related
medicines e.g. codeine, dihydrocodeine
and morphine (used as strong painkillers
and in some cough medicines).
medicines used for the treatment of
depression, including medicines known as
monoamine oxidase inhibitors (MAOIs) e.g.
phenelzine.
antihistamine medicines (used for
treatment of allergy and/or hay fever) e.g.
promethazine and chlorphenamine.
medicines known as antipsychotics (used
for the treatment of schizophrenia) e.g.
chlorpromazine and haloperidol.
certain medicines for the treatment of high
blood pressure (antihypertensives) e.g.
clonidine.

If you are taking any of the following medicines,
your doctor may need to prescribe a lower dose
of buprenorphine:
! the antifungal medicine, ketoconazole.
! medicines used to treat infections caused
by viruses (antiviral agents) e.g. ritonavir,
saquinavir and indinavir, which are used in
the treatment of HIV infections.
! oral contraceptive medicines containing
gestodene.
! certain medicines called 'macrolide
antibiotics'(used for the treatment of
infections).
If you are taking any of the following medicines,
your doctor may need to prescribe a higher
dose of buprenorphine:
! medicines used for the treatment of
epilepsy e.g. phenobarbital,
carbamazepine and phenytoin.
! the antibiotic medicine, rifampicin (used for
the treatment of tuberculosis).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Natzon Sublingual Tablets with food and
drink
These tablets should not be taken at the same
time as food or drink. You should not drink
alcohol or take any medicines that contain
alcohol while taking Natzon sublingual tablets.
Pregnancy and breast-feeding
Before taking these tablets, tell your doctor if
you are pregnant or trying to become pregnant.
If you become pregnant during treatment with
buprenorphine, tell your doctor straight away.
Since buprenorphine is passed into breast milk,
you must not breast feed while taking this
medicine.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
If you feel drowsy while being treated with this
medicine, you should 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.
Natzon Sublingual Tablets contain lactose
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicine.
3. How to take Natzon Sublingual Tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The tablets are described as 'sublingual'. This
means that the tablet should be placed under
the tongue and kept there until fully dissolved.
Do not chew or swallow the tablets whole - the
medicine will not work this way and you may get
withdrawal symptoms. Do not take the tablets at
the same time as food or drink.

The following side effects have also been
reported:
The most common side effects are:
constipation, headache, difficulty in sleeping,
weakness or lack of energy, drowsiness,
nausea and vomiting (feeling and being sick),
fainting and dizziness (especially when
changing position from sitting or lying down to
standing) and sweating.
After your first dose, you may suffer from opioid
withdrawal symptoms. This is more likely if
buprenorphine is taken less than six hours after
using an opioid (e.g. heroin).
Rare side effects: severe difficulty in breathing,
hallucinations.
! Athletes should be aware that this medicine
may cause a positive reaction to 'antidoping
tests'.
! Drug dependence can occur as a result of
taking this medicine.
Other side effects: difficulty in urinating.

Adults and adolescents aged 16 years and
over:
The usual starting dose is 0.8 mg to 4 mg daily.
! If you are still taking opioids, the dose of
buprenorphine must be taken at least 6
hours after the last use of the opioid or when
the first signs of craving appear.
! If you have been receiving methadone, your
doctor should reduce the dose to no more
than 30 mg per day before starting
treatment with buprenorphine. This is
because buprenorphine can cause
withdrawal symptoms in patients who are
dependent on methadone, if taken less than
24 hours after using methadone.
During your treatment, your doctor may
increase your dose of buprenorphine to a
maximum single daily dose of 32 mg,
depending upon how you get on. After a period
of successful treatment, your doctor may
gradually reduce your dose. With careful
medical supervision, your dose may continue to
be reduced until it is stopped altogether.
Your doctor may wish to perform some tests to
assess how well your liver is working before
starting treatment with Natzon Sublingual
Tablets, and at regular intervals during
treatment.
Natzon Sublingual Tablets must not be used by
children or adolescents under 16 years old.
If you take more Natzon Sublingual Tablets
than you should
Tell your doctor immediately or contact your
nearest hospital casualty department.
Remember to take the pack and any remaining
tablets with you.
If you forget to take Natzon Sublingual
Tablets
You should tell your doctor and follow their
instructions. Do not take a double dose to make
up for the missed dose, unless your doctor tells
you to.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
If you stop taking Natzon Sublingual Tablets
Do not suddenly stop taking the tablets unless
told to do so by your doctor, as this may cause
withdrawal symptoms.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everyone gets them.
All medicines can cause allergic reactions
although serious allergic reactions are very
rare. If you get any of the following symptoms
after taking these tablets, you should contact
your doctor immediately:
! Any sudden wheeziness, difficulty in
breathing or dizziness, swelling of the
eyelids, face, lips or throat.
! Peeling and blistering of the skin, mouth,
eyes and genitals.
! Rash affecting your whole body.
If you develop severe fatigue, loss of appetite or
if your skin or eyes look yellow, tell your doctor
immediately.

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 Natzon Sublingual Tablets
Keep this medicine out of the sight and reach of
children.
Store your medicine in the original packaging to
protect from moisture.
Do not store above 30°C.
Do not use this medicine after the expiry date,
which is stated on the blister and carton after
EXP. The expiry date refers to the last day of
that month.
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 to
protect the environment.
6. Contents of the pack and other
information
What Natzon Sublingual Tablets contain
! The active substance is buprenorphine (as
buprenorphine hydrochloride). Each tablet
contains 0.4mg of buprenorphine.
! The other ingredients are lactose
monohydrate, mannitol (E421), maize
starch, citric acid (anhydrous), sodium
citrate, povidone (plasdone K29/32),
magnesium stearate, ascorbic acid and
edetic acid (EDTA).
What Natzon Sublingual Tablets look like
and the contents of the pack
Natzon 0.4mg Sublingual Tablets are off-white
to brownish, round, biplane tablets.
Your medicine is available in blisters containing
7, 14, or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Limited
115 Narborough Road
Leicester
LE3 0PA
United Kingdom.
Manufacturer
SMB TECHNOLOGY S.A.
39 rue du Parc Industriel
6900 Marche en Famenne
Belgium
This leaflet was last revised in December
2014.

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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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