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NATZON 2 MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

!

Natzon 2 mg and 8 mg 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 Tablets are and what they are used for
2. What you need to know before you take Natzon
Tablets
3. How to take Natzon Tablets
4. Possible side effects
5. How to store Natzon Tablets
6. Contents of the pack and other information
1. What Natzon Tablets are and what they are used
for
Natzon Tablets contain the active ingredient
buprenorphine. Buprenorphine belongs to a group of
medicines called opioid analgesics (also known as
"opiates" or "narcotics"). Opioid analgesics, 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 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 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
Tablets
Do not take Natzon 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 Tablets must not be used by children or
adolescents under 16 years old.

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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 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
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.

!

Warnings and precautions
Talk to your doctor or pharmacist before taking Natzon
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 Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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 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 Tablets

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

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.
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 Tablets, and at regular intervals during
treatment.
Natzon Tablets must not be used by children or
adolescents under 16 years old.
If you take more Natzon 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 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 stop taking Natzon Tablets
Do not suddenly stop taking the tablets unless told to do so
by your doctor, as this may cause withdrawal symptoms.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everyone gets them.
Tell your doctor immediately or seek urgent medical
attention
If you experience side effects such as:
! sudden wheeziness, difficulty in breathing, swelling of
the eyelids, face, lips, throat or hands; rash or itching
especially those covering your whole body. These
may be signs of life threatening allergic reaction.
! if you start to breath more slowly or weakly than
expected (respiratory depression).
! if you start to feel faint, as this may be a sign of low
blood pressure.
Also tell your doctor immediately if you experience side
effects such as:
! severe fatigue (tiredness), loss of appetite or if your
skin or eyes look yellow. These may be symptoms of
liver damage.
The following side effects have also been reported:
Very common, affects more than 1 per 10 users:
drug withdrawal symptoms
headache
hyperhidrosis (sweating)
insomnia (inability to sleep)
nausea (feeling sick)
pain

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Common, affects 1 to 10 per 100 users:
abdominal pain
anxiety
agitation
joint pain
weakness
back pain
bone pain
bronchitis
chest pain
chills
cough
decreased appetite
depression
diarrhoea
dry mouth
painful period
indigestion
shortness of breath
flatulence
gastrointestinal disorder
hostility
increase in muscle tension
infection
influenza
nervousness
tearing (watery eyes) disorder
swollen glands (lymph nodes)

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malaise
migraine
muscle spasms
muscle pain
dilation of pupil
neck pain
palpitations
paranoia
burning or tingling in hands and feet
swelling (hands and feet)
sore throat and painful swallowing
fever
rash
somnolence
syncope (fainting)
thinking abnormal
tooth disorder
tremor
flushing
yawning
dizziness
constipation
vomiting

Frequency not known:
! drug dependence
! drug withdrawal syndrome in new born
! hallucinations (sensing things that are not real)
! drop in blood pressure on changing position from
sitting or lying down to standing
! difficulty in urinating
Misusing this medicine by injecting it can cause
withdrawal symptoms, infections, other skin reactions and
potentially serious liver problems.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 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 Tablets contain
! The active substance is buprenorphine (as
buprenorphine hydrochloride). Each tablet contains 2
mg or 8 mg 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 Tablets look like and the contents of the
pack
Natzon 2 mg Sublingual Tablets are off-white to brownish,
oval, biplane tablets marked with “B2” on one side.
Natzon 8 mg Sublingual Tablets are off-white to brownish,
oval, biplane tablets marked with “B8” on one side.
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 2015.

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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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