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BUPRENORPHINE 2MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE / BUPRENORPHINE HYDROCHLORIDE / BUPRENORPHINE / BUPRENORPHINE HYDROCHLORIDE / BUPRENORPHINE / BUPRENORPHINE HYDROCHLORIDE

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Artwork No.

171216/1

Colours Used

Customer

Morningside

Black

Description

Natzon 2/8mg Leaflet

Keyline

Market

UK

Language

English

Size

148 x 380 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

3

Date

27-02-17

Software

Illustrator 11

Packaging Development

PACKAGE LEAFLET: INFORMATION FOR THE USER

Natzon 2 mg and 8 mg Sublingual Tablets
(Buprenorphine)

Quality Assurance (QA)

Quality Control (QC)

Production

Driving and using machines
If you feel drowsy while being treated with this medicine,
you should not drive or operate machinery.

Also tell your doctor immediately if you experience side
effects such as:
!
severe fatigue (tiredness), have no appetite or if
your skin or eyes look yellow. These may be
symptoms of liver damage.

The medicine can affect your ability to drive as it may
Read all of this leaflet carefully before you start
make you sleepy or dizzy.
Natzon can also cause withdrawal symptoms if you stop
taking this medicine because it contains important
!
Do not drive while taking this medicine until you know Other side effects
taking it abruptly.
information for you.
how it affects you.
Side-effects reported with Natzon
!
Keep this leaflet. You may need to read it again.
!
It is an offence to drive if this medicine affects your Very common side effects: : May affect more than 1 in 10
!
If you have any further questions, ask your doctor or
!
Liver damage
people
ability to drive.
pharmacist.
Liver damage has been reported after taking Natzon,
Drug withdrawal syndrome, headache, hyperhidrosis
!
However, you would not be committing an offence if:
!
This medicine has been prescribed for you only. Do
especially when the medicine is misused. This could also
 The medicine has been prescribed to treat a (sweating), insomnia (inability to sleep), nausea (feeling
not pass it on to others. It may harm them, even if
be due to viral infections (chronic hepatitis C), alcohol
sick), pain
medical or dental problem and
their signs of illness are the same as yours.
abuse, anorexia or use of other medicines with the ability
 You have taken it according to the instructions
!
If you get any side effects, talk to your doctor or
to harm your liver (see section 4). Regular blood tests
given by the prescriber or in the information Common side effects: May affect up to 1 in 10 people
pharmacist. This includes any possible side effects
may be conducted by your doctor to monitor the
Abdominal pain, agitation, anxiety, joint pain, weakness,
provided with the medicine and
not listed in this leaflet. See section 4.
condition of your liver. Tell your doctor if you have any
back pain, bone pain, bronchitis, chest pain, chills,
 It was not affecting your ability to drive safely
liver problems before you start treatment with Natzon.
constipation, cough, decreased appetite, depression,
What is in this leaflet:
Talk to your doctor or pharmacist if you are not sure diarrhoea, dizziness, dry mouth, painful period,
1. What Natzon Sublingual Tablets are and what they
!
Blood pressure
whether it is safe for you to drive while taking this indigestion, shortness of breath, flatulence,
are used for
This product may cause your blood pressure to drop
gastrointestinal disorder, hostility, increase in muscle
medicine.
2. What you need to know before you take Natzon
suddenly, causing you to feel dizzy if you get up too quickly
tension, infection, influenza, nervousness, tearing
Sublingual Tablets
from sitting or lying down.
(watery eyes) disorder, swollen glands (lymph nodes),
Natzon Sublingual Tablets contain lactose
3. How to take Natzon Sublingual Tablets
If you have been told by your doctor that you have malaise, migraine, muscle spasms, muscle pain, dilation
4. Possible side effects
!
Diagnosis of unrelated medical conditions
intolerance to some sugars, contact your doctor before of the pupil, neck pain, palpitations, paranoia, burning or
5. How to store Natzon Sublingual Tablets
This medicine may mask pain symptoms that could assist
tingling in hands and feet, swelling (hands and feet), sore
taking this medicine.
6. Contents of the pack and other information
in the diagnosis of some diseases. Do not forget to advise
throat and painful swallowing, fever, rash, somnolence,
your doctor if you take this medicine.
syncope (fainting), thinking abnormal, tooth disorder,
3. How to take Natzon Sublingual Tablets
1. What Natzon Sublingual Tablets are and what
tremor; flushing, vomiting (being sick), yawning
they are used for
Other medicines and Natzon Sublingual Tablets
Always take this medicine exactly as your doctor or
Tell your doctor or pharmacist if you are taking, have
pharmacist has told you. Check with your doctor or Frequency not known: Frequency cannot be estimated
Natzon belongs to a group of medicines called an opioid
recently taken or might take any other medicine.
from the available data
pharmacist if you are not sure.
(also known as "opiates" or "narcotics"). Opioids, such
Drug dependence, drug withdrawal syndrome in
as morphine or diamorphine (heroin), are often subject
The following medicines have sedative effects (make you
The tablets are described as 'sublingual'. This means that newborn, hallucinations (sensing things that are not
to abuse, which can lead to dependence (addiction). If
feel sleepy/drowsy). These effects are increased if these
the tablet should be placed under the tongue and kept real), drop in blood pressure on changing position from
you are addicted to these drugs, you need a regular dose
medicines are taken while you are being treated with
there until fully dissolved. This will take about 5-10 sitting or lying down to standing, difficulty in urinating
to feel "normal". Otherwise you will develop withdrawal
buprenorphine:
minutes. Do not chew or swallow the tablets whole - the Misusing this medicine by injecting it can cause
symptoms within a day or so of the last dose. Withdrawal
!
Benzodiazepines (used to treat anxiety or sleep
medicine will not work this way and you may get withdrawal symptoms, infections, other skin reactions
symptoms include sweating, feeling hot and cold, runny
disorders) such as diazepam, temazepam,
withdrawal symptoms. Do not take the tablets at the same and potentially serious liver problems.
eyes and nose, feeling or being sick, diarrhoea, stomach
alprazolam. Your doctor will prescribe the correct
time as food or drink.
cramps, poor sleep and just feeling awful.
dose for you. Taking the wrong dose of
If any of the side effects gets serious, or if you notice any
benzodiazepines may cause death due to
Your doctor will tell you how many tablets to take and you side effects not listed in this leaflet, please tell your
Natzon Sublingual Tablets are used as a substitution
doctor or pharmacist.
respiratory failure (inability to breathe).
should always follow this advice.
(replacement) treatment in patients who are addicted to
!
Other medicines that may make you feel sleepy
opioid drugs such as heroin and morphine. The tablets
which are used to treat illnesses such as anxiety,
To avoid sudden withdrawal symptoms, treatment with Reporting of side effects
prevent or reduce the unpleasant withdrawal symptoms
sleeplessness, convulsions / seizures, pain. These
Natzon should be given when there are already clear If you get any side effects, talk to your doctor, pharmacist
experienced when addicts stop using opioid drugs.
or nurse. This includes any possible side effects not
types of medicines will reduce your alertness levels
signs of withdrawal symptoms.
listed in this leaflet. You can also report side effects
making it difficult for you to drive and use machines.
Treatment with Natzon Sublingual Tablets may form one
They may also cause central nervous system
Adults and adolescents aged 16 years and over: The directly via the Yellow Card Scheme at:
aspect of a specialist support programme aimed at
www.mhra.gov.uk/yellowcard. By reporting side effects
depression, which is very serious. Below is a list of
usual starting dose is 0.8 mg to 4 mg daily.
resolving opioid addiction.
you can help provide more information on the safety of
examples of these types of medicines:
 other opioid containing medicines such as
If you are still taking opioids, the dose of buprenorphine this medicine.
This should be used in adults and adolescents over 16
methadone, certain pain killers and cough
must be taken at least 6 hours after the last use of the
years of age who are also receiving medical, social and
5. How to store Natzon Sublingual Tablets
suppressants
opioid or when the first signs of craving appear.
psychological support.
 antidepressants (used to treat depression) such
as isocarboxazide, phenelzine, selegeline,
If you have been receiving methadone, your doctor Keep this medicine out of the sight and reach of children.
The tablets are not to be used for pain relief purposes.
tranylcypromine, and valproate may increase the
should reduce the dose to no more than 30 mg per day Store your medicine in the original packaging to protect
effects of this medicine
before starting treatment with buprenorphine. This is from moisture.
2. What you need to know before you take Natzon
 sedative H1 receptor antagonists (used to treat
because buprenorphine can cause withdrawal symptoms Do not store above 30°C.
Sublingual Tablets
allergic reactions) such as diphenhydramine and
in patients who are dependent on methadone, if taken less Do not use this medicine after the expiry date, which is
stated on the blister and carton after EXP. The expiry
chlorphenamine
than 24 hours after using methadone.
Do not take Natzon Sublingual Tablets:
date refers to the last day of that month.
 barbiturates (used to cause sleep or sedation)
!
if you are allergic to buprenorphine or any of the
such as phenobarbital, secobarbital
During your treatment, your doctor may increase your Do not throw away any medicines via wastewater or
other ingredients of this medicine (listed in section
 tranquilisers (used to cause sleep or sedation)
dose of buprenorphine to a maximum single daily dose of household waste. Ask your pharmacist how to throw
6).
such as chloral hydrate.
32 mg, depending upon how you get on. After a period of away medicines you no longer use. These measures will
!
if you have severe breathing problems.
!
Naltrexone may prevent Natzon from working. If you
successful treatment, your doctor may gradually reduce help to protect the environment.
!
if you have severe liver disease.
take naltrexone whilst you are taking Natzon you may
your dose. With careful medical supervision, your dose
!
if you are an alcoholic or regularly drink large
experience a sudden onset of prolonged and intense
6. Contents of the pack and other information
may continue to be reduced until it is stopped altogether.
amounts of alcohol.
withdrawal symptoms.
!
if you have delirium tremens ('DTs', 'the shakes' and
!
Clonidine (used to treat high blood pressure) may
Your doctor may wish to perform some tests to assess What Natzon Tablets contain
hallucinations).
extend the effects of this medicine.
The active substance is buprenorphine (as
how well your liver is working before starting treatment !
!
if you are breast-feeding (see the section
!
Anti-retrovirals (used to treat AIDS) such as ritonavir,
buprenorphine hydrochloride). Each tablet contains
with Natzon Sublingual Tablets, and at regular intervals
'Pregnancy and breast-feeding' below for more
nelfinavir, indinavir may increase the effects of this
2 mg or 8 mg of buprenorphine.
during treatment.
information).
medicine.
!
The other ingredients are lactose monohydrate,
!
Some antifungal agents (used to treat fungal
mannitol (E421), maize starch, citric acid
Natzon Sublingual Tablets must not be used by children or
infections) such as ketoconazole and itraconazole
Natzon Sublingual Tablets must not be used by children
(anhydrous), sodium citrate, povidone (plasdone
adolescents under 16 years old.
and certain antibiotics (macrolide) may extend the
or adolescents under 16 years old.
K29/32), magnesium stearate, ascorbic acid and
effects of this medicine.
edetic acid (EDTA).
If you take more Natzon Sublingual Tablets than you
!
Some medicines may decrease the effect of Natzon.
Warnings and precautions
should
These include medicines used to treat epilepsy (such
Talk to your doctor or pharmacist before taking Natzon
Tell your doctor immediately or contact your nearest What Natzon Tablets look like and the contents of the
as carbamazepine and phenytoin) and medicines
Sublingual Tablets:
hospital casualty department. Remember to take the pack pack
used to treat tuberculosis (rifampicin).
!
if you have asthma or any other breathing problems.
and any remaining tablets with you. Overdose may cause Natzon 2 mg Sublingual Tablets are off-white to
!
if you have any kidney problems.
brownish, oval, biplane tablets marked with “B2” on one
serious and life threatening breathing problems.
To get the greatest benefit from taking Natzon, you must
!
if you have any liver problems.
side.
tell your doctor about all the medicines you are taking,
!
low blood pressure
Natzon 8 mg Sublingual Tablets are off-white to
If you forget to take Natzon Sublingual Tablets
including alcohol, medicines containing alcohol, street
!
recently suffered head injury or brain disease
You should tell your doctor and follow their instructions. Do brownish, oval, biplane tablets marked with “B8” on one
drugs, and any prescription medicine you are taking that
!
a urinary disorder (especially linked to enlarged
not take a double dose to make up for the missed dose, side.
has not been prescribed for you by your doctor.
prostate in men)
unless your doctor tells you to.
!
thyroid problems
Your medicine is available in blisters containing 7, 14, or
!
adrenocortical disorder (e.g. Addison's disease)
Natzon Sublingual Tablets with food and drink
If you have any further questions on the use of this 28 tablets.
Alcohol may increase drowsiness and may increase the
medicine, ask your doctor or pharmacist.
risk of respiratory failure (inability to breathe) if taken with
Important Things to be Aware of:
Not all pack sizes may be marketed.
Natzon sublingual tablets. Do not take Natzon together
!
Misuse, abuse and diversion
If you stop taking Natzon Sublingual Tablets
with alcohol. Do not swallow or consume food or drink
This medicine can be a target for people who abuse
Do not suddenly stop taking the tablets unless told to do so Marketing Authorisation Holder
until the tablet is completely dissolved.
prescription medicines, and should be kept in a safe
Morningside Healthcare Limited
by your doctor, as this may cause withdrawal symptoms.
115 Narborough Road
place to protect it from theft. Do not give this medicine
Leicester
Pregnancy and breast-feeding
to anyone else. It can cause death or otherwise harm
4. Possible side effects
LE3 0PA
Before taking these tablets, tell your doctor if you are
them.
pregnant or trying to become pregnant. If you become
Like all medicines, this medicine can cause side effects, United Kingdom.
pregnant during treatment with buprenorphine, tell your
!
Breathing problems
although not everyone gets them.
Manufacturer
doctor straight away.
Some people have died from respiratory failure (inability
SMB TECHNOLOGY S.A.
to breathe) because they misused this medicine or took
Serious side effects
When taken during pregnancy, particularly late
it in combination with other central nervous system
Tell your doctor immediately or seek urgent medical 39 rue du Parc Industriel
6900 Marche en Famenne
pregnancy, medicines like Natzon may cause drug
depressants, such as alcohol, benzodiazepines
attention
Belgium
withdrawal symptoms including problems with breathing
(tranquilisers), or other opioids.
If you experience side effects such as:
in your new born baby. These symptoms may occur
!
Any sudden wheeziness, difficulty in breathing or
several days after birth.
!
Dependence
dizziness, swelling of the eyelids, face, tongue, lips, This leaflet was last revised in March 2017.
This product can cause dependence.
throat or hands. rash or itching especially those
Since buprenorphine is passed into breast milk, you must
covering your whole body. These may be signs of a
not breast feed while taking this medicine.
!
Withdrawal symptoms
life-threatening allergic reaction.
This product can cause withdrawal symptoms if you take
!
if you start to breathe more slowly or weakly than
Ask your doctor or pharmacist for advice before taking any
it less than 6 hours after you use a short-acting opioid
expected (respiratory depression).
medicine.
(e.g. morphine, heroin) or less than 24 hours after you
!
if you start to feel faint, as this may be a sign of low
use a long-acting opioid such as methadone.
blood pressure.

Expand Transcript

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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