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NATZON 0.4MG SUBLINGUAL TABLET

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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:
(Buprenorphine)
severe fatigue (tiredness), have no appetite or if
!
your skin or eyes look yellow. These may be
The medicine can affect your ability to drive as it may
Read all of this leaflet carefully before you start
symptoms of liver damage.
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
!
taking it abruptly.
information for you.
how it affects you.
The frequency of possible side effects listed below is
!
Keep this leaflet. You may need to read it again.
It is an offence to drive if this medicine affects your defined using the following convention:
!
!
Liver damage
!
If you have any further questions, ask your doctor or
ability to drive.
very common (affects more than 1 user in 10)
!
Liver damage has been reported after taking Natzon,
pharmacist.
However, you would not be committing an offence if:
!
common (affects 1 to 10 users in 100)
!
especially when the medicine is misused. This could also
!
This medicine has been prescribed for you only. Do
 The medicine has been prescribed to treat a !
not known (frequency cannot be estimated from the
be due to viral infections (chronic hepatitis C), alcohol
not pass it on to others. It may harm them, even if
medical or dental problem and
available data).
abuse, anorexia or use of other medicines with the ability
their signs of illness are the same as yours.
 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 Side effects reported with Natzon
pharmacist. This includes any possible side effects
may be conducted by your doctor to monitor the
provided with the medicine and
Very common side effects:
not listed in this leaflet. See section 4.
condition of your liver. Tell your doctor if you have any
 It was not affecting your ability to drive safely
Drug withdrawal syndrome, headache, hyperhidrosis
liver problems before you start treatment with Natzon.
(sweating), insomnia (inability to sleep), nausea (feeling
What is in this leaflet:
Talk to your doctor or pharmacist if you are not sure sick), pain
1. What Natzon Sublingual Tablets are and what they
!
Blood pressure
whether it is safe for you to drive while taking this Common side effects:
are used for
This product may cause your blood pressure to drop
Abdominal pain, agitation, anxiety, joint pain, weakness,
medicine.
2. What you need to know before you take Natzon
suddenly, causing you to feel dizzy if you get up too quickly
back pain, bone pain, bronchitis, chest pain, chills,
Sublingual Tablets
from sitting or lying down.
constipation, cough, decreased appetite, depression,
Natzon Sublingual Tablets contain lactose
3. How to take Natzon Sublingual Tablets
If you have been told by your doctor that you have diarrhoea, dizziness, dry mouth, painful period,
4. Possible side effects
!
Diagnosis of unrelated medical conditions
intolerance to some sugars, contact your doctor before indigestion, shortness of breath, flatulence,
5. How to store Natzon Sublingual Tablets
This medicine may mask pain symptoms that could assist
gastrointestinal disorder, hostility, increase in muscle
taking this medicine.
6. Contents of the pack and other information
in the diagnosis of some diseases. Do not forget to advise
tension, infection, influenza, nervousness, tearing
your doctor if you take this medicine.
(watery eyes) disorder, swollen glands (lymph nodes),
3. How to take Natzon Sublingual Tablets
1. What Natzon Sublingual Tablets are and what
malaise, migraine, muscle spasms, muscle pain, dilation
they are used for
Other medicines and Natzon Sublingual Tablets
Always take this medicine exactly as your doctor or of the pupil, neck pain, palpitations, paranoia, burning or
Tell your doctor or pharmacist if you are taking, have
pharmacist has told you. Check with your doctor or tingling in hands and feet, swelling (hands and feet), sore
Natzon belongs to a group of medicines called an opioid
recently taken or might take any other medicine.
throat and painful swallowing, fever, rash, somnolence,
pharmacist if you are not sure.
(also known as "opiates" or "narcotics"). Opioids, such
syncope (fainting), thinking abnormal, tooth disorder,
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 tremor; flushing, vomiting (being sick), yawning
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 Frequency not known:
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 Drug dependence, drug withdrawal syndrome in
to feel "normal". Otherwise you will develop withdrawal
buprenorphine:
minutes. Do not chew or swallow the tablets whole - the newborn, hallucinations (sensing things that are not
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 real), drop in blood pressure on changing position from
symptoms include sweating, feeling hot and cold, runny
disorders) such as diazepam, temazepam,
withdrawal symptoms. Do not take the tablets at the same sitting or lying down to standing, difficulty in urinating
eyes and nose, feeling or being sick, diarrhoea, stomach
alprazolam. Your doctor will prescribe the correct
Misusing this medicine by injecting it can cause
time as food or drink.
cramps, poor sleep and just feeling awful.
dose for you. Taking the wrong dose of
withdrawal symptoms, infections, other skin reactions
benzodiazepines may cause death due to
Your doctor will tell you how many tablets to take and you and potentially serious liver problems.
Natzon Sublingual Tablets are used as a substitution
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
If any of the side effects gets serious, or if you notice any
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 side effects not listed in this leaflet, please tell your
prevent or reduce the unpleasant withdrawal symptoms
sleeplessness, convulsions / seizures, pain. These
Natzon should be given when there are already clear doctor or pharmacist.
experienced when addicts stop using opioid drugs.
types of medicines will reduce your alertness levels
signs of withdrawal symptoms.
making it difficult for you to drive and use machines.
Reporting of side effects
Treatment with Natzon Sublingual Tablets may form one
They may also cause central nervous system
Adults and adolescents aged 16 years and over: The If you get any side effects, talk to your doctor, pharmacist
aspect of a specialist support programme aimed at
depression, which is very serious. Below is a list of
or nurse. This includes any possible side effects not
usual starting dose is 0.8 mg to 4 mg daily.
resolving opioid addiction. This should be used in adults
examples of these types of medicines:
listed in this leaflet. You can also report side effects
and adolescents over 16 years of age who are also
 other opioid containing medicines such as
If you are still taking opioids, the dose of buprenorphine directly via the Yellow Card Scheme at:
receiving medical, social and psychological support.
methadone, certain pain killers and cough
must be taken at least 6 hours after the last use of the www.mhra.gov.uk/yellowcard. By reporting side effects
suppressants
you can help provide more information on the safety of
opioid or when the first signs of craving appear.
The tablets are not to be used for pain relief purposes.
 antidepressants (used to treat depression) such
this medicine.
as isocarboxazide, phenelzine, selegeline,
If you have been receiving methadone, your doctor
2. What you need to know before you take Natzon
tranylcypromine, and valproate may increase the
5. How to store Natzon Sublingual Tablets
should reduce the dose to no more than 30 mg per day
Sublingual Tablets
effects of this medicine
before starting treatment with buprenorphine. This is
 sedative H1 receptor antagonists (used to treat
because buprenorphine can cause withdrawal symptoms Keep this medicine out of the sight and reach of children.
Do not take Natzon Sublingual Tablets:
allergic reactions) such as diphenhydramine and
in patients who are dependent on methadone, if taken less Store your medicine in the original packaging to protect
!
if you are allergic to buprenorphine or any of the
chlorphenamine
from moisture.
than 24 hours after using methadone.
other ingredients of this medicine (listed in section
 barbiturates (used to cause sleep or sedation)
Do not store above 30°C.
6).
such as phenobarbital, secobarbital
During your treatment, your doctor may increase your Do not use this medicine after the expiry date, which is
 tranquilisers (used to cause sleep or sedation)
!
if you have severe breathing problems.
dose of buprenorphine to a maximum single daily dose of stated on the blister and carton after EXP. The expiry
such as chloral hydrate.
!
if you have severe liver disease.
32 mg, depending upon how you get on. After a period of date refers to the last day of that month.
!
Naltrexone may prevent Natzon from working. If you
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if you are an alcoholic or regularly drink large
successful treatment, your doctor may gradually reduce Do not throw away any medicines via wastewater or
take naltrexone whilst you are taking Natzon you may
amounts of alcohol.
your dose. With careful medical supervision, your dose household waste. Ask your pharmacist how to throw
experience a sudden onset of prolonged and intense
!
if you have delirium tremens ('DTs', 'the shakes' and
away medicines you no longer use. These measures will
may continue to be reduced until it is stopped altogether.
withdrawal symptoms.
hallucinations).
help to protect the environment.
!
Clonidine (used to treat high blood pressure) may
!
if you are breast-feeding (see the section
Your doctor may wish to perform some tests to assess
extend the effects of this medicine.
'Pregnancy and breast-feeding' below for more
6. Contents of the pack and other information
how well your liver is working before starting treatment
!
Anti-retrovirals (used to treat AIDS) such as ritonavir,
information).
with Natzon Sublingual Tablets, and at regular intervals
nelfinavir, indinavir may increase the effects of this
What Natzon Sublingual Tablets contain
during treatment.
medicine.
Natzon Sublingual Tablets must not be used by children
!
The active substance is buprenorphine (as
!
Some antifungal agents (used to treat fungal
or adolescents under 16 years old.
buprenorphine hydrochloride). Each tablet contains
Natzon Sublingual Tablets must not be used by children or
infections) such as ketoconazole and itraconazole
0.4mg of buprenorphine.
adolescents under 16 years old.
and certain antibiotics (macrolide) may extend the
Warnings and precautions
!
The other ingredients are lactose monohydrate,
effects of this medicine.
Talk to your doctor or pharmacist before taking Natzon
mannitol (E421), maize starch, citric acid
If you take more Natzon Sublingual Tablets than you
!
Some medicines may decrease the effect of Natzon.
Sublingual Tablets:
(anhydrous), sodium citrate, povidone (plasdone
should
These include medicines used to treat epilepsy (such
!
if you have asthma or any other breathing problems
K29/32), magnesium stearate, ascorbic acid and
Tell your doctor immediately or contact your nearest
as carbamazepine and phenytoin) and medicines
!
if you have any kidney problems
edetic acid (EDTA).
hospital casualty department. Remember to take the pack
used to treat tuberculosis (rifampicin).
!
if you have any liver problems
and any remaining tablets with you. Overdose may cause
!
low blood pressure
What Natzon Sublingual Tablets look like and the
serious and life threatening breathing problems.
To get the greatest benefit from taking Natzon, you must
!
recently suffered head injury or brain disease
contents of the pack
tell your doctor about all the medicines you are taking,
!
a urinary disorder (especially linked to enlarged
Natzon 0.4mg Sublingual Tablets are off-white to
If you forget to take Natzon Sublingual Tablets
including alcohol, medicines containing alcohol, street
prostate in men)
You should tell your doctor and follow their instructions. Do brownish, round, biplane tablets.
drugs, and any prescription medicine you are taking that
!
thyroid problems
not take a double dose to make up for the missed dose,
has not been prescribed for you by your doctor.
!
adrenocortical disorder (e.g. Addison's disease).
Your medicine is available in blisters containing 7, 14, or
unless your doctor tells you to.
28 tablets.
Natzon Sublingual Tablets with food and drink
Important Things to be Aware of:
If you have any further questions on the use of this
Alcohol may increase drowsiness and may increase the
Not all pack sizes may be marketed.
!
Misuse, abuse and diversion
medicine, ask your doctor or pharmacist.
risk of respiratory failure (inability to breathe) if taken with
This medicine can be a target for people who abuse
Natzon sublingual tablets. Do not take Natzon together
prescription medicines, and should be kept in a safe
Marketing Authorisation Holder
If you stop taking Natzon Sublingual Tablets
with alcohol. Do not swallow or consume food or drink
place to protect it from theft. Do not give this medicine
Do not suddenly stop taking the tablets unless told to do so Morningside Healthcare Limited
until the tablet is completely dissolved.
115 Narborough Road
to anyone else. It can cause death or otherwise harm
by your doctor, as this may cause withdrawal symptoms.
Leicester
them.
Pregnancy and breast-feeding
LE3 0PA
4. Possible side effects
Before taking these tablets, tell your doctor if you are
United Kingdom.
!
Breathing problems
pregnant or trying to become pregnant. If you become
Some people have died from respiratory failure (inability
Like all medicines, this medicine can cause side effects,
pregnant during treatment with buprenorphine, tell your
Manufacturer
to breathe) because they misused this medicine or took
although not everyone gets them.
doctor straight away.
SMB TECHNOLOGY S.A.
it in combination with other central nervous system
depressants, such as alcohol, benzodiazepines
All medicines can cause allergic reactions although 39 rue du Parc Industriel
When taken during pregnancy, particularly late
(tranquilisers), or other opioids.
serious allergic reactions are very rare. If you get any of 6900 Marche en Famenne
pregnancy, medicines like Natzon may cause drug
the following symptoms after taking these tablets, you Belgium
withdrawal symptoms including problems with breathing
!
Dependence
should contact your doctor immediately:
in your new born baby. These symptoms may occur
This product can cause dependence.
Any sudden wheeziness, difficulty in breathing or This leaflet was last revised in January 2017.
!
several days after birth.
dizziness, swelling of the eyelids, face, tongue, lips,
!
Withdrawal symptoms
throat or hands. rash or itching especially those
Since buprenorphine is passed into breast milk, you must
This product can cause withdrawal symptoms if you take
covering your whole body. These may be signs of a
not breast feed while taking this medicine.
it less than 6 hours after you use a short-acting opioid
life-threatening allergic reaction.
(e.g. morphine, heroin) or less than 24 hours after you
!
if you start to breathe more slowly or weakly than
Ask your doctor or pharmacist for advice before taking any
use a long-acting opioid such as methadone.
expected (respiratory depression).
medicine.
!
if you start to feel faint, as this may be a sign of low
blood pressure.

Natzon 0.4mg Sublingual Tablets

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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