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GABUP 2 MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE HYDROCHLORIDE

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3. How to take Gabup Sublingual Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Always take this medicine exactly as your doctor or pharmacist
has told you.

Gabup 0.4 mg, 1 mg, 2 mg, 4 mg, 6 mg and 8 mg Sublingual Tablets
(Buprenorphine)

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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 or nurse.
• 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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet:
1. What Gabup Sublingual Tablet is and what it is used for
2. What you need to know before you take Gabup Sublingual
Tablets
3. How to take Gabup Sublingual Tablets
4. Possible side effects
5. How to store Gabup Sublingual Tablets
6. Contents of the pack and other information

1. What Gabup Sublingual Tablet is and what it
is used for
Gabup 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.
Gabup 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 Gabup 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
Gabup Sublingual Tablets
Do not take Gabup Sublingual Tablets:
• if you are allergic to buprenorphine or any of the other
ingredients in 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, breastfeeding and fertility’ below for more information).
Gabup Sublingual Tablets must not be used by children or
adolescents under 16 years old.
Take special care with Gabup Sublingual Tablets
Tell your doctor before taking these tablets:
• if you have asthma or any other breathing problems
• if you have any kidney problems
• if you have any liver problems.
Gabup Sublingual Tablets contain buprenorphine which can
become addictive if used continually for a long period of
time. Drug dependence may occur as a result of taking this
medicine.
Other medicines and Gabup Sublingual Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

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 Gabup:
• benzodiazepines (used for treatment of anxiety or sleep
disorders) e.g. diazepam and temazepam: you should not
take these medicines while you are taking Gabup, 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 Gabup:
• 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 Gabup:
• 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.
Gabup Sublingual Tablets with food, drink and alcohol
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 Gabup Sublingual Tablets.
Pregnancy, breast-feeding and fertility
Before taking these tablets, tell your doctor if you are
pregnant or trying to become pregnant. If you become
pregnant during treatment with Gabup, tell your doctor
straight away.
Since Gabup 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
This medicine can affect your ability to drive and operate
machinery.
Do not drive whilst taking this medicine until you know how
this medicine affects you.
It may be an offence to drive if your ability to drive safely is
affected.
There is further information for patients who are intending to
drive in Great Britain - go to https://www.gov.uk/drug-drivinglaw
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine
Gabup Sublingual Tablets contain lactose.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.
Continued overleaf

Check with your doctor or pharmacist if you are not sure. You
must place the tablet under your tongue (sublingual) and
allow it to dissolve, which will take 5 to 10 minutes. This is the
only way to take the tablets. Do not chew or swallow them
whole, as they will not work.
Your doctor will tell you how many tablets to take and you
should always follow this advice.
To avoid sudden withdrawal symptoms, treatment with Gabup
Sublingual Tablets should be given when there are already
clear signs of withdrawal symptoms.
Adults and children over the age of 16 years:
when beginning treatment the dose is between 0.8 to 4 mg,
taken once a day.
For drug addicts who have not had any withdrawal
treatment:
one dose of Gabup Sublingual Tablets should be taken at
least 6 hours after the last use of the opioid (narcotic such as
morphine or heroin), or when the first signs of craving appear.
If you take it less than six hours after you use a narcotic you
may get withdrawal symptoms.
For patients taking methadone:
before beginning treatment, your doctor should reduce your
dose of methadone to not more than 30 mg a day. Gabup
Sublingual Tablets may cause withdrawal symptoms in
patients who are dependent on methadone if used within 24
hours of the last dose of methadone.
During your treatment, your doctor may increase your dose
of Gabup Sublingual Tablets, to a maximum single daily dose
of 32 mg, depending upon your response. Once you have
been stable for a while, your doctor will gradually reduce
your dose and it may be possible to stop it altogether. Do not
suddenly stop taking the tablets, as this may cause withdrawal
symptoms.
If you take more Gabup 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 Gabup 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 stop taking Gabup Sublingual 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 product,
ask your doctor or pharmacist.

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.
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 Gabup is taken less than six
hours after using an opioid (e.g. heroin).
Rare side effects:
Severe difficulty in breathing, hallucinations and the inability
to empty the bladder completely.
• Athletes should be aware that this medicine may cause a
positive reaction to ‘anti-doping tests’
• Drug dependence can occur as a result of taking this
medicine.

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 or
nurse. This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via the national
reporting system listed in Yellow Card Scheme Website:
http://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 Gabup Sublingual Tablets
Keep this medicine out of the sight and reach of children
Store your medicine in the original packaging to protect from
light and moisture.
The 0.4 mg and 1 mg strength of Gabup Sublingual Tablets
should not be stored above 25oC. The 2 mg, 4 mg, 6 mg and 8
mg strengths of Gabup Sublingual Tablets do not require any
special temperature storage conditions.
Do not use Gabup Sublingual Tablets after the expiry date,
which is stated on the carton after EXP. The expiry date refers
to the last day of that month.
Do not throw away any medicine 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 Gabup Sublingual Tablets contain:
• The active substance is buprenorphine (as buprenorphine
hydrochloride). Each tablet contains 0.4 mg, 1 mg, 2 mg, 4
mg, 6 mg or 8 mg of buprenorphine.
• The other ingredients are lactose monohydrate, mannitol,
maize starch, citric acid (anhydrous), sodium citrate,
povidone (K30), magnesium stearate, talc and silica
(colloidal anhydrous).
What Gabup Sublingual Tablets look like and the contents
of the pack
Gabup 0.4 mg Sublingual Tablets are white, round tablets
marked with “→” on one side.
Gabup 1 mg Sublingual Tablets are white, round tablets
marked with “1” on one side and with “→” on the other side.
Gabup 2 mg Sublingual Tablets are white, round tablets
marked with “2” on one side and with “→” on the other side.
Gabup 4 mg Sublingual Tablets are white, round tablets
marked with “4” on one side and with “→” on the other side.
Gabup 6 mg Sublingual Tablets are white, round tablets
marked with “6” on one side and with “→” on the other side.
Gabup 8 mg Sublingual Tablets are white, round tablets
marked with “8” on one side and with “→” on the other side.
Your medicine is available in blisters containing 7 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Martindale Pharmaceuticals Ltd
Trading as Martindale Pharma
Bampton Road
Harold Hill
Romford, Essex
RM3 8UG
United Kingdom
Manufacturer:
Ethypharm,
Chemin de la Poudrière, 76120
Grand-Quevilly, France
or
Ethypharm,
Z.I. de Saint-Arnoult, 28179
Châteauneuf-en-Thymerais, France
This leaflet was last updated in May 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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