BRITLOFEX TABLETS 0.2MG

Active substance: LOFEXIDINE HYDROCHLORIDE

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BritLofex PIL UK 008 5854-01

16/11/12

09:57

Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER
TABLETS 0.2mg
LOFEXIDINE HYDROCHLORIDE

Read all of this leaflet carefully before you start using
this medicine.
– Keep this leaflet. You may need to read it again.
– This leaflet does not contain all the information about
your medicine.
– If you have any further questions, ask your doctor or
community drugs worker.
– This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
– If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or community drugs worker.
In this leaflet:
1. What BritLofex is and what it is used for
2. Before you take BritLofex
3. How to take BritLofex
4. Possible side effects
5. How to store BritLofex
6. Further information
1. WHAT BRITLOFEX IS AND WHAT IT IS USED FOR
BritLofex belongs to a group of medicines called alpha2
adrenergic agonists and is an imidazoline derivative.
The tablets are taken to relieve the symptoms such as chills,
sweating, stomach cramps, muscle pain and runny nose
which you experience when you stop taking an opioid
(e.g. methadone, heroin, dihydrocodeine etc.)
BritLofex will not stop you from craving opioids.
2. BEFORE YOU TAKE BRITLOFEX
Do not take BritLofex if:
– you are allergic to Lofexidine or to other imidazoline
derivatives or to any ingredients of BritLofex (see
Section 6 for a full list of ingredients).
Take special care with BritLofex
Before taking BritLofex tablets, tell your doctor or community
drugs worker if:
– you are, or think you might be, pregnant;
– you are breast-feeding;
– you have a heart condition (e.g. angina), or have had
a recent heart attack;
– you have a low pulse rate;
– you have low blood pressure;
– you have a low potassium level
– you have kidney problems;
– you suffer from depression;
– you are taking tablets for depression;
– you are taking barbiturates or other sedatives;
– you have ever had a stroke;
– you have been diagnosed with the heart condition
QT prolongation or have a family history of QT problems;
– you are elderly (aged 65 and over) and are receiving
treatment for high blood pressure.

Taking other medicines
Certain medicines need to be used with caution whilst
taking BritLofex. Please consult your doctor or community
drugs worker if you are currently taking, or intend to take
any other medication whilst taking BritLofex.
BritLofex may increase the effects of alcohol, medicines
called barbiturates and other drugs that make you sleepy.
BritLofex may increase the effects of medicines used to lower
high blood pressure and it could make your blood pressure
drop too low.
Taking medicines known as tricyclic antidepressants may
reduce the effects of BritLofex.
Other medicines known to change heart rhythm or alter the
balance of electrolytes (e.g. sodium, potassium etc) should be
avoided. Taking these drugs with BritLofex may increase the
risk of QT prolongation.
Taking BritLofex with food and drink
It is recommended that you do not drink alcohol or take
opioids while you are undergoing detoxification with BritLofex.
Pregnancy and breast-feeding
Ask your doctor or community drugs worker for advice before
taking any medicine.
Driving and using machines
BritLofex tablets may make you feel light-headed or drowsy.
You must not drive or operate machinery if you feel
light-headed or drowsy.
Important information about some of the ingredients
of BritLofex
– BritLofex tablets contain sunset yellow (E110) which can
cause allergic reactions. If you have ever been told that
you are allergic to sunset yellow (E110), contact your doctor
before taking this medicine.
– BritLofex tablets contain lactose (a kind of sugar). If you
have ever been told that you have intolerance to some
sugars, contact your doctor before taking this medicine.
WARNING!
If you are unable to continue with your detoxification
programme you should contact your doctor or
community drugs worker as soon as possible.

3. HOW TO TAKE BRITLOFEX
Read the label on your medicine before you start to take it.
Your doctor or community drugs worker will tell you when and
how often to take the tablets.
Your doctor or community drugs worker will explain how to
stop using opioids and the course of treatment to follow
during the withdrawal stages. Please follow these instructions
as closely as possible:
– On the first day the usual dose is 4 tablets.
– After that, the dose can then be increased gradually,
depending on the severity of your symptoms, but any
increase must not be more than 4 tablets a day.
– The maximum daily dose is 12 tablets.
– You must not take more than 4 tablets at a time.

BritLofex PIL UK 008 5854-01

16/11/12

09:57

Sometimes the dosage may differ from this. For example,
you may be prescribed a higher starting dose. Your doctor or
community drugs worker will tell you the number of tablets
you need to take each day.
BritLofex is usually taken for 7–10 days. Sometimes, however,
it may be taken for a longer or a shorter time. Your doctor or
community drugs worker will tell you how long to take the
tablets for.
When the withdrawal symptoms are less severe the daily
dose of BritLofex can be reduced, gradually. You should
never stop taking these tablets suddenly.
Swallow your tablets whole, with a drink of water.
BritLofex tablets are not suitable for children (aged under 18).
If you take more BritLofex than you should
If you take more tablets than you have been told to, tell your
doctor or community drugs worker or contact your nearest
hospital emergency department immediately. Always take the
tablets as your doctor or community worker has told you to.
If you forget to take BritLofex
If you forget to take a dose, take another as soon as you
remember, but do not take more than 4 tablets at a time.
How to stop taking BritLofex
Never stop your tablets suddenly because your blood
pressure might rise if you do so. The dose should be lowered
gradually, over several days. Your doctor or community drugs
worker will tell you how to do this.
After finishing your tablets
After completing the course of BritLofex tablets you should
be detoxified from opioids and no longer have withdrawal
symptoms. However, if you are still having withdrawal
symptoms after you have finished your tablets, tell your
doctor or community drugs worker.
Your doctor or community drugs worker will offer advice on
how to remain opioid free.
4. POSSIBLE SIDE EFFECTS
If you experience an allergic reaction stop taking BritLofex
and contact a doctor or your nearest hospital emergency
department immediately. The signs of an allergic reaction
may include:
− Rash
− Breathing difficulties
− Swelling of the face, lips, throat or tongue
Like all medicines, BritLofex can cause side effects,
although not everybody gets them.
BritLofex tablets may sometimes cause the following:
Very common side effects (more than 1 user in 10):
− light-headedness or dizziness
− feeling sleepy or falling asleep
− drop in blood pressure
− slow heart beat
− dry mouth or throat
− dry nose
Side effects with unknown frequency:
− an allergic reaction which may include:
• Rash
• Breathing difficulties
• Swelling of the face, lips, throat or tongue
− changes in heart rhythm

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If you think you have any of these or any other side effects not
mentioned in the leaflet, contact your doctor or community
drugs worker.
When you stop taking opioids, the withdrawal symptoms can
make you feel unwell. If you think, however, that it is the
BritLofex tablets which are making you feel unwell, tell your
doctor or community drugs worker.
5. HOW TO STORE BRITLOFEX
− Always keep BritLofex and all other medicines out of the
reach and sight of children.
− Do not use BritLofex after the expiry date which is
printed on the pack. The expiry date refers to the last day
of that month.
− Store your tablets below 25ºC. Store them in the
original package.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the safety of others and the environment.
Remember: this medicine is for you. Do not give it to others,
even if they have the same symptoms as you.
You may want to read this leaflet again. Do not throw it away
until you have finished your medicine.
6. FURTHER INFORMATION
If you are not already doing so, you may wish to contact your
local drug addiction service. They will be able to offer you
advice and support on how to come off drugs. You will find
their address in the 'Yellow Pages' telephone directory under
'Counselling & Advice'.
What BritLofex contains
The active ingredient of each peach coloured BritLofex tablet
is Lofexidine hydrochloride. Each tablet contains 0.2mg of
Lofexidine hydrochloride.
The other ingredients are: lactose, citric acid, povidone,
microcrystalline cellulose, calcium stearate, sodium lauryl
sulphate, Opadry OY-S-9480 Brown (which contains sunset
yellow-E110). These are included to help make the tablets.
What BritLofex looks like and contents of the pack
BritLofex tablets are round and peach coloured.
They are supplied in packs of 60 tablets.
Marketing Authorisation Holder
The Marketing Authorisation is held by:Britannia Pharmaceuticals Ltd
Park View House, 65 London Road, Newbury
Berkshire, RG14 1JN, United Kingdom
Manufacturers
Stada Production Ireland Limited
Waterford Road, Clonmel, Co Tipperary, Ireland
Genus Pharmaceuticals, Park View House, 65 London Road
Newbury, Berkshire, RG14 1JN, United Kingdom
Distributed by:
Genus Pharmaceuticals
Park View House, 65 London Road, Newbury,
Berkshire RG14 1JN, United Kingdom
This leaflet was last revised in November 2012.
xxxxxxx xxxx / XXXXXX

UK 008

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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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