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LOFEPRAMINE TABLETS 70MG

Active substance(s): LOFEPRAMINE HYDROCHLORIDE

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Lofepramine 70 mg
Film-coated Tablets
(lofepramine)
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 Lofepramine is and what it is used for
2. What you need to know before you take
Lofepramine
3. How to take Lofepramine
4. Possible side effects
5. How to store Lofepramine
6. Contents of the pack and other information

1. What Lofepramine is and what it
is used for
Lofepramine belongs to a group of medicines
known as tricyclic antidepressants. This
medicine is believed to work by increasing
the levels of two naturally occurring
chemicals within the brain, noradrenaline and
5 hydroxytryptamine (also called serotonin).
Lofepramine is used to help relieve the
symptoms of depression.

2. What you need to know before
you take Lofepramine
Do not take Lofepramine if you:

TBC

• are allergic to lofepramine hydrochloride
or any of the other ingredients of this
medicine (listed in section 6)
• have taken other tricyclic anti-depressants,
such as imipramine and suffered an
unusual or allergic reactions
• have severe liver or kidney disease
• suffer from mania (feeling over-excited
with unusual behaviour)
• are being treated for a heart disease such
as an arrhythmia (abnormal heart rhythm)
• have a blockage of the electrical conduction
system of the heart (heart block)
• are recovering from a heart attack
• have narrow-angle glaucoma (high pressure
in the eye) that is not being treated
• have an enlarged prostate gland causing
problems with passing urine
• have chronic constipation, especially if you
are elderly or bed-ridden, as you are at risk
of developing a blockage in the intestine
(paralytic ileus)
• are taking any of the following medicines:
* a monoamine oxidase inhibitor (MAOI)
used to treat depression or within 2 weeks
before or 2 weeks after you take a MAOI
* amiodarone (to treat an irregular
heart rhythm)
* terfenadine (an antihistamine)
If you are unsure if any of the above applies to
you, please consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Lofepramine if you:
• suffer from a condition caused by
a tumour of the adrenal gland (e.g.
phaeochromocytoma or neuroblastoma)
• have liver or kidney disease
• have ever had an epileptic seizure (a fit)
• have recently stopped drinking alcohol
• have a blood disorder or porphyria ( a rare
blood pigment disorder)
• are having electroconvulsive therapy
• know that you have high blood pressure
(hypertension)
• have a heart condition known as
‘congenital long QT syndrome’, or a family
history of QT prolongation, which is a
disturbance of the heart rhythm
• have any other heart disorder
• have an overactive thyroid gland and are
taking medicine to treat the condition
• have ever had raised pressure in the eye (in
particular an eye condition called narrowangle glaucoma)
• have ever had an enlarged prostate gland.
• have in the past suffered from mania (feeling
over-excited with unusual behaviour)
During treatment, if you are going to be
given a general anaesthetic for an operation
or a local anaesthetic for a small operation or
dental procedure, tell your doctor or dentist
you have been taking lofepramine, as this
medicine may increase the risk of side effects.

Thoughts of suicide and worsening of
your depression or anxiety disorder
If you are depressed and/or have any
anxiety disorders you can sometimes have
thoughts of harming or killing yourself.
These may be increased when first starting
antidepressants, since these medicines all
take time to work, usually about two weeks
but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about
killing or harming yourself
• If you are a young adult. Information
from clinical trials has shown an increased
risk of suicidal behaviour in young adults
(less than 25 years old) with psychiatric
conditions who were treated with an
antidepressant.
If you have thoughts of harming or killing
yourself at any time, contact your doctor or
go to a hospital straight away.
You may find it helpful to tell a relative or
close friend that you are depressed or have
an anxiety disorder, and ask them to read this
leaflet. You might ask them to tell you if they
think your depression or anxiety is getting
worse, or if they are worried about changes in
your behaviour.

Other medicines and Lofepramine
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.

The following medicines must not be
taken with lofepramine:
• monoamine oxidase inhibitors (MAOIs)
used to treat depression, e.g. moclobemide,
selegiline, phenelzine
• terfenadine, an antihistamine used to treat
allergic conditions
• amiodarone, used to treat problems with
heart rhythm

TBC

Package leaflet: Information for the patient

Tell your doctor or pharmacist if you are
taking any of the following:
• other antidepressants e.g. fluvoxamine,
fluoxetine, sertraline, paroxetine
• medicines to treat mental health conditions
e.g. chlorpromazine, levomepromazine
• alprazolam, to treat anxiety
• sedatives including barbiturates
• medicine to control heart rhythms e.g.
disopyramide, procainamide, propafenone,
quinidine or sotalol
• medicines that cause problems with the
electrical signals in the heart, such as
some antibiotics known as macrolides (e.g.
clarithromycin, azithromycin, erythromycin)
or medicines to treat or prevent malaria
• medicine to lower high blood pressure
e.g. guanethidine, betanidine, reserpine,
clonidine, methyldopa
• medicines that can lower potassium levels
in the blood, such as diuretics. These
include ‘loop’ diuretics such as furosemide,
commonly used to treat high blood
pressure, and thiazide diuretics such as
hydrochlorothiazide, which are mainly used
to treat heart failure
• other medicine for high blood pressure
or heart conditions e.g. digoxin,
verapamil, diltiazem
• ‘sublingual’ tablets to treat angina, e.g.
glyceryl trinitrate, as lofepramine can cause
a dry mouth so the tablets may not dissolve
under the tongue properly
• medicine containing atropine, adrenalin,
ephedrine, isoprenaline, noradrenaline,
phenylephedrine, phenylpropanolamine
• altretamine to treat ovarian cancer
• medicines to control epilepsy, e.g.
lamotrigine, gabapentin, pregabalin
• disulfiram, used to treat alcoholism
• medicines to treat Parkinson’s disease e.g.
biperiden, procyclidine
• medicine to thin the blood (anticoagulants)
such as warfarin
• cimetidine to treat ulcers or heartburn
• rifampicin, a medicine to treat serious
infections such as tuberculosis
• ritonavir, for the treatment of HIV infection
• cold remedies particularly decongestants
or hayfever preparationspainkillers
• medicines for treatment of thyroid problems
• oral contraceptives or hormone
replacement therapy containing
oestrogens or progestogens
• antihistamine medicines for treatment of
allergic conditions

Lofepramine with alcohol
Do not drink alcohol whilst taking this
medicine. Alcohol can make the feeling of
drowsiness worse.

Pregnancy, breast-feeding
Do not take lofepramine if you are pregnant,
think you may be pregnant or are trying to
become pregnant.
Ask your doctor or pharmacist for advice
before taking lofepramine.

LT1360AG

Description Lofepramine 70 mg all
Component Type LeafletInsert
Affiliate Item Code 789680
Superceded Affiliate Item Code 10002801
TrackWise PR No. 789680
MA No. N/A
Packing Site/Printer N/A
Supplier Code LT1360AG

Date: 07 JAN 2016

Pharma Code tbc

No. of colours

SAP No. N/A

Colours

1

Time: 12:19
Page Count

1/2

Black

Vendor Job No. 270969
Trackwise Proof No. 1
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

Driving and using machines
Do not drive or operate machinery if you
feel dizzy or drowsy or you have eyesight
problems while taking this medicine.
Lofepramine contains lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
This medicine also contains the colouring
agent ponceau 4R (E124), which may cause
allergic reactions.

3. How to take Lofepramine
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
You should take your tablets as long as your
doctor says. Remember that you may need to
take Lofepramine for 2 to 4 weeks before you
begin to feel better. So do not stop taking this
medicine just because you do think that it is
not working.
The tablets should be swallowed with a drink
of water. The score line is only there to help
you break the tablet if you have difficulty
swallowing it whole.

The recommended dose is:
Adults: the usual starting dose is two tablets
daily (one in the morning and one in the
evening). After a short time, your doctor may
tell you to increase the dose to three tablets a
day. If this happens, ask your doctor when to
take the third tablet.
Elderly: your doctor may give you a lower dose.
Use in children: Lofepramine is not suitable
for children.
If you take more Lofepramine than you
should contact your doctor or nearest
hospital emergency department
immediately. Take the container and any
remaining tablets with you.
If you forget to take Lofepramine take
the next dose as soon as you remember
unless it is almost time for your next dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Lofepramine - speak
to your doctor first before stopping this
medicine. Your doctor will tell you how to
gradually reduce your medicine. This will
help avoid unwanted side effects such
as sleeplessness, excessive sweating or
feeling agitated.
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 everybody
gets them.

If you notice any of the following side
effects, stop taking this medicine
and contact your doctor or go to the
nearest hospital casualty department
straight away:
Rare (may affect up to 1 in 1,000 people):
• unusual bruising or bleeding of the skin,
feel feverish or unusually tired, have a sore
throat or sore tongue (which may mean
you have a blood disorder)
• unusual secretion of ADH, a hormone that
causes the body to retain water and dilute
the blood, causing a lower than normal
level of sodium in the blood, which may
make you feel weak and confused with
aching muscles
• fits (convulsions)
Not known (frequency cannot be estimated
from the available data):
• feelings or thoughts of harming or killing
yourself, worsening of your depression or
anxiety, or changes in your behaviour
• increased pressure in the eye (glaucoma)
• serious or changes to the heart’s rhythm,
causing ‘missed’ or ‘skipped’ beats,
or sudden increase in heart rate (QT
prolongation or ‘Torsade de Pointes’)
• worsening of existing heart failure
• yellowing of the skin and whites of the eyes
(jaundice), stomach pain with fever, dark
urine or pale stools, which may be signs of
serious liver problems
• inability to pass urine or to empty
the bladder

Other possible side effects:
Rare (may affect up to 1 in 1,000 people):
• feeling over-excited
• drowsiness
• taste changes






bleeding into the skin
excessive sweating
change in sex drive or sexual function
swelling or tenderness of the breasts
(in men)
• leaking of breast milk (in men and
in women)
• irritation of the lining of the mouth,
nose, wind pipe, intestines, stomach or
urinary tract
• changes in blood glucose levels (shown in
blood test)
Very rare (may affect up to 1 in 10,000 people):
• reduced coordination of movement
• ringing in the ears
Not known (frequency cannot be estimated
from the available data):
• dry mouth, feeling or being sick, diarrhoea,
constipation
• blurred vision or difficulty focussing,
dilated pupils
• dizziness, headache, tingling or prickling
feeling (pins and needles), shaking
• low blood pressure
• changes to heart rhythm, especially an
increase in heart beat
• difficulty in urinating
• feeling anxious or agitated, mood swings,
confusion, seeing or hearing things that are
not there (hallucinations)
• difficulty sleeping, nightmares
• feeling generally unwell
• skin rashes or skin allergies, sensitivity of
skin to light
• swelling of the face
• pain in the testicles
• increased levels of liver enzymes, seen in a
blood test
An increased risk of bone fractures has
been observed in patients taking this type
of medicines.

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 Lofepramine
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry
date, which is stated on the pack after Exp.
The expiry date refers to the last day of
that month.
Store in the original package in order to
protect from light and moisture.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to 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 Lofepramine contains
• The active substance is lofepramine.
Each film-coated tablet contains 70 mg
lofepramine as the hydrochloride.
• The other ingredients (excipients) are
lactose, maize starch, ascorbic acid,
talc, glycerol, glycerol monostearate
40-55, disodium edetate, dimeticone,
hypromellose, colloidal anhydrous silica.
The film-coating also contains: propylene
glycol, hypromellose, ponceau 4R (E124),
titanium dioxide (E171), indigotine (E132)

What Lofepramine Tablets look like and
contents of the pack
Your medicine comes as a round,
biconvex, violet-brown film-coated tablet,
approximately 10 mm diameter and with a
score line on one side.
The tablets are available in blister packs of 28,
56, 1008, 2016 tablets or in tablet containers
in packs of 56, 250, 500 and 1000 tablets or in
amber glass bottle in packs of 56 tablets.
Not all sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturer
McDermott Laboratories Ltd., T/A Gerard
Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters
Bar, Hertfordshire, EN6 1TL, United Kingdom.
This leaflet was last revised in 11/2015

LT1360AG

Description Lofepramine 70 mg all
Component Type LeafletInsert
Affiliate Item Code 789680
Superceded Affiliate Item Code 10002801
TrackWise PR No. 789680
MA No. N/A
Packing Site/Printer N/A
Supplier Code LT1360AG

Date: 07 JAN 2016

Pharma Code tbc

No. of colours

SAP No. N/A

Colours

1

789680

Time: 12:19
Page Count

2/2

Black

Vendor Job No. 270969
Trackwise Proof No. 1
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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