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Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or
• 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 gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

Mylan Design Department,
Albany Gate, Darkes Lane,
Potters Bar, Herts, EN6 1AG


Proof Revision Reason: Adding codes & approval

Font & Point Size:

Myriad Pro 13 & 7.5pt

Re.g. Officer: Surabhi Melmane




Change/Creation Reason: Re-branding.

PL: 04569/0307

Packed @: Gerard


(if applicable)

(if applicable)

Supersedes: 10002775
Proof # & Date:4 13.07.11







AWCC: 0886
Dimensions: 170 x 240 mm

Pharma: TBC
Code: 10002801







Product: Lofepramine Tablets 70 mg x 56


Lofepramine belongs to a group of medicines called tricyclic
antidepressants. Lofepramine is believed to work by
increasing the levels of two naturally occurring chemicals
within the brain, noradrenaline and 5 hydroxytryptamine
(also called serotonin). Your doctor will prescribe
Lofepramine to help relieve the symptoms of depression
Do not take Lofepramine if you:
• are allergic (hypersensitive) to lofepramine hydrochloride
or to any of the other ingredients of this medicine. See
Section 6 'Further Information' for a list of other ingredients
• have taken other tricyclic anti-depressants, such as
Lofepramine and Imipramine and suffered an unusual or
allergic reaction
• have severe liver or kidney disease
• suffer from mania (feeling over-excited with unusual
• 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
• take at the same time 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.
Take special care with Lofepramine - You should tell your
doctor before taking this medicine if you:
• suffer from a condition caused by a tumour of the adrenal
gland (e.g. Phaeochromocytoma or Neuroblastoma) which
may caused attacks of headache, sweating, palpitations,
flushing of the face or pains in the chest and stomach
• have liver or renal 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)

Pregnancy and breast-feeding - Ask your doctor or
pharmacist for advice before taking any medicine.
Lofepramine may harm your unborn child. If you are
pregnant, think you may be pregnant or are trying to
become pregnant, you must talk to your doctor before
taking Lofepramine. Lofepramine may reach your baby
through the breast milk. Therefore, you must not take
Lofepramine if you are breast-feeding.

Thoughts of suicide and worsening of your depression or
anxiety disorder - If you are depressed and/or have 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.
Taking other medicines - Please tell your doctor or
pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a
prescription, or the following:
• other antidepressants e.g. Fluvoxamine, Fluoxetine
• medicine to treat mental illness e.g. Chlorpromazine
• Alprazolam, to treat anxiety
• sedatives including barbiturates
• medicine to control heart rhythms e.g. Disopyramide,
Procainamide, Propafenone, Quinidine or Sotalol
• medicine to lower high blood pressure e.g. Guanethidine,
Betanidine, Reserpine, Clonidine, Methyldopa, diuretics
('water' tablets)
• other medicine for high blood pressure or heart conditions
e.g. Digoxin, Verapamil, Diltiazem
• 'sublingual' tablets to treat angina, 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,
• altretamine to treat ovarian cancer
• medicine to control epilepsy, alcoholism e.g. Disulfiram,
or Parkinson's disease e.g. Biperiden
• medicine to thin the blood (anticoagulants) such as
• Cimetidine to treat ulcers or heartburn
• medicine for serious infections such as tuberculosis
e.g. Rifampicin, or HIV e.g. Ritonavir
• cold remedies particularly decongestants or hayfever
• painkillers
• thyroid medicine
• oral contraceptives or oestrogens such as

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.
Important information about some of the ingredients of
Lofepramine - This medicine contains lactose. If you doctor
has told you that you have an intolerance to some sugars,
such as lactose, contact your doctor before taking this
medicine. This medicine contains also a colouring agent:
ponceau 4R (E124), which may cause allergic reactions.
Always take Lofepramine exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure. The tablets should be swallowed with a drink of
water. You should take your tablets for 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 usual 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
Children - Lofepramine Tablets are 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
If you stop taking Lofepramine - Speak to your doctor first
before stopping this medicine. Your doctor will tell you how
to gradually reduce your medication. 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.

happen, stop taking Lofepramine and tell your doctor
immediately or go to your nearest hospital emergency
department: • 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).
It is also possible that Lofepramine may cause: • a dry
mouth • blurred vision • dizziness • palpitations (fast and
irregular heartbeat) • low blood pressure • interference with
heart function • constipation • difficulty in urinating • tremors
• excessive sweating • feeling anxious or agitated, mood
swings • headache • feeling generally unwell • glaucoma
(high pressure in the eye) • confusion • difficulty sleeping
• skin rashes or skin allergies, sensitivity of skin to light,
swelling of the face • feeling and being sick • a tingling
feeling over the body, pain in the testicles, effects on sexual
function • swelling or tenderness of the breasts or leaking of
milk (in men and women) • feelings of paranoia • drowsiness
• convulsions (fits) • taste changes • changes to the blood
(shown by a blood test) such as low sodium levels • changes
in blood glucose levels and change in number of red blood
cells • yellowing of the skin and whites of the eyes • loss of
muscle coordination • ringing in the ears.
An increased risk of bone fractures has been observed in
patients taking this type of medicines.
If any side effect gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
Keep out of the reach and sight of children. Do not take this
medicine after the expiry date, which is stated on the pack.
The expiry date refers to the last day of that month. Protect
from sunlight and moisture. 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 environment.
What Lofepramine contains - The active substance is
lofepramine hydrochloride. Each tablet contains 76.2 mg
lofepramine hydrochloride, equivalent to lofepramine base
70 mg. Other ingredients: lactose, corn starch, ascorbic acid,
talc, glycerol, glycerol monostearate, dimethicone,
hydroxypropyl methyl cellulose, silicon dioxide, edetate
disodium. The coating also contains: propanediol, ponceau
4R (E124), titanium dioxide (E171), indigotine (E132).
Contents of the pack - The tablets are available in blister
pack in packs of 28, 56, 1008 and 2016 tablets, or in
polypropylene pot with polyethylene cap in packs of 56, 250,
500 and 1000 tablets, or in amber glass bottle in packs of 56
tablets. Not all pack sizes may be marketed.


Customer: Mylan


Registration Officer


In this leaflet:
1. What Lofepramine is and what it is used for.
2. Before you take Lofepramine.
3. How to take Lofepramine.
4. Possible side effects.
5. How to store Lofepramine.
6. Further information.

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



hormone replacement therapy
• antihistamines.

• are having electroconvulsive therapy
• know that you have high blood pressure (hypertension)
• have a heart disorder
• have an overactive thyroid gland and are taking medicine
to treat the condition
• are going to be given a general anaesthetic for an
operation or a local anaesthetic for a small operation or
dental procedure
• have chronic constipation, especially if you are elderly or
• have had in the past: * raised pressure in the eye (in
particular an eye condition called narrow-angle glaucoma)
* symptoms of obstruction of the neck of the bladder (due
to e.g. an enlarged prostate gland).



Product Licence 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.

Like all medicines, Lofepramine can cause side effects,
although not everybody gets them. If any of the following

This leaflet was last approved
in: 05/2011

LT1360AF 10002801

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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.