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LOFEPRAMINE 70MG TABLETS

Active substance(s): LOFEPRAMINE HYDROCHLORIDE

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Package Leaflet: Information for the user

Lofepramine 70mg Tablets
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
pharmacist.
•  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
pharmacist.

In this leaflet:
1 What Lofepramine Tablets are and what they are
used for
2 Before you take Lofepramine Tablets
3 How to take Lofepramine Tablets
4 Possible side effects
5 How to store Lofepramine Tablets
6 Further information
1 What Lofepramine tablets are and what they are used

for

Lofepramine belongs to a group of medicines known as
antidepressants.
Lofepramine Tablets are used to treat the symptoms of depression.
Common symptoms include feelings of worthlessness or deep
sadness, difficulty with everyday tasks, sleeping too much or not
being able to sleep, and feeling anxious.

2 Before you take Lofepramine tablets

Do not take Lofepramine Tablets if you:

• are allergic (hypersensitive) to lofepramine
• are allergic to any of the other ingredients of Lofepramine
Tablets.
• have severe liver and/or kidney problems
• are being treated for heart problems such as an abnormal heart
rhythm or heart block
• are recovering from a recent heart attack
• have a mental illness knows as “mania”

Take special care with Lofepramine Tablets

Talk to your doctor before taking these tablets if any of the
following apply to you:
• if you are elderly
• if you have heart, liver or kidney problems
• if you have been told that you have a rare tumour known as
“neuroblastoma” or “phaeochromocytoma”
• if you have a condition called “porphyria”
• if you have ever had epilepsy, fits or convulsions
• if you have any other mental illness
• if you have an overactive thyroid gland
• if you have been told that you have a blood disorder
• if you have increased pressure in the eye (narrow angle
glaucoma)
• if you have a history of prostate gland problems
• if you are receiving electroconvulsive therapy for your
depression.
If you have any thoughts of suicide or harming yourself
whilst taking this medicine, you should contact your doctor
immediately (see Section 4 – Possible Side Effects).

Taking other medicines

If taken with some other medicines, the effects of lofepramine or
the other medicine may be changed. Please tell your doctor if you
are taking any of the following:
• medicines called monoamine oxidase inhibitors (used to treat
depression). You should not take lofepramine if you are taking
these medicines or you have done so in the last 14 days.
• other antidepressants called serotoin reuptake inhibitors ‘SSRIs’
(e.g. fluvoxamine, fluoxetine).
• cold remedies, nasal decongestants or other medicines
containing adrenaline, ephedrine, isoprenaline, noradrenaline,
phenylephedrine or phenylpropanolamine
• medicines which make you feel sleepy or less alert (e.g. sleeping
pills, tranquilisers and hypnotics) and alcohol
• medicines to treat thyroid problems
• medicines used to treat high blood pressure (e.g. guanethidine,
debrisoquine, clonidine, diuretics, diltiazem, verapamil, sotalol)
• medicines to treat abnormal heart beats (e.g. amiodarone,
disopyramide, procainamide, propafenone, quinidine, sotalol,
digitalis glycosides)
• medicines to treat epilepsy
• strong painkillers (e.g. nefopam, tramadol, codeine or morphine)
• rifampicin (used for serious bacterial infections such as
tuberculosis)
• anti-cholinergics – used to treat Parkinsons disease, irritable
bowel syndrome, bladder problems, asthma
• medicines to thin the blood (e.g. warfarin)
• antimalarials (e.g. halofantrine)
• medicines to treat certain mental illnesses (e.g. pimozide,
sertindole,clozapine)
• medicines for treating HIV infections (e.g. ritonavir)
• medicines for anxiety (e.g. alprazolam)
• antihistamines (for treating allergies)
• medicines for treating Parkinson’s disease (e.g. levodopa,
biperiden, entacapone)
• muscle relaxants such as baclofen
• cisapride (for stomach disorders)
• altretamine (for advanced ovarian cancer)
• cimetidine (to treat indigestion or a stomach ulcer)
• certain medicines for angina (e.g. diltiazem, verapamil and
“nitrates”)
• disulfiram (for treatment of alcohol dependence)
• estrogen (e.g. hormone replacement therapy and oral
contraceptives)
Tell your doctor that you are taking Lofepramine tablets if you
are going to have an operation. Anaesthetics may react with
Lofepramine Tablets.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Taking Lofepramine Tablets with food and drink

Swallow the tablets with a drink of water. You should not drink
alcohol whilst taking this medicine.

Pregnancy and breast-feeding

Lofepramine Tablets are not recommended if you are pregnant or
breast-feeding.

Driving and using machines

Lofepramine Tablets may cause dizziness or drowsiness especially
when you first start taking this medicine. If you suffer from any of
these side effects, do not drive or operate machinery

Important information about some of the ingredients of
Lofepramine Tablets
This medicine also 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 colouring agents sunset yellow FCF
(E110) and carmoisine (E122). These may cause allergic reactions.

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colours/plates:

Lofepramine 70mg 56 Tablets PIL - UK

1. Black

item no: AAAH1249

dimensions: 190 x 345

print proof no: 3

pharmacode:

origination date: 08.08.14

min pt size: 9

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originated by: S.Anson
approved for print/date

2.

revision date: 03.09.14

Technical Approval

revised by: S.Anson

date sent: 02.09.14

supplier: Actavis Malta Zejtun

technically app. date:

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3 How to take Lofepramine tablets
Always take Lofepramine Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.
Adults: The usual dose for adults is one tablet to be taken 2 or 3
times a day.
Elderly: Elderly patients may be prescribed lower doses.
Children: Lofepramine Tablets are not recommended for children.
Swallow the tablets with a drink of water.
Keep taking your medicine until your doctor tells you to stop.

If you take more Lofepramine Tablets than you should
If you (or someone else) swallow a lot of the tablets together,
or if you think your child has swallowed any of the tablets, tell
your doctor or go to the nearest hospital casualty department
immediately.

If you forget to take Lofepramine Tablets

• generally feeling unwell
• dry mouth
• constipation
• problems with the eyesight
• problems passing water
• sweating
• shakiness or tremor
• nausea (feeling sick)
• vomiting (being sick)
• changes of blood sugar level
• low salt (sodium) in the blood which may cause weakness,
confusion or difficulty thinking. Other symptoms might include
loss of appetite, nausea, vomiting or headaches,
• enlargement of one or both breasts in men
• production of breast milk in women who are not pregnant or
breast-feeding
• pain in testicles
• effects on sexual function
• mental change called hypomania (feeling elated or emotionally
“high”)
• uncoordinated movement
• changes in sense of taste
• ringing in the ears.
• increased sensitivity to the sunlight.

If you forget to take a dose, take it as soon as you remember. Do
not take a double dose to make up for a forgotten dose.
If you are unsure, speak to your doctor.

An increased risk of bone fractures has been observed in patients
taking this type of medicines.

If you stop taking Lofepramine Tablets

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
pharmacist.

Do not suddenly stop taking the tablets as this may cause
problems such as sleeplessness, agitation and sweating.
When you are feeling better, talk to your doctor before stopping
Lofepramine Tablets.

5 How to store Lofepramine tablets
Blister packs: Store below 25°C. Store in the original package.
Plastic containers: Store below 25°C. Keep the bottle tightly closed.

4 Possible side effects
Like all medicines, Lofepramine Tablets can cause side effects,
although not everybody gets them.

Keep out of the reach and sight of children.

Thoughts of suicide and worsening of your depression
or anxiety disorder

Do not use Lofepramine Tablets after the expiry date which is
stated on the carton or container after EXP. The expiry date refers to
the last day of that month.

If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These
thoughts 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.

If you have any of the following side effects you should
tell your doctor immediately:

• An allergic reaction: signs are swelling of the lips, face and tongue,
difficulty in breathing, feeling faint, rash or itching (affecting the
whole body)
• Unusual bruising or bleeding of the skin, mouth, nose or vagina
• Feeling feverish, unusually tired or generally unwell, or you have a
sore throat or sore tongue (you may have a blood disorder)
• Your skin or eyes start turning yellow or you have severe stomach
ache (you may have a liver problem or jaundice)
• You have a “fit” (seizure)
The following side effects have also been reported. Tell your doctor
if you get any troublesome symptoms that you think are side
effects.
• low blood pressure,
• an irregular or fast heartbeat (pulse)
• dizziness
• sleeping difficulties
• drowsiness
• agitation
• confusion
• hallucinations
• headache
• pins and needles

Do not use Lofepramine Tablets if you notice any visible signs of
deterioration.
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.

6 Further information

What Lofepramine Tablets contains

• The active substance is lofepramine (as lofepramine
hydrochloride). Each tablets contains 70mg lofepramine base (as
76.1mg lofepramine hydrochloride)
• The other ingredients are lactose, maize starch, citric acid,
hydrogenated vegetable oil, povidone and glycerol. The coating
on the tablets contains hypromellose 6cp (E464), carmoisine
(E122), indigo carmine aluminium lake (E132), titanium dioxide
(E171), sunset yellow FCF aluminium lake (E110), iron oxide red
(E172) and macrogol 400.

What Lofepramine Tablets looks like and contents of the
pack
Lofepramine Tablets are violet brown film-coated tablets.

Lofepramine Tablets come in blister packs of 28, 30, 56 and 100
tablets and in a plastic container of 250 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
Arrow Generics Limited, Whiddon Valley, Barnstaple, Devon,
EX32 8NS, United Kingdom
Manufacturer
Actavis Ltd, BLB 016, Bulebel Industrial Estate, Zejtun,
ZTN 3000, Malta
This leaflet was last revised in August 2014.

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
AAAH1249

Actavis, Barnstaple, EX32 8NS, UK

colours/plates:

Lofepramine 70mg 56 Tablets PIL - UK

1. Black

item no: AAAH1249

dimensions: 190 x 345

print proof no: 3

pharmacode:

origination date: 08.08.14

min pt size: 9

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 03.09.14

Technical Approval

revised by: S.Anson

date sent: 02.09.14

supplier: Actavis Malta Zejtun

technically app. date:

Non Printing Colours
1.
2.
3.

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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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