IMIPRAMINE 25MG TABLETS

Active substance: IMIPRAMINE HYDROCHLORIDE

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6. Further Information

1. What Imipramine Tablets are and
what they are used for

Read all of this leaflet carefully before you start taking this
medicine.

2. Before you take Imipramine Tablets

Ingredients
Each tablet contains 25 mg of the active ingredient, imipramine.
The other ingredients are lactose, talc, colloidal anhydrous silica,
stearic acid, sucrose, titanium dioxide (E171), sunset yellow
(E110), sodium methyl parahydroxybenzoate (E219),
sodium propyl parahydroxybenzoate (E217), erythrosine (E127),
indigo carmine (E132) and maize starch.
What the medicine looks like
The tablets are round, reddish brown sugar coated.
They are supplied to your pharmacist in packs of 28, 56, 100, 250,
500 or 1000 tablets. Not all pack sizes may be available.

Patient Information Leaflet

Imipramine 25 mg Tablets BP

3. How to take Imipramine Tablets

• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone
else to take. It may harm them, even if their symptoms
are the same as yours.

If you would like the leaflet in a different format, please contact the
licence holder at the above address.

4. Possible side effects

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Date of revision: May 2010

5. How to store Imipramine Tablets
6. Further information

• If you have any further questions, please ask your doctor
or pharmacist.
• 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.

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pharamcode
91
location and size
100% Black

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In this leaflet:

This medicine will be called Imipramine Tablets in this leaflet.

Product licence holder and manufacturer
The product licence holder is Dalkeith Laboratories Ltd., 2 Park
Street, Woburn, Bedfordshire, MK17 9PG, UK.
Manufactured by Surepharm Services Ltd., Bretby, Burton upon
Trent, Staffs, DE15 0YZ, UK.
Product Licence Number:
PL 17496/0011

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component code
100% Black

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Rash, feeling faint, difficulty breathing, swelling of the face, lips or
tongue, breathlessness, cough and raised temperature. These may
be the symptoms of a severe allergic reaction.
The following side effects have also been reported.
More than 1 in 10 people have experienced:
• Weight gain
• Shaking
• Constipation
• Dry mouth, sweating and hot flushes
• Problems with eyesight and blurred vision
• Increased heart rate, dizziness or fainting due to low blood
pressure.
Less than 1 in 10 people have experienced:
• Changes in libido (interest in sex), tiredness, drowsiness,
difficulty sleeping, anxiety, hallucinations (seeing or hearing
things that are not real), restlessness, confusion, mood changes,
over-excitedness, headache, dizziness

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STOPPING TREATMENT WITH IMIPRAMINE
If the doctor tells you that you no longer need to take the tablets,
you should carefully follow his/her advice about how to stop your
course of treatment. If you stop taking these tablets suddenly you
may get withdrawal symptoms such as stomach pain, diarrhoea,
headache, difficulty sleeping, feeling or being sick, nervousness and
anxiety. Your doctor may wish to see you more regularly when he
starts to reduce your tablets.

4. Possible side effects
Like all medicines Imipramine may sometimes cause side effects,
particularly in the elderly. These tablets can affect people in many
different ways. Changes in behaviour may occur in children.
Some side effects can be serious. Stop taking Imipramine
Tablets and tell your doctor straightaway if you notice the
following very rare symptoms:

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3. How to take Imipramine Tablets

Driving and using machinery
Imipramine Tablets may make you feel drowsy, dizzy or confused.
They might also affect your eyesight. If you are affected you should
not drive or operate machinery.
Important information about some of the ingredients
• If you have been told that you have an intolerance to some
sugars, contact your doctor before taking this medicine as it
contains lactose and sucrose
• The tablet colouring contains sunset yellow (E110) which may
sometimes cause allergic reactions and sodium methyl
parahydroxybenzoate (E219) and sodium propyl
parahydroxybenzoate (E217) which may cause allergic reactions
(possibly delayed)

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The tablets should be swallowed with a drink of water.
The doctor will decide what dose of tablets you need to take. Always
take the tablets exactly as the doctor has told you. The dose will be
on the pharmacist’s label. If you are not sure, ask your doctor or
pharmacist. Carry on taking them for as long as you have been told
unless you have any problems. In that case, check with your doctor.
You will be given a low dose to begin with, which will be gradually
increased by your doctor. The usual doses are given below.
To treat a depressive illness
Adults: Start on 75 mg a day, in divided doses. This dose will be
increased gradually to 150 - 200 mg a day. Once you start to feel
better your doctor will gradually reduce the dose. If you are in
hospital the doses may be higher than those given above.

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• Palpitations (feeling your heart beating), fast or irregular heartbeat
• Loss of appetite, feeling or being sick
• Changes in liver function (usually only detected by blood tests)
• Skin rash or itching
• Problems passing urine
• Numbness or tingling anywhere in the body.
Less than 1 in 1,000 people have experienced:
• Psychosis (signs of this are personality change, loss of contact with
reality, delusions, hallucinations, incoherent speech and agitation)
• Ringing in the ears
• Fits.

Always tell your doctor or pharmacist about all the medicines you
are taking. This means medicines you have bought yourself as well
as those you have on prescription from your doctor.
Other special warnings
• 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 adults aged less
than 25 years with psychiatric conditions who were treated with
8 an antidepressant.

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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
• Your doctor will want to check your blood pressure before you
start taking these tablets. He/she might also want to carry out
certain tests (e.g. liver, heart or blood tests) while you are taking
these tablets
• If you are going to have a local or general anaesthetic make sure
the doctor or dentist knows you are taking imipramine
• If you are taking this medicine for a long time you must go to the
dentist regularly for check-ups as this medicine may cause tooth
decay
• Avoid drinking alcohol while you are taking this medicine.

Elderly: Patients over 60 years of age will start on 10 mg a day.
The dose will be increased gradually to 30 – 50 mg a day, to be
taken in divided doses.
To treat bed wetting
Children aged 6 or over: Take 25 – 75 mg a day, at bedtime. The
dose depends on the child’s body weight. The doctor will gradually
reduce the dose and treatment should not continue for any longer
than 3 months.
If you take more tablets than you should
You should contact your doctor or go to your nearest hospital
casualty department immediately. Take your tablets or the pack with
you so that the doctor knows what you have taken.
If you forget to take a dose of Imipramine Tablets
If you miss a dose don’t worry. Do not take a double dose to make
up for the forgotten dose, just carry on with the normal routine.

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• Nicotine. Let your doctor know if you are a heavy smoker or are
using nicotine replacement therapy to help you stop smoking
• CNS depressants such as sleeping tablets, sedatives or
tranquillisers
• Thioridazine or phenothiazines, used to treat psychiatric disorders
• Alprazolam, to treat anxiety
• Other drugs to treat depression, including drugs called selective
serotonin reuptake inhibitors (SSRIs e.g. fluoxetine or
fluvoxamine)
• Anticoagulants, to prevent blood clotting e.g. warfarin
• Disulfiram, to treat alcohol dependence
• Terbinafine, to treat ringworm and some nail infections
• Drugs to treat thyroid problems
• Anticholinergic drugs such as biperiden and other drugs for
Parkinsonism, antihistamines (for allergies) and atropine to relax
intestinal smooth muscle and regulate the heart rate.
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• Drugs to control high blood pressure such as betanidine,
guanethidine, methyldopa, reserpine and clonidine
• Propranolol, labetolol, diltiazem and verapamil, used to treat
irregular heartbeat, angina or high blood pressure
• Quinidine for heart problems
• Sympathomimetic drugs such as adrenaline, noradrenaline,
ephedrine, isoprenaline, phenylephrine and
phenylpropanolamine. These can be used to treat cold and sinus
problems, hay fever or other allergies, and may be present in
drugs which you can buy without a prescription
• Oral contraceptives or other drugs containing oestrogens such as
hormone replacement therapy (HRT)
• Cimetidine, to treat stomach ulcers
• Methylphenidate (Ritalin), used to treat attention deficit
hyperactivity disorder (ADHD) in children
• Phenytoin or carbamazepine, to treat epilepsy

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• You have constipation that has persisted for a long time
• You suffer from a panic disorder, as anxiety may increase during
the first few days of treatment
• You have ever had glaucoma or problems passing urine
• You have a mental illness such as schizophrenia
• You have low or unstable blood pressure
• You are being weaned off dependency on alcohol and some drugs
• You wear contact lenses.
If any of the conditions above apply to you, please discuss your
treatment with your doctor before taking this medicine.
Taking other medicines
Imipramine Tablets can affect some other medicines you may be
taking. Make sure your doctor knows if you are taking any of the
following:

Less than 1 in 10,000 people have experienced:
• Blood disorders which can cause fever, tiredness, bruising and
sometimes abnormal bleeding or make infections more likely
• Swelling of, or milk flow from, the breasts
• Weight loss
• Difficulty in controlling movements, muscle weakness or
stiffness, fever, muscle spasm, difficulty in speaking
• Raised blood pressure, heart problems
• Stomach problems, sore mouth or tongue
• Aggression
• Changes in blood sugar levels
• Hepatitis with or without jaundice (yellowing of the skin and
whites of the eyes)
• Oedema (build up of fluid under the skin)

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• Skin sensitivity to sunlight and red spots on the skin, hair loss
• Increased pressure inside the eye, widening of the pupils
• Paralytic ileus (symptoms include a swollen abdomen, being sick
and difficulty passing a motion)
Other effects which have been reported are:
• Low blood levels of sodium which can cause tiredness and
confusion, muscle twitching, fits and coma
• Dark skin patches
• Enlargement of the testicles
• Fainting
• Increased appetite, taste disturbances
• An increased risk of bone fractures has been observed in
patients taking this type of medicine.
If you notice any unwanted effects, even one not mentioned here,
please go and see your doctor.

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Some people must not take these tablets.
Do not take these tablets if:
• You know you are allergic to imipramine, or to any other similar
antidepressants, or to any of the other ingredients (these are
listed in section 6)
• You have recently had a heart attack, you suffer from heart block
or an irregular heartbeat

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2. Before you take Imipramine Tablets

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These tablets contain 25 mg of the active ingredient, imipramine.
Imipramine belongs to a group of medicines called antidepressants.
Imipramine Tablets are used to treat depressive illnesses in adults.
They can also be used in children to help treat bed wetting.

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• You have periods of mania (feeling elated or over-excited)
• You have severe liver disease
• You have glaucoma (increased pressure inside the eye)
• You have problems passing urine
• You are pregnant or breastfeeding (unless considered absolutely
essential by your doctor)
• You are taking, or have taken, a monoamine oxidase inhibitor
(also used to treat depression) in the last 3 weeks or you are
taking a reversible MAO-A inhibitor, such as moclobemide.
Imipramine Tablets should not be taken by children under 6 years of
age.
You must be especially careful if:
• You suffer from epilepsy, have brain damage or are undergoing
electro-convulsive therapy (ECT)
• You suffer from severe kidney disease, acute porphyria,
hyperthyroidism (an overactive thyroid gland) or you have a
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1. What Imipramine Tablets are and
what they are used for

Keep out of the reach and sight of children.
Do not store above 25˚C. Store in the original package in order to
protect the tablets from moisture.
Do not use the tablets after the expiry date shown on the carton or
label.
If your doctor tells you to stop taking the tablets, please take any
left over back to your pharmacist to be destroyed.

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5. How to store Imipramine Tablets

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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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