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IMIPRAMINE 25 MG TABLETS

Active substance(s): IMIPRAMINE HYDROCHLORIDE

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Patient Information Leaflet

Imipramine 10 mg and 25 mg Tablets
This medicine will be called Imipramine Tablets
in this leaflet.

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:




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

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

In
1.
2.
3.
4.
5.
6.

this leaflet:
What Imipramine Tablets are and what they are used for
Before you take Imipramine Tablets
How to take Imipramine Tablets
Possible side effects
How to store Imipramine Tablets
Further information

 

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



















 
These tablets are available in two different strengths containing either
10 mg or 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.
 

2. Before you take Imipramine Tablets
 

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
• 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.

 

 

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
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


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 tumour of the adrenal gland
• 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.

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
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.





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.

 

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
Continued, please turn over.




The tablet colouring contains sunset yellow (E110) which may
sometimes cause allergic reactions
The 25 mg tablets contain sodium methyl parahydroxybenzoate
(E219) and sodium propyl parahydroxybenzoate (E217) which
may cause allergic reactions (possibly delayed).

 

3. How to take Imipramine Tablets




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.

Less than 1 in 10,000 people have experienced:

 

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.
 

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.
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, although not everybody gets them. 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:

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
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











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)
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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse
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 Imipramine Tablets

Keep out of the sight and reach of children.
Do not store above 25˚C. Store in the original package or container
and keep the container tightly closed, 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. rther Infrmation

6. Further Information
Ingredients
Each tablet contains either 10 mg or 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). In addition the 10 mg tablets contain aluminium
hydroxide gel and the 25 mg tablets contain sodium methyl
parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate
(E217), erythrosine (E127), indigo carmine (E132) and maize starch.
 

What the medicine looks like
The 10 mg tablets are round, orange sugar coated and the 25 mg
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.
 

Product licence holder and manufacturer
The product licence holder is Crescent Pharma Ltd., Units 3 & 4,
Quidhampton Business Units, Polhampton Lane, Overton, Hampshire,
RG25 3ED, UK.
Manufactured by Surepharm Services Ltd., Bretby, Burton upon Trent,
Staffs, DE15 0YZ, UK.
 

Date of revision: October 2014
If you would like the leaflet in a different format, please contact the
licence holder at the above address.

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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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