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IMIPRAMINE HYDROCHLORIDE 25MG/5ML ORAL SOLUTION

Active substance(s): IMIPRAMINE HYDROCHLORIDE

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poor blood circulation which makes the toes and
fingers numb and pale
skin rash or itching
darkening of skin
loss of balance
muscle weakness or stiffness, muscle spasm
difficulty in controlling movements
changes to the electrical waves in your brain
difficulty in speaking
inflammation of the lungs which causes
breathlessness, cough and raised temperature
n feeling your heartbeat or
irregular heartbeat
n heart failure
n red or brownish spots on skin
n fits, confusion or delirium

n sleep disturbances or difficulty in sleeping
n raised blood pressure
n low blood pressure
n hallucinations
n believing in things that are not real (delusions)
n change in blood sugar levels
n a condition called ‘syndrome of inappropriate anti-

Patient Information Leaflet
Imipramine Hydrochloride 25mg/5ml Oral Solution

If any of the side effects gets serious, or if you notice any other side effects not mentioned in this leaflet, please tell your
doctor or pharmacist.

Read all of this leaflet carefully before you start taking this medicine
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or your pharmacist.
n This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
n If any of these side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Imipramine Hydrochloride Oral Solution is and what it is used for
2. Before you take Imipramine Hydrochloride Oral Solution
3. How to take Imipramine Hydrochloride Oral Solution
4. Possible side effects
5. How to store Imipramine Hydrochloride Oral Solution
6. Further Information

5. How to store Imipramine Hydrochloride Oral Solution



Keep out of the reach and sight of children
Keep the medicine in a cool place (below 25°C).
Keep the bottle tightly closed and in its carton when not in use.
Do not use for more than 1 month after first opening.
Do not use Imipramine Hydrochloride Oral Solution after the expiry date which is stated on the carton as {EXP MM/
YYYY}.
The expiry date refers to the last day of that month.
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.

Imipramine Hydrochloride Oral Solution contains the active ingredient imipramine. This belongs to a class of medicines
called tricyclic antidepressants and is used to treat:
n the symptoms of depression
n night-time bed-wetting in children.






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diuretic hormone secretion’ which will cause a lowering
of salt in your body
severe reduction in number of white blood cells which
makes infections more likely
reduction in blood platelets, which increases risk of
bleeding or bruising
other blood disorders
raised levels of enzymes in your liver
inflammation of the mouth or sores on the tongue.

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

6. Further Information
What Imipramine Hydrochloride Oral Solution contains
The active ingredient is imipramine. Each 5ml contains 25mg imipramine hydrochloride.
The other ingredients are betacyclodextrin (E459), sorbitol (E420), saccharin sodium (E954), hydroxyethylcellulose,
propylene glycol (E1520), banana flavour, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and water
(see end of section 2 “Important information about some of the other ingredients” for further information on sorbitol
and benzoates).
What Imipramine Hydrochloride Oral Solution looks like and contents of the pack
Imipramine Hydrochloride Oral Solution is a clear, colourless, banana-flavoured solution.
It comes in bottles of 150ml.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE.
This leaflet was last approved in 02/2013
IMJ SPC Group

1. What Imipramine Hydrochloride Oral Solution is and what it is used for

2. Before you take Imipramine Hydrochloride Oral Solution
Do not take Imipramine Hydrochloride Oral Solution if you:
n are allergic (hypersensitive) to imipramine or any other tricyclic antidepressant, or to any of the other ingredients of
Imipramine Hydrochloride Oral Solution (see Section 6, and end of Section 2)
n have serious heart or liver disease
n have narrow angle glaucoma (increased pressure in the eye)
n have difficulty in passing water
n suffer from mania
n have had a heart attack in the past 3 months
n are taking (now or recently) any other medicines for depression (particularly monoamine oxidase inhibitors [MAOIs]
such as moclobemide within the last 3 weeks).
Children under 6 years old should not take this medicine.
Take special care with Imipramine Hydrochloride Oral Solution:
Before you take this medicine tell your doctor if you have:
n epilepsy (fits) or brain damage
n severe kidney disease
n a history of low blood pressure
n a tumour of the adrenal gland (called phaeochromocytoma or neuroblastoma)
n an overactive thyroid
n constipation, especially if you are elderly or bedridden
n an intolerance to some sugars
n a withdrawal from alcohol or any anticonvulsive drugs
n electroconvulsive therapy (ECT) treatment and are taking Imipramine Hydrochloride Oral Solution – you will be
carefully supervised.
If you think that any of the above apply to you then tell your doctor before taking Imipramine Hydrochloride Oral
Solution.
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. This is because these medicines all take about two weeks
but sometimes longer to work properly.
You may be more likely to think like this if:
n you have previously had thoughts about killing or harming yourself.
n you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults less
than 25 years with psychiatric conditions who were treated with an antidepressant.

Continued overleaf

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.
While you are taking Imipramine Hydrochloride Oral Solution:
n you will need routine tests (blood, heart and liver tests) from time to time. These will be carried out by your doctor
n you will be closely monitored as improvement may not occur for the first 2 – 4 weeks of treatment
n if you already suffer from a panic disorder, you may experience an increase in your feeling of anxiety when you start
treatment with Imipramine Hydrochloride Oral Solution. This is usually worse in the first few days and should go
away in the first 2 weeks
n have regular dental check-ups as long term treatment may increase the risk of tooth decay
n if you need an operation tell your doctor that you are taking the solution
n contact lens wearers may notice reduced production of tears.
Children taking Imipramine Hydrochloride Oral Solution may have behavioural changes.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
In particular, tell your doctor if you are taking any of the following medicines, because they may interact with Imipramine
Hydrochloride Oral Solution:
n medications for depression called MAOIs (monoamine n cimetidine an anti-ulcer drug
oxidase inhibitors) such as moclobemide – see Section n methylphenidate used to treat behavioural disorders in
“Do not take Imipramine Hydrochloride Oral Solution” children
n medication for depression called SSRIs (Selective
n disulfiram or alprazolam for alcohol abuse
serotonin reuptake inhibitors) such as fluoxetine and
n barbiturates, tranquillizers (such as phenothiazines,
fluvoxamine
thioridazine or benzodiazepines), general or local
n a medication used to treat depression and to help stop anaesthetics
smoking called amfebutamone
n treatments for Parkinson’s disease such as biperiden,
n medication for heart problems such as calcium channel selegiline or entacapone
blockers (e.g. diltiazem, verapamil) or beta blockers (e.g. n medication to treat epilepsy such as carbamazepine or
labetalol, propranolol)
phenytoin
n medication for irregular heartbeat such as those
n antifungal medication such as terbinafine
containing quinidine disopyramide or amiodarone
n noradrenaline, mainly used to treat low blood pressure
n medications for high blood pressure such as
in emergencies
guanethidine, betanidine, reserpine, clonidine, alpha-
n nicotine found in cigarettes or in medications used to
methyldopa or diuretics (water tablets)
help stop smoking
n medication to treat angina that you spray or dissolve
n blood-thinning tablets (anticoagulants) e.g. warfarin
under you tongue such as glyceryl trinitrate or
n apraclonidine or brimonidine to treat glaucoma
isosorbide dinitrate
n ritonavir to treat HIV
n medication for colds, sinus problems, containing
n medication to decrease your appetite such as
decongestants such as ephedrine, phenylephrine or
sibutramine
phenylpropanolamine
n altretamine normally used to treat ovarian cancer
n antihistamines for hay fever or allergies
n painkillers such as nefopam, tramadol, codeine or
n isoprenaline used to treat asthma
dihydrocodeine
n oral contraceptives or oestrogens (e.g. hormone
n baclofen a muscle relaxant.
replacement therapy [HRT])
Taking Imipramine Hydrochloride Oral Solution with food and drink
DO NOT DRINK alcohol while you are taking this medicine.
Pregnancy and Breast-feeding
Ask your doctor for advice before taking any medicine.
Treatment with Imipramine Hydrochloride Oral Solution should be avoided during pregnancy unless your doctor
considers it necessary.
If Imipramine is taken in the last 3 months of pregnancy, your baby may be born with withdrawal symptoms. These may
be shortness of breath, tiredness, uncontrollable crying and irritability.
If you are breastfeeding, you may be advised to stop taking Imipramine Hydrochloride Oral Solution gradually, or to stop
breastfeeding, because imipramine passes into breast milk.
Driving and using machines
You may feel dizzy or sleepy or have blurred vision when you take this medicine.
DO NOT drive or operate machinery without advice from your doctor or pharmacist.

Important information about some of the other ingredients of Imipramine Hydrochloride Oral Solution
Sorbitol – 1.5g per 5ml spoonful. This may have a mild laxative effect. Also, tell your doctor if you have an hereditary
intolerance to some sugars
n Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) – may cause allergic reactions (possibly delayed).
n

3. How to take Imipramine Hydrochloride Oral Solution
Always take Imipramine Hydrochloride Oral Solution exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Depression:
Adults: At first, one 5ml spoonful (25mg) one to three times a day. Your doctor may increase
your dose gradually as needed. However, the dose is usually not more than 6 to 8 spoonfuls
(150-200mg) a day unless you are in hospital.
Elderly: Your doctor may prescribe lower doses of Imipramine Hydrochloride Oral Solution,
particularly when you first start taking this medicine.
Night-time Bed-wetting
Children over 6 years: 1 to 3 spoonfuls (25mg-75mg) a day at bedtime depending on the age and weight of the child.
Treatment with Imipramine Hydrochloride Oral Solution must be checked after 3 months.
Keep taking your medicine until your doctor tells you to stop. Do not stop suddenly because you do not feel any better –
the solution may take up to 4 weeks to work.
If you take more Imipramine Hydrochloride Oral Solution than you should
If you (or a child) accidentally take too much Imipramine Hydrochloride Oral Solution, tell your doctor at once or contact
your hospital casualty department. Overdosage in children is serious and could be potentially fatal.
If you forget to take Imipramine Hydrochloride Oral Solution
It is important to take your medicine at the right times. If you forget to take a dose, take the next dose at the usual time
DO NOT take a double dose to make up for the forgotten dose.
If you stop taking Imipramine Hydrochloride Oral Solution
Keep taking your medicine until your doctor tells you to stop. Do not stop suddenly because you do not feel any better. If
you need to stop treatment, your doctor will tell you how to reduce the dose gradually. This is to help prevent unwanted
effects such as headache, sickness, stomach upset, diarrhoea, sleeplessness, nervousness and anxiety.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Imipramine Hydrochloride Oral Solution can cause side effects, although not everybody gets them.
Allergic reactions – skin rash or itching, swelling of the face, lips, tongue or throat, or difficultly in breathing may be
signs of an allergic reaction. If this happens, STOP taking Imipramine Hydrochloride Oral Solution and seek medical
advice.
Serious side effects: tell a doctor straight away
n if you feel more depressed, including thinking about suicide
n trembling
The most common side effects are:
n dry mouth
n weight gain
n blurred vision
n fast heartbeat
n headache
n light headedness (especially when getting up
n hot flushes, sweating
from lying or sitting position).
n constipation
The above effects are often mild and may disappear during treatment. If they are severe or last for more than a few days,
tell your doctor.
You are unlikely to experience any of the following side effects but if you do – see your doctor as soon as possible.
n drowsiness, tiredness
n increased sensitivity to sunlight
n dizziness
n sexual difficulties
n restlessness, anxiety, irritability
n ringing in the ears
n nausea (feeling sick)
n mood changes, aggression
n any yellowing of your skin or the whites of your eyes
n activation of psychotic symptoms
n sore throat or fever
n vomiting, loss of appetite, weight loss
n glaucoma (increased pressure in the eye)
n paralytic ileus (no bowel movement)
n difficulty in passing water
n diarrhoea
n hair loss
n stomach pain
n swelling of the breasts and discharge of milk
n any general swelling
n dilation of the pupils
n tingling or numbness
Continued overleaf

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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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