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IMIPRAMINE HYDROCHLORIDE 25MG/5ML ORAL SOLUTION

Active substance(s): IMIPRAMINE HYDROCHLORIDE / IMIPRAMINE HYDROCHLORIDE / IMIPRAMINE HYDROCHLORIDE

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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 muscle weakness or stiffness, muscle spasm
n dizziness
n difficulty in controlling movements
n restlessness, anxiety, irritability
n changes to the electrical waves in your brain
n nausea (feeling sick)
n difficulty in speaking
n any yellowing of your skin or the whites of your eyes
n inflammation of the lungs which causes
n sore throat or fever
breathlessness, cough and raised temperature
n glaucoma (increased pressure in the eye)
n feeling your heartbeat or irregular heartbeat
n difficulty in passing water
n heart failure
n hair loss
n red or brownish spots on skin
n swelling of the breasts
n fits, confusion or delirium
and discharge of milk
n sleep disturbances or
n dilation of the pupils
difficulty in sleeping
n increased sensitivity to
n raised blood pressure
sunlight
n low blood pressure
n sexual difficulties
n hallucinations
n ringing in the ears
n believing in things that are not real (delusions)
n mood changes, aggression
n change in blood sugar levels
n activation of psychotic symptoms
n a condition called ‘syndrome of inappropriate anti-
n vomiting, loss of appetite, weight loss
diuretic hormone secretion’ which will cause a lowering
n paralytic ileus (no bowel movement)
of salt in your body
n diarrhoea
n severe reduction in number of white blood cells which
n stomach pain
makes infections more likely
n any general swelling
n reduction in blood platelets, which increases risk of
n tingling or numbness
bleeding or bruising
n poor blood circulation which makes the toes and
n other blood disorders
fingers numb and pale
n raised levels of enzymes in your liver
n skin rash or itching
n impaired liver function
n darkening of skin
n inflammation of the mouth or sores on the tongue.
n loss of balance
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 or pharmacist. 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 Hydrochloride Oral Solution
Keep this medicine out of the sight and reach 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 this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.

Patient Information Leaflet
Imipramine Hydrochloride 25mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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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 only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
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.

What is in this leaflet
1. What Imipramine Hydrochloride Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information

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

2. What you need to know before you take Imipramine Hydrochloride Oral Solution
Do not take Imipramine Hydrochloride Oral Solution if:
n you are allergic to imipramine or any other tricyclic antidepressant, or to any of the other ingredients of this medicine
(listed in Section 6, and end of Section 2)
n you have serious heart or liver disease
n you have narrow angle glaucoma (increased pressure in the eye)
n you have difficulty in passing water
n you suffer from mania
n you suffer with porphyria - a genetic disorder of the red blood cells (haemoglobin) causing skin blisters, abdominal
pain and brain/nervous system disorders
n you have had a heart attack in the past 3 months
n you 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.

What Imipramine Hydrochloride Oral Solution looks like and contents of the pack
Imipramine Hydrochloride Oral Solution is a clear, colourless, banana-flavoured solution.

Warnings and precautions
Talk to your doctor or pharmacist before taking Imipramine Hydrochloride if you have:
n epilepsy (fits) or brain damage
n severe kidney disease
n a history of low blood pressure or poor circulation
n a tumour of the adrenal gland (called phaeochromocytoma or neuroblastoma)
n an overactive thyroid and are taking medicines to treat a thyroid disorder
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.

It comes in bottles of 150ml.

If you think that any of the above apply to you then tell your doctor before taking Imipramine Hydrochloride Oral Solution.

Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE.

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.
Continued overleaf

6. Contents of the pack and other 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).

This leaflet was last revised in 05/2016.

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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.
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.
Other medicines and Imipramine Hydrochloride
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:
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medications for depression called MAOIs (monoamine
oxidase inhibitors) such as moclobemide – see Section
“Do not take Imipramine Hydrochloride Oral Solution”
medication for depression called SSRIs (Selective
serotonin reuptake inhibitors) such as fluoxetine and
fluvoxamine
a medication used to treat depression and to help stop
smoking called amfebutamone
medication for heart problems such as calcium channel
blockers (e.g. diltiazem, verapamil) or beta blockers (e.g.
labetalol, propranolol)
medication for irregular heartbeat such as those
containing quinidine disopyramide or amiodarone
medications for high blood pressure such as
guanethidine, debrisoquine, betanidine, reserpine,
clonidine, alpha-methyldopa or diuretics (water tablets)
medication to treat angina that you spray or dissolve
under you tongue such as glyceryl trinitrate or
isosorbide dinitrate
medication for colds, sinus problems, containing
decongestants such as phenylephrine or
phenylpropanolamine
antihistamines for hay fever or allergies
isoprenaline used to treat asthma
oral contraceptives or oestrogens (e.g. hormone
replacement therapy [HRT])

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cimetidine an anti-ulcer drug
methylphenidate used to treat behavioural disorders in
children
disulfiram or alprazolam for alcohol abuse
barbiturates, tranquillizers (such as phenothiazines,
thioridazine or benzodiazepines), general or local
anaesthetics
treatments for Parkinson’s disease such as biperiden,
selegiline or entacapone
medication to treat epilepsy such as carbamazepine or
phenytoin
antifungal medication such as terbinafine
noradrenaline, adrenaline and ephedrine, mainly used
to treat low blood pressure in emergencies
nicotine found in cigarettes or in medications used to
help stop smoking
blood-thinning tablets (anticoagulants) e.g. warfarin
apraclonidine or brimonidine to treat glaucoma
ritonavir to treat HIV
medication to decrease your appetite such as
sibutramine
altretamine normally used to treat ovarian cancer
painkillers such as nefopam, tramadol, codeine or
dihydrocodeine
baclofen a muscle relaxant.

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.
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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
n 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)
.

3. How to take Imipramine Hydrochloride Oral Solution

Always take this medicine exactly as your doctor or pharmacist has told you. 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, this medicine 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
The most common side effects are:
n dry mouth
n blurred vision
n headache
n hot flushes, sweating
n constipation

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trembling
weight gain
fast heartbeat
light headedness (especially when getting up
from lying or sitting position).

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.
Continued overleaf

Expand Transcript

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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