Patient leaflet - Imipramine Hydrochloride 25 mg / 5 ml oral solution
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.
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.
If you think that any of the above apply to you then tell your doctor before taking Imipramine Hydrochloride Oral Solution. The use of Buprenorphine together with Imipramine Hydrochloride can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Imipramine Hydrochloride).
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. Continued overleaf
Patient Information Leaflet
Imipramine Hydrochloride 25mg/5ml Oral Solution
Imi25mgin5mlSoln-PL-UK-3
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:
n medications for depression called MAOIs
(monoamine oxidase inhibitors) such as
moclobemide – see Section
“Do not take Imipramine Hydrochloride Oral
Solution”
n buprenorphine/opioids (naloxone, tramadol, codeine or
dihydrocodeine) - These medicines may interact with
imipramine and you may experience symptoms such
as involuntary, rhythmic contractions of muscles,
including the muscles that control movement of the
eye, agitation, hallucinations, coma, excessive sweating,
tremor, exaggeration of reflexes, increased muscle
tension, body temperature above 38°C. Contact your
doctor when experiencing such symptoms
n medication for depression called SSRIs (Selective
serotonin reuptake inhibitors) such as fluoxetine and
fluvoxamine
n a medication used to treat depression and to help
stop smoking called amfebutamone
n medication for heart problems such as calcium
channel blockers (e.g. diltiazem, verapamil) or beta
blockers (e.g. labetalol, propranolol)
n medication for irregular heartbeat such as those
containing quinidine disopyramide or amiodarone
n medications for high blood pressure such as
guanethidine, debrisoquine, betanidine, reserpine,
clonidine, alpha-methyldopa or diuretics (water tablets)
n medication to treat angina that you spray or dissolve
under you tongue such as glyceryl trinitrate or
isosorbide dinitrate
n medication for colds, sinus problems, containing
decongestants such as phenylephrine or
phenylpropanolamine
n antihistamines for hay fever or allergies n isoprenaline used to treat asthma
n oral contraceptives or oestrogens (e.g. hormone
replacement therapy [HRT])
n cimetidine an anti-ulcer drug
n methylphenidate used to treat behavioural disorders
in children
n disulfiram or alprazolam for alcohol abuse n barbiturates, tranquillizers (such as phenothiazines,
thioridazine or benzodiazepines), general or local anaesthetics
n treatments for Parkinson’s disease such as
biperiden, selegiline or entacapone
n medication to treat epilepsy such as carbamazepine
or phenytoin
n antifungal medication such as terbinafine n noradrenaline, adrenaline and ephedrine, mainly
used to treat low blood pressure in emergencies n nicotine found in cigarettes or in medications used to
help stop smoking
n blood-thinning tablets (anticoagulants) e.g. warfarin n apraclonidine or brimonidine to treat glaucoma n ritonavir to treat HIV
n medication to decrease your appetite such as
sibutramine
n altretamine normally used to treat ovarian cancer n nefopam, a painkiller
n 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.
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.
Imipramine Hydrochloride Oral Solution contains methyl and propyl hydroxybenzoates, sorbitol and propylene glycol:
n methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) – may cause allergic reactions (possibly delayed)
n sorbitol (E420). This medicine contains 1.05g in each
5ml spoonful. Sorbitol is a source of fructose. If your
doctor has told you that you (or your child) have an
intolerance to some sugars or if you have been
diagnosed with hereditary fructose intolerance (HFI), a
rare genetic disorder in which a person cannot break
down fructose, talk to your doctor before you (or your
child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
n propylene glycol (E1520). This medicine contains 510.4mg propylene glycol in each 5ml spoonful. If you are pregnant, breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. n This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium free’.
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 difficulty 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
n trembling
n weight gain
n fast heartbeat
n light headedness (especially when getting up from lying or sitting position).
Continued overleaf Imi25mgin5mlSoln-PL-UK-3
n muscle weakness or stiffness, muscle spasm n difficulty in controlling movements
n changes to the electrical waves in your brain n difficulty in speaking
n 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-
diuretic hormone secretion’ which will cause a lowering of salt in your body
n severe reduction in number of white blood cells
which makes infections more likely
n reduction in blood platelets, which increases risk of
bleeding or bruising
n other blood disorders
n raised levels of enzymes in your liver
n impaired liver function
n 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. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
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 solution 70% (E420), saccharin sodium (E954), hydroxyethylcellulose, propylene glycol (E1520), banana flavour, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (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
Essential Pharma Ltd, 8a Crabtree Road, Egham, Surrey, TW20 8RN, UK.
Manufacturer
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. This leaflet was last revised in 06/2024.