Active ingredient
- imipramine hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0206.
Imipramine Hydrochloride 25mg/5ml Oral Solution
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.
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:
2. What you need to know before you take Imipramine Hydrochloride Oral Solution
Do not take Imipramine Hydrochloride Oral Solution if:
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:
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:
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:
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:
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:
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
The most common side effects are:
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.
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 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
This leaflet was last revised in 11/2020.
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879