Active ingredient
- lofepramine 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: PL 00427/0094.
Lofepramine Rosemont 70mg/5ml Oral Suspension
Package leaflet: Information for the user
Lofepramine Rosemont 70mg/5ml Oral Suspension
What is in this leaflet
1. What Lofepramine Rosemont is and what it is used for
2. What you need to know before you take Lofepramine Rosemont
3. How to take Lofepramine Rosemont
4. Possible side effects
5. How to store Lofepramine Rosemont
6. Contents of the pack and other information
1. What Lofepramine Rosemont is and what it is used for
The name of your medicine is Lofepramine Rosemont 70mg/5ml Oral Suspension (called Lofepramine in this leaflet).
This belongs to a group of medicines called tricyclic antidepressants.
Lofepramine alters the levels of chemicals in your brain to relieve the symptoms of depression.
Lofepramine can be used to treat the symptoms of depression.
2. What you need to know before you take Lofepramine Rosemont
Do not take Lofepramine and tell your doctor if:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Lofepramine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lofepramine if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lofepramine.
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.
Children and adolescents
Lofepramine is not suitable for use in children or adolescents under the age of 18.
Having operations and tests
Tell your doctor, anaesthetist or dentist that you are taking lofepramine if you are going to have an anaesthetic for an operation or dental treatment.
Other medicines and Lofepramine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines bought without a prescription, including herbal medicines.
Do not take Lofepramine if you are taking the following medicines:
In particular tell your doctor if you are taking any of the following medicines:
Also:
Lofepramine with food, drink and alcohol
Do not drink alcohol whilst taking Lofepramine.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Babies born to mothers who have taken tricyclic antidepressants may suffer from withdrawal symptoms, difficulty in breathing and agitation.
Talk to your doctor before breast-feeding because Lofepramine passes into breast milk.
Driving and using machines
Lofepramine may make you feel drowsy. If you experience this, do not drive or use machinery. The amount of alcohol in Lofepramine may also affect your ability to drive or use machines.
Lofepramine Rosemont contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, liquid maltitol, sorbitol solution and ethanol.
3. How to take Lofepramine Rosemont
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
The usual doses are given below. These may be changed by your doctor:
Adults
The usual dose is 70mg (5ml of suspension) two to three times a day.
Older people
Your doctor will start you on a lower dose and gradually increase it as you may be more sensitive to the medicine.
Children
This medicine should not be used in children.
If you take more Lofepramine than you should
If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.
If you forget to take Lofepramine
If you stop taking Lofepramine
Do not stop taking the medicine unless your doctor tells you to. If you stop taking the medicine abruptly, you may get withdrawal effects such as feeling irritable, unable to sleep and sweating more than usual.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Stop taking Lofepramine and see a doctor straight away if you have:
Serious side effects: tell a doctor straight away
If you get any of the following side effects, see your doctor as soon as possible:
Tell your doctor if you get any of these side effects:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Website: 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 Lofepramine Rosemont
6. Contents of the pack and other information
What Lofepramine Rosemont contains
What Lofepramine Rosemont looks like and contents of the pack
A white to pale yellow/orange suspension with a cherry odour.
It comes in a brown glass bottle holding 150ml of suspension.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 11/2015
H8XD1RBJ1
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