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Nortriptyline Colonis 10mg/ 5ml Oral Solution
Nortriptyline Colonis 10mg/ 5 ml Oral Solution
1. What Nortriptyline Oral Solution is and what it is used for
2. What you need to know before you take Nortriptyline Oral Solution
3. How to take Nortriptyline Oral Solution
4. Possible side effects
5. How to store Nortriptyline Oral Solution
6. Contents of the pack and other information
Nortriptyline Colonis 10mg/ 5ml Oral Solution (referred to as Nortriptyline Oral Solution in this leaflet) contains the active ingredient nortriptyline, which is a tricyclic antidepressant.
Nortriptyline Oral Solution is used to treat major depression in adults.
Talk to your doctor or pharmacist before taking Nortriptyline Oral Solution if
Prolonged QT interval
A heart problem called "prolonged QT interval" (which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with Nortriptyline. Tell your doctor if you:
If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
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 and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
If any of the above applies to you, tell your doctor or pharmacist.
Children and adolescents
Do not give this medicine to children and adolescents aged below 18 years as safety and efficacy have not been established in this age group.
Some medicines may affect the action of other medicines and this can sometimes cause serious side effects.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:
You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm.e.g.:
If you are going to have an operation and receive general or local anaesthetics, you should tell your doctor that you are taking this medicine. Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.
You should not drink alcohol while you are being treated with Nortriptyline Oral Solution as alcohol might increase the sedative effect of nortriptyline.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nortriptyline should not be used during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention and constipation.
Do not take Nortriptyline Oral Solution if you are breast-feeding.
Do not drive or use machinery when you are on Nortriptyline Oral Solution unless you are sure your judgement and co-ordination are not affected. Antidepressants may affect your ability to drive or to operate machinery safely.
Nortriptyline Colonis 10mg/5ml Oral Solution contains sodium benzoate and sodium.
This medicine contains 0.50 mg sodium benzoate in each ml.
This medicine contains less than 1 mmol sodium (23 mg) per 75ml oral solution, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Note: For doses over 20mg (10ml), Nortriptyline Colonis 25mg/5ml Oral Solution should be used.
The usual dose is 30 to 50 mg/day (15 to 25 ml/day) in divided doses.
Treatment may start at a low level 10-20 mg daily (5-10 ml daily) and may be increased as required to the maximum dose of 50mg (25ml). If you require a dose of 50mg (25ml) or over, your doctor will arrange for you to have a recording of your heart (ECG) and blood tests.
In case of renal impairment, your doctor will increase or decrease the dose carefully and gradually. In most cases, however, the usual dosage will be given.
Patients with liver diseases or people known as "poor metabolisers" usually receive lower doses. Your doctor may take blood samples to determine the level of nortriptyline in the blood. Do not take Nortriptyline Oral Solution if you have severe liver disease (see section 2 Do not take Nortriptyline Oral Solution).
Use in children and adolescent patients:
Nortriptyline Oral Solution should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established.
Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision.
Duration of treatment
It may take a few weeks before you feel any improvement. Following remission maintenance treatment may be needed longer term, usually up to 6 months. This should be at the lowest dose that stops the symptoms of depression coming back.
Nortriptyline Oral Solution is for oral use.
A double-ended dosing spoon is provided with the product. The small spoon measures a 2.5 ml dose and the larger spoon measures 5 ml.
Pour the liquid into the dosing spoon according to your dose. Do not overfill the spoon.
After taking your dose you should wash the dosing spoon with water and leave to air dry.
Do not take more oral solution than your doctor tells you to. If you ever take too much, or if a child has taken any nortriptyline, go to the nearest hospital casualty department or tell your doctor at once.
Symptoms of overdose include blurred vision, fast or irregular heartbeats, difficulties passing water, dry mouth and tongue, intestinal blockage, fits, fever, agitation, confusion, hallucinations, uncontrolled movements, low blood pressure, weak pulse, pallor, difficulty breathing, blue discolouration of the skin, decreased heart rate, drowsiness, loss of consciousness, coma, various cardiac symptoms such as heart block, heart failure, cardiogenic shock, metabolic acidosis and hypokalaemia.
An overdose can be very dangerous.
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. If you have missed several doses, discuss this with your doctor.
Antidepressants may not make you feel better for the first two weeks or more of treatment, so keep taking Nortriptyline Oral Solution until your doctor tells you to stop. Do not stop taking the oral solution or reduce the dose without telling your doctor first.
If you stop using Nortriptyline Oral Solution abruptly after prolonged therapy you may have withdrawal symptoms, including not being able to sleep, headache, nausea, irritability and sweating.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have also been reported:
Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Not known: frequency cannot be estimated from the available data
Abrupt cessation of treatment after prolonged therapy may cause nausea, headache and malaise, these are withdrawal symptoms.
There may be an increased risk of bone fractures in patients 50 years and older taking nortriptyline.
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 Yellow Card Scheme Website: 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
After first opening use within 3 months.
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 protect the environment.
Nortriptyline Oral Solution is a clear colourless and odourless solution. It is supplied in a 250 ml, amber, type III glass bottle, safely closed with a child-resistant, screw cap with tamper evident closure.
A double-ended dosing spoon is also provided to measure doses as prescribed by the doctor.
This leaflet was last revised in August 2021.