Patient Leaflet Updated 10-Dec-2019 | Kent Pharma UK Ltd
Nortriptyline 10 mg & 25 mg Capsules
Package leaflet: Information for the user
Nortriptyline 10 mg Capsules
Nortriptyline 25 mg Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Nortriptyline hydrochloride (referred to as Nortriptyline in the remainder of the leaflet)
WHAT IS IN THIS LEAFLET
1. What Nortriptyline is and what it is used for
2. What you need to know before you take Nortriptyline
3. How to take Nortriptyline
4. Possible side effects
5. How to store Nortriptyline
6. Contents of the pack and other information
1. WHAT NORTRIPTYLINE IS AND WHAT IT IS USED FOR
Nortriptyline is a medicine used to treat major depression in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE
Do not take Nortriptyline if:
Warnings and precautions
Talk to your doctor or pharmacist before taking Nortriptyline 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 heartbeat) have been reported with Nortriptyline.
Tell your doctor if you:
Thoughts of suicide and worsening of your depression
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.
Children and adolescents
Do not give this medicine to children and adolescents aged below 18 years for these treatments as safety and efficacy have not been established in this age group.
Other medicines and Nortriptyline
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.
Nortriptyline with alcohol
You should not drink alcohol during treatment with Nortriptyline Capsules as alcohol might increase the sedative effect.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nortriptyline is not recommended 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.
Your doctor will advise you whether to start/continue/stop breast-feeding, or stop using this medicine taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Driving and using machines
Do not drive or work with tools or machinery while you are on Nortriptyline 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 contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE NORTRIPTYLINE
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate form/strength should be selected for the starting doses and any subsequent dose increases.
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start at a low level (10-20 mg daily) and may be increased as required to the maximum dose of 50mg. If you require a dose of 50mg 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.
Use in children and adolescent patients:
Nortriptyline 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.
If you take more Nortriptyline than you should
Do not take more capsules than your doctor tells you to. If you ever take too many, 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, hypokalaemia.
An overdose can be very dangerous.
If you forget to take Nortriptyline
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.
If you stop taking Nortriptyline
Antidepressants may not make you feel better for the first two weeks or more of treatment, so keep taking Nortriptyline Capsules until your doctor tells you to stop. Do not stop these capsules without discussing it with your doctor first. If you stop using Nortriptyline Capsules abruptly after prolonged therapy you may have withdrawal symptoms, including not being able to sleep, headache, nausea, irritability and sweating.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following:
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
An increased risk of bone fractures has been observed in patients taking this type of medicines.
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 NORTRIPTYLINE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on bottle, blister or carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nortriptyline contains
What Nortriptyline looks like and contents of the pack
10 mg – Size 4 capsules with opaque yellow caps and opaque white bodies with “APO 10” with white to off-white powder.
25 mg – Size 2 capsules with opaque yellow caps and opaque white bodies with “APO 25” with white to off-white powder.
Nortriptyline 10 mg and 25 mg capsules are supplied in cartons containing 100 capsules or bottles containing 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in July 2019
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