Patient leaflet - Nortriptyline 25 mg film-coated tablets
1. WHAT NORTRIPTYLINE TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine contains nortriptyline.
Nortriptyline Tablets are used in the treatment of symptoms of depression in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE TABLETS:
Do not take Nortriptyline if:
you are allergic (hypersensitive) to Nortriptyline or any of the
other ingredients of Nortriptyline Tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue;
- you have had a recent heart attack or heartbeat disorder;
- you have severe liver disease;
- you suffer from mania (abnormally raised mood);
you are breast-feeding;
you are taking, or have taken in the last two weeks,
monoamine oxidase inhibitors (another type of antidepressant);
you are taking adrenaline-like drugs including ephedrine,
isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These drugs are often contained in cough and cold remedies.
Warnings and precautions
Talk to your doctor before taking these tablets if:
- you have a cardiac condition called Brugada syndrome
- you feel suicidal or aggressive – tell your doctor;
- you are agitated, overactive, or suffer from schizophrenia;
- you have heart disease;
- you have a thyroid condition;
- you have a history of epilepsy;
- you have high pressure in the eyes (glaucoma);
- you have an enlarged prostate;
you are going to have electroconvulsive therapy (electric
shock);
- you are diabetic;
you are going to receive an anaesthetic, e.g. for an operation
- tell your doctor;
you have had an allergic reaction to another tricyclic
antidepressant in the past;
you are pregnant, think you might be pregnant or planning to
become pregnant or breast-feeding you should not take Nortriptyline Tablets unless your doctor tells you to.
If you use Buprenorphine together with Nortriptyline tablets
can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Nortriptyline tablets”).
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, 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 previously had thoughts about killing or
harming yourself;
If you are a young adult. Information from clinical trials has
shown an increased risk of suicidal behaviour in adults aged 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 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.
If any of these points apply to you, tell your doctor or pharmacist. Other medicines and Nortriptyline Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
The following medicines may interact with your Nortriptyline Tablets:
- guanethidine, debrisoquine, bethanidine, clonidine (used to treat high blood pressure);
- barbiturates (used for anxiety or to make you feel sleepy);
alcohol (you should not drink alcohol);
- fluoxetine (another antidepressant);
- cimetidine (for heartburn and ulcers);
- phenothiazines (for mental illness);
- carbamazepine (for epilepsy);
- propafenone, flecainide, encainide, quinidine (for heartbeat disorders).
- Valproic acid (medicine used for the treatment of epilepsy and bipolar disorder)
Buprenorphine/opioids: These medicines may interact with
Nortriptyline tablets 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
It may still be all right for you to be given Nortriptyline Tablets. Your doctor will be able to decide what is suitable for you. Driving and using machines
Nortriptyline Tablets may affect alertness. Use caution when driving or operating
heavy machinery until you’re aware of how this drug affects you. If you feel Nortriptyline Tablets affect your ability to drive or use machines, tell your doctor immediately.
Nortriptyline Tablets contains lactose
If you are lactose intolerant, contact your doctor before taking this medicine.
Nortriptyline 25 mg Tablets contain sunset yellow (E110), which may cause allergic reactions.
3. HOW TO TAKE NORTRIPTYLINE TABLETS
Always take Nortriptyline Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be given once
a day, usually at night. The dose should begin at a low level, 10mg, 3-4 times daily, for example and be increased gradually as required. The maximum dose is 150mg per day. Elderly:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start with 10mg
three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses. Treatment may start with 10mg three times a day. Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision.
Following remission maintenance treatment may be needed longer term. This should be at the lowest dose that stops the symptoms of depression coming back.
If you take more Nortriptyline Tablets than you should
Go to the nearest casualty department or contact your doctor immediately. Take the tablet carton with you.
If you forget to take Nortriptyline Tablets
If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose.
If you stop taking Nortriptyline Tablets
Do not stop taking the tablets or reduce the dose without telling your doctor first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a headache or feel generally unwell. 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. 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.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor straight away if you get any sudden wheezi-ness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body.
The following side effects have been reported:
Very common: may affect more than 1 in 10 people:
- low or high blood pressure
- fast or irregular heartbeat
- palpitations
- heart attack (myocardial infarction)
- stroke
- blurred vision,
- feeling sick (nausea) and vomiting
- not eating (anorexia)
- indigestion
- diarrhoea
- constipation.
- peculiar taste
- inflamed mouth
- abdominal cramps
- black tongue
- weight gain or loss
- sweating
- flushing
- urinating often and at night
- sleepiness
- dizziness
- weakness
- tiredness
- headache
- swollen glands
- hair loss (alopecia).
Rare: may affect up to 1 in 1,000 people:
confusion (especially in the elderly) with seeing or hearing
things (hallucinations)
- difficulty in focusing
- dilated pupils
- constipation, blockage of the digestive tract
inflamed glands under the tongue or inflammation of the
gums (gingivitis)
- unable to urinate or delayed urination
Very rare: may affect up to 1 in 10,000 people:
- alterations in brain functions
- development of breasts in men
- breast enlargement and milk production in women
- increased or decreased sex drive
- failure to have an erection (impotence)
- swollen testicles
- altered blood sugar levels
- yellow eyes and skin (jaundice)
- altered liver function
- inflamed liver (hepatitis) and liver damage
blood disorders which may cause you to bruise easily,
become anaemic or be unable to fight off infections Frequency unknown:
Brugada Syndrome (unmasking) (symptoms may include
very fast heartbeat, dizziness, fainting, seizures). Tell your doctor straight away if you get these symptoms.
- not knowing where you are (disorientation)
- oedema (swelling of the ankles)
- false beliefs (delusions)
- anxiety, restlessness, agitation
- not sleeping (insomnia)
- nightmares
- panic
- long-lasting abnormal mood
- worsening of mental illness
- numbness, tingling, pins and needles in the hands or feet
- disorder of the peripheral nerves
- co-ordination problems
- tremors
- Low sodium concentration in the blood
- abnormal movements
- altered brainwave (ECG) patterns
- ringing in the ears (tinnitus)
- rash
- light sensitivity
- fever
- reaction to other similar drugs
- syndrome of inappropriate secretion of antidiuretic hormone
fits (seizures)
- dry mouth
- itching
- swelling (oedema)
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 national reporting system via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE NORTRIPTYLINE TABLETS
- Keep out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the blister, carton or bottle after EXP. The expiry date refers to the last day of that month.
- This medicine does not require any special storage condi-tions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.
6. CONTENTS OF PACK AND OTHER INFORMATION What Nortriptyline Tablets contain:
The active substance is nortriptyline hydrochloride. Each tablet contains the equivalent to 10mg or 25mg of nortriptyline base. The other ingredients are:
Nortriptyline 10 mg
Lactose Monohydrate, Anhydrous Calcium Hydrogen Phosphate, Maize Starch,
Magnesium Stearate, Hypromellose (HPMC E-5), Macrogol (PEG 6000).
Nortriptyline 25 mg
Lactose Monohydrate, Anhydrous Calcium Hydrogen Phosphate, Maize Starch, Magnesium Stearate, Hypromellose (HPMC E-5), Macrogol (PEG 6000), Sunset Yellow Lake (E-110) and Titanium dioxide (E-171).
What Nortriptyline Tablets looks like and contents of the pack
Nortriptyline 10 mg Tablets are white to off coloured, round biconvex, film-coated
tablets, debossed with ‘N’ on one side and 10 on other side. Nortriptyline 25 mg Tablets are orange coloured, round biconvex, film-coated tablets, debossed with ‘N25’ on one side and scored on other side.
The Tablets are available in PVC/aluminium blister packs of 10s, 30s, 100s.
The Tablets are available in HDPE container with Polypropylene screw on cap pack size: 100 tablets. Discard 60 days after first opening the container
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
RUDIPHARM LIMITED
Unit 6, Salbrook Road Industrial Estate
Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom Manufacturer:
RUDIPHARM LIMITED
Oak House, Reeds Crescent,
Watford, WD24 4QP, UK
To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293 827819 (UK only)
Please be ready to give the following information:
Product name Reference number Nortriptyline 10mg tablets PL 49565/0090 Nortriptyline 25mg tablets PL 49565/0091
This leaflet was last revised in March 2026.
Nortriptyline Tablets - PIL
Nortriptyline Tablets
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