Patient leaflet - Nortriptyline 25 mg tablets
1. What Nortriptyline Tablets are and what they are used for
Nortriptyline belongs to a class of medicines called tricyclic antidepressants. Nortriptyline tablets are used to treat major depression in adults.
2. What you need to know before you take Nortriptyline Tablets
You should not take Nortriptyline Tablets until you are sure it is safe for you to do so. Nortriptyline Tablets are for adults only.
Do not take Nortriptyline Tablets if you:
- are allergic to nortriptyline or any of the other ingredients of this medicine (listed in section 6)
- have recently had a heart attack or if you have other heart problems such as palpitations or irregular heartbeats
- have severe liver disease
- suffer from mania (abnormally raised mood)
- are breast-feeding
are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (e.g.
phenelzine, isocarboxazid or tranylcypromine). If you are taking moclobemide you must stop this at least 24 hours before starting nortriptyline
- 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 or pharmacist before taking Nortriptyline Tablets if you:
- are having an operation under general anaesthetic, discuss this with your GP. You may need to stop taking Nortriptyline Tablets several days before the operation. If your GP tells you to carry on taking Nortriptyline Tablets, make sure the doctors treating you in hospital know that you are taking Nortriptyline.
- have thyroid problems
- have suffered from an allergic type reaction with another tricyclic antidepressant, as cross sensitivity may occur
- ever had epilepsy
- are diabetic
- have an enlarged prostate
- have glaucoma or raised intra-ocular pressure
- are agitated or suffer from schizophrenia
- have low blood pressure or heart failure
- have suffered from urinary retention
- are taking medicines containing buprenorphine, including buprenorphine/naloxone used for treatment of opioid addiction. The use of these medicines together with Nortriptyline Tablets can lead to
serotonin syndrome, a potentially life-threatening condition (see “Other medicines and
Nortriptyline Tablets”)
- have a cardiac condition called Brugada syndrome.
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 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.
Other medicines and Nortriptyline Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should not take Nortriptyline Tablets without discussing with your doctor if you are taking any of the following medicines:
- moclobemide - you must stop this at least 24 hours before starting nortriptyline
- medicine for your heart or for high blood pressure
- cimetidine
- any other medicines including other antidepressants or medicine for bowel complaints, breathing difficulties, bronchitis, glaucoma or prostate trouble
- levothyroxine
- antifungal medicines such as fluconazole and terbinafine
- antihistamines - astemizole or terfenadine
- the pain killer tramadol
- medicines containing buprenorphine, including buprenorphine/naloxone used for treatment of opioid addiction. These medicines may interact with nortriptyline 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
- valproic acid (used for the treatment of epilepsy and bipolar disorder).
Nortriptyline Tablets with food, drink and alcohol
You should not drink alcohol while you are being treated with Nortriptyline Tablets. You may find that you get more drunk or feel more depressed.
Pregnancy and breast-feeding
Do not take Nortriptyline Tablets if you are breast-feeding.
The safety of nortriptyline for use during pregnancy has not been established. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or use machinery when you are on Nortriptyline Tablets 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 Tablets contain lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Nortriptyline Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults
- The usual dose an adult will start on is 25mg two to three times daily. You will usually be told to increase your dose gradually (no more rapidly than by 25mg every other day) until you are taking the usual maintenance dose of 75 to 100mg a day. Once you feel better, you will be told to carry on taking Nortriptyline Tablets at the same dose. Do not take more than six 25mg tablets a day (150mg).
- If your doctor tells you to take more than four 25mg tablets a day, they may arrange for you to have regular blood tests.
- If you are elderly, you will usually be told to start on one 10mg tablet three times a day. Dose increases should also be gradual by no more than 10mg every other day. 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.
- Antidepressants may not make you feel better for the first two weeks or more of treatment, so keep taking Nortriptyline Tablets until your doctor tells you to stop. Do not stop these tablets without discussing it with your doctor first.
- Do not suddenly stop taking the tablets. Your doctor will tell you how to cut them down gradually.
Use in children and adolescents
Nortriptyline should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established.
If you take more Nortriptyline Tablets than you should
Do not take more tablets 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. An overdose can be very dangerous.
If you forget to take Nortriptyline Tablets
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 Tablets
If you stop taking Nortriptyline Tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects get 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 wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body.
Tell your doctor or pharmacist immediately if you experience any of the following serious side effects:
- sudden chest pain which may spread to the neck or arm, with a shortness of breath and a clammy feeling (these may be signs of a heart attack)
- sudden collapse, numbness or weakness in the arms or legs, headache, dizziness and confusion, disturbances in vision, difficulty swallowing, slurred, mixed up or loss of speech (these may be signs of a stroke)
- bruising, bleeding, pallor or persistent sore throat and fever. These symptoms can be the first signs that your blood or bone marrow may be affected. Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting).
- persistent constipation with a swollen stomach, fever and vomiting. These symptoms may be due to parts of the intestine becoming paralysed.
- inflammation of the liver, yellowing of your skin or whites of your eyes, dark urine, pale stools, tiredness, fever, nausea, weakness, drowsiness and abdominal pain, with test results showing abnormal liver function
- thoughts of harming or killing yourself at any time (see section 2)
- Brugada Syndrome (unmasking) (symptoms may include very fast heartbeat, dizziness, fainting, seizures).
The following side effects have also been reported:
- fast or irregular heartbeat (palpitations)
- abnormal heart rhythm
- swelling of the ankles, feet or legs (oedema)
- confusion (especially in the elderly) with seeing or hearing things (hallucinations)
- not knowing where you are (disorientation)
- 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
- co-ordination problems
- tremors
- abnormal movements
- fits (seizures)
- altered brainwave (EEG) patterns
- ringing in the ears (tinnitus)
- dry mouth
- rarely, inflamed glands under the tongue or inflammation of the gums (gingivitis)
- blurred vision, difficulty in focusing, dilated pupils
- unable to urinate or delayed urination
- rash
- itching
- light sensitivity
- fever
- reaction to other similar drugs
- feeling sick (nausea) and being sick (vomiting)
- not eating (anorexia)
- indigestion
- diarrhoea
- constipation
- peculiar taste
- inflamed mouth
- abdominal cramps
- black tongue
- 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
- weight gain or loss
- sweating
- flushing
- urinating often and at night
- sleepiness
- dizziness
- weakness
- tiredness
- headache
- swollen glands
- hair loss (alopecia)
- an increased risk of bone fractures has been observed in patients taking this type of medicine
- low sodium concentration in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 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 Tablets
- Keep this medicine out of the sight and reach of children.
- Do not take this medicine after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of that month.
- Do not store above 25°C. Store in the original container. Keep the container tightly closed.
- 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 Tablets contain
The name of this medicine is Nortriptyline 10mg or 25mg Tablets.
The active substance in your tablet is nortriptyline hydrochloride. Each tablet contains 10mg or 25mg of nortriptyline (as the hydrochloride) respectively. Other ingredients include lactose monohydrate, maize starch and magnesium stearate.
What Nortriptyline Tablets look like and contents of the pack
Nortriptyline 10 mg Tablets are white to off white, round, biconvex, uncoated tablets, debossed ‘NO’ on one side and ‘10’ on other side.
Nortriptyline 25 mg Tablets are white to off white, round, biconvex, uncoated tablets, debossed ‘NO’ on one side and ‘25’ on other side.
Nortriptyline 10mg & 25mg Tablets are packed in a white HDPE bottle, with a white polypropylene child resistant cap and tamper evident film, containing 100 tablets.
Marketing Authorisation Holder and Manufacturer
Accord, Barnstaple, EX32 8NS, UK