Patient leaflet - Nortriptyline 10 mg film-coated tablets

1. What Nortriptyline tablets are and what they are used for

Nortriptyline tablets contain the active substance nortriptyline hydrochloride, which is a tricyclic antidepressant. Nortriptyline tablets relieve symptoms of depression in adults.

2. What you need to know before you take Nortriptyline tablets

Do not take Nortriptyline tablets

Ÿ If you are allergic to nortriptyline hydrochloride or any of the other

ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, diﬃculty breathing or swelling of the face, lips, throat or tongue.

Ÿ If you have had a recent heart attack or heartbeat disorder. Ÿ If you have severe liver disease.

Ÿ If you suﬀer from mania (abnormally raised mood).

Ÿ If you are breast-feeding.

Ÿ If the child is under 6 years of age.

Ÿ If you are taking, or have taken in the last two weeks, monoamine

oxidase inhibitors (another type of antidepressant).

Ÿ If 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 or pharmacist before taking Nortriptyline tablets Ÿ If you feel suicidal or aggressive – tell your doctor.

Ÿ If you are agitated, overactive or suﬀer from schizophrenia. Ÿ If you have heart disease.

Ÿ If you have a cardiac condition called Brugada syndrome. Ÿ If you have a thyroid condition.

Ÿ If you have a history of epilepsy.

Ÿ If you have high pressure in the eyes (glaucoma).

Ÿ If you have an enlarged prostate.

Ÿ If you are going to have electroconvulsive therapy (electric shock). Ÿ If you are diabetic.

Ÿ If you are going to receive an anaesthetic, e.g. for an operation – tell

your doctor.

Ÿ If you have had an allergic reaction to another tricyclic antidepressant in

the past.

Ÿ If you are pregnant, think you might be pregnant or planning to become

pregnant or are breastfeeding, you should not take Nortriptyline tablets unless your doctor tells you to.

The use of Buprenorphine together with Nortriptyline tablets can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Nortriptyline tablets”).

Children and adolescents

Nortriptyline should not be used in the treatment of depression in children and adolescents under the age of 18 years.

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:

Ÿ If you have previously had thoughts about killing or harming yourself. Ÿ 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 the above applies 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.

The following medicines may interact with your Nortriptyline tablets: Ÿ guanethidine, debrisoquine, bethanidine, clonidine (used to treat high blood pressure)

Ÿ barbiturates (used for anxiety or to make you feel sleepy) Ÿ alcohol (you should not drink alcohol)

Ÿ ﬂuoxetine (another antidepressant)

Ÿ cimetidine (for heartburn and ulcers)

Ÿ phenothiazines (for mental illness)

Ÿ carbamazepine (for epilepsy)

Ÿ propafenone, ﬂecainide, encainide, quinidine (for heartbeat disorders) Ÿ valproic acid (medicine used for the treatment of epilepsy and bipolar disorder)

Ÿ 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 alright for you to be given Nortriptyline tablets. Your doctor will be able to decide what is suitable for you.

Pregnancy and breastfeeding

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.

Do not take Nortriptyline tablets if you are breastfeeding.

Driving and using machines

Nortriptyline tablets may aﬀect alertness. Use caution when driving or operating heavy machinery until you're aware of how this medicinal product aﬀects you. If you feel Nortriptyline tablets aﬀect your ability to drive or use machines, tell your doctor immediately.

Nortriptyline tablets contain lactose

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 recommended adult dose is 25 mg 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, 10 mg, 3-4 times daily, for example and be increased gradually as required. The maximum dose is 150 mg per day.

Elderly

The recommended dose is 30 to 50 mg/day in divided doses. Treatment may start with 10 mg three times a day. Nortriptyline 50 mg tablets are not appropriate for use in elderly patients.

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.

Children and adolescents (under age 18)

Nortriptyline should not be used in the treatment of depression in children and adolescents under the age of 18 years.

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 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:

Ÿ 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)

Ÿ 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) Ÿ 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 Ÿ thoughts of harming or killing yourself at any time (see section 2) Ÿ persistent constipation with a swollen stomach, fever and vomiting.

These symptoms may be due to parts of the intestine becoming paralysed.

Ÿ 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) Ÿ Brugada Syndrome (unmasking) (symptoms may include very fast

heartbeat, dizziness, fainting, seizures). Tell your doctor straight away if you get these symptoms.

The following side eﬀects have been reported (Not known: frequency cannot be estimated from the available data):

Ÿ low or high blood pressure

Ÿ fast or irregular heartbeat

Ÿ palpitations (perceived abnormalities of the heartbeat) Ÿ oedema (swelling of the ankles)

Ÿ confusion (especially in the elderly) with seeing or hearing things

(hallucinations)

Ÿ not knowing where you are (disorientation)

Ÿ false beliefs (delusions)

Ÿ anxiety, restlessness, agitation (severe restlessness, crankiness or

uneasiness)

Ÿ not sleeping (insomnia)

Ÿ nightmares

Ÿ panic

Ÿ long-lasting abnormal mood

Ÿ worsening of mental illness

Ÿ numbness, tingling, pins and needles in the hands or feet Ÿ coordination problems

Ÿ tremors

Ÿ abnormal movements

Ÿ ﬁts (seizures)

Ÿ altered brainwave (EEG) patterns

Ÿ ringing in the ears (tinnitus)

Ÿ dry mouth

Ÿ rarely, inﬂamed glands under the tongue or inﬂammation of the gums

(gingivitis)

Ÿ blurred vision, diﬃculty in focusing, dilated pupils

Ÿ unable to urinate or delayed urination

Ÿ rash

Ÿ itching

Ÿ light sensitivity

Ÿ swelling (oedema)

Ÿ fever

Ÿ reaction to other similar drugs

Ÿ feeling sick (nausea) and vomiting

Ÿ not eating (anorexia)

Ÿ indigestion

Ÿ diarrhoea

Ÿ constipation

Ÿ peculiar taste

Ÿ inﬂamed mouth

Ÿ abdominal cramps

Ÿ black tongue

Ÿ development of breasts in men, breast enlargement and milk production

in women

Ÿ increased or decreased sex drive

Ÿ failure to have an erection (impotence)

Ÿ swollen testicles

Ÿ altered blood sugar levels

Ÿ weight gain or loss

Ÿ sweating

Ÿ ﬂushing

Ÿ urinating often and at night

Ÿ sleepiness

Ÿ dizziness

Ÿ weakness

Ÿ tiredness

Ÿ headache

Ÿ swollen glands

Ÿ hair loss (alopecia)

Ÿ an increased risk of bone fractures has been observed in patients taking this type of medicine

Ÿ low sodium concentration in the blood.

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 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 use this medicine after the expiry date which is stated on the 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 tablets contain

Ÿ The active substance is nortriptyline hydrochloride.

Each Nortriptyline ﬁlm-coated tablet contains nortriptyline hydrochloride equivalent to 10 mg, 25 mg or 50 mg nortriptyline base.

Ÿ The other ingredients are:

Tablet core: Lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate.

Tablet coating: Hydroxypropyl methyl cellulose, titanium dioxide, Macrogol 6000.

What Nortriptyline tablets look like and contents of the pack

Nortriptyline 10 mg ﬁlm-coated tablets are white to oﬀ-white in colour, about 5.5 mm in diameter, round, ﬁlm-coated tablets, debossed with “10” on one side and plain on the other side.

Nortriptyline 25 mg ﬁlm-coated tablets are white to oﬀ-white in colour, about 8.00 mm in diameter, round, ﬁlm-coated tablets, debossed with “25” on one side and plain on the other side.

Nortriptyline 50 mg ﬁlm-coated tablets are white to oﬀ-white in colour, about 9.8 mm in diameter, round, ﬁlm-coated tablets debossed with “50” on one side and plain on the other side.

Nortriptyline ﬁlm-coated tablets are available in blister packs of 30 and 100 ﬁlm-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

DAWA Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited,