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Children and adolescents TBC Do not give this medicine to children and adolescents aged below 18 years for these Package leaflet: Information for the user treatments as safety and efficacy have not been established in this age group. Nortriptyline 10 mg Other medicines and Nortriptyline Tell your doctor or pharmacist if you are taking, have film-coated tablets recently taken or might take any other medicines: • monoamine oxidase inhibitors Nortriptyline 25 mg • (MAOIs) e.g. , , , , or film-coated tablets (used to treat depression) or (used nortriptyline to treat Parkinson’s disease). These should not be taken at the same time as Nortriptyline (see Read all of this leaflet carefully before you section 2 Do not take Nortriptyline ) start taking this medicine because it contains • , , , noradrenaline, important information for you. and phenyl - propanolamine • Keep this leaflet. You may need to read it again. (these may be present in cough or cold medicine, • If you have any further questions, ask your and in some anaesthetics) doctor or pharmacist. • medicine to treat high blood pressure for • This medicine has been prescribed for you example blockers (e.g. only. Do not pass it on to others. It may harm and ), , debrisoquine, them, even if their signs of illness are the same , and as yours. • drugs such as certain medicines • If you get any side effects talk to your doctor to treat Parkinson’s disease and gastrointestinal or pharmacist. This includes any possible side disorders (e.g. , ) effects not listed in this leaflet. See section 4. • (used to treat schizophrenia) • (painkiller) What is in this leaflet • medicines to treat fungal infections 1. What Nortriptyline is and what it is used for (e.g. fluconazole, terbinafine, , and 2. What you need to know before you take itraconazole) Nortriptyline • (e.g. barbiturates) 3. How to take Nortriptyline • (e.g. SSRIs (, 4. Possible side effects , ), and ) 5. How to store Nortriptyline • medicines for certain heart conditions (e.g. beta 6. Contents of the pack and other information blockers and antiarrhythmics) 1. What Nortriptyline is and what it is • (used to treat stomach ulcers) used for • (used to treat ADHD) • oral contraceptives Nortriptyline contains the active ingredient • rifampicin (to treat infections) nortriptyline hydrochloride, which is a • and (used to treat . Nortriptyline is used to treat major epilepsy) depression in adults. • St. John’s Wort () a herbal 2. What you need to know before you take remedy used for depression Nortriptyline • thyroid . You should also tell your doctor if you take or have Do not take Nortriptyline if: recently taken medicine that may affect the heart´s • you are allergic (hypersensitive) to nortriptyline rhythm. e.g.: or any of the other ingredients of Nortriptyline • medicines to treat irregular heartbeats (see list of ingredients in Section 6). An allergic (e.g. and ) reaction may include rash, itching, difficulty • and (used to treat breathing or swelling of the face, lips, throat or allergies and hay ) tongue • medicines used to treat some mental illnesses • you have had a recent heart attack or heartbeat (e.g. and ) disorder, heart block or coronary artery disease • (used to treat certain types of • you are taking, or have stopped taking within indigestion) the last 14 days, a monoamine oxidase • halofantrine (used to treat malaria) inhibitor (e.g. phenelzine, isocarboxazid • (used to treat pain and for or tranylcypromine). If you are taking detoxification) moclobemide you must stop this at least • diuretics (‘water tablets’ e.g. ) 24 hours before starting nortriptyline • valproic acid (medicine used for the treatment of • You have to stop treatment with Nortriptyline epilepsy and bipolar disorder) and wait for 14 days before you start treatment with a monoamine oxidase inhibitor If you are going to have an operation and receive general or local anaesthetics, you should tell your Warnings and precautions doctor that you are taking this medicine. Likewise, Talk to your doctor before taking these tablets if: you should tell your dentist that you take this • you feel suicidal or aggressive medicine if you are to receive a local anaesthetic. • you are agitated, overactive, or suffer from schizophrenia Taking Nortriptyline with • you have heart disease You should not drink alcohol while you are being • you have a thyroid condition or receive thyroid treated with Nortriptyline as alcohol might increase medication the effect. • you have a history of epilepsy • you have high pressure in the eyes () Pregnancy and breast-feeding • you have an enlarged prostate If you are pregnant or breast-feeding, think you may • you are going to have electroconvulsive therapy be pregnant or are planning to have a baby, ask your (electric shock) doctor for advice before taking this medicine. • you are diabetic as you might need and Nortriptyline should not be used during pregnancy adjustment of your antidiabetic medicine unless your doctor considers it clearly necessary • you are going to receive an anaesthetic, and only after careful consideration of the benefit e.g. for an operation - tell your doctor as it and risk. If you have taken this medicine during the might be necessary to stop the treatment with last part of the pregnancy, the newborn may have nortriptyline before you are given anaesthetics withdrawal symptoms such as irritability, increased • you have had an allergic reaction to another muscle tension, tremor, irregular breathing, poor in the past drinking, loud crying, , and • you have difficulty in passing constipation. • you have bipolar disorder, as some patients may Your doctor will advise you whether to start/ enter into a manic phase continue/ stop breast-feeding, or stop using • you have pylorus stenosis (narrowing of the this medicine taking into account the benefit of gastric outlet) and paralytic ileus (blocked for your child and the benefit of intestine) therapy for you. • you have excessive fever (hyperpyrexia) Driving and using machines • you are going to have electroconvulsive therapy Do not drive or use machinery when you are on • you are elderly as you are more likely to suffer Nortriptyline unless you are sure your judgement from certain side effects, such as dizziness when you stand up due to low blood pressure and co-ordination are not affected. Antidepressants (see also section 4 Possible side effects) may affect your ability to drive or to operate • you have severe disease machinery safely. Prolonged QT interval Nortriptyline contains lactose monohydrate A heart problem called ‘prolonged QT interval’ If you have been told by your doctor that you have (which is shown on your electrocardiogram, ECG) an intolerance to some sugars, contact your doctor and heart rhythm disorders (rapid or irregular heart before taking this medicine. beat) have been reported with Nortriptyline. Tell 3. How to take Nortriptyline your doctor if you: • have slow heart rate Always take this medicine exactly as your doctor or • have or had a problem where your heart cannot pharmacist has told you. Check with your doctor or pump the blood round your body as well as it pharmacist if you are not sure. should (a condition called heart failure) Adults: • are taking any other medication that may cause • The recommended adult dose is 25 mg heart problems, or • have a problem that gives you a low level of three or four times daily or the dose may be potassium or , or a high level of given once a day, usually at night. The dose potassium in your blood should begin at a low level, 10 mg, 3-4 times daily, for example and be increased gradually as Thoughts of and worsening of your required. The maximum dose is 150 mg per day. depression • If your doctor tells you to take more than If you are depressed you can sometimes have four 25 mg tablets a day, he or she may arrange thoughts of harming or killing yourself. These may for you to have regular blood tests. be increased when first starting antidepressants, since these medicines all take time to work, usually Elderly about two weeks but sometimes longer. The usual dose is 30 to 50 mg/day in divided doses. You may be more likely to think like this: Treatment may start at a low level (10-20 mg daily) • if you have previously had thoughts about and may be increased as required to the maximum killing or harming yourself dose of 50 mg. If you require a dose of 50 mg • if you are a young adult. Information from clinical or over, your doctor will arrange for you to have trials has shown an increased risk of suicidal a recording of your heart (ECG) and blood tests. behaviour in adults aged less than 25 years with psychiatric conditions who were treated The 50 mg tablets are not appropriate for use in with an antidepressant elderly patients. If you have thoughts of harming or killing Renal impairment yourself at any time, contact your doctor or go to In case of renal impairment, your doctor will increase a hospital straight away. or decrease the dose carefully and gradually. In most cases, however, the usual dosage will be given. You may find it helpful to tell a relative or close friend that you are Hepatic impairment depressed and ask them to read this leaflet. Patients with liver diseases or people known as You might ask them to tell you if they think ‘poor metabolisers’ usually receive lower doses. Your your depression is getting worse, or if they are doctor may take blood samples to determine the worried about changes in your behaviour. level of nortriptyline in the blood.

Description Nortriptyline_25mg_10mg_all Date: 15 Mar 19 Time: 16:25

Component Type Leaflet Pharma Code TBC No. of colours 1 Page Count 1 / 2 Affiliate Item Code 1802940 SAP No. N/A Colours Black Superceded Affiliate Item Code N/A Vendor Job No. 102035720/0020 Non-Print TrackWise PR No. 1802940 Trackwise Proof No. 1 Colours MA No. PL 04569/1754, Client Market United Kingdom PL 04569/1755 Equate CMYK Nortriptyline Insert K Line with Packing Site/Printer TBC Keyline/Drawing No. 05.12.2018 Supplier Code TBC Barcode Info N/A Main Font Myriad Pro Body Text Size 9 pt 3D Render ID N/A Dimensions 160 x 530 mm Min Text Size used 9 pt Sign-offs

v3/Jul 2017 • ringing sounds in ear TBC • an enlarged or swollen tongue • skin rash Use in children and adolescent • swelling of the face Nortriptyline should not be used in children and Rare (may affect up to 1 in 1,000 people): adolescents aged less than 18 years, as safety and • mouth or gum problems efficacy have not been established. • confusional states (delirium), especially in the Lower dosages are recommended for outpatients elderly perhaps with and restlessness than for patients in hospital who will be under close • (in patients with schizophrenia) supervision. • more serious heart problems along with ringing in the ears, stomach cramps and clumsiness can Duration of treatment also occasionally occur It may take a few weeks before you feel any • increases in libido have been reported. improvement. Following remission maintenance • a rash, which may be itchy or get worse in treatment may be needed longer term, usually up sunlight. to 6 months. This should be at the lowest dose that • Withdrawal symptoms; if you suddenly stop stops the symptoms of depression coming back. taking the tablets, you may not be able to sleep and may feel irritable or sweaty If you take more Nortriptyline than you should • Decreased appetite Do not take more tablets than your doctor tells you • Hair loss to. If you ever take too many, or if a child has taken • Enlargement of male breast tissue any nortriptyline, go to the nearest hospital casualty • Weight loss department or tell your doctor at once. • abnormal results of liver function tests Symptoms of overdose include blurred vision, fast • fever or irregular heartbeats, difficulties passing water, dry mouth and tongue, intestinal blockage, fits, fever, Very rare (may affect up to 1 in 10,000 people): agitation, , hallucinations, uncontrolled • alterations in brain function (including perhaps movements, low blood pressure, weak pulse, ) pallor, difficulty breathing, blue discolouration of • swelling of ankles and in severe cases of the the skin, decreased heart rate, drowsiness, loss of face & tongue consciousness, coma, various cardiac symptoms • blood disorders may also occur along such as heart block, heart failure, cardiogenic shock, with changes in blood sugar level. In severe cases metabolic acidosis, hypokalaemia. men may suffer from swelling of breasts & An overdose can be very dangerous. testicles whilst women may also notice an increase in breast size and spontaneous lactation. If you forget to take Nortriptyline In extreme cases there may be swelling & If you forget to take a dose, take it as soon as damage to liver cells. you remember. If it is almost time for your next • Increased pressure within eye dose do not take a double dose to make up for • abnormal heart rhythm that can lead to sudden a forgotten dose, just carry on as before. If you have cardiac death (so called torsades de pointes) missed several doses, discuss this with your doctor. • heart muscle disease If you stop using Nortriptyline • feeling of inner restlessness and a compelling Antidepressants may not make you feel better for need to be in constant motion the first two weeks or more of treatment, so keep • disorder of the peripheral nerves taking Nortriptyline until your doctor tells you to • allergic inflammation of the lung alveoli and of stop. Do not stop these tablets without discussing it the lung tissue with your doctor first. Not known (frequency cannot be estimated from If you stop using Nortriptyline abruptly after the available): prolong therapy you may have withdrawal • changes of blood sugar levels symptoms, including not being able to sleep, • paranoia headache, nausea, irritability and sweating. • movement disorders (involuntary movements or 4. Possible side effects decreased movements) • hypersensitivity inflammation of heart muscle Like all medicines, this medicine can cause side • hepatitis effects, although not everybody gets them. • syndrome of inappropriate secretion of Tell your doctor immediately if you experience antidiuretic hormone (SIADH) any of the following: Reporting of side effects Rare (may affect up to 1 in 1,000 people): If you get any side effects, talk to your doctor • bad constipation, a swollen stomach, fever and or pharmacist. This includes any possible side . These symptoms may be due to parts effects not listed in this leaflet. You can also report of the intestine becoming paralysed side effects directly via the Yellow Card Scheme • any yellowing of the skin and the white in the at:www.mhra.gov.uk/yellowcard or search for eyes (jaundice). Your liver may be affected MHRA Yellow Card in the Google Play or Apple App. • bruising, bleeding, pallor or persistent sore throat By reporting side effects you can help provide more and fever. These symptoms can be the first signs information on the safety of this medicine. that your blood or bone marrow may be affected. Effects on the blood could be a decrease in 5. How to store Nortriptyline the number of red cells (which carry oxygen Keep this medicine out of the sight and reach of around the body), white cells (which help to fight children. infection) and platelets (which help with clotting) • suicidal thoughts or behaviour Do not use this medicine after the expiry date which is stated on the blister, carton or bottle Very rare (may affect up to 1 in 10,000 people): after EXP. The expiry date refers to the last day of • attacks of intermittent blurring of vision, that month. rainbow vision, and eye pain. You should immediately have an eye examination before the This medicine does not require any special storage treatment with this medicine can be continued. conditions. This condition may be signs of acute glaucoma Do not throw away any medicines via wastewater or The following side effects have also been household waste. Ask your pharmacist how to throw reported: away medicines you no longer use. These measures Very common (may affect more than will help protect the environment. 1 in 10 people): • dry mouth 6. Contents of the pack and other • excessive sweating information • constipation What Nortriptyline contains • nausea (feeling sick) The active substance is nortriptyline. • headache Each 10 mg film-coated tablet contains 11.4 mg of • tremor nortriptyline (as hydrochloride). • dizziness Each 25 mg film-coated tablet contains 28.5 mg of • blocked nose nortriptyline (as hydrochloride). • accommodation disorder of the eyes • irregular or heavy heart beats The other ingredients are: • weight gain Tablet core: lactose monohydrate, maize starch, • aggression microcrystalline cellulose (E460), magnesium stearate (E470b) Common (may affect up to 1 in 10 people): Tablet film-coating: hypromellose (E464), titanium • strange body movements dioxide (E171), macrogol • flushing • weakness What Nortriptyline looks like and contents of • fatigue the pack • dizziness when you stand up due to Nortriptyline 10 mg film-coated tablets are white, low blood pressure () round, 5.5 mm in diameter and debossed with ‘10’ • disturbed coordination on one side. • disturbed attention Nortriptyline 25 mg film-coated tablets are white, • confusion round, 8 mm in diameter and debossed with ‘25’ • heart block on one side. • a heart problem called ‘prolonged QT interval’ Nortriptyline 10 mg film-coated tablets are available (which is shown on your electrocardiogram, ECG) in blisters packs containing 30 or 100 tablets and in • changes in taste plastic bottles containing 100 or 500 tablets. • blurred vision (dilated pupils) Nortriptyline 25 mg film-coated tablets are available • decreases in libido and erectile dysfunction in blisters packs containing 30 or 100 tablets and in • agitation plastic bottles containing 100 or 500 tablets. • tingling in arms & legs • problems urinating (increased or decreased) Not all pack sizes may be marketed. • feeling thirsty Marketing Authorisation Holder • low sodium concentration in the blood Mylan, Uncommon (may affect up to 1 in 100 people): Station Close, • changes in sleep patterns (including nightmares) Potters Bar, • numbness Herts EN6 1TL, • vomiting United Kingdom. • high blood pressure Manufacturers • anxiety McDermott Laboratories Limited T/A Gerard • loss of appetite Laboratories T/A Mylan Dublin, Unit 35/36 Baldoyle • diarrhoea Industrial Estate, Grange Road, Dublin 13, Ireland • liver problems including jaundice • changes in sexual performance This leaflet was last revised in March 2019 • increased production or outflow of breast milk Other sources of information without breast feeding This leaflet is also available in other formats for • increased pressure in the eye ball 214116S partially-sighted patients. To request a copy of • collapse conditions this leaflet in large print please call the Medical • worsening of cardiac failure Information Direct Line: • convulsions (body muscles contract and +44 (0)1707 853 000 (UK only) relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body) DD/DRUGS/DD/752 1802940 EE1411GBR12-00

Description Nortriptyline_25mg_10mg_all Date: 15 Mar 19 Time: 16:25

Component Type Leaflet Pharma Code TBC No. of colours 1 Page Count 2 / 2 Affiliate Item Code 1802940 SAP No. N/A Colours Black Superceded Affiliate Item Code N/A Vendor Job No. 102035720/0020 Non-Print TrackWise PR No. 1802940 Trackwise Proof No. 1 Colours MA No. PL 04569/1754, Client Market United Kingdom PL 04569/1755 Equate CMYK Nortriptyline Insert K Line with Packing Site/Printer TBC Keyline/Drawing No. 05.12.2018 Supplier Code TBC Barcode Info N/A Main Font Myriad Pro Body Text Size 9 pt 3D Render ID N/A Dimensions 160 x 530 mm Min Text Size used 9 pt Sign-offs

v3/Jul 2017