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Nortriptyline 10 Mg Film-Coated Tablets Nortriptyline 25 Mg Film-Coated Tablets 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. moclobemide, phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine film-coated tablets (used to treat depression) or selegiline (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 • adrenaline, ephedrine, isoprenaline, noradrenaline, important information for you. phenylephrine 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 calcium channel blockers (e.g. diltiazem only. Do not pass it on to others. It may harm and verapamil), guanethidine, debrisoquine, them, even if their signs of illness are the same bethanidine, clonidine reserpine and methyldopa as yours. • Anticholinergic 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. atropine, hyoscyamine) effects not listed in this leaflet. See section 4. • thioridazine (used to treat schizophrenia) • tramadol (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, ketoconazole, and 2. What you need to know before you take itraconazole) Nortriptyline • sedatives (e.g. barbiturates) 3. How to take Nortriptyline • antidepressants (e.g. SSRIs (fluoxetine, 4. Possible side effects paroxetine, fluvoxamine), and bupropion) 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 • cimetidine (used to treat stomach ulcers) used for • methylphenidate (used to treat ADHD) • oral contraceptives Nortriptyline contains the active ingredient • rifampicin (to treat infections) nortriptyline hydrochloride, which is a tricyclic • phenytoin and carbamazepine (used to treat antidepressant. Nortriptyline is used to treat major epilepsy) depression in adults. • St. John’s Wort (Hypericum perforatum) a herbal 2. What you need to know before you take remedy used for depression Nortriptyline • thyroid medication. 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. quinidine and sotalol) reaction may include rash, itching, difficulty • astemizole and terfenadine (used to treat breathing or swelling of the face, lips, throat or allergies and hay fever) tongue • medicines used to treat some mental illnesses • you have had a recent heart attack or heartbeat (e.g. pimozide and sertindole) disorder, heart block or coronary artery disease • cisapride (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 • methadone (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. furosemide) 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 alcohol • 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 sedative effect. • you have a history of epilepsy • you have high pressure in the eyes (glaucoma) 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 tricyclic antidepressant in the past drinking, loud crying, urinary retention, and • you have difficulty in passing urine 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 breastfeeding 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 liver 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 magnesium, 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 suicide 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.
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