Nortriptyline 10Mg & 25Mg Tablets

Package leaflet: Information for the patient Nortriptyline 10mg & 25mg Tablets

Read all of this leaflet carefully before you start taking this You may be more likely to think like this: medicine because it contains important information for you. • if you have previously had thoughts about killing or harming yourself • Keep this leaflet. You may need to read it again. • if you are a young adult. Information from clinical trials has • If you have any further questions, ask your doctor or shown an increased risk of suicidal behaviour in adults aged pharmacist. less than 25 years with psychiatric conditions who were treated • This medicine has been prescribed for you only. Do not pass it with an antidepressant. on to others. It may harm them, even if their signs of illness are the same as yours. If you have thoughts of harming or killing yourself at any time, • If you get any side effects, talk to your doctor or pharmacist. contact your doctor or go to a hospital straight away. This includes any possible side effects not listed in this leaflet. See section 4. You may find it helpful to tell a relative or close friend that What is in this leaflet you are depressed or have an anxiety disorder, and ask them to 1. What Nortriptyline Tablets are and what they are used read this leaflet. You might ask them to tell you if they think your for depression or anxiety is getting worse, or if they are worried about 2. What you need to know before you take Nortriptyline changes in your behaviour. Tablets 3. How to take Nortriptyline Tablets Other medicines and Nortriptyline Tablets 4. Possible side effects Tell your doctor or pharmacist if you are taking, have recently taken 5. How to store Nortriptyline Tablets or might take any other medicines. 6. Contents of the pack and other information 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 1. What Nortriptyline Tablets are and what they are used starting nortriptyline for • medicine for your heart or for high blood pressure • cimetidine Nortriptyline belongs to a class of medicines called tricyclic • any other medicines including other antidepressants or antidepressants. Nortriptyline tablets are used to treat major medicine for bowel complaints, breathing difficulties, bronchitis, depression. glaucoma or prostate trouble • levothyroxine • antifungal medicines such as fluconazole and terbinafine 2. What you need to know before you take Nortriptyline • antihistamines - astemizole or terfenadine Tablets • the pain killer tramadol You should not take Nortriptyline Tablets until you are sure it is safe • buprenorphine (a drug used for severe pain or opioid drug for you to do so. Nortriptyline Tablets are for adults only. addiction). This medicine may interact with nortriptyline and you may experience symptoms such as involuntary, rhythmic Do not take Nortriptyline Tablets if you: contractions of muscles, including the muscles that control • are allergic to nortriptyline or any of the other ingredients of this movement of the eye, agitation, hallucinations, coma, excessive medicine (listed in section 6) sweating, tremor, exaggeration of reflexes, increased muscle • have recently had a heart attack or if you have other heart tension, body temperature above 38°C. Contact your doctor problems such as palpitations or irregular heartbeats when experiencing such symptoms • have severe liver disease • valproic acid (medicine used for the treatment of epilepsy and • suffer from mania (abnormally raised mood) bipolar disorder). • are breast-feeding • are taking, or have stopped taking within the last 14 days, a Nortriptyline Tablets with food, drink and alcohol monoamine oxidase inhibitor (e.g. phenelzine, isocarboxazid or You should not drink alcohol while you are being treated with tranylcypromine). If you are taking moclobemide you must stop Nortriptyline Tablets. You may find that you get more drunk or feel this at least 24 hours before starting nortriptyline more depressed. • are taking adrenaline-like drugs including ephedrine, Pregnancy and breast-feeding isoprenaline, noradrenaline, phenylephrine and Do not take Nortriptyline tablets if you are breast-feeding. phenylpropanolamine. These drugs are often contained in cough and cold remedies. The safety of nortriptyline for use during pregnancy has not been established. If you are pregnant, think you may be pregnant or are Warnings and precautions planning to have a baby, ask your doctor or pharmacist for advice Talk to your doctor or pharmacist before taking Nortriptyline Tablets before taking this medicine. if you: • are having an operation under general anaesthetic, discuss this Driving and using machines with your GP. You may need to stop taking Nortriptyline Tablets Do not drive or use machinery when you are on Nortriptyline several days before the operation. If your GP tells you to carry Tablets unless you are sure your judgement and co-ordination are on taking Nortriptyline Tablets, make sure the doctors treating not affected. Antidepressants may affect your ability to drive or to you in hospital know that you are taking Nortriptyline. operate machinery safely. • have thyroid problems • have suffered from an allergic type reaction with another Nortriptyline Tablets contain lactose monohydrate tricyclic antidepressant, as cross sensitivity may occur If you have been told by your doctor that you have an intolerance • ever had epilepsy to some sugars, contact your doctor before taking this medicinal • are diabetic product. • have an enlarged prostate • have glaucoma or raised intra-ocular pressure • are agitated or suffer from schizophrenia 3. How to take Nortriptyline Tablets • have low blood pressure or heart failure • have suffered from urinary retention Always take this medicine exactly as your doctor or pharmacist has • are taking buprenorphine. The use of these medicines together told you. Check with your doctor or pharmacist if you are not sure. with Nortriptyline tablets can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and The recommended dose is: Nortriptyline tablets”). Adults • The usual dose an adult will start on is 25mg two to three times Thoughts of suicide and worsening of your depression or daily. You will usually be told to increase your dose gradually (no anxiety disorder more rapidly than by 25mg every other day) until you are taking If you are depressed and/or have anxiety disorders you can the usual maintenance dose of 75 to 100mg a day. Once you feel sometimes have thoughts of harming or killing yourself. These better, you will be told to carry on taking Nortriptyline Tablets at may be increased when first starting antidepressants, since these the same dose. Do not take more than six 25mg tablets a day medicines all take time to work, usually about two weeks but (150mg). sometimes longer.

Nortriptyline 10mg & 25mg Tablets PIL - UK

approved for print/date Item number: BBBA8990 Colours Non Printing Colours 1. Black 1. Profile Originator: S.Anson Dimensions: 160 x 270 2. 2. Origination Date: 17.09.2020 Min Body Text Size: 7pt Revision Date: 27.10.2020 Supplier: Centaur 3. 3. Revised By: S.Anson 4. 5. Proof Round Technical Date sent: 17.09.2020 6. 2 Approval Date received: 17.09.2020 [email protected]

Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 • If your doctor tells you to take more than four 25mg tablets a • ringing in the ears (tinnitus) day, he or she may arrange for you to have regular blood tests. • dry mouth • If you are elderly you will usually be told to start on one 10mg • rarely, inflamed glands under the tongue or inflammation of the tablet three times a day. Dose increases should also be gradual gums (gingivitis) by no more than 10mg every other day. If you require a dose • blurred vision, difficulty in focusing, dilated pupils of 50mg or over, your doctor will arrange for you to have a • unable to urinate or delayed urination recording of your heart (ECG) and blood tests. • rash • Antidepressants may not make you feel better for the first two • itching weeks or more of treatment, so keep taking Nortriptyline Tablets • light sensitivity until your doctor tells you to stop. Do not stop these tablets • fever without discussing it with your doctor first. • reaction to other similar drugs • Do not suddenly stop taking the tablets. Your doctor will tell you • feeling sick (nausea) and being sick (vomiting) how to cut them down gradually. • not eating (anorexia) • indigestion If you take more Nortriptyline Tablets than you should • diarrhoea Do not take more tablets than your doctor tells you to. If you ever • constipation take too many, or if a child has taken any nortriptyline, go to the • peculiar taste nearest hospital casualty department or tell your doctor at once. An • inflamed mouth overdose can be very dangerous. • abdominal cramps • black tongue If you forget to take Nortriptyline Tablets • development of breasts in men, breast enlargement and milk If you forget to take a dose, take it as soon as you remember. If it is production in women almost time for your next dose do not take a double dose to make • increased or decreased sex drive up for a forgotten dose, just carry on as before. If you have missed • failure to have an erection (impotence) several doses, discuss this with your doctor. • swollen testicles • altered blood sugar levels If you stop taking Nortriptyline Tablets • weight gain or loss If you stop taking Nortriptyline Tablets abruptly after prolonged • sweating therapy, you may have withdrawal symptoms, including not being • flushing able to sleep, headache, nausea, irritability and sweating. • urinating often and at night • sleepiness • dizziness 4. Possible side effects • weakness • tiredness Like all medicines, this medicine can cause side effects, although • headache not everybody gets them. If any of the side effects gets • swollen glands serious, or if you notice any side effects not listed in this • hair loss (alopecia) leaflet, please tell your doctor or pharmacist. • an increased risk of bone fractures has been observed in patients taking this type of medicine. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Reporting of side effects Tell your doctor straight away if you get any sudden If you get any side effects, talk to your doctor, pharmacist or nurse. wheeziness, difficulty in breathing, swelling of the eyelids, This includes any possible side effects not listed in this leaflet. You face or lips, rash or itching, especially affecting your whole can also report side effects directly via the Yellow Card Scheme body. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Tell your doctor or pharmacist immediately if you experience any of the following serious side effects: By reporting side effects you can help provide more information on • sudden chest pain which may spread to the neck or arm, with a the safety of this medicine. 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, 5. How to store Nortriptyline Tablets headache, dizziness and confusion, disturbances in vision, difficulty swallowing, slurred, mixed up or loss of speech (these • Keep this medicine out of the sight and reach of children. may be signs of a stroke) • Do not take this medicine after the expiry date, which is stated • bruising, bleeding, pallor or persistent sore throat and fever. on the label and carton. The expiry date refers to the last day of These symptoms can be the first signs that your blood or that month. bone marrow may be affected. Effects on the blood could be a • Do not store above 25°C. Store in the original container. Keep decrease in the number of red cells (which carry oxygen around the container tightly closed. the body), white cells (which help to fight infection) and platelets • Do not throw away any medicines via wastewater or household (which help with clotting). waste. Ask your pharmacist how to throw away medicines • persistent constipation with a swollen stomach, fever and you no longer use. These measures will help protect the vomiting. These symptoms may be due to parts of the intestine environment. becoming paralysed. • inflammation of the liver, yellowing of your skin or whites of your eyes, dark urine, pale stools, tiredness, fever, nausea, weakness, 6. Contents of the pack and other information drowsiness and abdominal pain, with test results showing abnormal liver function What Nortriptyline Tablets contain • thoughts of harming or killing yourself at any time (see section The name of this medicine is Nortriptyline 10mg or 25mg Tablets. 2). The active substance in your tablet is nortriptyline hydrochloride. Each tablet contains 10mg or 25mg of nortriptyline (as the The following side effects have also been reported: hydrochloride) respectively. Other ingredients include lactose monohydrate, maize starch and magnesium stearate. • fast or irregular heartbeat (palpitations) • abnormal heart rhythm What Nortriptyline Tablets look like and contents of the • swelling of the ankles, feet or legs (oedema) pack • confusion (especially in the elderly) with seeing or hearing things Nortriptyline 10 mg Tablets are white to off white, round, biconvex, (hallucinations) uncoated tablets, debossed ‘NO’ on one side and ‘10’ on other side. • not knowing where you are (disorientation) Nortriptyline 25 mg Tablets are white to off white, round, biconvex, • false beliefs (delusions) uncoated tablets, debossed ‘NO’ on one side and ‘25’ on other side. • anxiety, restlessness, agitation • not sleeping (insomnia) Nortriptyline 10mg & 25mg Tablets are packed in a white HDPE • nightmares bottle, with a white polypropylene child resistant cap and tamper • panic evident film, containing 100 tablets. • long-lasting abnormal mood • worsening of mental illness Marketing Authorisation Holder and Manufacturer • numbness, tingling, pins and needles in the hands or feet Accord, Barnstaple, EX32 8NS, UK • co-ordination problems • tremors This leaflet was last revised in October 2020. • abnormal movements • fits (seizures) • altered brainwave (EEG) patterns BBBA8990

Nortriptyline 10mg & 25mg Tablets PIL - UK