passing water (urine), dilation of the pupil of • The other ingredients are carnauba wax, the eye, glaucoma and blockage of the small colloidal silica, gelatin, lactose, magnesium intestine) stearate, maize starch, polyvidone, stearic Package leaflet: Information for the patient Heart: feeling faint when getting up (postural acid, sucrose, E170, E171, E211, E414, E460, hypotension), high or severely low blood and E553. The 10mg tablets also contain pressure, fast/racing heart, palpitations, E110, E123 and E127. The 25mg tablets also Imipramine 10mg irregular heartbeats, changes in ECG readings contain sodium hydroxide, E216 and E218 Stomach and intestines: feeling or being and E172. and 25mg tablets sick, loss of appetite, inflammation of the Read all of this leaflet carefully before • have heart disease such as irregular heart mucus membranes in the mouth, tongue What Imipramine tablets look like and you start taking this medicine because it beats, heart block or have recently had a lesions contents of the pack contains important information for you. heart attack Liver: impaired liver function, hepatitis, Imipramine tablets are red (10mg) or tan • Keep this leaflet. You may need to read it • suffer from periods of increased and including changes in liver function (as seen in (25mg) circular, biconvex, sugar-coated again. exaggerated behaviour (mania) blood tests), jaundice (yellowing of the skin tablets, diameter 5.9mm (10mg) or 6.4mm • If you have any further questions, ask • have severe liver disease and/or whites of the eyes) (25mg). your doctor or pharmacist. • suffer with porphyria (a genetic disorder • This medicine has been prescribed for of the red blood cells haemoglobin causing Other: hair loss, ringing in the ears, small you. Do not pass it on to others. It may skin blisters, abdominal pain and brain/ purple red spots. An increase risk of bone Pack sizes are 28 tablets harm them, even if their signs of illness nervous system disorders) fractures has been observed in patients are the same as yours. • are not able to pass water taking this type of medicine. Marketing Authorisation holder and • If you get any side effects, talk to your • have increased pressure in the eye Withdrawal symptoms: feeling or being sick, Manufacturer: Accord, Barnstaple, EX32 doctor or pharmacist. This includes any (glaucoma) stomach pain, diarrhoea, difficulty sleeping, 8NS, UK. possible side effects not listed in this • are taking monoamine oxidase inhibitors nervousness, anxiety, headache, irritability leaflet. See section 4. (MAOI) or you have taken MAOIs within the Children: changes in behaviour. This leaflet was last revised in previous 14 days for depression December 2020. • if the child is under 6 years old. Reporting of side effects What is in this leaflet If you get any side effects, talk to your doctor, 1 What Imipramine tablets are and Warnings and precautions pharmacist or nurse. This includes any what they are used for possible side effects not listed in this leaflet. You can also report side effects directly via 2 What you need to know before Thoughts of suicide and worsening of the Yellow Card Scheme at: www.mhra.gov. you take Imipramine tablets your depression or anxiety disorder If you are depressed and/or have anxiety uk/yellowcard or search for MHRA Yellow Card 3 How to take Imipramine tablets in the Google Play or Apple App Store. disorders you can sometimes have thoughts By reporting side effects you can help provide 4 Possible side effects of harming or killing yourself. These may be more information on the safety of this medicine. 5 How to store Imipramine tablets increased when first starting antidepressants, since these medicines all take time to work, 6 5 Contents of the pack and other usually about two weeks but sometimes How to store Imipramine tablets information longer. You may be more likely to think like this: Keep out of the sight and reach of children. • If you have previously had thoughts about What Imipramine tablets are and Store below 25°C in a dry place. 1 killing or harming yourself. Do not take Imipramine tablets after the what they are used for • If you are a young adult. Information from expiry date stated on the label/carton/bottle. clinical trials has shown an increased risk The expiry date refers to the last day of that Imipramine belongs to a group of medicines of suicidal behaviour in young adults month. called tricyclic antidepressant drugs. These (less than 25 years old) with psychiatric Do not throw away any medicines via medicines alter the levels of chemicals in the conditions who were treated with an wastewater or household waste. Ask your brain to relieve the symptoms of depression. antidepressant. pharmacist how to throw away medicines you Imipramine is used: If you have thoughts of harming or killing no longer use. These measures will help to • to treat the symptoms of depression. yourself at any time, contact your doctor or protect the environment. • for the relief of bed-wetting at night by go to a hospital straight away. children. You may find it helpful to tell a relative or close friend that you are depressed or have 6 Contents of the pack and other information 2 What you need to know before an anxiety disorder, and ask them to read this you take Imipramine Tablets leaflet. You might ask them to tell you if they think your depression or anxiety is getting What Imipramine tablets contain worse, or if they are worried about changes in • The active substance (the ingredient that Do not take Imipramine tablets and tell your your behaviour. makes the tablets work) is imipramine doctor if you or your child (if they are the hydrochloride. Each tablet contains either patient): 10mg or 25mg of the active ingredient. • are allergic (hypersensitive) to imipramine, other tricyclic antidepressants or any of the other ingredients (see section 6). Continued top of next column 50994808 BBBA9000 Continued top of next column Continued over page 296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1 Imipramine 10mg Tablets PIL -UK Imipramine, Tablets, 10 & 25 mg, 28s - UK approved for print/date Item number: BBBA9000 Colours Non Printing Colours JDE No.: 1. Black 1. Profile 50994808 Originator: R.Paul Dimensions: 296 x 210 Origination Date: Min Body Text Size: 2. 2. Dimensions: 296x210 (Reel Fed) 21.09.2020 8pt Revision Date: 07.12.2020 Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Blisters Revised By: R.Paul 4. Pharmacode: 5. 4035 Proof Round Technical Date sent: N/A 6. Date Sent: 21-09-20 6 Approval Date received: Technologist: RH [email protected] Technically Approved Cartons and label leaflets only (labels only when specified) GTIN 13 (Belgium & Slovenia): German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 6 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.12.2019 Check with your doctor or pharmacist • medicines to treat some heart conditions Dental check ups or you think a child may have swallowed before taking Imipramine tablets if you or such as diltiazem, verapamil, labetalol, As Imipramine tablets can cause problems any, contact your nearest hospital casualty your child (if they are the patient): propranolol, quinidine with your teeth, it is advisable to have regular department or tell your doctor immediately. • have any psychiatric disorder (eg • medicines to treat angina that you spray dental checks ups. Symptoms of an overdose include fast or schizophrenia or manic depression) or dissolve under your tongue (eg glyceryl irregular heartbeat, low blood pressure, • are taking buprenorphine. The use of trinitrate “GTN”, isosorbide dinitrate) Imipramine tablets contain drowsiness, fits, coma, agitation, muscle buprenorphine together with Imipramine • any medicines to treat high blood pressure • lactose and sucrose rigidity, being sick or fever. tablets can lead to serotonin syndrome, a such as guanethidine, debrisoquine, If you have been told by your doctor potentially life-threatening condition (see bethanidine methyldopa, reserpine, you have an intolerance to some sugars, If you forget to take Imipramine “Other medicines and Imipramine tablets”) clonidine or diuretics (“water” tablets) contact your doctor before taking this tablets • are withdrawing from alcohol or • medicines to treat some mental illnesses medicinal product. Do not take a double dose to make up for a medicines used to treat fits such as thioridazine, chlorpromazine • sunset yellow (E110), amaranth (E123), forgotten dose. If you forget to take a dose, • have ever had glaucoma or an enlarged • cimetidine (to treat ulcers) propylhydroxybenzoate (E216) and take another as soon as you remember and prostate gland • entacapone or selegiline (to treat methylhydroxybenzoate (E218) then your next dose at the usual time. • have an overactive thyroid gland and are Parkinson’s disease) Imipramine 10mg tablets contain sunset taking medicines to treat a thyroid disorder • oral contraceptives (“the pill”) or hormone yellow (E110) and amaranth (E123) which If you stop taking imipramine tablets • have a history of epilepsy or brain replacement therapy (HRT) may cause allergic reactions. Talk to your doctor before you stop taking damage • appetite suppressants Imipramine 25mg tablets contain the tablets and follow their advice as you • have low blood pressure or poor • sympathomimetic medicines propylhydroxybenzoate (E216) and may experience withdrawal symptoms (see circulation such as adrenaline (epinephrine), methylhydroxybenzoate (E218) which may section 4). • have severe kidney disease ephedrine, isoprenaline, noradrenaline cause allergic reactions (possibly delayed). (norepinephrine), phenylephrine and • have a tumour of the adrenal gland (eg • sodium benzoate (E211) 4 phaeochromocytoma or neuroblastoma) phenylpropanolamine (these may be This medicine contains sodium benzoate Possible side effects • suffer from panic attacks present in many cough and cold remedies 0.0025mg in each 10mg tablet and Like all medicines, Imipramine tablets can • suffer from long term constipation or local anaesthetics) 0.0022mg in each 25mg tablet.