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BBBA9359 Lofepramine 70Mg 56 Tablets • low salt (sodium) in the blood which may 6 Contents of the pack and other cause weakness, confusion or difficulty information thinking. Other symptoms might include loss of appetite, nausea, vomiting or What Lofepramine Tablets contain headaches Package Leaflet: Information for the user • The active substance is lofepramine (as • enlargement of one or both breasts in men lofepramine hydrochloride). Each tablet • production of breast milk in women who contains 70mg lofepramine base (as 76.1mg are not pregnant or breast-feeding Lofepramine 70mg Tablets lofepramine hydrochloride). • pain in testicles • The other ingredients are lactose, maize • effects on sexual function starch, citric acid, hydrogenated vegetable • mental change called hypomania (feeling Read all of this leaflet carefully before 2 What you need to know before oil, povidone and glycerol. The coating elated or emotionally “high”) you start taking this medicine because it you take Lofepramine tablets on the tablets contains hypromellose 6cp • uncoordinated movement contains important information for you. (E464), carmoisine (E122), indigo carmine • changes in sense of taste • Keep this leaflet. You may need to read aluminium lake (E132), titanium dioxide Do not take Lofepramine Tablets if • ringing in the ears it again. (E171), sunset yellow FCF aluminium lake you: • increased sensitivity to the sunlight. (E110), iron oxide red (E172) and macrogol • If you have any further questions, ask • are allergic (hypersensitive) to lofepramine, 400. your doctor, pharmacist or nurse. other tricyclic antidepressents such as An increased risk of bone fractures has been • This medicine has been prescribed for clomipramine and imipramine, or any of the observed in patients taking this type of you only. Do not pass it on to others. It other ingredients of Lofepramine Tablets. An medicines. What Lofepramine Tablets look like and contents of the pack may harm them, even if their signs of allergic reaction can include a rash, itching or shortness of breath Reporting of side effects Lofepramine Tablets are violet brown illness are the same as yours. film-coated tablets, approx 10mm diameter. • If you get any side effects, talk to your • have severe liver and/or kidney problems If you get any side effects, talk to your doctor, • are being treated for heart problems such pharmacist or nurse. This includes any doctor, pharmacist or nurse. This as an abnormal heart rhythm or heart block possible side effects not listed in this leaflet. Lofepramine Tablets come in blister packs includes any possible side effects not of 28, 30, 56 and 100 tablets and in a plastic • are recovering from a recent heart attack You can also report side effects directly via listed in this leaflet. See section 4. • have a mental illness known as “mania”. the Yellow Card Scheme at: container of 250 tablets. Not all pack sizes may be marketed. www.mhra.gov.uk/yellowcard What is in this leaflet: Warnings and precautions Talk to your doctor, pharmacist or nurse By reporting side effects you can help Marketing Authorisation Holder 1 What Lofepramine Tablets are and before taking Lofepramine tablets if you: provide more information on the safety of Accord Healthcare Limited what they are used for Sage House • are elderly this medicine. 2 What you need to know before 319 Pinner Road • have heart, liver or kidney problems North Harrow you take Lofepramine Tablets • have been told that you have a rare 3 How to take Lofepramine Tablets tumour known as “neuroblastoma” or 5 How to store Lofepramine tablets Middlesex HA1 4HF 4 Possible side effects “phaeochromocytoma” Blister packs: Store below 25ºC. Store in the United Kingdom 5 How to store Lofepramine Tablets • have a condition called “porphyria” • have ever had epilepsy, fits or convulsions original package. 6 Contents of the pack and other Plastic containers: Store below 25ºC. Keep the Manufacturer • have any other mental illness bottle tightly closed. Accord, Barnstaple, EX32 8NS, UK. information • have an overactive thyroid gland • have been told that you have a blood Keep out of the sight and reach of children. This leaflet was last revised in disorder October 2020 1 What Lofepramine tablets are and • have increased pressure in the eye (narrow Do not use Lofepramine Tablets after the what they are used for angle glaucoma) expiry date which is stated on the carton or • have a history of prostate gland problems container after EXP. The expiry date refers to If you would like a leaflet Lofepramine belongs to a group of medicines • are receiving electroconvulsive therapy for your depression. the last day of that month. with larger text, please known as antidepressants. Do not use Lofepramine Tablets if you notice contact 01271 385257. Lofepramine Tablets are used to treat If you have any thoughts of suicide or any visible signs of deterioration. the symptoms of depression. Common harming yourself whilst taking this symptoms include feelings of worthlessness medicine, you should contact your doctor Medicines should not be disposed of via or deep sadness, difficulty with everyday immediately (see Section 4 – Possible Side wastewater or household waste. Ask your tasks, sleeping too much or not being able to Effects). pharmacist how to dispose of medicines no sleep and feeling anxious. longer required. These measures will help to protect the environment. Continued top of next column Accord Healthcare Ltd, North Harrow, HA1 4HF, UK 50994656 BBBA9359 Continued top of next column Continued over page 296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1 Lofepramine, 56 Tablets , 70mg, Lofepramine 70mg 56 tablets PIL - UK - UK JDE No.: 50994656 approved for print/date Item number: BBBA9359 Colours Non Printing Colours 1. Black 1. Profile Dimensions: 296x210 (Reel Fed) Originator: C.Grant Dimensions: 296x210 2. 2. Component: Leaflet for Blisters Origination Date: 07/10/2020 Min Body Text Size: 9pt Revision Date: Supplier: Accord Barnstaple 3. 3. Pharmacode: 4178 Revised By: 4. 5. Date Sent: 21-09-20 Proof Round Technical Date sent: N/A Technologist: RH 6. 01 Approval Date received: Technically Approved [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 Other medicines and Lofepramine • estrogen (e.g. hormone replacement Use in children and adolescents: If you have thoughts of harming or killing tablets therapy and oral contraceptives). Lofepramine Tablets are not recommended yourself at any time, contact your doctor Tell your doctor or pharmacist if you are for children. or go to a hospital straight away. taking, have taken or might take any other Tell your doctor that you are taking medicines: Lofepramine tablets if you are going to have Swallow the tablets with a drink of water. You may find it helpful to tell a relative or • medicines called monoamine oxidase an operation. Anaesthetics may react with close friend that you are depressed or have inhibitors (used to treat depression). You Lofepramine Tablets. Keep taking your medicine until your doctor an anxiety disorder, and ask them to read this should not take lofepramine if you are tells you to stop. leaflet. You might ask them to tell you if they taking these medicines or you have done so Please tell your doctor or pharmacist if you think your depression or anxiety is getting in the last 14 days are taking or have recently taken any other If you take more Lofepramine Tablets worse, or if they are worried about changes in • other antidepressants called serotonin medicines, including medicines obtained than you should your behaviour. reuptake inhibitors ‘SSRIs’ (e.g. fluvoxamine, without a prescription. If you (or someone else) swallow a lot of the fluoxetine) tablets together, or if you think your child If you have any of the following side • cold remedies, nasal decongestants or Lofepramine Tablets with food and has swallowed any of the tablets, tell your effects you should tell your doctor other medicines containing adrenaline, drink doctor or go to the nearest hospital casualty immediately: ephedrine, isoprenaline, noradrenaline, Swallow the tablets with a drink of water. You department immediately. • An allergic reaction: signs are swelling of the phenylephedrine or phenylpropanolamine should not drink alcohol whilst taking this lips, face and tongue, difficulty in breathing, • medicines which make you feel sleepy or medicine. If you forget to take Lofepramine Tablets feeling faint, rash or itching (affecting the less alert (e.g. sleeping pills, tranquilisers and whole body) If you forget to take a dose, take it as soon as hypnotics) and alcohol Pregnancy and breast-feeding • Unusual bruising or bleeding of the skin, you remember. Do not take a double dose • medicines to treat thyroid problems Lofepramine Tablets are not recommended if mouth, nose or vagina to make up for a forgotten dose. If you are • medicines used to treat high blood pressure you are pregnant or breast-feeding. • Feeling feverish, unusually tired or generally unsure, speak to your doctor. (e.g. guanethidine, debrisoquine, clonidine, unwell, or you have a sore throat or sore diuretics, diltiazem, verapamil, sotalol) Driving and using machines tongue (you may have a blood disorder) • medicines to treat abnormal heart If you stop taking Lofepramine Tablets Lofepramine Tablets may cause dizziness or Do not suddenly stop taking the tablets • Your skin or eyes start turning yellow or you beats (e.g. amiodarone, disopyramide, drowsiness especially when you first start have severe stomach ache (you may have a procainamide, propafenone, quinidine, as this may cause problems such as taking this medicine. If you suffer from any sleeplessness, agitation and sweating. When liver problem or jaundice) sotalol, digitalis glycosides) of these side effects, do not drive or operate • You have a “fit” (seizure).
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