CITALOPRAM - 20 Pr. CITALOPRAM - 40 Citalopram Tablets, USP PART III: CONSUMER INFORMATION

Transcription

1 PART III: CONSUMER INFORMATION Pr CITALOPRAM - 20 Pr CITALOPRAM - 40 Citalopram Tablet, USP Thi leaflet i part III of a three-part "Product Monograph" publihed when CITALOPRAM wa approved for ale in Canada and i deigned pecically for Conumer. Pleae read thi information before you tart to take your medicine. Keep the leaflet while you are taking CITALOPRAM a you may want to read it again. Thi leaflet i a ummary and will not tell you everything about CITALOPRAM. Contact your doctor or pharmacit you have any quetion about the drug. Alway keep medicine out of the reach of children. ABOUT THIS MEDICATION What the medication i ued for: CITALOPRAM ha been precribed to you by your doctor to relieve your ymptom of depreion. Treatment with thee type of medication i mot afe and effective when you and your doctor have good communication about how you are feeling. What it doe: CITALOPRAM belong to a group of medicine known a antidepreant, more pecically to the family of medicine called SSRI (Selective Serotonin Reuptake Inhibitor). CITALOPRAM i thought to work by increaing the level of a chemical in the brain called erotonin (5- hydroxytryptamine). When it hould not be ued: Do not ue CITALOPRAM at the ame time a pimozide. Do not ue CITALOPRAM you are currently or have recently taken monoamine oxidae antidepreant (e.g. elegiline, moclobemide). Do not take CITALOPRAM you are allergic to it, or to any of the component of it formulation (for lit of ingredient ee below). CITALOPRAM and contact your doctor ly you experience an allergic reaction or any evere ide effect. Do not ue CITALOPRAM you have been diagnoed with a congenital long QT yndrome What the medicinal ingredient i: citalopram hydrobromide What the nonmedicinal ingredient are: Crocarmelloe odium, hydroxyethyl celluloe, lactoe monohydrate, magneium tearate, microcrytalline celluloe, polyethylene glycol and titanium dioxide. What doage form it come in: CITALOPRAM i available a 20 mg, or 40 mg tablet in unit doe and bottle. WARNINGS AND PRECAUTIONS Treatment with thee type of medication i mot afe and effective when you and your doctor have good communication about how you are feeling. CITALOPRAM i not for ue in children under 18 year of age. New or Worened Emotional or Behavioural Problem Particularly in the firt few week or when doe are adjuted, a mall number of patient taking drug of thi type may feel wore intead of better. They may experience new or worened feeling of agitation, hotility, anxiety, impulivity or thought about uicide, elf-harm or harm to other. Suicidal thought and action can occur in any age group but may be more likely in patient 18 to 24 year old. Should thi happen to you, or to thoe in your care, conult your doctor ly. Cloe obervation by a doctor i neceary in thi ituation. Do not dicontinue your medication on your own. You may be more likely to think like thi you have previouly had thought about harming yourelf. You may find it ful to tell a relative or cloe friend that you are depreed or have an anxiety diorder, and ak them to read thi leaflet. You might ak them to tell you they think your depreion or anxiety i ting wore, or they are worried about change in your behaviour. Effect on Pregnancy and Newborn If you are already taking/uing CITALOPRAM and have jut found out that you are pregnant, you hould talk to your doctor ly. You hould alo talk to your doctor you are planning to become pregnant. Poible complication at birth (from taking any newer antidepreant, including CITALOPRAM): Pot-marketing report indicate that ome newborn whoe mother took an SSRI (Selective Serotonin Page 1 of 6

2 Reuptake Inhibitor) uch a CITALOPRAM or other newer antidepreant during pregnancy have developed complication at birth requiring prolonged hopitalization, breathing upport and tube feeding. Reported ymptom include: feeding and/or breathing dficultie, eizure, tene or overly relaxed mucle, jitterine and contant crying. In mot cae, the newer antidepreant wa taken during the third trimeter of pregnancy. Thee ymptom are conitent with either a direct advere effect of the antidepreant on the baby, or poibly a dicontinuation yndrome caued by udden withdrawal from the drug. Thee ymptom normally reolve over time. However, your baby experience any of thee ymptom, contact your doctor a oon a you can. Peritent Pulmonary Hypertenion of the Newborn (PPHN) and newer antidepreant: Preliminary information ug that ue of SSRI during the econd half of pregnancy may be aociated with an increaed rate of a eriou lung condition called peritent pulmonary hypertenion of the newborn (PPHN) that caue breathing dficultie in newborn oon after birth. According to the tudy, babie born with thi condition were 6 time more likely than healthy babie to have been expoed to SSRI. In the general population, PPHN i known to occur at a rate of about 1-2 per 1000 newborn. If you are pregnant and taking an SSRI, or other newer antidepreant, you hould dicu the rik and benefit of the variou treatment option with your doctor. It i very important that you do NOT top taking thee medication without firt conulting your doctor. Rik of Bone Fracture: Taking CITALOPRAM may increae your rik of breaking a bone you are elderly or have oteoporoi or have other major rik factor for breaking a bone. You hould take extra care to avoid fall epecially you dizzy or have low blood preure. Angle-cloure Glaucoma: CITALOPRAM can caue dilation of the pupil which may trigger an acute glaucoma attack in an individual with narrow ocular angle. Having your eye examined before you take CITALOPRAM could identy you are at rik of having angle-cloure glaucoma. Seek attention you experience: eye pain change in viion welling or redne in or around the eye. Before you ue CITALOPRAM, tell your doctor or pharmacit: All your condition, including heart problem, hitory of eizure, manic-depreive illne, liver or kidney dieae or diabete. You have a bleeding diorder or have been told that you have low platelet. If you have QT/QTc prolongation or a family hitory of QT/QTc prolongation. If you have a peronal hitory of fainting pell. If you have a family hitory of udden cardiac death at <50 year. If you have electrolyte diturbance (e.g., low blood potaium, magneium, or calcium level) or condition that could lead to electrolyte diturbance (e.g., vomiting, diarrhea, dehydration). If you have an eating diorder or are following a trict diet. If you had a recent bone fracture or were told you have oteoporoi or rik factor for oteoporoi. If you are pregnant or thinking about becoming pregnant, or you are breat feeding. Any medication (precription or nonprecription) which you are taking or have taken within the lat 14 day, epecially monoamine oxidae inhibitor, pimozide, any other antidepreant, triptan ued to treat migraine, lithium, tramadol or drug containing tryptophan. Your habit of alcohol and /or treet drug conumption. Any natural or herbal product you are taking (e.g. St. John Wort. If you drive a vehicle or perform hazardou tak during your work. Page 2 of 6

3 INTERACTIONS WITH THIS MEDICATION Seriou Drug Interaction Do not ue CITALOPRAM you are taking or have recently taken: Monoamine oxidae inhibitor (e.g., phenelzine, tranylcypromine, moclobemide or elegiline) Pimozide Linezolid (an antibiotic) Methylene blue (intravenou) The following lit include ome, but not all, of the drug that may increae the rik of ide-effect while receiving CITALOPRAM. You hould check with your doctor or pharmacit before taking any other medication (precription, non-precription or natural/herbal) with CITALOPRAM. Other drug that may interact with CITALOPRAM include: drug to treat heart rhythm diturbance (antiarrhythmic) antipychotic opioid painkiller drug to treat infection drug to treat nauea and vomiting cancer drug athma drug diuretic (water pill) Carbamezepine Other SSRI e.g., Cipralex (ecitalopram) or any other antidepreant (e.g., imipramine, deipramine) Lithium Tryptophan Cimetidine Triptan (e.g., umatriptan, zolmitriptan, naratriptan) Fluconazole, Ketoconazole, Itraconazole Erythromycin Warfarin Omeprazole Any herbal product uch a St. John Wort Certain medicine which may affect blood clotting and increae bleeding, uch a oral anticoagulant (e.g. warfarin, dabigatran), acetylalicyiic acid (e.g. Apirin) and other nonteroidal anti-inflammatory drug (ibuprofen) Certain medicine ued to treat pain, uch a fentanyl (ued in anaetheia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine. Certain medicine ued to treat cough, uch a dextromethorphan. Avoid drinking alcohol while taking CITALOPRAM. Drug from the cla that CITALOPRAM belong to may increae the chance of a bleeding event uch a noe bleed, bruiing and even le threatening bleeding. Thi i more likely you have a hitory of a bleeding diorder or are taking other drug that are known to affect your platelet. Treatment with an SSRI in patient with diabete may alter glycaemic control (hypoglycaemia and hyperglycaemia). Tell your doctor all the medicine (precription or over the counter) and natural health product that you are uing or thinking of taking. PROPER USE OF THIS MEDICATION Uual doe: It i important that you take CITALOPRAM exactly a your doctor ha intructed. Uually your doctor will precribe 20 mg per day, which you will take once daily preferably at the ame time each day. If you are elderly, your doctor may precribe a lower doe. Thi doe may be increaed. Never change the doe of CITALOPRAM you are taking, or that omeone in your care i taking unle your doctor tell you to. Doage direction hould be followed carefully. Never exceed the precribed doe. Swallow the tablet whole with a drink of water. Do not chew them. CITALOPRAM can be taken with or without food. You hould continue to take CITALOPRAM even you do not feel better, a it may take everal week for your medication to work. Improvement may be gradual. Continue to take CITALOPRAM for a long a your doctor recommend it. Do not top taking your tablet abruptly even you begin to feel better, unle you are told to do o by your doctor. Your doctor may tell you to continue to take CITALOPRAM for everal month. Continue to follow your doctor intruction. Overdoe: If you have accidentally taken too much CITALOPRAM contact your doctor or the Regional Poion Control Centre ly, even you do not feel ick. If you go to the Page 3 of 6

4 doctor or the hopital, take the CITALOPRAM container with you. If you think you have taken too much CITALOPRAM, contact your profeional, hopital emergency department or regional Poion Control Centre ly, even there are no ymptom. Mied Doe: If you for a doe, take the next doe a planned. Do not take a double doe to make up for a forgotten doe. SIDE EFFECTS AND WHAT TO DO ABOUT THEM CITALOPRAM may caue unwanted effect (ide-effect). Thee may include fatigue, dry mouth, increaed weating, tremor (hakine), nauea, diarrhea, omnolence (leepine), ejaculation diorder and upper repiratory tract infection. Contact your doctor before topping or reducing your doage of citalopram. Symptom uch a dizzine, abnormal dream, electric hock enation, agitation, anxiety, emotional indference, dficulty concentrating, headache, migraine, tremor (hakine), nauea, vomiting, weating or other ymptom may occur after topping or reducing the doage of citalopram. Such ymptom may alo occur a doe i mied. Thee ymptom uually diappear without needing treatment. Tell your doctor ly you have thee or any other ymptom. Your doctor may adjut the doage of citalopram to reduce the ymptom. Side-effect are often mild and may diappear after a few day. If they are troubleome or peritent, or you develop any other unuual ide-effect while taking CITALOPRAM, pleae conult your doctor. Uually CITALOPRAM doe not affect your ability to carry out normal daily activitie. However, you hould not drive a car or operate machinery until you are reaonably certain that CITALOPRAM doe not affect you adverely. Pot-marketing report indicate that ome newborn whoe mother took an SSRI (Selective Serotonin Reuptake Inhibitor) uch a CITALOPRAM or other newer antidepreant during pregnancy have developed complication at birth requiring prolonged hopitaliation, breathing upport and tube feeding. Reported ymptom include: feeding and/or breathing dficultie, eizure, tene or overly relaxed mucle, jitterine and contant crying. In mot cae, the newer antidepreant wa taken during the third trimeter of pregnancy. Thee ymptom are conitent with either a direct advere effect of the antidepreant on the baby, or poibly a dicontinuation yndrome caued by udden withdrawal from the drug. Thee ymptom normally reolve over time. However, your baby experience any of thee ymptom, contact your doctor a oon a you can. If you are pregnant and taking an SSRI, or other newer antidepreant, you hould dicu the rik and benefit of the variou treatment option with your doctor. It i very important that you do NOT top taking thee medication without firt conulting your doctor. If you experience any ymptom of a poible heart rhythm diturbance, uch a dizzine, palpitation, fainting or eizure, you hould eek attention. Seriou ide effect and what to do about them profeional Uncommon Rare Low Platelet: Bruiing or unuual bleeding from the kin or other area Mania: Overactive behaviour and thought Gatrointe tinal bleeding: Vomiting blood or paing blood in tool evere cae Page 4 of 6

5 Seriou ide effect and what to do about them profeional Glaucoma: Eye pain and change in viion, welling or redne in or around the eye Low odium level in blood: Symptom of tiredne, weakne, confuion combined with achy, tf or uncoordinate d mucle Serotonin Syndrome: A combination of ymptom, poibly including: agitation, confuion, tremor, udden jerking of mucle, high fever evere cae Seriou ide effect and what to do about them profeional Very Rare Very Rare See Warning & Precaution Unknown Liver diorder: Symptom include nauea, vomiting, lo of appetite combined with itching, yellowing of the kin or eye, dark urine Seizure: Lo of concioune with uncontrollab le haking ( fit ) Akathiia: Feeling retle and unable to it or tand till New or Worened Emotional or Behavioural Problem Abnormal heart rate or rhythm, palpitation, fainting evere cae Page 5 of 6

6 Seriou ide effect and what to do about them profeional Unknown Sign of eriou kin reaction: e.g.: Steven- Johnon Syndrome: SJS (kin rah, redne of the kin, blitering of the lip, eye or mouth, kin peeling, accompanied by fever, chill, headache, cough, body ache) evere cae Thi i not a complete lit of ide effect. For any unexpected effect while taking CITALOPRAM, contact your doctor or pharmacit. HOW TO STORE IT A with all medicine, keep CITALOPRAM out of the reach and ight of children. Store your tablet at room temperature (15 C-30 C), in a dry place. Keep the container tightly cloed. Reporting Side Effect You can improve the afe ue of health product for Canadian by reporting eriou and unexpected ide effect to Health Canada. Your report may to identy new ide effect and change the product afety information. 3 way to report: Online at MedEffect ( By calling (toll-free); By completing a Conumer Side Effect Reporting Form and ending it by: - Fax to (toll-free), or - Mail to: Canada Vigilance Program Health Canada, Potal Locator 0701E Ottawa, ON K1A 0K9 Potage paid label and the Conumer Side Effect Reporting Form are available at MedEffect ( NOTE: Contact your health profeional you need information about how to manage your ide effect. The Canada Vigilance Program doe not provide advice. MORE INFORMATION Thi leaflet plu the full product monograph, prepared for health profeional, can be obtained by contacting Pro Doc Ltée at , or info@prodoc.qc.ca. Thi leaflet wa prepared by Pro Doc Ltée, Laval, Québec, H7L 3W9 Lat revied: February 14, 2018 There i an expiry date on the label. Do not ue the medicine after thi date. If your doctor tell you to top taking your medicine, you hould return any leftover tablet to the pharmacit, unle your doctor tell you to keep them at home. REMEMBER: Thi medicine i for YOU. a doctor can precribe it, o never offer it to any other peron, even their ymptom eem to be the ame a your. Page of