National Geographic : 2006 Jul
PATIENT INFORMATION La-iic. capsules (LEER- i- kah) Read the Patient Information that comes with LYRICAbefore you start taking it and each time you get a refill.There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treat ment. Ifyou have any questions about LYRICA, ask your doctor or pharmacist. What is the most important information Ishould knowabout LYRICA? 1. LYRICA may cause dizziness and sleepiness. * Donot drive a car, work with machines, or doother dangerous activi ties until you knowhowLYRICA affects howalert youare. Askyour doctor when it is okay to dothese activities. 2. LYRICA may cause problems with your eyesight, including blurry vision. * Callyour doctor if youhave any changes inyour eyesight. What isLYRICA? LYRICA is a prescription medicine used inadults, 18 years and older, to treat: * pain from damaged nerves (neuropathic pain) that happens with diabetes * pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) * partial seizures when taken together with other seizure medicines Pain From Damaged Nerves (neuropathic pain) Diabetes and shingles can damage your nerves. Pain from damaged nerves may feel sharp, burning, tingling, shooting, or numb. Ifyou have diabetes, the pain can be inyour arms, hands, fingers, legs, feet, or toes. Ifyou have shin gles, the pain is inthe area of your rash. Youmay experience this kindof pain even with a very light touch. LYRICAcan help relieve the pain. Some people taking LYRICAhad less pain bythe end ofthe first week of LYRICA therapy. LYRICAmay not work for everyone. LYRICAhas not been studied for nerve pain in children under 18 years of age. Partial Seizures Partial seizures start inone part ofthe brain. Aseizure can make you fearful, confused, or just feel "funny." Youmay smell strange smells. Aseizure may cause your arm or legto jerk or shake. Itcan spread to other parts ofyour brain, make you pass out, and cause your whole body to start jerking. LYRICAcan lower the number ofseizures for people who are already taking seizure medicine. LYRICAhas not been studied for partial seizures in children under 18 years ofage. WhoShould NotTakeLYRICA? Donot take LYRICA ifyouare allergic toany ofits ingredients. The active ingredient ispregabalin. See the end ofthis leaflet for a complete list of ingre dients in LYRICA. What should Itell mydoctor before taking LYRICA? Tellyour doctor about all your medical conditions, including ifyou: * have any kidney problems or get kidney dialysis * have heart problems including heart failure * have a bleeding problem or a low blood platelet count * are pregnant or plan to become pregnant. It is not known ifLYRICA may harm your unborn baby. Youand your doctor willhave to decide if LYRICAis right for you while you are pregnant. * are breastfeeding. It is not known ifLYRICApasses into breast milk and ifit can harm your baby. Youand your doctor should decide whether you should take LYRICA or breastfeed, but not both. Tellyour doctor about all the medicines you take including prescription or non-prescription medicines, vitamins orherbal supplements. LYRICAand other medicines may affect each other. Especially tellyour doctor ifyou take: * rosiglitazone (Avandia®) or pioglitazone (Actos®)for diabetes. Youmay have a higher chance ofweight gain or swelling ifthese medicines are taken with LYRICA.See "What are the possible side effects of LYRICA." * any narcotic pain medicine (such as oxycodone), tranquilizers or medi cines for anxiety (such as lorazepam). Youmay have a higher chance for dizziness and sleepiness ifthese medicines are taken with LYRICA. See "What isthe most important information I should know about LYRICA?" * any medicines that make you sleepy Knowallthe medicines you take. Keepa list of them with you to show your doctor and pharmacist each time you get a new medicine. Tellyour doctor ifyou plan tofather a child. Animal studies showed that pregabalin, the active ingredient in LYRICA, made male animals less fertile. Also, in animal studies, birth defects occurred inthe offspring ofmale animals who were treated with pregabalin. It isnot known ifthese effects would happen in people. Howshould Itake LYRICA? * Take LYRICAexactly as prescribed. Your doctor may adjust your dose during treatment. Donot change your dose without talking to your doctor. * Donot stop taking LYRICAsuddenly without talking to your doctor. If you stop taking LYRICAsuddenly, you may have headaches, nausea, diarrhea or trouble sleeping. Talkwith your doctor about how to slowly stop LYRICA. * LYRICAisusually taken 2 or 3 times a day, depending on your medical condition. Your doctor willtellyou how much LYRICAto take and when to take it. TakeLYRICAat the same times each day. * LYRICAmay be taken with or without food. * Ifyou miss a dose bya few hours, take itas soon as you remember. Ifit is close to your next dose, just take LYRICAat your next regular time. Do not take two doses at the same time. * Ifyou take too much LYRICA, callyour doctor or poison control center or go to the nearest emergency room right away. What Should IAvoidWhile TakingLYRICA? * Donot drive a car, work with machines, ordo other dangerous activi ties until youknowhowLYRICA affects howalert you are. See "What is the most important information I should know about LYRICA?" * Donot drink alcohol while taking LYRICA. LYRICA and alcohol can affect each other and increase side effects such as sleepiness and dizzi ness. This can be dangerous. Donot take other medicines without talking to your doctor. Other medicines include prescription and non-prescription medicines, vitamins, and herbal supplements. LYRICAand other medicines may affect each other and increase the side effects of sleepiness and dizziness. Beespecially careful about medi cines that make you sleepy (such as sleeping pills, anxiety medicines, tran quilizers and some antihistamines, pain relievers and seizure medicines). What are the possible side effects ofLYRICA? LYRICA may cause side effects including: * dizziness and sleepiness. See "What is the most important information Ishould know about LYRICA?" * eyesight problems. See "What is the most important information I should know about LYRICA?" * weight gain and swelling ofthe hands and feet (edema). Weight gain may affect the management of diabetes. Weight gain and swelling can also be a serious problem for people with heart problems. * unexplained muscle problems, such as muscle pain, soreness, or weakness. Ifyou develop these symptoms, especially if you also feel sick and have a fever, tellyour doctor right away. Themost common side effects of LYRICA are: * dizziness * blurry vision * weight gain * sleepiness * trouble concentrating * swelling of hands and feet * dry mouth LYRICAcaused skin sores inanimals. Although skin sores were not seen in studies in people, ifyou have diabetes, you should pay extra attention to your skin while taking LYRICAand tellyour doctor of any sores or skin problems. LYRICAmay cause some people to feel"high." Tellyour doctor, if you have abused prescription medicines, street drugs, or alcohol inthe past. Tellyour doctor about any side effect that bothers you or that does not go away. These are not allthe side effects of LYRICA. For more information, ask your doctor or pharmacist. Howshould Istore LYRICA? * Store LYRICA at room temperature, 59 to 86° F(15 to 300C)in its orig inalpackage. * Safely throw away LYRICA that is out of date or no longer needed. * KeepLYRICA and all medicines out ofthe reach ofchildren. General information about LYRICA Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. Donot use LYRICA for a condition for which it was not prescribed. Donot give LYRICA to other people, even ifthey have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about LYRICA.Ifyou would likemore information, talk with your doctor. Youcan ask your doctor or pharmacist for information about LYRICAthat is written for health professionals. Youcan also visit the LYRICA website at www.LYRICA.com or call1-866 -4LYRICA. What are the ingredients InLYRICA? Activeingredient: pregabalin Inactive ingredients: lactose monohydrate, cornstarch, talc;Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White cap sule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aidthat may or may not be present inthe capsule shells. Imprinting ink:shellac, black iron oxide, propylene glycol, potassium hydroxide. Zi Distributed by: Parke-Davis Division of Pfizer Inc New York, NY 10017 LAB-0299-2 .0 July 2005 © 2006 Pfizer Inc. Allrights reserved. PB265744C Avandia is a registered trademark ofGlaxoSmithKline. Actos is a registered trademark of Takeda Chemicals Industries, Ltd.and used under license byTakeda Pharmaceuticals of America, Inc. and EliLillyand Co.