Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 11/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name:CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 200 JAU/mL bottle Active ingredient:Standardized Japanese cedar pollen extract original solution 10,000 JAU/mL Dosage form:Clear and colorless solution Print on wrapping:シダトレンスギ花粉舌下液 200JAU/mL ボトル Effects of this medicine This medicine, made from cedar pollen, is started at a low concentration/dose to make your body accustomed to the pollen for amelioration of allergic symptoms caused by cedar pollen (symptoms of cedar pollinosis). It is usually used to improve the symptoms of cedar pollinosis. Before using this medicine, be sure to tell your doctor and pharmacist ・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have experienced shock by taking this medicine. If you have bronchial asthma, cancer or a systemic disease that affects immune system. ・If you are pregnant or breastfeeding. ・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) ・Your dosing schedule prescribed by your doctor is<< to be written by a healthcare professional>> ・In general, for adults and children over 12 years of age, the following doses will be administered sublingually once daily for 2 weeks after the initiation of administration: Day 1, 0.2 mL; Day 2, 0.2 mL; Day 3, 0.4 mL; Day 4, 0.4 mL; Day 5, 0.6 mL; Day 6, 0.8 mL; and Day 7, 1 mL. The medicine should be retained for 2 minutes, and then swallowed. Gargling, eating and drinking should be avoided for the next 5 minutes. This medicine is to be taken in the first week of the updosing period. Strictly follow the instructions. ・It is recommended that you take the medicine in the presence of a family member or during daytime in case anaphylaxis develops and treatment becomes necessary. ・If you have cold, asthma or are not feeling well, ask your doctor whether you can take the medicine. ・Consult with your doctor before taking the medicine if you have received surgery or treatment for your mouth, such as tooth extraction or if you have a wound or inflammation inside the mouth, such as stomatitis. ・If the medicine gets on your hands, wash it off immediately. Symptoms such as itching may appear if you rub your eyes with the medicine on your hands. ・If you miss a dose and realize that you have missed a dose by the end of that day, take the dose for that day. However, if you realize on the next day that you have missed a dose, take the medicine at the dose for the day before. Even if you cannot keep a drop under your tongue for 2 minutes before swallowing, do not take another dose on the same day. Take it on the next day at the dose for the day before. You should never take two doses at one time. ・If you accidentally take more than your prescribed dose, spit it out and gargle. On the next day, take the medicine at the dose for the day before. If you notice any abnormality, visit a medical institution immediately. ・Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine ・Do not get involved in heavy exercise, drink alcohol or take a bath within 2 hours before and after taking this medicine. Improved blood circulation in the body may promote the absorption of this medicine, leading to development of adverse reactions. Possible adverse reactions to this medicine The most commonly reported adverse reactions include stomatitis, swelling under the tongue, throat itching, oral swelling, ear itching and headache. If any of these symptoms occurs, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated 1/2 in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. ・facial pallor, cold sweat, respiratory distress [shock, anaphylaxis] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information ・Store this medicine in a cold place (at 2 to 8 degrees Celsius). ・Keep out of the reach of children. ・Discard the remainder. Do not store them. For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 2/2