Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 02/2020
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails 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:AMBROXOL HYDROCHLORIDE TABLETS 15mg "CEO"Active ingredient:Ambroxol hydrochloride
Dosage form:white tablet, diameter: 7.0 mm, thickness: approx. 2.4 mm
Print on wrapping:(face) アンブロキソール塩酸塩錠 15mg「CEO」, アンブロキソー
ル,15mg, (back) AMBROXOL TABLETS 15mg「CEO」, アンブロキソール, 15mg, G228, 気道潤滑去痰剤
Effects of this medicine
This medicine promotes secretion of the respiratory mucous membrane and increases ciliary movement. It
consequently makes phlegm/nasal discharge easier.
It is usually used for expectoration of phlegm in acute bronchitis, bronchial asthma, chronic bronchitis,bronchiectasis, pulmonary tuberculosis, pneumoconiosis and difficulty in expectoration after surgery or for dischargeof pus in chronic sinusitis.
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 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, take 1 tablet (15 mg of the active ingredient) at a time, 3 times a day. The dosage may be
adjusted according to your age and symptoms. Strictly follow the instructions.
・If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip themissed dose and continue your regular dosing schedule. You should not take two doses at one time.
・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include angioedema (edema of face, eyelids, lips), rash, hives,
hives-like erythema and itch. If any of them occurs, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・respiratory distress, facial edema, hives [shock, anaphylactoid symptoms]
・high fever, redness in wide area of skin, bloodshot eyes [mucocutaneous ocular syndrome]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of children. Store away from light, heat and moisture.
・Discard the remainder. Do not store them.
For healthcare professional use only//

For further information, talk to your doctor or pharmacist.

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