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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.
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Brand name :
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PHENOBAL POWDER 10%
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Dosage form:
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powder (pale red)
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Effects of this medicine
This medicine promotes receptor affinity of inhibitory transmitter (GABA), increases Cl- channel permeability and promotes to suppress nerve function by binding to the binding sites of barbiturates that are in subunits of GABAA receptors.
It is usually used to treat insomnia, convulsive seizures in epilepsy, autonomic seizures or psychomotor seizures, and to relieve anxiety/tension state.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have acute intermittent porphyria...aftereffects of trauma (head injury) or progressive arteriosclerosis, heart/liver/renal disorder...neurosis, hypothyroidism, or tendency to drug dependence or its medical history.
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If you are pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is (( to be written by a healthcare professional))
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In general, for adults, take 0.3 to 2 g (30 to 200 mg of the active ingredient) in 1 to 4 divided doses a day. For insomnia, take 0.3 to 2 g (30 to 200 mg of the active ingredient) at a time before bedtime.
The dosage may be adjusted according to your disease, age/symptoms. Strictly follow the instructions.
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For insomnia, take this medicine just before bedtime. If you need to wake up in the middle of sleep after you once fall asleep to do some work, do not take this medicine.
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If you miss a dose, take the missed dose when you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
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If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
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Do not stop taking this medicine unless your doctor instructs you to do so.
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Precautions while taking this medicine
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This medicine may cause drowsiness and decreased attention/concentration/reflex movement. Avoid driving a car or operating dangerous machinery.
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Pay attention that alcohol (drinking) may intensify medicinal effects.
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Avoid taking any food containing St. John's wort with this medicine, since it may diminish medicinal effects.
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Possible adverse reactions to this medicine
The most commonly reported adverse reactions include drowsiness, dizziness and generalized red rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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fever, bloodshot eyes, generalized skin redness and swelling of the skin with rash or blisters [toxic epidermal necrolysis, mucocutaneous ocular syndrome, erythroderma (exfoliative dermatitis)]
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rash, fever, swelling in lymph nodes [hypersensitivity syndrome]
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unable to stop using this medicine and becoming dependent on it [dependence]
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sore throat, fever, nose or gum bleeding [granulocytopenia, decreased platelets]
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general malaise, nausea, yellow discoloration of the skin and the white of eyes [liver dysfunction]
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.
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Storage conditions and other information
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Keep out of the reach of children. Store away from direct light and moisture. Store at room temperature (1 to 30 degrees Celsius).
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Discard the remainder. Do not store them. Ask the pharmacist or medical institution on how to discard the remainder.
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