Dainihonsumitomo "Dops" 100mg x100 / 200mg x 100

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:DOPS OD Tablets 100mg

Active ingredient:Droxidopa

Dosage form:white/faintly reddish  tablet(φ: 8.0mm, thickness: 3.6mm)

Print on wrapping:ドプスOD錠, 100mg, DS053

Effects of this medicine

This medicine directly turns into l-noradrenaline in the body and improves nerve function.

It is usually used to improve freezing of gait/dizziness on standing up caused by Parkinson disease, orthostatic hypotension/faint/dizziness on standing up caused by Shy-Drager syndrome or familial amyloid polyneuropathy, dizziness/light-headed feelings/dizziness on standing up/lassitude/feeling of weariness occurred in hemodialysis patient who has orthostatic hypotension.

Before using this medicine, be sure to tell your doctor and pharmacist

・If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.

If you are a patient with glaucoma, ventricular tachycardia, or cocaine addiction.

If you are a dialysis patient who has peripheral vascular lesion such as diabetic gangrene.

・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>>

・General dosage regimen: For the improvement of freezing of gait, and dizziness on standing up caused by Parkinson disease: For adults, start with 1 tablet (100mg of the active ingredient) once a day. Increase the dose by 1 tablet (100mg) every other day, and then the optimum dose (standard maintenance daily dose) will be decided. The standard maintenance daily dose is 2 tablets (200mg) at a time, 3 times a day, but the dose may be adjusted according to your age and symptoms. The maximum dose is 9 tablets (900mg) a day. Strictly follow the instructions of your doctor/pharmacist.

・For the improvement of orthostatic hypotension, faint, and dizziness on standing up caused by Shy-Drager syndrome or familial amyloid polyneuropathy: For adults, start with 2-3 tablets (200-300mg) in 2-3 divided doses a day. Increase the dose by 1 tablet (100mg) a day every several-7 days, and then the optimum dose (standard maintenance daily dose) will be decided. The standard maintenance daily dose is 1-2 tablet(s) (100-200mg) at a time, 3 times a day, but the dose may be adjusted according to your disease, age and symptoms. The maximum dose is 9 tablets (900mg) a day. Strictly follow the instructions of your doctor/pharmacist.

・For the improvement of dizziness, light-headed feelings, dizziness on standing up, lassitude, and feeling of weariness in hemodialysis patient with orthostatic hypotension: For adults, take 2-4 tablets (200-400mg) 30-60 minutes before receiving hemodialysis, but the dose may be reduced according to your age and symptoms. The maximum dose is 4 tablets (400mg) at a time. Strictly follow the instructions of your doctor/pharmacist.

・This medicine may be moistened with saliva on the tongue, then lightly squashed with the tongue, and swallowed with saliva. It may also be taken with water like usual drugs.

・Take the missed dose. However, you have to wait more than 4 hours before the next dose. (If you are instructed to take it 3 times a day.) DO NOT take a double dose to make up for the missed dose.

If you take this medicine for the improvement of dizziness, light-headed feelings, dizziness on standing up, lassitude, and feeling of weariness in hemodialysis patient with orthostatic hypotension and you realize that you missed a dose before receiving hemodialysis, take the missed dose as soon as possible. DO NOT take a double dose to make up for the missed dose.

・If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.

・Do not stop taking the medicine without the instructions of your doctor.

Precautions while taking this medicine

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: nausea, loss of appetite, stomachache (stomach discomfort, etc.), elevation of blood pressure, headache, top-heavy feeling, hallucination, dizziness, palpitation, lassitude, cyanosis (skin/mucosa (especially in the lips or finger/toe nails) turning into purplish blue), rash, itch, etc.

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.

・sudden onset of fever, stiff muscle, tremor in the limbs [neuroleptic malignant syndrome]

・sore throat, headache, nose bleeding [leukopenia, agranulocytosis, neutropenia, thrombocytopenia]

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

・Keep out of the reach of children. Store away from heat, moisture and direct sunlight.

・Discard the remainder. Do not store them.