Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 04/2023
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:PREGABALIN OD TABLETS 25mg 「OHARA」
Active ingredient:Pregabalin
Dosage form:white tablet, diameter: 6.5 mm, thickness: 3.4 mm
Imprint or print on wrapping:プレガバリン OD 25mg「オーハラ」、プレガバリン OD、25mg、疼痛治療薬、口腔内崩壊錠、Pregabalin OD 25mg「OHARA」
Effects of this medicine
This medicine suppresses calcium influx and release of excitatory neurotransmitters such as glutamic acid in central
nervous system to tranquilize over-excited nerves and relieve pain.
It is usually used to treat neuropathic pain and pain associated with fibromyalgia.
The following patients may need to be careful when using this medicine.Be sure to tell your doctor andpharmacist.
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
If you have renal dysfunction, congestive heart failure, a history of angioedema, tendency or history of drug
dependence or a mental disorder.
・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))・For neuropathic pain : In general, for adults, as an initial dose, take 75 mg of the active ingredient at a time, twice
a day, and then the daily dose may be gradually increased up to 300 mg in a week or more. The dosage may beadjusted according to the age or symptoms. However, the maximum daily dose is 600 mg in two divided doses.
For pain associated with fibromyalgia : In general, for adults, as an initial dose, take 75 mg of the active ingredientat a time, twice a day. The daily dose may be gradually increased up to 300 mg in a week or more and may be
maintained at 300 to 450 mg. The dosage may be adjusted according to the age or symptoms. However, themaximum daily dose is 450 mg in two divided doses.
This preparation contains 25 mg of the active ingredient in a tablet. In any case, strictly follow the instructions.
・You can take this medicine without water. Moisten the tablet with saliva on your tongue and crush it lightly withyour tongue, then swallow it with saliva. You can also take it with a glass of water or lukewarm water like regular
tablets.
・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 follow your regular dosing schedule. You should never take two doses at one time.
・If you accidentally take more than your prescribed dose, restlessness, agitation, falling asleep unless stimulated,confusional state, depression and convulsion may occur. If these symptoms appear at the same time, consult withyour doctor immediately.
・Do not stop taking this medicine unless your doctor instructs you to do so. If you suddenly stop taking thismedicine, insomnia, nausea, headache or diarrhea may occur.
Precautions while taking this medicine
・As this medicine may cause dizziness, somnolence or loss of consciousness and there is a case resulted in a car
accident, do not operate dangerous machinery such as driving a car while taking this medicine. Especially, if you
are an elderly, pay close attention because there is a case resulted in falling and fracture due to these symptoms.
・This medicine may cause increased body weight. Especially, if you increase dosage or take this medicine for a longperiod, weight gain may possibly occur. Weight check should be performed periodically, and consult with yourdoctor if you start to gain weight. You may be advised to improve content of meals and do exercises, etc.
・This medicine may cause reduced visual acuity, focus disorder, blurred vision or double vision. Consult with yourdoctor if any of them occurs.
・Pay attention that alcohol drinking may intensify medicinal effects.
・If you are breastfeeding, stop breastfeeding while using this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include dizziness, somnolence, edema and increased body weight. 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 indicated1/2

in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・light headedness, a state close to sleep with impaired consciousness, loss of consciousness [dizziness, somnolence,loss of consciousness]
・respiratory distress, general edema, palpitation on exertion [heart failure, pulmonary edema]・muscle pain, lassitude, reddish brown urine [rhabdomyolysis]・decreased urine output, edema of limbs or face, malaise [renal failure]・swelling of face/tongue/lips/throat, hives, respiratory distress [angioedema, shock, anaphylaxis]
・lassitude, malaise, cold sweat [hypoglycemia]
・dry cough, respiratory distress, fever [interstitial pneumonia]
・high fever, bloodshot eyes, red rash [Stevens-Johnson syndrome, erythema multiforme]
・loss of appetite/nausea/vomiting, general malaise, jaundice, itch [fulminant hepatitis, liver dysfunction]
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 direct sunlight, heat and moisture.
・Discard the remainder. Do not store them. If you do not know how to dispose, ask your pharmacy or medical
institution on how to discard the remainder. Do not give it to others.
For healthcare professional use only//

For further information, talk to your doctor or pharmacist.
SIE②

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