くすりのしおり

Internal
Published: 12/2014

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 :
SALAGEN Granules 0.5%
 Active ingredient:
Pilocarpine hydrochloride
 Dosage form:
white to slightly yellowish white granules
 Print on wrapping:
口腔乾燥症状改善薬, サラジェン顆粒0.5%, 5mg/1g分包, SALAGENGranules

Effects of this medicine

This medicine directly acts on muscarinic M3 receptors in salivary gland to prompt saliva secretion. It consequently improves symptoms of dry mouth and also improves symptoms such as difficulty in talking or swallowing.
It is usually used to improve dry mouth symptoms associated with radiation therapy to the head and neck and in patients with Sjogren's syndrome.

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: heart disease, bronchial asthma, chronic obstructive pulmonary disease, gastrointestinal obstruction or obstruction of the urinary bladder, epilepsy, parkinsonism or Parkinson's disease, iritis, edema or pain in salivary gland, interstitial pneumonia, pancreatitis, hypersensitive enteropathy, peptic ulcer, gallbladder disorder or gallstone, stone formation (in urinary tract, kidney), prostatic hyperplasia or hyperthyroidism.
  • 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 package (5 mg of the active ingredient) at a time, three times daily, after meal (avoid taking on an empty stomach, take within 30 minutes after meal). Strictly follow the instructions.
  • If you miss a dose and realize that over 30 minutes after meal, skip the missed 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, 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

  • This medicine may cause visual impairment due to constricted pupil. Pay close attention in driving a car during the night and operating dangerous machinery in a dark place.
  • This medicine may cause excess sweating. Be sure to intake enough water to avoid dehydration.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include excess sweating, rhinitis, diarrhea, urinary frequency, headache, flush, nausea, chill, vomit, dizziness, abdominal pain, cough and malaise. 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.
  • fever, cough, phlegm, breathing difficulty  [interstitial pneumonia]
  • fainting, loss of consciousness  [syncope, loss of consciousness]
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 light, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.