Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Caution should be exercised in patients who are known or expected to sweat excessively and who cannot drink enough liquids, since dehydration could develop.
Pilocarpine has been reported to increase airway resistance in asthmatic patients. Also, patients with significant cardiovascular disease may be unable to compensate for transient changes in haemodynamics or heart rhythm induced by pilocarpine. Therefore, Salagen should be administered to patients with controlled asthma or significant cardiovascular disease only if the benefits are believed to outweigh the risks, and under close medical supervision.
Salagen should be used with caution in patients with the following illnesses/pathologies: - Chronic bronchitis and/or chronic obstructive pulmonary disease. These patients have hyperactive airways and may experience adverse effects due to increased bronchial smooth muscle tone and increased bronchial secretions.
- Known or suspected cholelithiasis or biliary tract disease. Contractions of the gallbladder or biliary smooth muscle could precipitate complications including cholecystitis, cholangitis and biliary obstruction.
- Peptic ulceration, due to the risk of increased acid secretion.
- Underlying cognitive or psychiatric disturbances. Cholinergic agonists, like pilocarpine hydrochloride, may have dose-related central nervous system effects.
- Caution should be exercised when administering Salagen in patients with renal insufficiency.
- Pilocarpine may increase ureteral smooth muscle tone and could theoretically precipitate renal colic (or “ureteral reflux”), particularly in patients with nephrolithiasis.
- Salagen should be administered with caution in patients with narrow-angle glaucoma.

Effects on Driving

4.7 Effects on ability to drive and use machines
Patients who experience dizziness during Salagen treatment should be advised not to drive or operate machinery.
Pilocarpine has been reported to cause impairment of depth perception and visual blurring. The latter may result in decreased visual acuity, especially at night and in patients with central lens changes. If this occurs, patients should be advised not to drive at night or perform hazardous activities in reduced lighting.