Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
PILOCARPINE HYDROCHLORIDE
MEGAPHARM LTD
N07AX01
TABLETS
PILOCARPINE HYDROCHLORIDE 5 MG
PER OS
Required
EISAI INC., USA
PILOCARPINE
PILOCARPINE
For the treatment of symptoms of xerostomia and salivary gland hypofunction caused by radiotherapy for cancer of the head and neck. Sjogren detected by biopsy.
2017-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a physician’s prescription only SALAGEN TABLETS ACTIVE INGREDIENT: Each tablet contains pilocarpine hydrochloride 5.0 mg. For a list of inactive and allergenic ingredients in the preparation, see section 6 “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your physician or pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? • For the treatment of symptoms of xerostomia and salivary gland hypofunction caused by radiotherapy for cancer of the head and neck. • Sjogren detected by biopsy. THERAPEUTIC GROUP: Parasympathomimetics 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are allergic to the active ingredient, pilocarpine hydrochloride, or to any of the additional ingredients that the medicine contains )see section 6 “Additional information”(. • You are under the age of 18. • You have untreated asthma. • You have untreated heart or kidney disease. • You have a chronic disease that is being treated with medicines that act like SALAGEN. • You have an inflammation of the iris of the eye )iritis(. SPECIAL WARNINGS REGARDING THE USE OF SALAGEN: BEFORE YOU TAKE SALAGEN, TELL YOUR PHYSICIAN IF YOU SUFFER FROM: • impaired lung function )e.g., asthma, chronic bronchitis and/or chronic obstructive pulmonary disease(. • heart disease )e.g., heart failure, arrhythmias(. • gallbladder problems )e.g. gallstones(. • stomach problems )e.g., gastric ulcers(. • impaired liver function. • nervous system problems or mental disorders. • impaired kidney function )e.g., renal insufficiency or kidney stones(. • eye disorders )e.g., narrow-angle g Soma hati kamili
1. NAME OF THE MEDICINAL PRODUCT Salagen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of pilocarpine hydrochloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of symptoms of dry mouth from xerostomia and salivary gland hypofunction caused by radiotherapy for cancer of the head and neck. The treatment of symptoms of dry mouth in patients with Sjogren's Syndrome detected by biopsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment. Head & Neck Cancer Patients: The recommended initial dose of Salagen Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15-30 mg per day. (Not to exceed 10 mg per dose.) Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with Salagen Tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance. Sjogren's Syndrome Patients: The recommended dose of Salagen Tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Salagen is contraindicated in patients with clinically significant, uncontrolled cardior Soma hati kamili