Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
PYRIDOSTIGMINE BROMIDE
RAFA LABORATORIES LTD
N07AA02
TABLETS
PYRIDOSTIGMINE BROMIDE 30 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
PYRIDOSTIGMINE
PYRIDOSTIGMINE
Pyridostigmine belongs to the cholinesterase inhibitor group and is indicated for the treatment of myasthenia gravis.
2021-06-30
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is sold with a doctor's prescription only PYRIDOSTIGMINE 30 PYRIDOSTIGMINE 60 TABLETS ACTIVE INGREDIENT: Each tablet of Pyridostigmine 30 contains: Pyridostigmine bromide 30 mg Each tablet of Pyridostigmine 60 contains: Pyridostigmine bromide 60 mg For a list of the other ingredients, please see section 6. See also 'Important information about some of the medicine's ingredients in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of myasthenia gravis. THERAPEUTIC GROUP: cholinesterase inhibitors. The tablets contain the active ingredient pyridostigmine bromide which acts as an inhibitor of the enzyme cholinesterase and thus prevents the increased degradation of acetyl choline, a substance which transmits pulses from the nerve to the muscle. In patients who suffer from myasthenia gravis the muscles quickly become tired and weak. In severe cases, they even reach a state of muscle paralysis. 2. BEFORE YOU TAKE THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients this medicine contains (for a list of the other ingredients, please see section 6). • You suffer from a mechanical obstruction of the intestines or the urinary tract. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE : • If you are about to undergo surgery, notify the medical team that you are taking this medicine. BEFORE STARTING THE TREATMENT WITH PYRIDOSTIGMINE TELL YOUR DOCTOR IF: • You suffer from asthma or other problems of the respiratory system such a Olvassa el a teljes dokumentumot
1 Pyridostigmine -DL-SPC-November 2023-02 SAMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pyridostigmine 30, Pyridostigmine 60 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Pyridostigmine 30 contains 30mg pyridostigmine bromide Each tablet of Pyridostigmine 60 contains 60mg pyridostigmine bromide For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets for oral use 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of myasthenia gravis. 4.2 Posology and method of administration _Adults_ Oral dosage forms: Multiple doses of 30 to 120 mg are given at intervals throughout the day. The total daily dose is usually in the range of 120 - 1200 mg but doses higher than these may be needed by some patients according to dose titration. _Children_ Children under 6 years old should receive an initial dose of 30 mg of pyridostigmine bromide. Children 6 - 12 years old should receive 60 mg. Dosage should be increased gradually, in increments of 30 mg daily, until maximum improvement is obtained. Total daily requirements are usually in the range to 30 - 360 mg. Special populations _Elderly_ There are no specific dosage recommendations in elderly patients. Renal impairment Pyridostigmine is mainly excreted unchanged by the kidney, therefore lower doses may be required in patients with renal disease and treatment should be based on titration of drug dosage to effect. Hepatic impairment There are no specific dosage recommendations in patients with hepatic impairment. 4.3 Contraindications - Hypersensitivity to the active substance, other bromides or to any of the excipients listed in section 6.1 - Mechanical obstruction of the digestive or urinary tract 2 4.4 Special warnings and precautions for use Pyridostigmine is to be used with particular caution in: -Patients with obstructive respiratory illnesses such as bronchial asthma and chronic obstructive pulmonary disease (COPD). Pyridostigmine is to be used with caution in: - Patients with arrhythmias such as bradycardia a Olvassa el a teljes dokumentumot