Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glycopyrronium bromide
DE Pharmaceuticals
A03AB02
Glycopyrronium bromide
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR THEM. ! Keep this leaflet. You may need to read it again. ! If you have any further questions, ask your doctor or pharmacist. ! This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child's. ! If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Glycopyrronium Bromide Tablets are and what they are used for 2. What you need to know before you give Glycopyrronium Bromide Tablets 3. How to use Glycopyrronium Bromide Tablets 4. Possible side effects 5. How to store Glycopyrronium Bromide Tablets 6. Contents of the pack and other information 1. WHAT GLYCOPYRRONIUM BROMIDE TABLETS ARE AND WHAT THEY ARE USED FOR This medicine is called Glycopyrronium Bromide and belongs to a group of medicines known as quaternary ammonium anticholinergics, which are agents that block or reduce the transmission between nerve cells. This reduced transmission can de-activate the cells that produce saliva. Glycopyrronium Bromide is used to treat excessive production of saliva (sialorrhoea) in children and adolescents aged 3 years and older. Sialorrhoea (drooling or excessive salivation) is a common symptom of many diseases of the muscles or nerves. It is mainly caused by poor control of muscles in the face. Glycopyrronium Bromide Tablets act on the salivary glands to reduce production of saliva. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE GLYCOPYRRONIUM BROMIDE TABLETS DO NOT GIVE GLYCOPYRRONIUM BROMIDE TABLETS IF THE CHILD OR ADOLESCENT: ! is ALLERGIC (hypersensitive) to Glycopyrronium Bromide or any of the other ingredients of this medicine (listed in section 6), ! has GLAUCOMA (increased pressure in the eye), ! has a condition called MYASTHENIA GRAVIS which leads to muscle weakness and fatigue, Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glycopyrronium Bromide 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg of Glycopyrronium Bromide For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White to off white round scored uncoated tablet engraved with “GP” & “1” on either side of score line and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in adults as add-on therapy in the treatment of peptic ulcer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage of Glycopyrronium Bromide 1 mg or 2 mg Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of Glycopyrronium Bromide is 8 mg. Glycopyrronium Bromide 1mg Tablets. The recommended initial dosage of Glycopyrronium Bromide 1 mg Tablets for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate. Glycopyrronium Bromide 2mg Tablets. The recommended dosage of Glycopyrronium Bromide 2 mg Tablets for adults is one tablet two or three times daily at equally spaced intervals. Paediatric population Glycopyrronium Bromide Tablets are not recommended for use in children. Method of administration For oral administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. In common with other antimuscarinics: angle-closure glaucoma; myasthenia gravis (large doses of quaternary ammonium compounds have been shown to block end plate nicotinic receptors); paralytic ileus; pyloric stenosis; prostatic enlargement. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Glycopyrronium Bromide Tablets should be used with caution in the elderly. They should also be used with caution Прочитајте комплетан документ