البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glycopyrronium bromide
Drugsrus Ltd
A03AB02
Glycopyrronium bromide
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000; GTIN: 5050114912633
OTHER MEDICINES AND GLYCOPYRRONIUM BROMIDE TABLETS Tell your doctor or pharmacist if you or your patient are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Glycopyrronium Bromide Tablets with the following medicines can affect the way Glycopyrronium Bromide Tablets or the listed medicine works or can increase the risk of side effects: potassium chloride solid oral dose (see section above “DO NOT TAKE GLYCOPYRRONIUM BROMIDE TABLETS IF YOU:”) anticholinergic medicines (see section above “DO NOT TAKE GLYCOPYRRONIUM BROMIDE TABLETS IF YOU:”) antispasmodics used to treat sickness or vomiting e.g., domperidone and metaclopramide topiramate, used to treat epilepsy antihistamines such as promethazine, used to treat some allergies neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses skeletal muscle relaxants (botulinum toxin) antidepressants such as amitriptyline, clomipramine, lofepramine or imipramine (known as tricyclic antidepressants) opioids used to treat severe pain corticosteroids, used to treat inflammatory disease (e.g., prednisolone) Talk to your doctor or pharmacist for further information about any medicines to avoid or if you are in doubt about any of the above medicines. LONG TERM USE Long term efficacy and safety of Glycopyrronium Bromide Tablets has not been studied beyond 24 weeks of use. Continued use should be discussed with the patient's doctor every 3 months to check that Glycopyrronium Bromide Tablets are still right for the patient. PREGNANCY AND BREAST-FEEDING Glycopyrronium Bromide Tablets must not be given if the patient is pregnant or thinks they may be pregnant or is breastfeeding (see section 2 'Do not take'). Discuss with the patient's doctor whether there is a need for contraception. DRIVING AND USING MACHINES Glycopyrronium Bromide Tablets may affect vision and co- ordination. This may affect the performance of skilled tasks such as اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glycopyrronium Bromide 2mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg of Glycopyrronium bromide (or Glycopyrrolate). Contains lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets White to off-white, round flat beveled tablet (nominal diameter 7mm) debossed “2” on one side and break line on other side without any visible defects. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) due to chronic neurological disorders of childhood onset in patients aged 3 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Posology _ Glycopyrronium bromide tablets are recommended for short-term intermittent use (see section 4.4 and 5.1). Glycopyrronium bromide tablets should be prescribed by physicians experienced in the treatment of patients with neurological disorders. PAEDIATRIC POPULATION Children and adolescents aged 3 years and older The dosing schedule for Glycopyrronium bromide tablets is based on the weight of the child with the initial dosing of 0.02 mg/kg to be given orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. For greater detail, see Table 1. During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient's caregiver. Younger children may be more susceptible to adverse events and this should be kept in mind when dose adjustments are carried out. Following the dose titration period, the child’s sialorrhoea should be monitored, in conju اقرأ الوثيقة كاملة