Concurrent use of anticholinergic agents with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.

Ritodrine: tachycardia

Increased antimuscarinic side-effects: amantadine; tricyclic antidepressants; antihistamines; clozapine; disopyramaide; MAOIs; nefopam; pethidine; phenothiazines (increased antimuscarinic side effects of phenothiazines but reduced plasma concentrations)

Domperidone/Metoclopramide: antagonism of effect on gastro-intestinal activity Ketoconazole: reduced absorption of ketoconazole

Levodopa: absorption of levodopa possibly reduced

Memantine: effects possibly enhanced by memantine

Nitrates: possibly reduced effect of sublingual nitrates (failure to dissolve under the tongue owing to dry mouth)

Parasympathomimetics: antagonism of effect

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of Glycopyrronium Bromide Injection in pregnant women. Animal studies for glycopyrronium bromide are insufficient with respect to reproductive toxicity (see section 5.3). Use of Glycopyrronium Bromide Injection is not recommended during pregnancy.

Breast-feeding

It is unknown whether glycopyrronium is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Glycopyrronium Bromide Injection therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

Human data concerning effects of glycopyrronium bromide on fertility are not available.

4.7 Effects on ability to drive and use machines

Glycopyrronium Bromide 200 micrograms/ml Injection is used in anaesthesia. It is not anticipated that patients will be driving or operating machinery under its influence. However, systemic administration of antimuscarinics may cause blurred vision, dizziness and other effects that may impair a patient's ability to perform skilled tasks such as driving. These activities should not be undertaken until any disturbance of visual accommodation or balance has resolved.

4.8 Undesirable effects

Side effects of antimuscarinics such as glycopyrronium bromide are basically extensions of the fundamental pharmacological actions.

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data

Tabulated list of adverse reactions:

System organ class

Adverse reaction

Frequency

Immune system disorders

Hypersensitivity

Angioedema

Not known

Gastrointestinal disorders

Dry mouth

Very common

Constipation

Nausea

Vomiting

Not known

Renal and urinary disorder

Urinary retention

Common - Very common

Urinary urgency

Micturition disorder

Not known

Nervous system disorders

Drowsiness

Common - Very common

Confusion**

Dizziness

Not known

Eye disorders

Visual disturbances

Common - Very common

Angle closure glaucoma

Very rare

Accommodation disorder

Photophobia

Not known

Cardiac disorders