Other drugs with anticholinergic activity, such as tricyclic antidepressants, some H1-antihistamines, antiparkinsonian drugs, disopyramide, mequitazine, phenothiazines, neuroleptic drugs, atropinic antispasmodics, clozapine and quinidine, because of the risk of potentialisation of atropinic adverse effects (urinary retention, constipation, dry mouth).
4.6 Fertility, pregnancy and lactation
Pregnancy

Data on a limited number of exposed pregnancies indicate no adverse effects of atropine on pregnancy or on the health of the fetus/new-born child.

Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Studies of the pharmacokinetics of atropine in mother and fetus in late pregnancy indicated that atropine rapidly crosses the placental barrier. Intravenous administration of atropine during pregnancy or at term may cause tachycardia in the fetus and the mother.

Atropine should not be used during pregnancy unless clearly necessary.

Breast-feeding

Small amounts of atropine may pass into human breast milk. Infants have an increased sensitivity to the anticholinergic effects of atropine. Atropine may inhibit the production of milk, particularly upon repeated use. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from treatment taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. If it is decided during treatment to continue breastfeeding, the child should be monitored for anticholinergic effects.

Fertility

There are no data on effects of this atropine sulfate on fertility in humans. Atropine sulfate reduced fertility in male rats, presumably as a consequence of an inhibitory effect on the transport of sperm and semen during the process of emission.
4.7 Effects on ability to drive and use machines
Atropine may cause confusion or blurred vision and patients should be advised of it.
4.8 Undesirable effects
The pattern of adverse effects seen with atropine can mostly be related to their pharmacological actions at muscarinic and, at high doses, nicotinic receptors. Adverse effects are dose-related and usually reversible when therapy is discontinued. The most common effects occurring with relatively small doses are visual disturbances, reduced bronchial secretion, dry mouth, constipation, reflux, flushing, difficulty in micturition and dryness of the skin. Transient bradycardia may develop followed by tachycardia, with palpitations and arrhythmias.

The eva luation of adverse reactions is based on the following definition of frequency:

Very Common: ≥1/10;

Common: ≥1/100 to <1/10;

Uncommon: ≥1/1,000 to <1/100;

Rare: ≥1/10,000 to <1/1,000;

Very rare: <1/10,000;

Not known: cannot be estimated from the available data

Frequency
 Very Common

(≥1/10)
 Common

(≥1/100 to <1/10)
 Uncommon

(≥1/1,000 to <1/100)
 Rare

(≥1/10,000 to <1/1,000)
 Very Rare

(<1/10,000)
 Not known

(cannot be estimated from the available data)