hypertension who are unresponsive to standard therapy (see section 4.6).
Careful monitoring of blood pressure must be exercised when administering nifedipine with I.V.
magnesium sulfate, owing to the possibility of an excessive fall in blood pressure, which could
harm both mother and foetus. For further information regarding use in pregnancy, refer to section
4.6.
4.6 Fertility, pregnancy and lactation
Pregnancy
Nifedipine should not be used during pregnancy unless the clinical condition of the woman
requires treatment with nifedipine (see section 4.4).
In animal studies, nifedipine has been shown to produce embryotoxicity, foetotoxicity and
teratogenicity (see section 5.3).
There are no adequate well controlled studies in pregnant women.
From the clinical evidence available a specific prenatal risk has not been identified, although an
increase in perinatal asphyxia, caesarean delivery, as well as prematurity and intrauterine growth
retardation have been reported. It is unclear whether these reports are due to the underlying
hypertension, its treatment, or to a specific drug effect.
The available information is inadequate to rule out adverse drug effects on the unborn and
newborn child. Therefore any use in pregnancy requires a very careful individual risk benefit
assessment and should only be considered if all other treatment options are either not indicated
or have failed to be efficacious.
Acute pulmonary oedema has been observed when calcium channel blockers, among others
nifedipine, have been used as a tocolytic agent during pregnancy (see section 4.8), especially in
cases of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use
of beta-2 agonists.
4.8 Undesirable effects
System

Organ

Common

Uncommon

Rare

Not Known

Class
(MedDRA)
Respipatory,
Thoracic,

and

Nosebleed

Dyspnoea

Nasal cogestion

Pulmonary
edema**

Mediastial
Disorders

**cases have been reported when used as tocolytic during pregnancy (see section 4.6)
5. Pharmacological properties
5.3 Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of single
and repeated dose toxicity, genotoxicity and carcinogenic potential.
Following acute oral and intravenous administration of nifedipine in various animal species, the
following LD50 (mg/kg) values were obtained:
Mouse:

Oral: 494 (421-572)*;

i.v.: 4.2 (3.8-4.6)*.

12

21