Page 145 - MEMENTO THERAPEUTIQUE RCP 2024

Approved SPC FR/H/296/01/II/18

Patients with asthma combined with a chronic rhinitis, a chronic sinusitis and/or nasal polyposis, have a higher
incidence of allergic manifestations when intaking aspirin and/or non-steroidal anti-inflammatory drugs than
the rest of the population.
NSAIDs may induce an increased disposition to bleeding of eye tissues during surgery: it is advised to use
these eye drops with caution in patients having a predisposition to bleeding or treated with drugs likely to
increase the bleeding time.

Cross-sensitivity
Cross-sensitivity reactions with acetylsalicylic acid and other NSAIDs are possible (see section 4.3).

Contact lenses
Contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore,
patients should be advised not to wear contact lenses unless clearly indicated by their doctor.

Excipient
VOLTARENOPHTABAK contains macrogolglycerol ricinoleate (see section 4.8.).

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy
The inhibition of prostaglandin synthesis by NSAIDs can affect the pregnancy and/or development of the
embryo or foetus.

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Risks associated with use during the 1 trimester
Data from epidemiological studies suggest an increased risk of miscarriage, heart defects and gastroschisis
after treatment with a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of a
cardiovascular malformation is less than 1% in the general population compared to approximately 1.5% in
people exposed to NSAIDs. The risk seems to increase the greater the dosage and duration of treatment. In
animals, administration of a prostaglandin synthesis inhibitor has been shown to increase the risk of pre- and
post-implantation loss and embryo/foetal mortality. In addition, a higher incidence of certain malformations,
including cardiovascular malformations, has been reported in animals that were administered a prostaglandin
synthesis inhibitor during the organogenesis phase of gestation.

Risks associated with use after 12 weeks of amenorrhea and until birth
From 12 weeks of amenorrhea and until birth, all NSAIDs, through prostaglandin synthesis inhibition, can
expose the foetus to renal function impairment:
in utero from 12 weeks of amenorrhea (start of foetal diuresis): oligohydramnios (most often reversed when
treatment is discontinued), or even anamnios, in particular in cases of prolonged exposure.
at birth, there is a risk of persistent renal failure (which may or may not be reversed) in particular in the event
of prolonged exposure or exposure in late pregnancy (with a risk of delayed severe hyperkalaemia).

Risks associated with use after 24 weeks of amenorrhea and until birth
After 24 weeks of amenorrhea, NSAIDs can expose the foetus to cardiopulmonary toxicity (premature
closure of the ductus arteriosus and pulmonary hypertension). Constriction of the ductus arteriosus can occur
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from the start of the 6 month (after 24 weeks of amenorrhea) and can lead to right heart failure in the foetus
or neonate or even intrauterine foetal death. This risk is greater the closer the treatment is taken to term (less
reversibility). This applies even to occasional use.

At the end of pregnancy, the mother and neonate can suffer from