Page 146 - MEMENTO THERAPEUTIQUE RCP 2024

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

increased bleeding time due to an anti-aggregation effect which may occur even after administration of very
low dosages;
inhibition of uterine contractions delaying or prolonging delivery.

Therefore
Unless absolutely necessary, this medicinal product should not be prescribed to women planning a pregnancy
or during the first 5 months of pregnancy (first 24 weeks of amenorrhea). If this medicinal product is
administered to a woman wishing to conceive or who is in her first 5 months of pregnancy, she should be
given the lowest dosage for as short a time as possible. Long-term use is strongly discouraged.
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From the start of the 6 month (from 24 weeks of amenorrhea): this medicinal product is contraindicated, even
for occasional use. If the medicinal product is taken inadvertently after this date, heart and kidney monitoring
will be necessary in the foetus and/or neonate, depending on the time of exposure. The duration of monitoring
will be adapted to the elimination half-life of the medicinal product.

Breast-feeding
No effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to
diclofenac sodium is limited after ocular application. VOLTARENOPHTABAK can be used during
breastfeeding.

Fertility
Like all NSAIDs, this medicinal product can temporarily affect ovulation and fertility in women. It is
therefore not recommended for women wishing to conceive. Women having difficulty conceiving or who are
taking fertility tests should consider discontinuing treatment.

4.7 Effects on ability to drive and use machines

A transient visual discomfort may occur after instillation of VOLTARENOPHTABAK, eye drops, solution.
If affected, the patient should be advised not to drive or operate hazardous machinery until normal vision is
restored.

4.8 Undesirable effects

Infections and infestations
Not known (cannot be estimated from the available data)
Rhinitis

Immune system disorders
Rare (≥1/10,000, <1/1,000)
Hypersensitivity

Eye disorders
Uncommon (≥1/1,000, <1/100)
Burning sensation in eye upon instillation, visual disturbances upon instillation

Rare (≥1/10,000, <1/1,000)
Punctate keratitis, corneal thinning, corneal ulceration

Not known (cannot be estimated from the available data)
Conjunctival hyperaemia, conjunctivitis allergic, eyelid oedema

Respiratory, thoracic and mediastinal disorders
Rare (≥1/10,000, <1/1,000)
Dyspnoea, asthma aggravated