minor updates to section 4.6 upon clarification with RMS, "Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma depending on sampling time after administration” should remain in section 4.6.

4.6     Fertility, pregnancy and lactation

 Pregnancy

For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.  Caution should nevertheless be exercised when prescribing to pregnant women.

 Breast-feeding
 

Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded.  Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

Change to section 4.8- Undesirable effects: Addition of hepatitis
Change to section 10- Date of revision of the text: updated to May 2018

- Addition of ADRs “nightmare” and “arthralgia”

- Addition of ADR “acute generalized exanthematous pustulosis”

4.2.        Posology and Method of Administration

• Heading “Special population” added.

4.4         Special warnings and precautions for use

• Some text added and deleted.

4.8.        Undesirable Effects

·       Some text added and deleted.

10          DATE OF REVISION OF THE TEXT

·       Date of revision updated.

4.4     Special warnings and precautions for use

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

4.8         Undesirable effects

Metabolism and nutrition disorders:

Not known: increased appetite

Psychiatric disorders:

Not known: suicidal ideation

Ear and labyrinth disorders:

Not known: vertigo

Renal and urinary disorders:

Not known: urinary retention

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml of solution contains 1 mg cetirizine dihydrochloride

Excipients with known effect:    

- one ml of solution contains 450 mg sorbitol (solution at 70 %, non crystallizing)

- one ml of solution contains 1.35 mg methylparahydroxybenzoate

- one ml of solution contains 0.15 mg propylparahydroxybenzoate

For the full list of excipients, see section 6.1

4.2     Posology and method of administration

Method of administration:

The solution can be swallowed as such.

Paediatric population

Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.

4.6     Fertility, pregnancy and lactation

Breast-feeding

Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

4.4     Special warnings and precautions for use

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/l).  Nevertheless, precaution is recommended if alcohol is taken concomitantly.

Caution in epileptic patients and patients at risk of convulsions is recommended.

Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

 4.6     Fertility, pregnancy and lactation

Preagnancy

For cetirizine very rare clinical data on exposed pregnancies are available.  Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.  Caution should be exercised when prescribing to pregnant women.

Lactation

Cetirizine is excreted in human milk at concentrations representing 0.25 to 0.90 those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

4.8       Undesirable effects

Post-marketing experience