TEXAMER Film-coated tablet Ref.[51219] Active ingredients: Levocetirizine

Alcohol

Caution is recommended with intake of alcohol (see section 4.5).

TEXAMER lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.5). It is therefore advisable to determine individual response before driving or performing complicated tasks.

Risk of urinary retention

TEXAMER may increase the risk of urinary retention, caution should therefore be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia).

Risk of seizure aggravation

Caution should be taken in patients with epilepsy and patients at risk of convulsion as TEXAMER may cause seizure aggravation.

Skin allergy tests

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

Treatment withdrawal

Pruritus may occur when TEXAMER is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

Information on excipients of TEXAMER

TEXAMER contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency or glucose-galactose malabsorption should not take TEXAMER.

TEXAMER contains lactose which may have an effect on the glycaemic control of patients with diabetes mellitus.

Paediatric population

Children aged less than 6 years

TEXAMER film-coated tablets are not indicated in patients under 6 years of age as this formulation does not allow for appropriate dose adaptation (see section 4.2 and 4.3).

No interactions/studies have been performed with levocetirizine, including no studies with CYP3A4 inducers.

Studies with ketoconazole, erythromycin, azithromycin, cimetidine, glipizide, diazepam and pseudoephedrine and the racemate compound cetirizine have shown no evidence of clinically relevant adverse interactions.

Alcohol

It is advisable to avoid excessive alcohol consumption, as simultaneous intake of TEXAMER and alcohol or other CNS depressants may increase the CNS depressant effects.

Theophylline

Decreases the clearance of cetirizine with 16%, whilst the disposition of theophylline is not altered by concomitant cetirizine administration.

Ritonavir

In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily) the extent of exposure to cetirizine was increased by about 40% while the disposition of ritonavir was decreased by 11%.

Food

The extent of absorption of TEXAMER is not reduced with food, although the rate of absorption is decreased.

Pregnancy

TEXAMER is contraindicated in pregnancy as safety has not been demonstrated.

Breastfeeding

TEXAMER is contraindicated in women who are breastfeeding their babies, since the active ingredient is excreted in breastmilk.

Fertility

No clinical data are available.

a) Tabulated summary of adverse reactions

^* Post marketing

b) Description of selected adverse reactions

After TEXAMER discontinuation, pruritus has been reported (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the online service for adverse drug reaction reporting by following the link:

https://www.sahpra.org.za/Publications/Index/8.

An email can be sent directly to the company, pharmacovigilance@pharmadynamics.co.za to ensure safety of the product.

Not applicable.