Texamer 5 mg FC tablets.

TEXAMER is indicated for the relief of symptoms associated with the following allergic conditions:

• Seasonal allergic rhinitis
• Perennial allergic rhinitis
• Chronic idiopathic urticaria

Safety and efficacy have not been demonstrated beyond six weeks.

Adults or children 12 years of age or older

The daily recommended dose is one 5 mg tablet.

Special populations

Adults with renal impairment

The dosing intervals must be individualised according to renal function. Use the table below to adjust the dosage intervals as indicated. The patientu2019s creatinine clearance (CLcr) can be estimated from the serum creatinine determination using the modified formula of Cockroft and Gault:

CLcr (ml/min) = (140 u2013 age in years) x weight in kg x (0,85 for women)

Serum creatinine (u03bcmol/l)

Dosage in patients with renal impairment

• Normal u2265 80 ml/min: 5 mg once daily
• Mild impairment 50 - 79 ml/min: 5 mg once daily
• Moderate impairment 30 to 49 ml/min: 5 mg every second day
• Severe impairment < 30 ml/min: 5 mg every third day
• End stage renal disease/ receiving dialysis < 10 ml/min: Contraindicated

Patients with hepatic impairment

No dosage adjustment is needed in patients with hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Adults with renal impairment above).

Elderly

Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (refer to Patients with renal impairment above).

Paediatric population

Children 6 - 12 years

The recommended daily dose is 5 mg once daily.

Children 2 - 6 years

TEXAMER film coated tablets should not be used in children aged 2 - 6 years, as no adjusted dosage is possible with the film-coated tablet formulation (see section 4.3 and 4.4).

Children aged less than 2 years

TEXAMER film coated tablets is contraindicated in children aged less than 2 years (see section 4.3 and 4.4).

In paediatric patients suffering from renal impairment

The dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his/her body weight. There are no specific data for children with renal impairment.

Duration of use

Intermittent allergic rhinitis (symptoms 4 days/week or during more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience is currently available for a 6-month treatment period.

Method of administration

The film coated tablet must be taken orally, swallowed with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake.

Missed dose

Doctors should advise patients who forget to take TEXAMER to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

• Hypersensitivity to levocetirizine, to cetirizine, to hydroxyzine, to any piperazine derivative or to any of the ingredients of TEXAMER (see section 6.1)
• patients with severe renal impairment at less than 10 mL/min creatinine clearance and patients undergoing dialysis
• in infants and children under 2 years as safety and efficacy have not been demonstrated (see section 4.2 and 4.4)
• in children from ages 2 - 6 years as no dosage adjustment is possible with the film coated tablet formulation (see section 4.2 and 4.4)
• pregnancy and lactation.

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, total lactase deficiency or glucose-galactose malabsorption should not take TEXAMER.

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, especially in sensitive patients, as simultaneous intake of TEXAMER and alcohol or other CNS depressants may increase the CNS depressant effects, including additional reductions in alertness and impairment of performance.

Theophylline

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

Ritonavir

In a multiple dose study of ritonavir (600 mg twice daily) and levocetirizine (10 mg daily) the extent of exposure to levocetirizine 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.

Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive and use machines. Some patients could experience somnolence, fatigue and asthenia during therapy with TEXAMER. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to TEXAMER into account.

System Organ Class

Frequency

Side effects

Immune system disorders

Frequency unknown

Hypersensitivity reactions including anaphylaxis* and angioedema

Metabolism and nutrition disorders

Frequency unknown

Increased appetite*, increased weight*

Psychiatric disorders

Frequent

Frequency unknown

Sleep disorders

Aggression*, agitation*, hallucinations*, depression*, suicidal ideation*, nightmare

Nervous system disorders

Frequent

Frequency unknown

Headache, somnolence

Convulsions*, paraesthesia*, dizziness*, syncope*, tremor*, dysgeusia*

Eye disorders

Frequency unknown

Visual disturbances*, blurred vision*, oculogyration

Ear and labyrinth disorders

Frequency unknown

Vertigo*

Cardiac disorders

Frequency unknown

Palpitations*, tachycardia*

Respiratory, thoracic and mediastinal disorders

Frequent

Frequency unknown

Pharyngitis, nasopharyngitis

Dyspnoea*

Gastrointestinal disorders

Frequent

Less frequent

Frequency unknown

Dry mouth, diarrhoea, constipation

Nausea, gastro-intestinal discomfort, abdominal pain

Vomiting*

Hepatobiliary disorders

Frequency unknown

Hepatitis*, abnormal liver function tests*

Skin and subcutaneous tissue disorders

Less frequent

Frequency unknown

Hypersensitivity skin reactions, urticaria, pruritus, Fixed drug eruptions*, angioneurotic oedema*, pruritus*, rash*, urticaria*

Musculoskeletal, connective tissue and bone disorders

Frequency unknown

Myalgia*, arthralgia

Renal and urinary disorders

Frequency unknown

Urinary retention*, dysuria*

General disorders and administrative site conditions

Frequent

Less frequent

Frequency unknown

Fatigue

Asthenia, malaise

Oedema*

*Post marketing

a. 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 requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. An email can be sent directly to the company, [email protected], to ensure safety of the product.

Signs and symptoms:

Symptoms of overdose may include drowsiness in adults. Overdosage in children may produce agitation and restlessness followed by drowsiness.

Management of overdose:

There is no known specific antidote to TEXAMER. Should overdose occur, symptomatic and supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.