Pollentyme Fc 5 mg FC Tablets

POLLENTYME FC is used in the symptomatic relief of allergic conditions including:

• Rhinitis: POLLENTYME FC tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
• Chronic urticaria: POLLENTYME FC tablets are indicated for the symptomatic relief of chronic urticaria in patients 12 years of age and older.

Posology

Pollentyme FC 5 mg film-coated tablets should be taken once daily with or without food.

Adults and children 12 years of age and older: One tablet daily.

Pollentyme FC 5 mg film-coated tablets has an effect within 1 to 2 hours after administration.

Safety and efficacy have not been established for treatment periods in excess of 4 weeks.

Special populations

Hepatic and Renal impairment

Patients with mild to moderate hepatic impairment or renal impairment should receive 5 mg every other day as a starting dose.

Peadiatric Population

The safety and efficacy of Pollentyme FC 5 mg film-coated tablets in children below the age of 12 years have not been established. No data are available.

Method of administration

For oral use.

• Hypersensitivity to desloratadine, cross sensitivity to other antihistamines or to any of the excipients (see section 6.1).
• Pregnancy and lactation (see section 4.6).

Renal and hepatic impairment

Pollentyme FC 5 mg film-coated tablets should be used with caution in patients with hepatic function and/or renal impairment. Dosage adjustment is recommended for patients with hepatic or renal function impairment.

Impaired metabolism of desloratadine

Patients that are slow metabolisers of Pollentyme FC 5 mg film-coated tablets may be more susceptible to dose-related adverse events. (see section 4.5).

Epilepsy

There have been occasional reports of convulsions in patients taking antihistamines such as Pollentyme FC 5 mg film-coated tablets and caution is therefore suggested in patients with epilepsy.

Use in the elderly

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or with concomitant medicines.

Paediatric patients

Pollentyme FC 5 mg film-coated tablets is not recommended for use in children under 12 years as safety is not established.

Weight gain

The use of Pollentyme FC 5 mg film-coated tablets has been associated with the risk of weight gain.

Skin test: Pollentyme FC 5 mg film-coated tablets should be discontinued prior to skin tests using allergen extracts as it may inhibit the cutaneous histamine response, thus producing false-negative results. Desloratadine should be discontinued at least 48 hours before skin test.

Pollentyme FC 5 mg film-coated tablets should be used with caution when the following medical conditions exists (below) and/or patients using other medication metabolised by the cytochrome P-450 system such as:

• emphysema
• prostatic hypertrophy
• narrow angle glaucoma
• cardiovascular disorder
• epilepsy or
• during acute attacks of asthma

Concomitant use of Pollentyme FC 5 mg film-coated tablets with ketoconazole, clarithromycin, erythromycin, fluoxetine, azithromycin and cimetidine may increase the plasma concentrations of Pollentyme FC 5 mg film-coated tablets.

Neither food nor grapefruit juice had an effect on the bioavailability of Pollentyme FC 5 mg film-coated tablets.

Concomitant administration of Pollentyme FC 5 mg film-coated tablets and azithromycin, may increase the Cmax and AUC of azitromycin. The Cmax and AUC of fluoxetine may be decreased when administered with Pollentyme FC 5 mg film-coated tablets, but the corresponding mean parameters of norfluoxetine may be increased.

In a clinical pharmacological trial, desloratadine tablets taken concomitantly with alcohol did not potentiate the performance-impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly.

Pregnancy

Pollentyme FC 5 mg film-coated tablets should not be used during pregnancy and lactation. Safety and efficacy in pregnancy and lactation have not been established. (see section 4.3).

Breastfeeding

Desloratadine and its metabolites have been detected in breast milk. (see section 4.3).

Fertility

There are no clinical data on fertility.

POLLENTYME FC lacks significant sedative effects. Patients should however be warned that individuals may experience sedation, dizziness and blurred vision. It is therefore advisable to determine individual response before driving or performing complicated tasks. (see section 4.8).

a. Summary of the safety profile

The most frequent adverse reactions reported were somnolence, headache, fatigue, asthenia, dry mouth and dizziness.

b. Tabulated summary of adverse reactions

System Organ Class Frequency Side Effects

Vascular disorders Frequency unknown Hypotension

Immune system disorders Less frequent Anaphylaxis, angioedema, urticaria, pruritus, oedema

Blood and lymphatic system disorders Less Frequent Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia.

Psychiatric disorders Less frequent Depression, confusion, hallucinations

Nervous system disorders Frequent Headache Less frequent Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures

Eye disorders Less Frequent Blurred vision

Cardiac disorders Frequency unknown Tachycardia and palpitations, QT prolongation

Respiratory, thoracic and mediastinal disorders Frequent Pharyngitis Frequency unknown Dyspnoea

Gastrointestinal disorders Less frequent Abdominal or stomach pain; dyspepsia (heartburn); nausea, vomiting,diarrhoea, dry mouth, anorexia.

Skin and subcutaneous tissue disorders Less frequent Rash, alopecia Frequency unknown Photosensitivity

Musculoskeletal, connective tissue and bone disorders Less frequent Myalgia

General disorders and administration site conditions Less frequent Fatigue, Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria Frequency unknown Asthenia

Reproductive system and breast disorder Less frequent Dysmenorrhoea

Hepato-biliary disorders Less frequent Hepatitis, elevations in liver enzymes, increased bilirubin, Frequency unknown Jaundice

Ear and labyrinth disorders Frequency unknown Tinnitus

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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Symptoms: Increase in mean heart rate, tachycardia, somnolence.

Treatment: Desloratadine and its metabolite 3-hydroxydesloratadine are not eliminated by haemodialysis. It is not known if desloratadine is eliminated by peritoneal dialysis. Supportive care: Treatment should be symptomatic and supportive. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.