Desloratadine Actavis · 4.4 Special warnings and precautions for use · 1

HOS-155487 · has-adverse-reaction-information · PDF-Seite 3

Summary of the safety profile In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3% of patients in excess of those treated with placebo. The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%). Tabulated list of adverse reactions 3 The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). System Organ Class Adverse reactions seen with Frequency desloratadine Metabolism and Not known Increased appetite nutrition disorders Psychiatric disorders Very rare Hallucinations Not known Abnormal behaviour*, aggression*, depressed mood Nervous system Common Headache disorders Very rare Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Eye disorders Not known Eye dryness Cardiac disorders Very rare Tachycardia, palpitations Not known QT prolongation* Gastrointestinal Common Dry mouth disorders Very rare Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea Hepatobiliary disorders Very rare Elevations of li

Auszug; vollständigen Abschnitt im Original lesen.

HOS-155483 · has-contraindication-information · PDF-Seite 2

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine. 2

HOS-155482 · has-indication-information · PDF-Seite 2

Desloratadine Actavis is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)

HOS-155485 · has-interaction-information · PDF-Seite 3

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1). Paediatric population Interaction studies have only been performed in adults. In a clinical pharmacology 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.

HOS-155486 · has-pregnancy-information · PDF-Seite 3

Pregnancy A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foetal/ neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy. Breast-feeding Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility There are no data available on male and female fertility.

HOS-155484 · has-warning-information · PDF-Seite 3

In the case of severe renal insufficiency, desloratadine should be used with caution (see section 5.2). Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children (see section 4.8), being more susceptible to develop new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.