Rupafin 10mg Tablets
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction4.6. Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
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1. Name of the medicinal product
Rupafin 10 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains:
10 mg of rupatadine (as fumarate)
Excipients: lactose
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Round, light salmon coloured tablets.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).
4.2 Posology and method of administration
Adults and adolescents (over 12 years of age)
The recommended dose is 10 mg (one tablet) once a day, with or without food.
Elderly
Rupafin should be used with caution in elderly people (see section 4.4).
Paediatric patients
Rupatadine 10 mg Tablets is not recommended for use in children below age 12. In children aged 6 to 11 years, the administration of rupatadine 1 mg/ml oral solution is recommended.
Patients with renal or hepatic insufficiency
As there is no clinical experience in patients with impaired kidney or liver functions, the use of Rupafin 10 mg Tablets is at present not recommended in these patients.
4.3 Contraindications
Hypersensitivity to rupatadine or to any of the excipients.
4.4 Special warnings and precautions for use
The administration of Rupafin with grapefruit juice is not recommended (see section 4.5).
Cardiac safety of rupatadine was assessed in a thorough QT/QTc study. Rupatadine up to 10 times therapeutic dose did not produce any effect on the ECG and hence raises no cardiac safety concerns. However rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, patients with ongoing pro-arrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia.
Rupafin 10 mg Tablets should be used with caution in elderly patients (65 years and older). Although no overall differences in effectiveness or safety were observed in clinical trials, higher sensitivity of some older individuals cannot be excluded due to the low number of elderly patients enrolled (see section 5.2).
Regarding use in children less than 12 years old and in patients with renal or hepatic impairment, see section 4.2.
Due to the presence of lactose mo