Rupafin 10mg

Rupafin 10mg Description, Presentation and Dosage

Rupafin 10mg Description

Rupafin 10mg Drug Description

Each tablet contains: 10 mg of rupatadine (as fumarate) Excipients: lactose

Rupafin 10mg Presentation

Rupafin 10mg Presentation

Tablet. Round, light salmon coloured tablets.

Rupafin 10mg Manufacturer

GlaxoSmithKline UK


04 June 2009

Rupafin 10mg Dosage

Rupafin 10mg Adult Dosage

Adults and adolescents (over 12 years of age)

The recommended dose is 10 mg (one tablet) once a day, with or without food.

Paediatric patients

Rupafin 10 mg Tablets is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.

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.

Rupafin 10mg Elderly Dosage

Rupafin should be used with caution in elderly people.

Drug Information Secondary

Rupafin 10mg Precautions, Reactions and Contraindications

Rupafin 10mg Special Precautions

Rupafin 10mg Special Precautions

The administration of Rupafin with grapefruit juice is not recommended.

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.

Due to the presence of lactose monohydrate in Rupafin 10 mg tablets, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Rupafin 10mg Adverse Reactions

Rupafin 10mg Adverse Reactions

Rupatadine 10 mg has been administered to over 2025 patients in clinical studies, 120 of whom received rupatadine for at least 1 year.

The most common adverse reactions in controlled clinical studies were somnolence (9.5%), headache (6.9%) and fatigue (3.2%).

The majority of adverse reactions observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy. The frequencies are summarised according to the following scheme:

System Organ Class Common (GREATER-THAN OR EQUAL TO 1/100 to < 1/10) Uncommon (GREATER-THAN OR EQUAL TO 1/1000 to < 1/100) Investigations   Blood creatine phosphokinase increased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal, Weight increased Nervous system disorders Somnolence, Headache, Dizziness

Disturbance in attention

Respiratory, thoracic and mediastinal disorders   Epistaxis, Nasal dryness, Pharyngitis, Cough, Dry throat, Pharyngolaryngeal pain, Rhinitis Gastrointestinal disorders Dry mouth Nausea, Abdominal pain upper, Diarrhoea, Dyspepsia, Vomiting, Abdominal pain, Constipation Skin and subcutaneous tissue disorders   Rash Musculoskeletal and connective tissue disorders   Back pain, Arthralgia, Myalgia Metabolism and nutrition disorders   Increased appetite General disorders and administration site conditions Fatigue, Asthenia Thirst, Malaise, Pyrexia
Psychiatric disorders   Irritability

Rupafin 10mg Contraindications

Rupafin 10mg Contraindications

Hypersensitivity to rupatadine or to any of the excipients.