rupatadine worldwide rupatadine brands - portalrinitis.com · donado e, arnaiz e, pérez i,...

RupatadineBrandsWorldwide

Rupatadine Worldwide

Rupatadine Commercialised

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Rupatadine is a new generation antihistamine and PAF antagonist indicated for the symptomatic treatment of Allergic Rhinitis and Urticaria in adults and adolescents (above 12 years of age).

Rupatadine is available in tablets containing 10 mg of Rupatadine and the recommended dose is 10 mg (one tablet) once a day, with or without food.

Rupatadine shows a positive and significant improvement ofthe overall Quality of Life in patients with Allergic Rhinitis andUrticaria.

Rupatadine 10 mg/day has shown a good long-term safety profile up to one year of treatment.

Adequate evidence of both long-term Rupatadine safety andcardiac safety place the drug within the new recommended guidelines.

Rupatadine pediatric Oral Solution has been recently approved for the symptomatic treatment of Allergic Rhinitis in children from 6 to 11 years old.

About Rupatadine

• Effective treatment option

• Dual mode of action: antihistamine and PAF antagonist 1

• Fast onset of action and sustained symptom relief 2-4

• Long-term safety study (1 year treatment) 5

• QoL improvement 6,7

• Can be taken with or without food 8

Rupatadine:

The prescribing information may vary in different countries. Before prescribing Rupatadine please consult the full local approved Summary of Product Characteristics (SPC).

References: 1. Merlos M, Giral M, Balsa D, Ferrando R, Queralt M, Puigdemont A et al. Rupatadine, a new potent, orally active dual antagonist of histamine and platelet-activating factor (PAF). J Pharmacol Exp Ther 1997;280:114–121. 2. Stuebner P, Horak F, Zieglmayer R, Arnaiz E, Leuratti C, Pérez I et al. Effects of rupatadine vs placebo on allergen-induced symptoms in patients exposed to aeroallergens in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol 2006;96:37–44. 3. Giménez-Arnau A, Donado E, Arnaiz E, Pérez I, Izquierdo I. Fast onset of action of rupatadine in the reduction of pruritos in patients suffering from chronic urticaria: pooledanalysis. Allergy 2007;62(Suppl. 83):306. 4. Fantin S, Maspero J, Bisbal C, Agache I, Donado E, Garcia O et al. A 12-week placebo-controlled study of rupatadine 10 mg once daily comparative with cetirizine 10 mg once daily, in the treatment of persistent allergic rhinitis. Allergy 2008; 63: 924-31. 5. Valero A, de la Torre F, Castillo JA, Rivas P et al. Safety of rupatadine administered over a period of 1 year in the treatment of persistent allergic rhinitis. Drug Safety 2009, 32(1):33-42. 6. Giménez-Arnau A, Pujol RM, Ianosi S et al. Rupatadine in the treatment of chronic idiopathic urticaria: a double-blind, randomized, placebo-controlled multicenter study. Allergy 2007;62:539–546. 7. Valero A, Izquierdo I, Giralt J, Bartra J, del Cuvillo A, Mullol J et al. Rupatadine Improves Nasal Symptoms, Quality of Life (ESPRINT-15) and Severity in a Subanalysis of a Cohort of Spanish Allergic Rhinitis Patients. J Investig Allergol Clin Immunol 2011; Vol. 21(3): 229-235. 8. Solans A, Carbó M, Peña J, Nadal T, Izquierdo I, Merlos M. Influence of food on the oral bioavailability of rupatadine tablets in healthy volunteers: a single-dose, randomized, open-label, two-way crossover study. Clin Ther 2007;29(5):900-8.

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Austria

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FranceRottapharm-MadausMadaus GmbHPrinz Eugen Straße, 81040 WienAustriaPhone: +43 150 58008500http://www.madaus.at

Nycomed Belgium Chaussée de Gand, 615 B-1080 Brussels Belgium Phone: +32 2 (0) 4640611

VivaxMoyzesova 868/6701701 Povazska BystricaSlovakiaPhone: +42 142 4328089

UAB Norameda Meistru 8a VilniusLT02189 Lithuania Phone: +37 052 306499 in cooperation withVIVAX Pharmaceuticals

Bouchara-Recordati 68 rue Marjolin BP 6792302 Levallois-Perret (Cedex)FrancePhone: +33 145191000

Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany Phone: +49 (0) 731 7047152 http://www.recordati.de

Dr. R. Pfleger GmbHDr.-Robert-Pfleger-Str. 12D-96052 BambergGermanyPhone: +49 (0) 951 60430http://www.dr-pfleger.de

GalenicaEleftherias Street, 414564 Kifisia-AthensGreecePhone: +30 210 5281831

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RecordatiVia M. Civitali, 120148 MilanoItalyPhone: +39 024 87871

Rottapharm | MadausVia Valosa di Sopra, 920900 MonzaItalyPhone: +39 039 73901

UAB Norameda Meistru 8a VilniusLT02189 Lithuania Phone: +37 052 306499 in cooperation withVIVAX Pharmaceuticals

Prophac sàrl B.P. 2063 L-1020 Luxembourg Phone: +00 352 4824821 [email protected]

BialBial-Portela & Cº, S.A.À Avenida da Siderurgia Nacional4745-457 S. Mamede do CoronadoPortugalPhone: +35 122 9866100http://www.bial.com

Takeda Polska Sp. z o.o. Al. Jerozolimskie 146 A 02-305 Warszawa Poland Phone: +48 22 6081300 http://www.nycomed.com/pl

BialBial-Portela & Cº, S.A.À Avenida da Siderurgia Nacional4745-457 S. Mamede do CoronadoPortugalPhone: +35 122 9866100http://www.bial.com

Portugal

VivaxMoyzesova 868/6701701 Povazska BystricaSlovakiaPhone: +42 142 4328089

Vifor PharmaAv. Camí Reial, 51-57P. I. Riera de Caldes08184 Palau-Solità i PlegamansBarcelona-SpainPhone: +34 902 121111http://www.viforpharma.es

Bial Industrial farmacéuticaClara del Rey, 31-1ª planta28002 MadridSpainPhone: +34 915 624196

RecordatiEdificio MarinaIsla de la Palma, 37-2°28703 San Sebastián de los ReyesMadrid-SpainPhone: +34 916 591550

Chiesi Pharmaceuticals B.V.Lange Kleiweg 52 J, 2288 GK RijswijkPostbus 1147, 2280 CC RijswijkHollandPhone: +31 (0) 704 132080http://www.chiesi.nl

Abdiibrahim İlaç Sanayi ve Ticaret A.Ş.Reşitpaşa MahallesiEski Büyükdere Caddesi, 4 MaslakSarıyer 34467 IstanbulTurkeyPhone: +90 212 3668400http://www.abdiibrahim.com.tr

GSK UKStockley Park WestUB11 1BT-UxbridgeUKPhone: +44 020 8990 2399http://www.health.gsk.co.uk

Abbott Products LLC 16A, bld.1, Leninrgadskoye shosse st. 125171, Moscow, Russia Phone:+7 (495) 258 42 80 http://abbottgrowth.ru/index.aspx


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NycomedEdificio PanamericanaPlaza Tronador 4890C1430DNN-Buenos AiresArgentinaPhone: +(54 11) 454 64717http://www.nycomed.com.ar

Grupo Menarini Central Americaand the Caribbean10 Calle 1-40, Zona 9Guatemala CiudadGuatemalaPhone: +(502) 242 74700Ext. 2735

Aché LaboratóriosFarmacêuticosRodovia Presidente Dutra, Km 222, 2Guarulhos, SP–CEP: 07034-904BrasilPhone: +(55) (11) 260 86234http://www.ache.com.br

Carnot LaboratorioNicolás San Juan, 1046Col. del ValleMéxico D.F. 03100MéxicoPhone: +(55) 548 87000http://www.carnot.com.mx


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Hyphens Pharma 138 Joo Seng Road, 3rd floor 368361 - Singapore Phone: +65 6338 8551 www.hyphens.com.sg

Rottapharm | Madaus Rottapharm (Thailand) Co., Ltd. 594 Luang Road, Pomprab, Pomprabsattrupai, Bangkok 10100Thailand Phone: +662 623 2551 website: www.rottapharm.co.th

El Kendi PharmaceuticalManufacturing Co.Haouch Kaouche, lot 596 B,groupe 685Dely Brahim, AlgiersAlgeriaPhone: + 213 (0) 21 36 61 89 /21 36 62 85http://www.elkendi.com

BialBial Angola, LdaRua Moisés Cardoso Cammy, 16, R/CIngombotaLuandaPhone: + 244 929 102233

BialBial Afrique Francophone S.A.R.L.Cocody SodeforRue C60, Villa 70308 BP 1920 Abidjan 08Ivory CoastPhone: +225 224 45419

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ABBREVIATED PRESCRIBING INFORMATION. The abbreviated prescribing information hereunder may vary in different countries. Before prescribing Rupatadine please consult the full local approved Summary of Product Characteristics (SPC).

Name of the medicinal product: Rupafin 10 mg Tablets. Qualitative and quantitative composition: Each tablet contains: 10 mg of rupatadine (as fumarate). Excipients: lactose 58 mg as lactose monohydrate. Pharmaceutical form: Tablet. Round, light salmon coloured tablets. Therapeutic indications: Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age). 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: Rupatadine should be used with caution in elderly people. Paediatric patients: Rupatadine 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 rupatadine 10 mg Tablets is at present not recommended in these patients. Contraindications: Hypersensitivity to rupatadine or to any of the excipients. Special warnings and precautions for use: The administration of rupatadine 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 proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. Rupatadine 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 rupatadine 10 mg tablets, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interaction with other medicinal products and other forms of interaction: Interaction with ketoconazole or erythromycin: The concomitant administration of rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure to rupatadine 10 times and 2-3 times respectively. These modifications were not associated with an effect on the QT interval or with an increase of the adverse reactions in comparison with the drugs when administered separately. However, rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Interaction with grapefruit: The concomitant administration of grapefruit juice increased 3.5 times the systemic exposure of rupatadine. Grapefruit juice should not be taken simultaneously. Interaction with alcohol: After administration of alcohol, a dose of 10 mg of rupatadine produced marginal effects in some psychomotor performance tests although they were not significantly different from those induced by intake of alcohol only. A dose of 20 mg increased the impairment caused by the intake of alcohol. Interaction with CNS depressants: As with other antihistamines, interactions with CNS depressants cannot be excluded. Interaction with statins: Asymptomatic CPK increases have been uncommonly

reported in rupatadine clinical trials. The risk of interactions with statins, some of which are also metabolised by the cytochrome P450 CYP3A4 isoenzyme, is unknown. For these reasons, rupatadine should be used with caution when it is coadministered with statins. Effects on the ability to drive and use machines: Rupatadine 10 mg had no influence on the ability to drive and use machines. Nevertheless, care should be taken before driving or using machinery until the patient’s individual reaction on rupatadine has been established. Pregnancy and lactation: Data on a limited number (2) exposed pregnancies indicate no adverse effects of rupatadine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Caution should be exercised when prescribing rupatadine to pregnant women. It is unknown whether rupatadine is excreted into breastmilk. Undesirable effects: 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. Common (≥ 1/100 to < 1/10): Nervous system disorders: somnolence, headache, dizziness; Gastrointestinal disorders: dry mouth; General disorders: fatigue, asthenia. Uncommon (≥ 1/1000 to < 1/100): blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, liver function test abnormal, weight increased; Nervous system disorders: disturbance in attention; Respiratory, thoracic and mediastinal disorders: epistaxis, nasal dryness, pharyngitis, cough, dry throat, pharyngolaryngeal pain, rhinitis; Gastrointestinal disorders: 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: thirst, malaise, pyrexia; Psychiatric disorders: irritability. Overdose: No case of overdose has been reported. In a clinical safety study rupatadine at daily dose of 100 mg during 6 days was well tolerated. The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs symptomatic treatment together with the required supportive measures should be given. Marketing authorisation holder: J. Uriach & Cía., S.A. Av. Camí Reial, 51-57. 08184 Palau-Solità i Plegamans (Spain). Date of revision of the text: February 2010.

For further information please contact our local representative or Grupo Uriach: Av. CamíReial, 51-57 Polígono Industrial Riera de Caldes 08184 Palau-Solità i Plegamans – Barcelona- Spain. Phone: +34 902 471511, Fax: +34 93 8630561.

Date of preparation: April 2012.

Prescribing Information

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