Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rupatadine fumarate
DE Pharmaceuticals
R06AX28
Rupatadine fumarate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
Package Leaflet: Information for the user RUPATADINE 10mg Tablets Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Rupatadine is and what it is used for 2. What you need to know before you take Rupatadine 3. How to take Rupatadine 4. Possible side effects 5. How to store Rupatadine 6. Contents of the pack and other information 1. WHAT RUPATADINE IS AND WHAT IT IS USED FOR Rupatadine is an antihistamine. Rupatadine relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose. Rupatadine is also used to relieve the symptoms associated with urticaria (an allergic skin rash) such as itching and hives (localised skin redness and swelling). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RUPATADINE Do not take Rupatadine • If you are allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Rupatadine. If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of Rupatadine 10mg tablets is at present not recommended in patients with impaired kidney or liver functions. If you have low blood levels of potassium and/or if you have a certain abnormal pattern to your heartbeat (known prolongation of the QT interval on the ECG) which can occur in some forms of heart disease, ask your doctor for advice. If you are older than 65, ask your doctor or your pharmacist. Children This medicine is not for use in children under 12 y read_full_document
OBJECT 1 RUPATADINE 10MG TABLETS Summary of Product Characteristics Updated 04-Jan-2019 | Aspire Pharma Ltd • 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 interaction • 4.6 Fertility, preganancy 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 data • 6. 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 1. Name of the medicinal product Rupatadine 10 mg Tablets 2. Qualitative and quantitative composition Each tablet contains: 10 mg of rupatadine (as fumarate) Excipient with known effect: lactose 57.57 mg as lactose monohydrate For the 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 Rupatadine 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 childr read_full_document