Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
Flamingo Pharma (UK) Ltd
N06AA10
Nortriptyline hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5060464500466 5060464502057
OBJECT 1 NORTRIPTYLINE 25 MG TABLETS Summary of Product Characteristics Updated 15-Jun-2020 | Flamingo Pharma (UK) 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, 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 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 Nortriptyline 25 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film coated tablet contains 25 mg of Nortriptyline as Nortriptyline hydrochloride. Excipient(s) with known effect: Lactose monohydrate Each film coated tablet contains 61.710 mg lactose monohydrate For the full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated Tablet Nortriptyline 25 mg Film-coated Tablets are orange coloured, circular biconvex film coated tablet debossed with “N” & “25” separated by break line on one side and plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Nortriptyline is indicated for the relief of symptoms of depression. It may also be used fo Prečítajte si celý dokument