Nortriptyline 25mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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下载 资料单张 (PIL)
25-12-2022
下载 产品特点 (SPC)
21-05-2019
下载 公众评估报告 (PAR)
20-04-2020

有效成分:

Nortriptyline hydrochloride

可用日期:

Flamingo Pharma (UK) Ltd

ATC代码:

N06AA10

INN(国际名称):

Nortriptyline hydrochloride

剂量:

25mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04030100; GTIN: 5060464500466 5060464502057

产品特点

                                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
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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
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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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
                                
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