Nortriptyline 10mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Nortriptyline hydrochloride

Mevcut itibaren:

Kent Pharma (UK) Ltd

ATC kodu:

N06AA10

INN (International Adı):

Nortriptyline hydrochloride

Doz:

10mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04030100; GTIN: 5015201009641

Bilgilendirme broşürü

210 mm
35 mm
280 mm
420 mm
Colours
CUSTOMER: Apotex
ORIGINATED BY: AWG MAT
PRODUCT:
Nortriptyline 10mg & 25mg Capsules
ITEM CODE:
CP.NOR.JNT.C.AP.V2P1
PROOF NO AND DATE: 1 12 Jun 20
REVISION:
Manufacturer responsible for batch
release update & MAH Address Update
ARTWORK FOR SUBMISSION
Supersedes:
CP.NOR.JNT.C.AP.V1P6
Pantone Blue
280 C
DIMENSIONS: 420mm x 280mm WHAT NORTRIPTYLINE IS AND WHAT IT IS USED FOR
Nortriptyline is a medicine used to treat major depression in adults. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE
DO NOT TAKE NORTRIPTYLINE IF:
• you are allergic (hypersensitive) to Nortriptyline or any of the
other
ingredients of this medicine (listed in section 6). An allergic
reaction may
include rash, itching, difficulty breathing or swelling of the face,
lips, throat or
tongue
• you have had a RECENT HEART ATTACK or heartbeat disorder, heart
block or
coronary artery disease
• you are taking, or have stopped taking in the last 14 days, a
monoamine
oxidase inhibitor (e.g. phenelzine, isocarboxazid or tranylcypromine).
If you
are taking moclobemide you must stop this at least 24 hours before
starting
Nortriptyline
• you have to stop treatment with Nortriptyline Capsules and wait
for 14
days before you start treatment with a monoamine oxidase inhibitor.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING NORTRIPTYLINE IF:
• you feel SUICIDAL or AGGRESSIVE;
• you are AGITATED, OVERACTIVE, or suffer from SCHIZOPHRENIA;
• you have HEART DISEASE;
• you have a THYROID condition or receive thyroid medication;
• you have a history of EPILEPSY;
• you have high pressure in the eyes (GLAUCOMA);
• you have an enlarged PROSTATE;
• you are going to have electroconvulsive therapy (ELECTRIC SHOCK);
• you are DIABETIC as you might need an adjustment of your
antidiabetic
medicine;
• you are going to receive an ANAESTHETIC, e.g. for an operation -
tell your
doctor as it might be necessary to stop the treatment with
Nortriptyline
before you are given anaesthetics;
• you

Ürün özellikleri

OBJECT 1
NORTRIPTYLINE 10 MG CAPSULES
Summary of Product Characteristics Updated 06-Dec-2019 | Kent 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 10 mg Capsules
2. Qualitative and quantitative composition
NORTRIPTYLINE 10 MG CAPSULES:
Capsules each containing Nortriptyline Hydrochloride EP equivalent to
10mg nortriptyline base.
Excipient(s) with known effect
Lactose
Sunset Yellow (E110)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
Hard gelatin capsules with a white, opaque body, yellow opaque cap and
a hard gelatin capsule with white to
off-white powder fill. The are imprinted with “APO 10”.
4. Clinical particulars
4.1 Therapeutic indications
Nortriptyline is indicated for the relief of symptoms of depression.
It may also be used for the treatment of
some cases of nocturnal enuresis.
4.2 Posology and method of administration
Posology
_Adults: _The usual adult dose is 25mg three or four times dai