Glyceryl trinitrate 500microgram sublingual tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Glyceryl trinitrate

Inapatikana kutoka:

Accord-UK Ltd

ATC kanuni:

C01DA02

INN (Jina la Kimataifa):

Glyceryl trinitrate

Kipimo:

500microgram

Dawa fomu:

Sublingual tablet

Njia ya uendeshaji:

Sublingual

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02060100; GTIN: 5012617013613

Taarifa za kipeperushi

Actavis BST - Packing Technical
[e-mail]
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Glyceryl Trinitrate Tablets
500 & 600 mcg x 100’s (UK)
130x210 (Reel Fed)
50895130
Leaflet for Bottles
4150
R.Wrey
30/03/16
130x210 Leaflet Reel Fed Profile (BST)
Glyceryl Trinitrate 500mcg & 600mcg Tablets PIL - UK
item no: AAAI9110
print proof no: 2
origination date: 04.04.16
originated by: S.Anson
revision date: 13.04.16
revised by: S.Anson
dimensions: 130 x 210
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.Text Safe Area
2.
3.
date sent: n/a
supplier: Actavis UK
technically app. date:
min pt size: 7
TECHNICAL APPROVAL
GLYCERYL TRINITRATE TABLETS
500MICROGRAMS AND 600MICROGRAMS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_Continued over page_
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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 any further questions, ask
your doctor, pharmacist or nurse.
• 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 GLYCERYL TRINITRATE TABLETS
ARE AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GLYCERYL TRINITRATE TABLETS
3 HOW TO TAKE GLYCERYL TRINITRATE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE GLYCERYL TRINITRATE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT GLYCERYL TRINITRATE TABLETS ARE AND
WHAT THEY ARE USED FOR
Glyceryl Trinitrate belongs to a group of medicines
called nitrate vasodilators. These medicines work by
relaxing the blood vessels of the heart. This reduces
the strain on the heart by making it easier to pump
blood.

Tabia za bidhaa

OBJECT 1
GLYCERYL TRINITRATE TABLETS 500 MICROGRAMS
Summary of Product Characteristics Updated 09-Mar-2018 | Accord-UK Ltd
1. Name of the medicinal product
GLYCERYL TRINITRATE TABLETS BP 500 micrograms
2. Qualitative and quantitative composition
Each tablet contains 500 micrograms Glyceryl Trinitrate BP.
Excipient with known effect: Lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White uncoated tablets.
White, circular, biconvex uncoated tablets, impressed “C” on one
face and the identifying letters “GF” on
the reverse.
4. Clinical particulars
4.1 Therapeutic indications
As a short-acting vasodilator
Relief of angina pectoris
Prophylaxis of angina pectoris
Relief of acute spontaneous coronary artery spasm
4.2 Posology and method of administration
Posology
_Adults_
_TREATMENT OF ACUTE ATTACKS OF ANGINA PECTORIS_
When angina starts, 500micrograms glyceryl trinitrate (one tablet)
should be taken and if symptoms do
not resolve, may be repeated at five minute intervals for a total of
three doses. If symptoms have not
resolved after a total of three doses, the patient should seek prompt
medical attention.
The patient should preferably rest in the sitting position because of
the risk of symptomatic postural
hypotension.
_PROPHYLAXIS OF ANGINA PECTORIS_
Glyceryl trinitrate, 500micrograms (one tablet), may be used prior to
activity which is likely to precipitate
angina pectoris.
_Paediatric population_
No data are available on the use of glyceryl trinitrate in children.
_Elderly_
Hypotension and syncope can be a particular problem with use of
nitrates in the elderly. Patients should
be advised to sit down whenever possible when taking sublingual
glyceryl trinitrate.
Method of administration
Glyceryl trinitrate must be placed under the tongue (administered
sublingually) and retained in the mouth
until dissolved or discarded. A local burning or tingling sensation
may occur.
4.3 Contraindications
• Hypersensitivity to the active substance, to other nitro
compounds, or to any of the