Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glyceryl trinitrate
Beaumont Pharma Ltd
C01DA02
Glyceryl trinitrate
400microgram/1dose
Sublingual spray
Sublingual
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100; GTIN: 5013675000744 5013837321960 5013675000751
Package leaflet: Information for the user Pump Spray glyceryl trinitrate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better. What is in this leaflet: 1. What Nitrolingual ® is and what it is used for 2. What you need to know before you take Nitrolingual ® 3. How to take Nitrolingual ® 4. Possible side effects 5. How to store Nitrolingual ® 6. Contents of the pack and other information 1. What Nitrolingual ® is and what it is used for Nitrolingual ® is a sublingual spray which means that you use it under your tongue. The active ingredient is called glyceryl trinitrate or GTN for short. GTN is one of a group of medicines called ‘nitrates’. These relax the muscles around the blood vessels and make it easier for the heart to do its work. Nitrolingual ® helps stop the pain of angina (pain in your chest, arms or neck especially when you exert yourself). You can also use the medicine immediately before doing things which you know will cause you angina pain. 2. What you need to know before you take Nitrolingual ® Do not take Nitrolingual ® • if you are allergic (hypersensitive) to nitrates or any of the other ingredients of Nitrolingual ® (listed in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. • if you are very ill because of very low blood pressure, severe blood loss, acute stroke, bleeding in the brain, a severe head injury or severe anaemia • if you have certain unusual heart conditions (such as acute Baca dokumen lengkapnya
OBJECT 1 NITROLINGUAL PUMPSPRAY Summary of Product Characteristics Updated 08-May-2018 | Intrapharm Laboratories Limited 1. Name of the medicinal product Nitrolingual Pumpspray 2. Qualitative and quantitative composition Each metered dose contains 400 micrograms glyceryl trinitrate. Excipients: contains 9.6 mg anhydrous ethanol per metered dose. For the full list of excipients, see section 6.1 3. Pharmaceutical form Sublingual spray. 4. Clinical particulars 4.1 Therapeutic indications For the treatment and prophylaxis of angina pectoris and the treatment of variant angina. 4.2 Posology and method of administration Posology _Adults and older people:_ At the onset of an attack or prior to a precipitating event: one or two 400 microgram metered doses sprayed under the tongue. If symptoms do not resolve, this 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. For the prevention of exercise induced angina or in other precipitating conditions: one or two 400 microgram metered doses sprayed under the tongue immediately prior to the event. _Paediatric population:_ No data are available on the use of glyceryl trinitrate in children. Method of administration _Precautions to be taken before handling or administering the medicinal product:_ The bottle should be held vertically with the valve head uppermost. If the pump is new, or has not been used for a week or more, the first actuation should be released into the air. The spray orifice should then be placed as close to the mouth as possible. The dose should be sprayed under the tongue and the mouth should be closed immediately after each dose. The spray should not be inhaled. Patients should be instructed to familiarise themselves with the position of the spray orifice, which can be identified by the finger rest on the top of the valve, in order to facilitate orientation for administration at night. During application the patient should rest, ideal Baca dokumen lengkapnya