Do not use Nitrolingual<\/h2>\n\n\n\n- if you are allergic (hypersensitive) to glyceryl trinitrate ( nitroglycerin ) or any of the other ingredients of this medicine (listed in section 6), or to other medicines containing nitrates<\/li>
- if you have hypertrophic obstructive cardiomyopathy (a disease of the heart muscle that causes obstruction of blood flow)<\/li>
- in case of increased pressure in the brain (eg head injury, cerebral haemorrhage)<\/li><\/ul>\n\n\n\n
If you are using Nitrolingual, do not use male\u00a0impotence\u00a0or\u00a0pulmonary\u00a0hypertension\u00a0containing so-called phosphodiesterase type 5 inhibitors (eg sildenafil, tadalafil, vardenafil) at the same time as this greatly increases the blood pressure-lowering effect of Nitrolingual, which can cause serious\u00a0side effects\u00a0(fainting, myocardial infarction).<\/p>\n\n\n\n
Take special care with Nitrolingual<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before using Nitrolingual if any of the following apply to you:<\/p>\n\n\n\n
- if you have heart disease, such as circulatory problems, narrowing of the heart valves, pericarditis or high pressure on the heart caused by fluid accumulation in the pericardium.<\/li>
- if you suffer from severe low blood pressure (when the upper (systolic) blood pressure is below 90 mmHg)<\/li>
- if you have a brain disease that can be traced to a disease in the blood vessels that supply the brain.<\/li>
- if you have lung disease (risk of worsening oxygenation)<\/li><\/ul>\n\n\n\n
Use of other medicines<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n
Nitrolingual lowers\u00a0blood pressure.\u00a0This effect can be enhanced if the drug is used in conjunction with<\/p>\n\n\n\n
- vasodilator<\/li>
- antihypertensive agents (eg beta – blockers , calcium channel blockers, diuretics , ACE inhibitors )<\/li>
- certain medicines commonly used for mental or emotional disorders ( neuroleptics , tricyclic antidepressants )<\/li>
- alcohol<\/li>
- saptopterin, a drug used to treat phenylketonuria (PKU)<\/li>
- phosphodiesterase inhibitors type 5 (eg sildenafil, vardenafil or similar medicines) for the treatment of impotence or high blood pressure in the lungs. If a patient being treated with such drugs has an acute angina attack, he \/ she must be hospitalized immediately before starting treatment with Nitrolingual.<\/li><\/ul>\n\n\n\n
N-acetylcysteine \u200b\u200bmay potentiate the vasodilatory effect of Nitrolingual.<\/p>\n\n\n\n
If you are taking other\u00a0organic nitrates\u00a0(eg\u00a0isosorbide dinitrate, isosorbide-5-mononitrate) a higher\u00a0dose\u00a0of Nitrolingual may be needed to achieve the desired effect on circulation.<\/p>\n\n\n\n
Nitrolingual can affect the following drugs:<\/p>\n\n\n\n
- Dihydroergotamine (a medicine used to treat migraines ) can counteract the effects of Nitrolingual and raise your blood pressure more than usual.<\/li>
- heparin . If you use the spray together with heparin , the coagulation capacity may be impaired and the risk of bleeding may increase. The heparin dose may need to be adjusted.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n
It is unknown whether Nitrolingual or its metabolite is excreted in human milk. A risk to breastfed children cannot be ruled out.<\/p>\n\n\n\n
There is no evidence of an adverse effect on\u00a0fertility.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Nitrolingual can affect the ability to react. Driving and other mechanical work should therefore be avoided immediately after spraying with Nitrolingual.<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n
Important information about some of the ingredients of Nitrolingual<\/h2>\n\n\n\n
Nitrolingual contains small amounts of alcohol (\u00a0ethanol\u00a0), less than 10 mg per\u00a0dose.<\/p>\n\n\n\n
HOW TO USE NITROLINGUAL<\/h2>\n\n\n\n
Always use Nitrolingual exactly as your doctor has told you.\u00a0Ask your doctor or pharmacist if you are unsure.\u00a0Patients should be instructed to sit down whenever possible when taking sublingual\u00a0glyceryl trinitrate<\/a>.<\/p>\n\n\n\nThe recommended\u00a0dose\u00a0is 1-2 sprays (0.4-0.8 mg) in the mouth under the tongue, without inhalation, at the beginning of an angina attack, or immediately before any known effort that causes angina.\u00a0More than three sprays at a time are not recommended.\u00a0If the pain does not go away, another 1-2 sprays (0.4-0.8 mg) can be given after 10 minutes.\u00a0If the pain still does not go away, seek medical attention immediately.<\/p>\n\n\n\n
Use for children<\/strong><\/p>\n\n\n\nThere are no data available from the use of Nitrolingual in children.<\/p>\n\n\n\n
Instructions for use<\/strong><\/p>\n\n\n\n1. The bottle does not need to be shaken before use.
Remove the plastic cap (according to figure A).<\/p>\n\n\n\n
Before using the spray for the first time,
test spray twice in the air.<\/p>\n\n\n\n
(If the spray bottle has been unused for more than 14 days
, repeat the test procedure.)<\/p>\n\n\n\n
During spraying – hold the dose bottle upside
down and with the mouthpiece as close to your mouth as possible.<\/p>\n\n\n\n
4. Spray the prescribed number of doses into your mouth –
under your tongue (figure B), without inhalation. Close your mouth immediately after spraying.<\/p>\n\n\n\n
If you are using Nitrolingual, do not use male\u00a0impotence\u00a0or\u00a0pulmonary\u00a0hypertension\u00a0containing so-called phosphodiesterase type 5 inhibitors (eg sildenafil, tadalafil, vardenafil) at the same time as this greatly increases the blood pressure-lowering effect of Nitrolingual, which can cause serious\u00a0side effects\u00a0(fainting, myocardial infarction).<\/p>\n\n\n\n
Take special care with Nitrolingual<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before using Nitrolingual if any of the following apply to you:<\/p>\n\n\n\n
- if you have heart disease, such as circulatory problems, narrowing of the heart valves, pericarditis or high pressure on the heart caused by fluid accumulation in the pericardium.<\/li>
- if you suffer from severe low blood pressure (when the upper (systolic) blood pressure is below 90 mmHg)<\/li>
- if you have a brain disease that can be traced to a disease in the blood vessels that supply the brain.<\/li>
- if you have lung disease (risk of worsening oxygenation)<\/li><\/ul>\n\n\n\n
Use of other medicines<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n
Nitrolingual lowers\u00a0blood pressure.\u00a0This effect can be enhanced if the drug is used in conjunction with<\/p>\n\n\n\n
- vasodilator<\/li>
- antihypertensive agents (eg beta – blockers , calcium channel blockers, diuretics , ACE inhibitors )<\/li>
- certain medicines commonly used for mental or emotional disorders ( neuroleptics , tricyclic antidepressants )<\/li>
- alcohol<\/li>
- saptopterin, a drug used to treat phenylketonuria (PKU)<\/li>
- phosphodiesterase inhibitors type 5 (eg sildenafil, vardenafil or similar medicines) for the treatment of impotence or high blood pressure in the lungs. If a patient being treated with such drugs has an acute angina attack, he \/ she must be hospitalized immediately before starting treatment with Nitrolingual.<\/li><\/ul>\n\n\n\n
N-acetylcysteine \u200b\u200bmay potentiate the vasodilatory effect of Nitrolingual.<\/p>\n\n\n\n
If you are taking other\u00a0organic nitrates\u00a0(eg\u00a0isosorbide dinitrate, isosorbide-5-mononitrate) a higher\u00a0dose\u00a0of Nitrolingual may be needed to achieve the desired effect on circulation.<\/p>\n\n\n\n
Nitrolingual can affect the following drugs:<\/p>\n\n\n\n
- Dihydroergotamine (a medicine used to treat migraines ) can counteract the effects of Nitrolingual and raise your blood pressure more than usual.<\/li>
- heparin . If you use the spray together with heparin , the coagulation capacity may be impaired and the risk of bleeding may increase. The heparin dose may need to be adjusted.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n
It is unknown whether Nitrolingual or its metabolite is excreted in human milk. A risk to breastfed children cannot be ruled out.<\/p>\n\n\n\n
There is no evidence of an adverse effect on\u00a0fertility.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Nitrolingual can affect the ability to react. Driving and other mechanical work should therefore be avoided immediately after spraying with Nitrolingual.<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n
Important information about some of the ingredients of Nitrolingual<\/h2>\n\n\n\n
Nitrolingual contains small amounts of alcohol (\u00a0ethanol\u00a0), less than 10 mg per\u00a0dose.<\/p>\n\n\n\n
HOW TO USE NITROLINGUAL<\/h2>\n\n\n\n
Always use Nitrolingual exactly as your doctor has told you.\u00a0Ask your doctor or pharmacist if you are unsure.\u00a0Patients should be instructed to sit down whenever possible when taking sublingual\u00a0glyceryl trinitrate<\/a>.<\/p>\n\n\n\n
The recommended\u00a0dose\u00a0is 1-2 sprays (0.4-0.8 mg) in the mouth under the tongue, without inhalation, at the beginning of an angina attack, or immediately before any known effort that causes angina.\u00a0More than three sprays at a time are not recommended.\u00a0If the pain does not go away, another 1-2 sprays (0.4-0.8 mg) can be given after 10 minutes.\u00a0If the pain still does not go away, seek medical attention immediately.<\/p>\n\n\n\n
Use for children<\/strong><\/p>\n\n\n\n
There are no data available from the use of Nitrolingual in children.<\/p>\n\n\n\n
Instructions for use<\/strong><\/p>\n\n\n\n
1. The bottle does not need to be shaken before use.
Remove the plastic cap (according to figure A).<\/p>\n\n\n\nBefore using the spray for the first time,
test spray twice in the air.<\/p>\n\n\n\n(If the spray bottle has been unused for more than 14 days
, repeat the test procedure.)<\/p>\n\n\n\nDuring spraying – hold the dose bottle upside
down and with the mouthpiece as close to your mouth as possible.<\/p>\n\n\n\n4. Spray the prescribed number of doses into your mouth –
under your tongue (figure B), without inhalation. Close your mouth immediately after spraying.<\/p>\n\n\n\n