0.4 mg / dose sublingual
spray Glyceryl trinitrate ( nitroglycerin )
WHAT NITROLINGUAL IS AND WHAT IT IS USED FOR
Nitrolingual is a mouth spray with nitroglycerin as an active substance. Nitrolingual dilates blood vessels and thus reduces the load on the heart and the heart’s oxygen needs. Nitroglycerin is rapidly absorbed by the blood through the oral mucosa and the effect occurs quickly.
Nitrolingual is used in:
Treatment of temporary angina ( angina pectoris ) and prevention of angina caused by exertion, such as physical exertion or any other situation that could previously cause angina. Symptom relief for acute heart failure or heart attack. Cramping of the coronary arteries of the heart during heart surgery ( angiography ).
BEFORE YOU USE NITROLINGUAL
Do not use Nitrolingual
- 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
- if you have hypertrophic obstructive cardiomyopathy (a disease of the heart muscle that causes obstruction of blood flow)
- in case of increased pressure in the brain (eg head injury, cerebral haemorrhage)
If you are using Nitrolingual, do not use male impotence or pulmonary hypertension containing 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 side effects (fainting, myocardial infarction).
Take special care with Nitrolingual
Talk to your doctor or pharmacist before using Nitrolingual if any of the following apply to you:
- 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.
- if you suffer from severe low blood pressure (when the upper (systolic) blood pressure is below 90 mmHg)
- if you have a brain disease that can be traced to a disease in the blood vessels that supply the brain.
- if you have lung disease (risk of worsening oxygenation)
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Nitrolingual lowers blood pressure. This effect can be enhanced if the drug is used in conjunction with
- vasodilator
- antihypertensive agents (eg beta – blockers , calcium channel blockers, diuretics , ACE inhibitors )
- certain medicines commonly used for mental or emotional disorders ( neuroleptics , tricyclic antidepressants )
- alcohol
- saptopterin, a drug used to treat phenylketonuria (PKU)
- 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.
N-acetylcysteine may potentiate the vasodilatory effect of Nitrolingual.
If you are taking other organic nitrates (eg isosorbide dinitrate, isosorbide-5-mononitrate) a higher dose of Nitrolingual may be needed to achieve the desired effect on circulation.
Nitrolingual can affect the following drugs:
- Dihydroergotamine (a medicine used to treat migraines ) can counteract the effects of Nitrolingual and raise your blood pressure more than usual.
- 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.
Pregnancy and breastfeeding
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.
It is unknown whether Nitrolingual or its metabolite is excreted in human milk. A risk to breastfed children cannot be ruled out.
There is no evidence of an adverse effect on fertility.
Driving and using machines
Nitrolingual can affect the ability to react. Driving and other mechanical work should therefore be avoided immediately after spraying with Nitrolingual.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of Nitrolingual
Nitrolingual contains small amounts of alcohol ( ethanol ), less than 10 mg per dose.
HOW TO USE NITROLINGUAL
Always use Nitrolingual exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Patients should be instructed to sit down whenever possible when taking sublingual glyceryl trinitrate.
The recommended dose is 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. More than three sprays at a time are not recommended. If the pain does not go away, another 1-2 sprays (0.4-0.8 mg) can be given after 10 minutes. If the pain still does not go away, seek medical attention immediately.
Use for children
There are no data available from the use of Nitrolingual in children.
Instructions for use
1. The bottle does not need to be shaken before use.
Remove the plastic cap (according to figure A).
Before using the spray for the first time,
test spray twice in the air.
(If the spray bottle has been unused for more than 14 days
, repeat the test procedure.)
During spraying – hold the dose bottle upside
down and with the mouthpiece as close to your mouth as possible.
4. Spray the prescribed number of doses into your mouth –
under your tongue (figure B), without inhalation. Close your mouth immediately after spraying.
5. Replace the plastic cap after use.
As the mouth is easy to feel, the bottle can easily be used even in the dark. Do not spray on a naked flame.
If you use more Nitrolingual than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. The fainting and pronounced side effects listed below may be symptoms of overdose.
If you forget to take Nitrolingual
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Nitrolingual can cause side effects, although not everybody gets them.
Side effects are grouped according to the following frequencies:
Common (affects 1 to 10 users in 100):
- Headaches may be common at the beginning of treatment, but often get better with continued use.
- Drops in blood pressure and / or drops in blood pressure when standing up ( orthostatic hypotension ). This can be especially true when glyceryl trinitrate is used for the first time or after a dose increase.
- Increased heart rate ( tachycardia )
- Weakness ( asthenia )
- Drowsiness and dizziness
Uncommon (affects 1 to 10 users in 1,000):
- Angina pectoris symptoms may be exacerbated (paradoxical nitrate reaction) if a sharp drop in blood pressure occurs.
- State of collapse ( cardiovascular collapse), occasionally with slow and irregular heartbeat (bradyarrhythmia) and fainting have been observed.
- Nausea, vomiting
- Blushing of the face
- Blue lips and skin (cyanosis)
Very rare (affects less than 1 user in 10,000):
- Severe inflammation of the skin (exfoliative dermatitis )
- Decreased blood flow to the brain (cerebral ischemia )
- Difficulty breathing
- Restlessness
- Drug rash
- Elevated levels of methemoglobin in the blood (Methemoglobinemia)
When using Nitrolingual spray, blood flow to less ventilated areas of the lungs can be redistributed. This can lead to the reduced oxygen content in the arterial blood. If the blood flow in the coronary arteries is disturbed, the heart may not get enough oxygen.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
HOW TO STORE NITROLINGUAL
Store at a maximum of 25 o C. The pump spray must be protected against high temperatures.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION
Content declaration
The active substance is glyceryl trinitrate ( nitroglycerin ).
1 spray dose contains: 0.4 mg / dose.
The other ingredients are Medium- chain triglycerides, anhydrous ethanol 9.60 mg/dose, medium-chain glycerides, peppermint oil, sodium ( S ) -lactate solution, ( S ) -lactic acid, water.
What the medicine looks like and the contents of the pack
Nitrolingual 0.4 mg/dose sublingual spray is a clear, colorless to pale yellow solution in a glass bottle, with or without transparent red plastic coating, with dosing pump and cork. The bottle contains about 200 or 215 doses.
Marketing Authorization Holder and Manufacturer
G. Pohl-Boskamp GmbH & Co. KG
Kieler Str. 11, 25551 Hohenlockstedt, Germany
Tel .: +49 (0) 4826 59 0
Fax: +49 (0) 4826 59 109
e-mail: info@pohl-boskamp.de
Agent: Navamedic AB, Göteborgsvägen 74, 433 63 Sävedalen
Email: infose@navamedic.com