Details for: MYLAN-NITRO SUBLINGUAL SPRAY
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243588 | MYLAN-NITRO SUBLINGUAL SPRAY | NITROGLYCERIN | 0.4 MG / ACT | METERED-DOSE AEROSOL | SUBLINGUAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
MYLAN-NITRO SUBLINGUAL SPRAY is used in adults for the treatment of acute attacks of angina pectoris – chest pain which occurs when the heart muscle does not get as much blood (hence as much oxygen) as it needs.
What it does
MYLAN-NITRO SUBLINGUAL SPRAY belongs to a group of drugs, which reduce the oxygen demand of the heart.
When it should not be used
Do not use MYLAN-NITRO SUBLINGUAL SPRAY if you:
- Are allergic to nitroglycerin or any of the non-medicinal ingredients in the formulation or to any other medication of the same group of medicines called nitrates
- Have an eye disease called closed angle glaucoma
- Are having a heart attack (myocardial infarction)
- Have low iron levels in your blood or low red blood cell count (severe anemia)
- Have low blood pressure (hypotension) or a diagnosis of heart failure
- Have a condition caused by an increase in normal brain pressure (increased intracranial pressure)
- Are taking tadalafil, vardenafil, sildenafil citrate or any similar medication for impotence (erectile dysfunction).
- Are taking riociguat for high blood pressure in your lungs (chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH))
What the medicinal ingredient is
Nitroglycerin
What the non-medicinal ingredients are
Ethanol, peppermint oil, propellant HFA 134a (1,1,1,2-tetrafluroethane).
What dosage form it comes in
MYLAN-NITRO SUBLINGUAL SPRAY (nitroglycerin) is supplied in aerosol bottles delivering 200 metered doses of 0.4 mg of nitroglycerin each.
Warnings and precautions
Serious Warnings and Precautions
Headaches or symptoms of low blood pressure, such as weakness or dizziness, especially when you go from lying/sitting to standing up, may be due to taking too much MYLAN-NITRO SUBLINGUAL SPRAY.
You may also notice a bluish discolouration to your skin, especially around your lips and mouth. If these symptoms occur, talk to your doctor, nurse, or pharmacists as your dose of MYLAN-NITRO SUBLINGUAL SPRAY may need to be reduced.
BEFORE you use MYLAN-NITRO SUBLINGUAL SPRAY talk to your doctor, nurse or pharmacist if you:
- are currently taking any other medications, whether on prescription or otherwise (see Interactions with this Medication section below).
- have headaches, weakness or dizziness especially when getting up suddenly from a laying down or sitting position, or symptoms of low blood pressure (hypotension).
- are breast feeding, pregnant, or think you might be pregnant.
- had a heart attack.
- are less than 18 years old
Tolerance to MYLAN-NITRO SUBLINGUAL SPRAY and similar drugs can occur after long periods of use. Chronic use can lead to angina attacks being brought on more easily. Do not suddenly stop using MYLAN-NITRO SUBLINGUAL SPRAY. Talk to your doctor if you wish to discontinue using MYLAN-NITRO SUBLINGUAL SPRAY.
Driving and using machines: Temporary dizziness may be associated with the use of MYLAN-NITRO SUBLINGUAL SPRAY. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything requiring you to be alert.
Avoid alcoholic beverages until you have discussed their use with your doctor.
The spray should be kept away from the eyes and it should not be inhaled.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Serious Drug Interactions
If you are currently taking medication for the treatment of impotence (erectile dysfunction) such as tadalafil, vardenafil, sildenafil citrate or any other similar medication (PDE5 inhibitors), the use of MYLAN-NITRO SUBLINGUAL SPRAY may lead to extreme low blood pressure resulting in fainting, heart attack and death.
If you are being treated with any of these drugs and need MYLANNITRO SUBLINGUAL SPRAY (e.g. in case of chest pain caused by an acute attack of angina pectoris) please seek emergency medical assistance immediately.
The following may interact with MYLAN-NITRO SUBLINGUAL SPRAY:
- Medications used to treat hypertension (high blood
pressure) such as:
- Diuretics (“water pills”)
- Calcium Channel Blockers [medications used to treat conditions such as high blood pressure, angina (chest pain), and other heart conditions (e.g. diltiazem, nifedipine, verapamil)]
- Tricyclic antidepressants (e.g.: imipramine, amitriptyline, desipramine, nortriptyline)
- Antipsychotics (medications used to treat schizophrenia or bipolar depression)
- Medications used to relieve muscle spasms including tizanidine
- Alcoholic beverages (when combined with MYLANNITRO SUBLINGUAL SPRAY it may cause your blood pressure to drop too low)
- Topical aesthetics prilocaine/lidocaine
- Medication used to treat pulmonary hypertension such as riociguat
- Sapropterin (a medication used to treat a disease called hyperphenylalaninemia)
- Dihydroergotamine (a medication used to treat migraine)
Proper use of this medication
Ideally, you should sit and rest while taking this medication.
- Holding container in upright position, remove the plastic cover.
- The container must be primed prior to the
first use. To prime, point away from face,
press the button firmly with the forefinger to
release one spray. Repeat this 3 times. Now
your container is primed and ready for use.
Repriming is only necessary when the container has not been used for more than 14 days. To reprime, release 1 spray as directed previously. There is no need to reprime the container between more frequent usage. - Hold the container upright with forefinger on top of the grooved button. There is no need to shake the container.
- Open your mouth and bring the container as close to it as possible.
- Press the button firmly with the forefinger to release the spray onto or under the tongue.
- Release button and close mouth.
- If you require a second dose, repeat steps 4, 5 and 6.
- Replace the plastic cover.
DO NOT SHAKE.
DO NOT INHALE THE SPRAY.
KEEP THE SPRAY AWAY FROM
EYES.
When using this product for the first time, familiarize yourself with how to use it by testing the spray into the air (away from yourself and others). Get the feel of the finger resting on the groove button so that you can use the spray in the dark.
Usual adult dose
MYLAN-NITRO SUBLINGUAL SPRAY should be taken as
prescribed by your doctor.
During an anginal attack, one or two doses should be sprayed onto
or under the tongue, without inhaling. Your doctor can help you
to discover the exact dose which will be best for you. Administer
at rest, ideally in the sitting position. A dose may be repeated
twice at 5-10 minute intervals. If the pain persists, seek
emergency medical assistance.
MAKE SURE THAT YOU HAVE A SPARE PUMPSPRAY
READILY AVAILABLE (TO PREVENT RUNNING OUT
WHEN NEEDED).
Overdose
Symptoms of overdosage may include: flushing, headache, nausea, dizziness, and hypotension.
Side effects and what to do about them
Along with its intended action, any medication, including
MYLAN-NITRO SUBLINGUAL SPRAY, may cause side
effects. After you have started taking MYLAN-NITRO
SUBLINGUAL SPRAY, it is important that you tell your doctor
at once about any unexplained symptom you might experience.
Side effects may include:
- Headache
- Sore throat and/or mouth, runny nose
- Restlessness
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| Symptom / effect | Talk with your doctor, nurse or pharmacist Only if severe | Talk with your doctor, nurse or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Allergic reaction involving skin rash or swelling of the face, lips and/or tongue accompanied by difficulty breathing | ✔ | ||
| Common | |||
| Severe, persistent headache | ✔ | ||
| Dizziness | ✔ | ||
| Weakness | ✔ | ||
| Abdominal pain | ✔ | ||
| Swelling of the ankles | ✔ | ||
| Tingling or pins and needles of a limb | ✔ | ||
| Shortness of breath | ✔ | ||
| Uncommon | |||
| Nausea | ✔ | ||
| Sweating | ✔ | ||
| Rash | ✔ | ||
| Flushing | ✔ | ||
| Chest pain | ✔ | ||
| Racing heart rate and/or palpitations (irregular heartbeat) | ✔ | ||
| Pallor | ✔ | ||
| Vomiting | ✔ | ||
| Low blood pressure (hypotension). This can be severe, leading to slow or fast heartbeat, fainting or dizziness when you change from lying/sitting to standing up. | ✔ | ||
| Fainting | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-NITRO SUBLINGUAL SPRAY, contact your doctor, nurse or pharmacist.
How to store
Contains alcohol. Do not open container forcefully or burn after
use. Do not spray toward flames. Do not place MYLAN-NITRO
SUBLINGUAL SPRAY in hot water or near radiators, stoves or
other sources of heat. Do not expose to temperature over 40°C.
Store at room temperature (15°C to 30ºC).
Keep in a safe place and out of the reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can
be obtained by contacting the sponsor, Mylan Pharmaceuticals
ULC at: 1-844-596-9526.
This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario, M8Z 2S6
Revised On: September 8, 2017
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca