0.4 mg/dose sublingual spray
glyceryl trinitrate
1. What Glytrin is and what it is used for
Your medicine is called Glytrin.
Glytrin is a sublingual spray (to be used under the tongue) that contains the active substance glyceryl trinitrate. Glyceryl trinitrate belongs to a group of medicines called nitrates. These drugs relax the muscle walls in the blood vessels so that the workload of the heart is reduced.
Glytrin is used to treat acute angina. It is also used to prevent angina caused by physical exertion, emotional stress, cold, etc.
Glyceryl trinitrate contained in Glytrin may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Glytrin
Do not use Glytrin and talk to your doctor
- If you are allergic to glyceryl trinitrate or other nitrates, or to any of the other ingredients of this medicine (listed in section 6).
- If you have very low blood pressure .
- In case of shock caused by low blood pressure .
- If you have severe anemia ( anemia ).
- If you have constrictive pericarditis (a type of pericarditis).
- If you have a very low heart rate .
- If you have glucose -6-phosphate dehydrogenase deficiency (a hereditary enzyme deficiency that mainly affects men).
- If you have suffered a brain injury or cerebral haemorrhage .
- If you have narrowing of the heart valves or arteries are , or chest pain caused by a heart muscle disease.
- In case of circulatory collapse (poor blood circulation).
- If you have toxic pulmonary edema (fluid / swelling in the lungs).
- In case of heart shock (a serious condition caused by very low blood pressure and which can lead to dizziness, high heart rate , pallor, sweating, restlessness and unconsciousness).
Do not use Glytrin with
- riociguat for high blood pressure in the blood vessels of the lungs
- sildenafil, tildenafil, vardenafil or similar phosphodiesterase inhibitors for erectile dysfunction ( impotence ).
Warnings and cautions
Talk to your doctor or pharmacist before using Glytrin if you have any of the following:
- Fluid in the pericardium ( cardiac tamponade )
- Low blood flow to the heart (eg acute myocardial infarction)
- Problems with blood pressure et
- Disease that increases the pressure in the brain
- Cataracts (may cause high pressure in the eye)
- Liver or kidney problems
- Underactive thyroid gland ( hypothyroidism , low level of thyroid hormone in the blood)
Also, discuss with your doctor if you have had any of these ailments before. You may need to be monitored more closely during the treatment.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age.
Other drugs and Glytrin
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Do not use Glytrin with
- riociguat for high blood pressure in the blood vessels of the lungs
- sildenafil, tildenafil, vardenafil or similar phosphodiesterase inhibitors for erectile dysfunction ( impotence ).
Discuss with your doctor before starting treatment with Glytrin if you are taking or have recently taken:
- Drugs for the treatment of problems with blood pressure or the heart, such as vasodilators, antihypertensives, beta-blockers , calcium channel blockers .
- Tricyclic antidepressant drugs or neuroleptics for mental illness.
- Diuretics .
- Dihydroergotamine for migraines .
- Heparin , a blood thinner to prevent blood clots. Your doctor needs to monitor you more closely.
- Organic nitrates (other medicines for acute angina).
Glytrin with alcohol
Be careful with alcohol intake as the effects of Glytrin may be intensified. Both Glytrin and alcohol can lower blood pressure and impair the ability to react.
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. Glytrin should not be used during breastfeeding.
Driving and using machines
Reactivity may be impaired. Therefore, avoid driving or handling machines while taking Glytrin.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Glytrin contains alcohol
Glytrin contains 7.5 mg of alcohol ( ethanol ) in each spray. The amount in a spray of this medicine corresponds to less than 1 ml of beer or 1 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects.
Prolonged use
Prolonged use of Glytrin or other nitrates may lead to impaired treatment effects. Therefore, avoid long-term use with high doses.
3. How to use Glytrin
- Glytrin should not be given to children.
- Always use this medicine exactly as your doctor and pharmacist have told you. Ask your doctor or pharmacist if you are unsure.
- Learn to use Glytrin before you have an attack as you may need to take Glytrin urgently or in the dark. Familiarize yourself with the spray button that has a finger rest to help you direct the spray jet.
- Always have a spare package on hand as it can be difficult to determine how many doses you have left in the container.
- Never use Glytrin near open flames, such as glowing cigarettes.
- Before using Glytrin for the first time , check that the spray works by pressing the pump button a few times until a fine shower of liquid is formed. Practice aiming the spray at a napkin or similar object, so that you can aim it correctly under the tongue when you need to use it. If you rarely need to use Glytrin , remember to check the spray regularly to make sure it is still working properly.
- At the beginning of an attack or to prevent an attack:
- Sit down
- Hold the container upright and close to your mouth
- Hold your breath
- Direct the spray under the tongue
- Press the button hard, once
- Close your mouth immediately
- Do not inhale the spray
- The usual dose is one to two doses . More than three doses are not recommended at a time.
- Rest for a while after taking Glytrin. Then get up slowly as you may faint.
If you use more Glytrin than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Usually, no special treatment is required.
The symptoms of overdose are usually the same as the side effects listed. Some people may experience shock-like reactions, with nausea, lethargy, and sweating.
In rare cases, lips and/or fingers assume a bluish color (cyanosis or methemoglobinemia).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious and rare side effects are (may affect up to 1 in 1000, unless otherwise specified), must immediately stop taking Glytrin and consult your doctor:
- Allergic skin reaction (with or without rash).
- Blisters on the tongue (may affect up to 1 in 100 people).
- Fainting
- Severe drop in blood pressure when you stand up
- Exacerbated angina symptoms
- Effects on blood circulation (decrease in blood pressure , which may be followed by loss of consciousness and collapse)
- Transient hypoxemia (lack of oxygen) (bluish coloration of the lips, hands or feet, which may be followed by loss of consciousness)
- Patients with coronary heart disease may have insufficient blood supply to the heart.
Continuous use of Glytrin may lead to habituation and reduced treatment effect. If symptoms persist, seek medical advice immediately.
| Very common (may affect more than 1 user in 10) | headache |
| Common (may affect up to 1 in 10 people) | dizziness, dizziness, nausea, flushing, numbness |
| Uncommon (may affect up to 1 in 100 people) | burning sensation, burning sensation |
| Rare (may affect up to 1 in 1,000 people) | sharp drop in blood pressure, altered pulse |
| Very rare (may affect up to 1 in 10,000 users) | scaly or flaky skin |
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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. By reporting side effects, you can help increase drug safety information.
5. How to store Glytrin
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Store in a cold place. Do not freeze.
- Glytrin is an aerosol spray and contains liquid under pressure. The container must not be exposed to temperatures above 50 ° C or punctured. This also applies to empty containers.
- 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.
6. Contents of the packaging and other information
Content declaration
- The active substance in Glytrin is glyceryl trinitrate . Each spray dose contains 0.4 mg of glyceryl trinitrate .
- The other ingredients are peppermint oil, ethanol and 1,1,1,2-tetrafluoroethane ( propellant ).
What the medicine looks like and contents of the pack
Glytrin is a colorless spray in a lacquered aluminum aerosol container, with a metering valve and a lid. Each container contains 200 doses.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ayrton Saunders (Ireland) Limited
8a Sandyford Business Center
Blackthorn Avenue, Sandyford
Dublin 18
Ireland
Manufacturer:
Pharmaserve (North West) Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn, Cheshire, WA7 1NU
UK