Consumer medicine information

Anginine Tablets

Glyceryl trinitrate

BRAND INFORMATION

Brand name

Anginine Tablets

Active ingredient

Glyceryl trinitrate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Anginine Tablets.

What is in this leaflet

This leaflet answers some common questions about Anginine. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Anginine against the benefits this medicine is expected to have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Anginine is used for

Anginine is used for angina. Angina is a pain or discomfort in the chest, often spreading to the arms or neck and sometimes to the shoulders and back. This is usually caused by too little blood and oxygen getting to the heart muscle. The pain of angina is usually brought on by exercise or stress. Other factors may also cause angina. Anginine is used to treat an angina attack or to prevent one developing.

Anginine belongs to a group of medicines called nitrates. It lets more blood and oxygen reach the heart muscle.

Your doctor may have prescribed Anginine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

There is no evidence that Anginine is addictive or habit forming.

Before you use it

When you must not use it

Do not use Anginine if you have ever had an allergic reaction to:

  • glyceryl trinitrate, the active ingredient in Anginine.
  • other medicines containing glyceryl trinitrate
    For example skin patches (such as Deponit, Minitran, Nitradisc, Nitro-Dur, Transiderm-Nitro), and sprays (such as Nitrolingual Spray).
  • any medicine or food containing nitrates or nitrites.
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following:

  • asthma, wheezing or shortness of breath
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • hayfever, lumpy rash ("hives") or itching
  • fainting
  • Do not use Anginine if you are pregnant, trying to become pregnant or breast-feeding, unless your doctor says you should.
  • Not all heart problems are suitable for treatment with Anginine.
    Do not use Anginine if you have a heart condition known as hypertrophic obstructive cardiomyopathy (HOCM).
  • Do not use Anginine if you have or have had a head injury.
  • Do not use Anginine if you have suffered a stroke due to a haemorrhage in the past.
  • Do not use Anginine if you are taking Phosphodiesterase 5 inhibitors such as sildenafil (Viagra®), tadalafil (Cialis®) and vardenafil (Levitra®)
  • Do not use Anginine after the expiry date (EXP) printed on the pack, or more than three months after you first open your bottle.
    If you use the tablets after the expiry date has passed, they may not work as well.
  • Do not use Anginine if the packaging is torn or shows any signs of tampering.
  • Do not take Anginine if the tablets show any visible signs of deterioration (e.g. broken or discoloured).

If you're not sure whether you should be using Anginine, talk to your doctor.

Before you start to use it

You must tell your doctor if you have:

  • an allergy to foods, dyes, preservatives or any other medicines
  • poor blood supply to the brain
  • a blood condition, such as anaemia (reduced red blood count)
  • lung problems
  • glaucoma- may be worsened by nitrates
  • a recent heart attack- nitrates may lower blood pressure and cause a fast heart beat which may aggravate problems associated with heart attack.
  • heart problems as a complication of lung problems
  • severe coronary artery problems as a complication of lung problems
  • poor liver function
  • an overactive thyroid gland (hyperthyroidism)
  • any other medical condition.

Taking other medicines

Tell your doctor if you are taking or using any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when using Anginine with other medicines.

It is especially important that your doctor knows if you are taking any of the following:

  • medicines for high blood pressure
  • medicines for heart conditions
  • medicines for depression
  • tranquillisers/sedatives
  • you must not use phosphodiesterase 5 inhibitors such as sildenafil (Viagra®), tadalafil (Cialis®) and vardenafil (Levitra®) if you are taking Anginine

Use in Children

Do not give Anginine tablets to children.

We do not have enough information on use in children so it is not recommended for that age group.

Use in Elderly

Elderly patients may be more sensitive to the side effects of Anginine tablets. It is advisable to take half a tablet as a starting dose.

How to use it

The pharmacist's label on the pack will tell you how to use Anginine

If there is something you do not understand, ask your doctor or pharmacist.

How much to use

At the first sign of an attack, sit down and place 1(one) Anginine tablet under your tongue or in your cheek, and allow it to dissolve.

If the Angina is not relieved within 5 minutes, take another dose of Anginine. You may use up to 2 tablets to relieve the angina pain or discomfort.

If a total of 2 fresh tablets and rest do NOT relieve your angina within 10 minutes, then you should immediately call an ambulance or the nearest hospital.

Anginine tablets are scored, so you can break or cut them in half. You should discuss your overall dose with your doctor.

How to use

Anginine is absorbed through the lining of your mouth.

Place your Anginine tablet under your tongue, or in your cheek and allow to dissolve.

It will dissolve more easily if your mouth is not dry.

DO NOT SWALLOW, CHEW OR CRUSH your Anginine tablet, as swallowed Anginine tablets are NOT EFFECTIVE.

While the tablet is dissolving, avoid any eating, drinking or smoking until the tablet has completely dissolved.

Sometimes you may feel tingling in your mouth when using Anginine . However, the tablet still works even if you do not feel tingling.

When to use it

Use Anginine tablets at the first symptom of an angina attack.

Your doctor may also advise you to use Anginine just before exercise or stressful situations to stop you getting an angina attack.

How long to use it

After using Anginine, you should get relief of your angina pain or discomfort within a few minutes. When this occurs you may spit out any of the tablet which remains in your mouth to avoid side effect such as headache.

If your angina pain or discomfort is not relieved by a total of 2 fresh Anginine tablets within 10 minutes, then you should immediately call an ambulance or nearest hospital.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have taken too much Anginine, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

Too much Anginine may cause bluish-coloured lips, fingernails or palms of hands; dizziness or fainting; feeling of extreme pressure in head; shortness of breath.

If you are not sure what to do, contact your doctor or pharmacist.

While you are using it

Things you must do

Use Anginine exactly as your doctor has prescribed.

If you do not follow your doctor’s instructions, you may not get relief from your attacks of angina.

Always carry your Anginine with you.

Tell all doctors, dentists, pharmacists and health professionals involved in your care that you are using Anginine.

Tell your doctor or pharmacist that you are using Anginine if you are about to be started on any new medicines.

Tell your doctor if you become pregnant or are trying to become pregnant.

Tell your doctor if, for any reason, you have not used your tablets exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Keep a record of the number of angina attacks, when they happen and the possible cause (e.g. during exercise).

Tell your doctor if you continue to have angina attacks or if your angina attacks seem worse when using Anginine.

This helps your doctor give you the best possible treatment.

Things you must not do

Do not stop using Anginine, or change the dose without first checking with your doctor.

Do not give this medicine to anyone else, even if his or her symptoms seem similar to yours.

Do not use Anginine to treat any other complaints unless your doctor says so.

Things to be careful of

Be careful driving or operating machinery until you know how Anginine affects you.

Anginine may cause dizziness or faintness in some people. Make sure you know how you react to Anginine before you drive a car, operate machinery or do anything else that could be dangerous if you become dizzy or faint.

Get up slowly when getting out of bed or standing up, as you may feel light-headed, dizzy or faint.

You may feel light-headed, dizzy or faint after using Anginine . This is because your blood pressure drops. While the medicine is working, it is better for you to sit down and rest for a while. Especially if you are feeling dizzy or faint. Standing up slowly, especially when you get up from lying or sitting, will help your body get used to the change in position and blood pressure.

Be careful when drinking alcohol while you are using Anginine.

If you drink alcohol whilst using Anginine, your blood pressure may drop, making you feel dizzy or faint.

Side-Effects

Check with your doctor as soon as possible if you have any problems while using Anginine, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like all medicines, Anginine can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most usual side-effects are:

  • headache
  • low blood pressure, feeling faint or dizzy
  • flushing (redness) of the face
  • fast heart beat

If you are troubled by a throbbing headache when you use Anginine, you may remove the remaining part of the tablet from your mouth once the angina pain is relieved. Ask your doctor or pharmacist to answer any questions you may have.

Rarely reported side-effects are:

  • blurred vision
  • dry mouth
  • severe and prolonged headache
  • slow heart beat
  • skin rash

Ask your doctor or pharmacist to answer any questions you may have.

If you think you are having an allergic reaction to Anginine, tell your doctor immediately or go to the casualty department at your nearest hospital. Symptoms usually include some or all of the following:

  • asthma, wheezing or shortness of breath
  • swelling of the face, lips or tongue
  • difficulty in swallowing
  • difficulty in breathing
  • hay fever
  • itching
  • lumpy rash ("hives")
  • fainting

Tell your doctor or pharmacist immediately if you notice any of the following:

  • severe nausea (feeling sick) and vomiting
  • swelling of the face
  • severe rash, hives, or itching of the skin
  • shortness of breath or other breathing problems
  • bluish colour of lips, nails or palms of the hands
  • severe dizziness or fainting (caused by impaired blood circulation to the brain)
  • weak or unusually fast heartbeat
  • severe headache
  • unusual tiredness or weakness
  • restlessness
  • worsening of your angina pain

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side-effects. You may not experience any of them.

After using it

Storage

Anginine tablets can easily lose their strength if not stored properly. Glyceryl trinitrate, the active ingredient in Anginine tablets, becomes less effective very easily.

  • Keep your Anginine tablets in a cool, dry and dark place where it stays below 25°C.
    Do not carry the tablets close to your body where they become warm.
  • Keep your supply of Anginine tablets in the original glass bottle.
    Always keep the lid tightly closed or your tablets will lose strength more quickly.
  • Obtain a fresh supply of Anginine within THREE months after you first open the bottle, even if you have not used all the tablets.
    It is helpful to write the date of opening on the label of the bottle.
    Do not use Anginine tablets after the expiry date on the bottle.
  • Do not store your Anginine tablets mixed with any other tablets.
  • Always keep Anginine tablets out of reach of children.
    A locked cupboard a least one and a half metres above the ground is a good place to store medicines which you do not need to carry.
  • Do not store it, or any other medicine, in a bathroom or near a sink.
    Heat and dampness can destroy some medicines.
  • Do not leave Anginine in the car or on windowsills.
    Keep your Anginine tablets out of direct sunlight.

Disposal

If your doctor tells you to stop using Anginine, or the Anginine has passed its expiry date, ask your pharmacist what to do with any Anginine left over.

Product description

What Anginine looks like

Anginine tablets are round flat white to off-white tablet scored on one face and plain on the other face

Each bottle contains 100 tablets.

Ingredients

Anginine contains 600 microgram of the active ingredient glyceryl trinitrate.

Anginine tablets also contain:

  • lactose
  • dextrin
  • maize starch
  • mannitol
  • glycerol
  • magnesium stearate

Anginine tablets contain lactose.

Anginine : AUST R 227783

Manufacturer

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Further Information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.

This leaflet was revised in Feb 2015

BRAND INFORMATION

Brand name

Anginine Tablets

Active ingredient

Glyceryl trinitrate

Schedule

S3

 

Name of the medicine

Glyceryl trinitrate.

Excipients.

Lactose, dextrin, maize starch, mannitol, glycerol, and magnesium stearate.

Description

Molecular formula: C3H5(O.NO2)3. MW: 227.1. CAS: 55-63-0. Glyceryl trinitrate is a white to pale yellow, thick, flammable, explosive liquid. It is slightly soluble in water (0.1% to 1% w/v) and soluble in acetone, alcohol, and ether.

Pharmacology

Actions.

Anginine is a vasodilator which relieves angina pectoris. Pain in angina pectoris is believed to be the result of myocardial ischaemia secondary to coronary artery disease. In the relief of acute anginal pain the effect is apparent after 2 to 3 minutes and lasts for up to 20 or 30 minutes.
Anginine redistributes blood flow along collateral channels and from epicardial to endocardial regions and, thus, may increase blood flow to ischaemic areas. Anginine also reduces oxygen demand by increasing venous capacitance causing pooling of blood in the peripheral veins and thereby reducing ventricular volume. Furthermore, the fall in arterial pressure will also reduce myocardial oxygen demand, although this may be offset by a reflex tachycardia. The beneficial effects of nitrates in pulmonary oedema depend on venous dilation and reduction of preload. Anginine causes coronary vasodilatation in coronary arteries that are in spasm, and may relieve pain in variant angina by this mechanism.
Anginine is thought to exert its vasodilator effect through the activation of guanylate cyclase in vascular smooth muscle cells by nitric oxide; this results in an increased synthesis of cyclic guanosine monophosphate, which leads to smooth muscle relaxation.

Pharmacokinetics.

Absorption.

Glyceryl trinitrate is readily absorbed through the buccal mucosa but is rapidly metabolised so it has a fleeting duration of action. Peak plasma levels of glyceryl trinitrate given sublingually appear within 4 minutes.

Distribution.

Glyceryl trinitrate has a volume of distribution of about 3 L/kg. It is taken up by vascular smooth muscle cells.

Metabolism.

In smooth muscle cells the nitrate group is cleaved to inorganic nitrite and then to nitric oxide (thought to be responsible for glyceryl trinitrate's vasodilatatory effect). Glyceryl trinitrate also undergoes hydrolysis in plasma and is rapidly hydrolysed in the liver by glutathione organic nitrate reductase to dinitrates and mononitrates. At least half of the intact glyceryl trinitrate is cleared from the blood in 1 to 3 minutes.

Excretion.

The main urinary metabolite of glyceryl trinitrate is the mononitrate.

Indications

Treatment of acute angina pectoris. As well as relieving the pain of an acute attack, it may be used prophylactically before physical exertion or mental stress which would be expected to produce an anginal attack.

Contraindications

Anginine is contraindicated, except for diagnostic purposes, in angina caused by hypertrophic obstructive cardiomyopathy as it may exaggerate outflow obstruction.
Anginine should not be used in patients with cerebral haemorrhage or head trauma.
Anginine is contraindicated in patients hypersensitive to glyceryl trinitrate.
Anginine is contraindicated in patients taking phosphodiesterase 5 inhibitors (see Interactions with Other Medicines).

Precautions

Anginine should be used with caution in patients with the following conditions.

Anaemia.


Cerebral vascular disease.

Symptoms may be precipitated by hypotension.

Severe coronary atherosclerosis.

Arterial hypotension and reflex tachycardia associated with administration of Anginine can be hazardous in these patients.

Glaucoma.

Nitrates may increase intraocular pressure.

Recent head trauma.

Nitrates may increase cerebrospinal fluid pressure.

Lung disease and cor pulmonale.

Anginine may worsen hypoxaemia in these patients. Transient hypoxaemia may accompany the use of Anginine and thereby cause a paradoxical response with further angina pectoris and electrocardiograph ST segment depression. This effect is thought to be due to pulmonary vascular shunting. Oxygen administration seems rational as adjunctive therapy in nitrate resistant angina, especially in patients prone to hypoxaemia such as the elderly and patients with lung disease and left ventricular failure.

Severe hepatic function impairment.

Use of Anginine may lead to increased risk of methaemoglobinaemia.

Hyperthyroidism.


Recent myocardial infarction.

There is a risk of hypotension and tachycardia, which may aggravate ischaemia.

Use in children.

The possible effects of Anginine in children have not been studied.

Use in the elderly.

The elderly may be particularly sensitive to the side effects of Anginine. Starting at a reduced dose is recommended.

Use in pregnancy.

(Category B2)
In reproductive toxicity studies in animals, glyceryl trinitrate had no effects upon fertility, organogenesis or perinatal and postnatal development. However, the administration of glyceryl trinitrate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Data on the use of Anginine during human pregnancy are not available.

Use in lactation.

No data are available on the excretion of glyceryl trinitrate or its metabolites in human milk.

Carcinogenicity, mutagenicity, impairment to fertility.

Studies have not been performed on the effects of glyceryl trinitrate on carcinogenicity, mutagenicity or effects on fertility.

Effects on ability to drive and operate machinery.

Since dizziness and syncope have been reported following treatment with Anginine, caution is recommended in patients performing skilled tasks.

Instructions to patients.

Anginine should be taken at the first sign of an attack of angina. It is preferable to take it sitting down. The tablet should be placed beneath the tongue or in the cheek and allowed to dissolve. It should not be swallowed, as it is then ineffective. If two fresh tablets and rest in a chair do not relieve the chest pain within 10 minutes, a doctor should be consulted.
Patients should be instructed on the storage conditions required to maintain the potency of Anginine. The tablets should be stored only in the manufacturer's bottle. No labels, other drugs, or any material apart from the manufacturer's packing should be put in the bottle.
The lid must always be kept tightly closed.
Anginine should be stored in a cool place. It should not be carried close to the body and should be kept out of direct sunlight.
An unopened bottle has a shelf life of 2 years if stored below 25°C. However, tablets unused three months after first opening a bottle should be discarded and a fresh supply obtained.

Interactions

Alcohol, antihypertensives, tricyclic antidepressants, phenothiazines, levodopa, opioid analgesics, hydralazine, calcium channel blocking agents, minoxidil and prazosin.

The risk of orthostatic hypotension and syncope with the use of Anginine may be enhanced by these medications.

Sympathomimetics.

Concurrent use may reduce the antianginal effects of Anginine, also Anginine may counteract the pressor effect of sympathomimetics, possibly resulting in hypotension.

Phosphodiesterase 5 inhibitors.

Consistent with their known effects on the nitric oxide/ cyclic guanosine monophosphate (cGMP) pathway, these agents have been shown to potentiate the hypotensive effects of nitrates, and their coadministration with Anginine is therefore contraindicated (see Contraindications).

Adverse Effects

The dose of Anginine may be limited by vascular headaches. Troublesome vascular side effects may be minimised by removing the tablet from the mouth before it is completely dissolved. Anginine induced hypotension may cause cerebral ischaemia.
The adverse effects of Anginine and their frequency are shown below.

Rare (≥ 0.01% and < 0.1%).

Blurred vision, dry mouth, severe and prolonged headache, skin rash, bradycardia.

Common (≥ 1% and < 10%).

Flushing of face and neck, headache, dizziness, nausea or vomiting, orthostatic hypotension, syncope, restlessness, tachycardia.

Dosage and Administration

For acute angina attacks, 600 to 900 microgram given as early in the attack as possible. Elderly patients are recommended to take a reduced dose of 300 microgram (half a tablet) as a starting dose. Glyceryl trinitrate is well absorbed through the buccal mucosa. It is therefore important that the tablets be placed under the tongue or in the cheek and allowed to dissolve rather than be swallowed. Repeated doses of glyceryl trinitrate may lead to tolerance, but cessation of the drug for a short period will re-establish its action.

Overdosage

Signs and symptoms.

Bluish coloured lips, fingernails, or palms of hands; extreme dizziness or syncope; feeling of extreme pressure in head; shortness of breath; unusual tiredness or weakness; fast heartbeat; fever; convulsions.
Cyanosis may occur at blood methaemoglobin concentrations of 1.5 g/100 mL. More pronounced signs of methaemoglobinaemia (pressure in head, tiredness or weakness, shortness of breath) occur at concentrations of 20 to 50 g/100 mL.

Treatment.

Supportive therapy with particular attention being paid to the respiratory and cardiovascular systems is indicated. Hypotension and syncope should be treated by recumbency and elevation of legs to aid venous return. Methaemoglobin concentrations should be monitored and methaemoglobinaemia treated by high flow oxygen and intravenous methylene blue.

Presentation

Tablets, 600 microgram (round, white, scored on one side, plain on reverse): 100's (bottle).

Storage

Store below 25°C. Protect from light.

Poison Schedule

S3.