SUSTONIT 6.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. SUSTONIT, 6.5 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Sustonit and what is it used for
4. Important information before taking Sustonit
   1. When not to take Sustonit:
   2. Warnings and precautions
   3. Sustonit and other medicines
   4. Sustonit and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Sustonit contains lactose monohydrate and red iron oxide (E 124)
5. How to take Sustonit
   1. Do not chew or crush the tablets. Swallow them whole.
   2. Taking a higher dose of Sustonit than recommended
   3. Missing a dose of Sustonit
   4. Stopping treatment with Sustonit
6. Possible side effects
   1. Reporting side effects
7. How to store Sustonit
   1. Contents of the pack and other information
   2. What Sustonit contains
   3. What Sustonit looks like and contents of the pack
   4. Marketing authorization holder
   5. Manufacturer

Package Leaflet: Information for the Patient

SUSTONIT, 6.5 mg, prolonged-release tablets

Glyceryl trinitrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Sustonit and what is it used for
• 2. Important information before taking Sustonit
• 3. How to take Sustonit
• 4. Possible side effects
• 5. How to store Sustonit
• 6. Contents of the pack and other information

1. What is Sustonit and what is it used for

Sustonit contains glyceryl trinitrate (nitroglycerin) and is a vasodilator and anti-anginal medicine. It mainly dilates venous vessels and, to a lesser extent, arterial vessels. It reduces the heart's demand for oxygen and the heart's workload, which improves exercise tolerance and reduces the frequency of angina attacks. Sustonit is intended to prevent angina attacks in stable angina pectoris.

2. Important information before taking Sustonit

When not to take Sustonit:

• if you are taking medicines containing sildenafil, vardenafil, tadalafil; during the use of glyceryl trinitrate (nitroglycerin), you must not take these medicines at the same time;
• if you have angina pectoris caused by hypertrophic cardiomyopathy (a heart disease characterized by thickening of the left ventricle);
• if you are allergic to glyceryl trinitrate, other nitrates, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe anemia;
• in patients with head injuries;
• in patients with hemorrhagic stroke;
• in patients with glaucoma (an eye disease with progressive damage to the optic nerve and at least partially related to increased intraocular pressure).

Warnings and precautions

Before starting treatment with Sustonit, discuss it with your doctor. The doctor will consider the use of the medicine in patients:

• in the early post-infarction period;
• with hyperthyroidism;
• with severe liver failure;
• with excessive gastric contractions or malabsorption syndrome.

The medicine should be used with caution in patients:

• with certain cardiovascular diseases, such as acute circulatory shock, including hypovolemic or cardiogenic shock with insufficient diastolic blood pressure, significant aortic stenosis, cardiac tamponade, constrictive pericarditis, orthostatic disorder, as the administration of a vasodilator in these patients may worsen their clinical condition;
• with left ventricular hypertrophy associated with aortic stenosis, as the medicine may impair blood supply to the heart muscle;
• with myocardial infarction, as arterial hypotension with a slowed heart rate may occur;
• with angina pectoris and moderate or severe aortic stenosis;
• with severe hypotension (systolic blood pressure below 90 mmHg) and in patients with cardiogenic shock;
• with cerebrovascular diseases, as hypotension may exacerbate symptoms;
• with pulmonary diseases or pulmonary heart disease, as the medicine may increase oxygen deficiency in the blood;
• in the elderly, as it may cause orthostatic hypotension (a sudden drop in blood pressure when changing body position from lying to standing).

If it is necessary to discontinue the medicine, you should strictly follow the doctor's instructions, as the medicine is discontinued with caution and gradually to avoid worsening the symptoms of coronary heart disease. The occurrence of hypotension may be a sign of an overdose of the medicine. In such a case, you should consult a doctor, who will modify the dosage of the medicine.

Sustonit and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• During the use of Sustonit, you must not take sildenafil, vardenafil, tadalafil (see "When not to take Sustonit" in section 2 of the leaflet).
• Taking the medicine with antihypertensive medicines, beta-blockers, vasodilators, calcium channel blockers, neuroleptics, tricyclic antidepressants, and sapropterin (a medicine used to treat a hereditary disease called phenylketonuria) may cause a decrease in blood pressure.
• Acetylcysteine (a medicine that reduces the viscosity of secretions, used in bronchitis) enhances the effect of Sustonit.
• The medicine may enhance the anticoagulant effect of heparin. If these medicines are taken together, the doctor will recommend appropriate blood tests.

In the case of using long-acting medicines containing organic nitrates, tolerance (gradual decrease in the effect of the medicine) to glyceryl trinitrate may occur. In such a situation, the doctor will decide to increase the dose of Sustonit or discontinue treatment with it.

Sustonit and alcohol

Do not consume alcohol while taking the medicine, as it increases the risk of lowering blood pressure and causing fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. The doctor will decide whether you can take the medicine during pregnancy and breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive or use machines, unless you experience side effects such as dizziness, headaches, and fainting.

Sustonit contains lactose monohydrate and red iron oxide (E 124)

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. Due to the presence of red iron oxide, the medicine may cause allergic reactions.

3. How to take Sustonit

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Usually, 1 to 2 tablets (corresponding to 6.5 mg to 13 mg of glyceryl trinitrate) are taken 2 times a day. It is recommended to use so-called asymmetric dosing, i.e., 2 times a day with an 8-hour interval (e.g., at 8:00 and 16:00). The longer interval after the second dose should fall during a period of low physical activity and when symptoms are usually mild.

Do not chew or crush the tablets. Swallow them whole.

Warning:do not take the medicine to stop an angina attack.

Taking a higher dose of Sustonit than recommended

If you take a higher dose of Sustonit than recommended, you may experience an overdose, which can cause a drop in blood pressure. After a significant overdose, severe circulatory disorders, accelerated heart rate, loss of consciousness, and cyanosis may occur. After taking large doses, an increase in intracranial pressure with accompanying cerebral symptoms (headaches, nausea, vomiting, seizures, paresis, impaired consciousness, coma) may occur. Abdominal colic pain and diarrhea have been reported. Procedure: consult a doctor. If you have taken too much of the medicine, it may be effective to remove the medicine from the gastrointestinal tract by inducing vomiting or gastric lavage. If necessary, the doctor will provide symptomatic treatment.

Missing a dose of Sustonit

Do not take a double dose to make up for a missed tablet.

Stopping treatment with Sustonit

Do not stop taking the medicine without consulting your doctor - see "Warnings and precautions" in section 2. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sustonit can cause side effects, although not everybody gets them. The following side effects are listed, taking into account their frequency.

Very common (more than 1 in 10 people):

• headache (due to a decrease in blood pressure).

Common (less than 1 in 10 people):

• dizziness (due to a decrease in blood pressure);
• drowsiness;
• accelerated heart rate, orthostatic hypotension (a sudden drop in blood pressure when changing body position from lying to standing);
• asthenia (fatigue, weakness);
• decrease in blood pressure (occurs especially when starting treatment and after increasing the dose).

Uncommon (less than 1 in 100 people)

• fainting;
• worsening of angina pectoris symptoms;
• slowing of heart rate;
• cyanosis;
• flushing;
• circulatory collapse (symptoms: severe weakness, barely perceptible pulse, usually very rapid, pale skin with a grayish-blue tint, covered with profuse sweat, frequent and shallow breathing, low blood pressure);
• nausea, vomiting.

Rare (less than 1 in 10,000 people):

• methemoglobinemia (reduced ability of the blood to bind and transport oxygen, symptoms: cyanosis, shortness of breath, headache, and dizziness, drowsiness, coma; may be fatal);
• restlessness;
• cerebral hypoperfusion;
• respiratory impairment;
• heartburn, unpleasant odor from the mouth;
• exfoliative dermatitis, drug rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sustonit

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Protect from light. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Contents of the pack and other information

What Sustonit contains

• The active substance is glyceryl trinitrate (nitroglycerin). Each prolonged-release tablet contains 6.5 mg of glyceryl trinitrate.
• The other ingredients are: hypromellose, lactose monohydrate, colloidal anhydrous silica, stearic acid, red iron oxide (E 124).

What Sustonit looks like and contents of the pack

Sustonit is a prolonged-release tablet. The tablets are pink, mottled, round, flat, with a beveled edge. The pack contains 30 prolonged-release tablets.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Production Plant in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet:December 2024