Effox long 50

Package Leaflet: Information for the Patient

Effox long 50,

50 mg, prolonged-release tablets

Isosorbide mononitrate

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Effox long 50 and what is it used for
• 2. Important information before taking Effox long 50
• 3. How to take Effox long 50
• 4. Possible side effects
• 5. How to store Effox long 50
• 6. Contents of the pack and other information

1. What is Effox long 50 and what is it used for

Effox long 50 contains 50 mg of isosorbide mononitrate, which causes dilation of the coronary blood vessels of the heart. It also causes dilation of venous and arterial blood vessels. This reduces the burden on the heart and thus the oxygen demand of the heart muscle. Effox long 50 also improves blood flow through the heart muscle, which reduces cardiac ischemia. As a result, chest pain decreases. Effox long 50 is used to prevent angina pectoris attacks (chest pain caused by limited blood flow to the heart muscle).

2. Important information before taking Effox long 50

When not to take Effox long 50

• if the patient has:
• hypersensitivity to the active substance, other nitrates, or any of the other ingredients of this medicine (listed in section 6);
• cardiogenic shock (except in situations where adequate blood pressure is achieved with appropriate treatment);
• hypertrophic cardiomyopathy with outflow obstruction (obstructive cardiomyopathy);
• constrictive pericarditis;
• cardiac tamponade;
• acute circulatory failure (shock or vascular collapse);
• significant hypotension (systolic blood pressure below 90 mm Hg);
• significantly decreased blood volume (severe hypovolemia);
• decreased hemoglobin, hematocrit, and decreased red blood cell count (severe anemia);
• if the patient is taking a medicine containing riociguat, which is used to treat pulmonary arterial hypertension.
• if the patient is taking phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil.

During treatment with Effox long 50, you must not take phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil. You must not stop taking Effox long 50 to take a medicine containing a phosphodiesterase type 5 inhibitor, such as sildenafil, tadalafil, vardenafil, as this may increase the risk of chest pain (see "Effox long 50 and other medicines").

Warnings and precautions

Before starting treatment with Effox long 50, you should discuss it with your doctor or pharmacist, even if the following warnings refer to situations that have occurred in the past. You should be particularly careful if you have:

• low filling pressure of the heart chambers, such as in recent myocardial infarction or impaired left ventricular function (left ventricular failure). You should avoid lowering systolic blood pressure below 90 mm Hg;
• valvular stenosis (aortic and/or mitral stenosis);
• increased intracranial pressure;
• orthostatic hypotension (low blood pressure associated with rapid change of position to standing or prolonged standing);
• pulmonary disease, pulmonary hypertension, or coronary heart disease. Under the influence of this medicine, increased blood flow to areas of the lungs with reduced oxygen supply (hypoxemia) may occur;
• lactose intolerance, as this medicine contains lactose (see "Effox long 50 contains lactose").

It has been shown that organic nitrates cease to act or become less effective if taken for a long time in large doses. To avoid such a situation, you should carefully follow the dosage recommendations. Effox long 50 should not be used to interrupt an ongoing angina pectoris attack, due to the lack of sufficiently rapid action. The insoluble residues of this medicine may be excreted in the feces in an unchanged form. In patients with delayed gastric emptying, decreased release of the active substance from this medicine may occur.

Children and adolescents

The safety and efficacy of this medicine in children and adolescents have not been established.

Effox long 50 and other medicines

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

• medicines that lower blood pressure, such as vasodilators (e.g., prazosin), beta-adrenergic blockers (e.g., propranolol), calcium antagonists (e.g., verapamil), angiotensin-converting enzyme inhibitors (e.g., captopril), monoamine oxidase inhibitors, and similar medicines;
• neuroleptics (e.g., chlorpromazine) used to treat mental disorders;
• tricyclic antidepressants (e.g., amitriptyline) used to treat depression;
• dihydroergotamine (used to treat migraine), whose use with this medicine may lead to increased levels of dihydroergotamine in the blood and enhancement of its action;
• sapropterin used to treat phenylketonuria.

You must not take this medicine with phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil, used to treat erectile dysfunction. Taking Effox Long 50 with these medicines may cause a drop in blood pressure to a dangerously low level. You must not stop taking this medicine to take phosphodiesterase type 5 inhibitors, as this will increase the risk of chest pain. During treatment with Effox long 50, you must not take medicines containing riociguat, which is used to treat pulmonary arterial hypertension.

Taking Effox long 50 with food, drink, and alcohol

While taking Effox long 50, you should avoid consuming alcohol, as it may enhance the blood pressure-lowering effect of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine. This medicine may be used during pregnancy only if necessary, when the benefit to the mother outweighs the potential risk to the fetus, and only under medical supervision. This medicine may be used during breastfeeding only if necessary, on the explicit advice of a doctor. There are data indicating that nitrates pass into breast milk and may cause changes in red blood cells (methemoglobinemia) in infants. The degree of nitrate excretion into breast milk has not been estimated. There are no data on the effect of Effox long 50 on human fertility.

Driving and using machines

Effox long 50 may impair your ability to drive and use machines. This effect may be enhanced in combination with alcohol.

Effox long 50 contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Effox long 50

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Your doctor will determine the dose of the medicine for each patient individually, according to the patient's clinical response. Treatment should be started with small doses, which should then be gradually increased until the desired therapeutic effect is achieved. You should use the smallest effective dose. Usually, 1 tablet is taken once a day (50 mg of isosorbide mononitrate per day). If there is an increased need for nitrates, the dose can be increased to 2 tablets once a day (100 mg of isosorbide mononitrate per day). The tablets should be swallowed whole, without chewing, with a glass of water. The score line on the tablet is not intended for breaking the tablet. Effox long 50 should be taken regularly, every day at the same time, as determined by your doctor. Your doctor will advise you on how long to take Effox long 50. You should not stop treatment abruptly, as this may increase the risk of angina pectoris. If treatment needs to be stopped, your doctor will advise you to gradually reduce the dose of the medicine over several days. If you feel that the effect of this medicine is too strong or too weak, you should consult your doctor.

Elderly patients

In elderly patients, there is no need to adjust the dose of the medicine.

Use in children and adolescents

The safety and efficacy of Effox long 50 in children and adolescents have not been established.

Overdose of Effox long 50

In case of overdose, you should immediately contact your doctor or pharmacist. Overdose may cause: excessive lowering of blood pressure (systolic blood pressure below 90 mm Hg), pale skin, excessive sweating, low heart rate, rapid heart rate, dizziness related to changes in body position, headaches, weakness, dizziness, nausea, vomiting, and diarrhea. Taking too much of this medicine may cause methemoglobinemia, leading to a bluish discoloration of the skin, which may be accompanied by rapid breathing, restlessness, loss of consciousness, and cardiac arrest. This is a possible reaction to Effox long 50 and similar medicines, due to the way they are metabolized when absorbed into the body. Very large doses of the medicine may cause increased intracranial pressure, which may lead to cerebral symptoms. If overdose of this medicine is detected early, your doctor may induce vomiting and/or perform gastric lavage and administer activated charcoal - if it has not been more than an hour since taking the medicine. In case of later detection of overdose, treatment involves maintaining blood pressure with intravenous fluids and applying specialized shock treatment (in the intensive care unit), if necessary. In severe cases, mechanical ventilation to support breathing or dialysis to support kidney function may be necessary.

Missed dose of Effox long 50

You should not take a double dose to make up for a missed dose.

Stopping treatment with Effox long 50

If you stop taking the medicine, you may be at increased risk of angina pectoris. If treatment needs to be stopped, your doctor will advise you to gradually reduce the dose of the medicine over several days. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with this medicine:

Very common (may affect up to 1 in 10 people):

• headache

Common (may affect up to 1 in 10 people):

• dizziness (including dizziness related to changes in body position)
• drowsiness
• rapid heart rate
• low blood pressure related to changes in body position
• feeling of weakness

Uncommon (may affect up to 1 in 100 people):

• increased chest pain
• vascular collapse (sometimes with slow heart rate and loss of consciousness)
• nausea
• vomiting
• allergic skin reactions (e.g., rash)
• sudden flushing of the face with a feeling of heat

Rare (may affect up to 1 in 10,000 people):

• heartburn

Frequency not known (cannot be estimated from the available data):

• low blood pressure
• exfoliative dermatitis
• angioedema - swelling of the skin and mucous membranes that can cause difficulty breathing and swallowing

During treatment with organic nitrates, significant lowering of blood pressure with nausea, vomiting, restlessness, pale skin, and excessive sweating has been reported. While taking this medicine, transient decreases in blood oxygen levels and reduced blood flow to the heart, which does not receive enough oxygen, may occur. This may lead, especially in people with coronary heart disease, to myocardial hypoxia. The occurrence of some of these side effects may require immediate medical attention and hospital treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to 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 You can also report side effects 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 Effox long 50

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Effox long 50 contains

• The active substance of the medicine is isosorbide mononitrate. One prolonged-release tablet contains 50 mg of isosorbide mononitrate.
• The other ingredients are: lactose monohydrate, talc, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, glycerol distearate, hypromellose, calcium hydrogen phosphate dihydrate.

What Effox long 50 looks like and contents of the pack

Effox long 50 is a white, round, prolonged-release tablet without visible discoloration or damage. The upper surface is flat, with beveled edges, a notch through the entire tablet, and an engraving "EL" on one side and "50" on the other side of the notch. The lower smooth surface is slightly convex. The score line on the tablet is not intended for breaking the tablet into halves. The pack contains 30, 60, or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Merus Labs Luxco II S.à.r.l.
208, Val des Bons Malades
L-2121 Luxembourg
Luxembourg
Manufacturer
Astrea Fontaine
Rue des Prés Potets
21121 Fontaine Les Dijon
France

Date of last revision of the leaflet: