Effox long 75

Leaflet accompanying the packaging: patient information

Effox long 75,

75 mg, prolonged-release tablets

Isosorbide mononitrate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Effox long 75 and what is it used for
• 2. Important information before taking Effox long 75
• 3. How to take Effox long 75
• 4. Possible side effects
• 5. How to store Effox long 75
• 6. Contents of the pack and other information

1. What is Effox long 75 and what is it used for

Effox long 75 contains 75 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 75 also improves blood flow through the heart muscle, which reduces cardiac ischemia. As a result, chest pain decreases. Effox long 75 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 75

When not to take Effox long 75

• 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 through appropriate treatment);
• thickened heart muscle with narrowing of the outflow tract from the left ventricle (hypertrophic obstructive cardiomyopathy);
• constrictive pericarditis;
• fluid accumulation between the heart and the membrane surrounding the heart (cardiac tamponade);
• acute circulatory failure ("shock" or vascular collapse);
• significant hypotension (systolic blood pressure below 90 mm Hg);
• significantly reduced blood volume in the blood vessels (severe hypovolemia);
• reduced hemoglobin, hematocrit, and reduced 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 75, do not take phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil. Do not stop taking Effox long 75 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 75 and other medicines").

Warnings and precautions

Before starting treatment with Effox long 75, discuss it with your doctor or pharmacist, even if the following warnings refer to situations that have occurred in the past. Be particularly careful if the patient has:

• low blood pressure in the heart chambers, such as in recent myocardial infarction, or in the case of impaired left ventricular function (left ventricular failure). Avoid lowering systolic blood pressure below 90 mm Hg;
• narrowing of the heart valves (aortic stenosis 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, there may be an increased blood flow to areas of the lungs that receive reduced oxygen (hypoxemia);
• lactose intolerance, as this medicine contains lactose (see "Effox long 75 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 this, carefully follow the dosage recommendations. Effox long 75 should not be used to interrupt an ongoing angina pectoris attack, due to the lack of sufficiently rapid action. Insoluble residues of this medicine may be excreted in the stool in an unchanged form. In patients with delayed gastric emptying, there may be a decrease in the release of the active substance from this medicine.

Children and adolescents

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

Effox long 75 and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as 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.

Do not take this medicine with phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil, used to treat erectile dysfunction. Taking Effox Long 75 with these medicines may cause a drop in blood pressure to a dangerously low level. Do 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 75, do not take medicines containing riociguat, which is used to treat pulmonary arterial hypertension.

Using Effox long 75 with food, drink, and alcohol

When taking Effox long 75, 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, consult your doctor 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 instruction 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 75 on human fertility.

Driving and using machines

Effox long 75 may impair the ability to drive and use machines. This effect may be enhanced in combination with alcohol.

Effox long 75 contains lactose

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

3. How to take Effox long 75

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, based on the patient's clinical response. Treatment should be started with small doses, which are then gradually increased until the desired therapeutic effect is achieved. Use the smallest effective dose. Usually, 1 tablet is taken once a day (75 mg of isosorbide mononitrate per day). The tablets should be swallowed whole, without chewing, with a glass of water. The score line is not intended for breaking the tablet. Effox long 75 should be taken regularly, every day at the same time, as determined by your doctor. Your doctor will advise how long to take Effox long 75. Do not stop treatment abruptly, as this may increase the risk of angina pectoris. If treatment needs to be discontinued, your doctor will advise gradual dose reduction over several days. If you feel that the effect of this medicine is too strong or too weak, consult your doctor.

Patients with impaired renal function

No dose adjustment is necessary in patients with impaired renal function.

Elderly patients

No dose adjustment is necessary in elderly patients.

Use in children and adolescents

The safety and efficacy of Effox long 75 in children and adolescents have not been established.

Overdose of Effox long 75

In case of overdose, contact your doctor or pharmacist immediately. Overdose may cause: excessive lowering of blood pressure (systolic blood pressure below 90 mm Hg), pallor, 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 75 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 the development of cerebral symptoms. If overdose of this medicine is detected early, the doctor may induce vomiting in the patient 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 75

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

Stopping treatment with Effox long 75

Stopping treatment may increase the risk of angina pectoris. If treatment needs to be discontinued, your doctor will advise gradual dose reduction over several days. If you have any further doubts about taking this medicine, consult 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
• skin allergic 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, pallor, and excessive sweating has been reported. During treatment with this medicine, there may be a transient decrease in blood oxygen levels and a decrease in blood flow to the heart, which does not receive enough oxygen. 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 those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Effox long 75

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 75 contains

• The active substance of the medicine is isosorbide mononitrate. One prolonged-release tablet contains 75 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 75 looks like and contents of the pack

Effox long 75 is a white, elongated, biconvex tablet. The upper surface has a score line and is engraved with "EL" on one side and "75" on the other side of the score line. The lower surface is smooth and has a score line. The score line is not intended for breaking the tablet. 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: