Effox long 50

Package leaflet: Information for the patient

Effox long 50,
50 mg, prolonged-release tablets
Isosorbide mononitrate
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Effox long 50 contains 50 mg of isosorbide mononitrate, which causes dilation of the
coronary blood vessels of the heart. It also dilates venous and arterial vessels. As a result,
the heart's workload is reduced, and thus the oxygen demand of the heart muscle decreases.
Effox long 50 also improves blood flow through the heart muscle, thereby reducing myocardial
ischemia. Consequently, chest pain symptoms are alleviated.
Effox long 50 is used for the prevention of angina attacks (chest pain caused by restricted
blood flow to the heart muscle).

2. Information before using Effox long 50

When not to take Effox long 50

• if the patient has:
  • hypersensitivity to the active substance, to other nitrates or to any of the other components of this medicine (listed in section 6);
  • cardiogenic shock (except in cases where appropriate treatment achieves sufficiently high end-diastolic pressure in the left ventricle);
  • hypertrophic muscle of the heart with narrowing of the outflow tract from the left ventricle (hypertrophic obstructive cardiomyopathy);
  • constrictive pericarditis;
  • accumulation of fluid between the heart and the surrounding membrane (cardiac tamponade);
  • acute circulatory failure (shock or collapse of blood vessels);
  • significant arterial hypotension (systolic blood pressure below 90 mm Hg);
  • significantly reduced blood volume in the vessels (severe hypovolemia);
• decreased hemoglobin concentration, hematocrit and reduced number of red blood cells (severe anemia);
  • if the patient is taking a medicine containing riociguat, which is used in the treatment of pulmonary arterial hypertension;
  • if the patient is taking drugs belonging to the group of phosphodiesterase type 5 inhibitors, e.g. sildenafil, tadalafil, vardenafil.

During treatment with Effox long 50, do not take drugs belonging to the group of phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, vardenafil. Treatment with Effox long 50 must not be interrupted in order to take a medicine containing a phosphodiesterase type 5 inhibitor, e.g. 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, discuss this with your doctor or pharmacist, even if the warnings below refer to conditions that occurred in the past.

Exercise particular caution if the patient has:

• low ventricular filling pressure, e.g. in recent myocardial infarction or impaired left ventricular function (left ventricular failure). Avoid reducing systolic blood pressure below 90 mm Hg;
• heart valve stenosis (aortic and/or mitral valve);
• increased intracranial pressure;
• orthostatic hypotension (low blood pressure associated with rapid change to standing position or prolonged standing);
• lung disease, pulmonary hypertension or ischemic heart disease. This medicine may increase blood flow through areas of the lungs receiving reduced oxygen (hypoxemia);
• lactose intolerance, because this medicine contains lactose (see section "Effox long 50 contains lactose").

It has been shown that organic nitrates become ineffective or less effective when administered in high doses over a prolonged period. To avoid this, strictly follow the recommended dosing instructions.

Effox long 50 should not be used to terminate an ongoing episode of chest pain (angina attack), due to insufficiently rapid onset of action.

Insoluble remnants of this medicine may be excreted in the stool in intact form.

In patients with delayed gastrointestinal transit, reduced 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

Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take, such as:

• antihypertensive medicines, such as vasodilators (e.g. prazosin), beta-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 in the treatment of psychiatric disorders;
• tricyclic antidepressants (e.g. amitriptyline) used in the treatment of depression;
• dihydroergotamine (used to treat migraine), whose use with this medicine may lead to increased blood concentration and enhanced effect;
• sapropterin used in the treatment of phenylketonuria.

Do not take this medicine with phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil, vardenafil, used to treat erectile dysfunction. Taking Effox long 50 together with these medicines may cause blood pressure to drop to dangerously low levels. Do not interrupt treatment with this medicine in order to take phosphodiesterase type 5 inhibitors, as this increases the risk of chest pain.

During treatment with Effox long 50, do not take medicines containing riociguat, which is used in the treatment of pulmonary arterial hypertension.

Taking Effox long 50 with food, drink and alcohol

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

This medicine may be used during pregnancy only if clearly 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 clearly necessary and on the explicit instruction of a physician. Data indicate that nitrates pass into human breast milk and may cause changes in red blood cells (methemoglobinemia) in infants. The extent of nitrate excretion into breast milk has not been quantified.

There are no data on the effect of Effox long 50 on human fertility.

Driving and operating machinery

Effox long 50 may impair the ability to drive vehicles and operate machinery. This effect may be intensified when combined with alcohol.

Effox long 50 contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Effox long 50

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor.
Your doctor will determine the dose individually for each patient, depending on the patient's clinical response.
Treatment should be initiated with low doses, which should then be gradually increased until the desired therapeutic effect is achieved. The lowest effective dose should be used.
The usual dose is 1 tablet once daily (50 mg of isosorbide mononitrate per day).
If there is an increased need for nitrates, the dose may be increased to 2 tablets once daily (100 mg of isosorbide mononitrate per day).
The tablets should be swallowed whole, without chewing, with water.
The break line on the tablet is not intended for dividing 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 you should continue taking Effox long 50. Do not stop treatment abruptly, as this may increase the risk of angina attacks.
If treatment needs to be discontinued, your doctor will recommend gradually reducing the dose over several days.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor.

Elderly patients
Dose adjustment is not required in elderly patients.

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

Taking more Effox long 50 than recommended
If you take more Effox long 50 than recommended, contact your doctor or pharmacist immediately.
Overdose may cause: excessive lowering of blood pressure (systolic pressure below 90 mm Hg), pale skin, excessive sweating, slow pulse, rapid heartbeat, dizziness upon changing body position, headache, weakness, dizziness, nausea, vomiting, and diarrhea.
Taking too high a dose of this medicine may cause methemoglobinemia, leading to 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 high doses of the medicine may increase intracranial pressure, which may lead to cerebral symptoms.
If overdose is detected early, the doctor may induce vomiting and/or perform gastric lavage and administer activated charcoal—provided that no more than one hour has passed since ingestion of the medicine. In cases where overdose is detected later, treatment consists of maintaining blood pressure with intravenous fluids and, if necessary, specialized shock treatment (in an intensive care unit). In severe cases, mechanical ventilation to assist breathing or dialysis to support kidney function may be required.

If you miss a dose of Effox long 50
Do not take a double dose to make up for a missed dose.

Stopping Effox long 50
If you stop taking this medicine, there may be an increased risk of angina attacks. If treatment needs to be discontinued, your doctor will recommend gradually reducing the dose over several days.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed during treatment with this medicine:
Very common (may affect at least 1 in 10 people):

• headache

Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 1 in 100 people):

• worsening of chest pain
• vascular collapse (sometimes with slowed heart rate and loss of consciousness)
• nausea
• vomiting
• skin allergic reactions (e.g. rash)
• sudden flushing of the face with sensation of warmth

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

• heartburn

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

• low blood pressure
• exfoliative dermatitis
• angioedema – swelling of the skin and mucous membranes which may cause difficulty in breathing and swallowing

Marked reduction in arterial pressure, accompanied by nausea, vomiting, restlessness, pallor and excessive sweating, has been reported during treatment with organic nitrates.
During treatment with this medicine, transient reduction in blood oxygen levels and consequently reduced blood flow to the heart may occur, resulting in insufficient oxygen supply.
This may lead, particularly in patients with coronary artery disease, to myocardial hypoxia.
The occurrence of some of these adverse effects may indicate the need for immediate medical attention and hospital treatment.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Effox long 50

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must 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 is isosorbide mononitrate. One prolonged-release tablet contains 50 mg of isosorbide mononitrate.
• The other ingredients are: monohydrate lactose, talc, anhydrous colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, polyvinylpyrrolidone, glycerol distearate, hypromellose, calcium hydrogen phosphate dihydrate.

What Effox long 50 looks like and contents of the pack
Effox long 50 is in the form of white, round tablets without visible discolorations or damage.
The upper surface is flat, with bevelled edges, a full-score line across the tablet, and engravings
"EL" on one side and "50" on the other side of the score. The lower smooth surface is slightly convex.
The dividing groove is not intended for splitting the prolonged-release tablet into halves.
The pack contains 30, 60 or 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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