OLICARD 60 mg Retard Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Olicard 60 retard
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
3. What is Olicard 60 retard and what is it used for
4. Important information before taking Olicard 60 retard
   1. When not to take Olicard 60 retard
   2. Warnings and precautions
   3. Olicard 60 retard and other medicines
   4. Olicard 60 retard with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Olicard 60 retard contains 261.7 mg of sucrose in one capsule.
5. How to take Olicard 60 retard
   1. Taking a higher dose of Olicard 60 retard than recommended
   2. Missing a dose of Olicard 60 retard
   3. Stopping treatment with Olicard 60 retard
6. Possible side effects
   1. Reporting side effects
7. How to store Olicard 60 retard
8. Contents of the pack and other information
   1. What Olicard 60 retard contains
   2. What Olicard 60 retard looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more detailed information, please contact the

Package Leaflet: Information for the Patient

Olicard 60 retard

60 mg, prolonged-release hard capsules, Isosorbide mononitrate

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

• 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Olicard 60 retard and what is it used for
• 2. Important information before taking Olicard 60 retard
• 3. How to take Olicard 60 retard
• 4. Possible side effects
• 5. How to store Olicard 60 retard
• 6. Contents of the pack and other information

1. What is Olicard 60 retard and what is it used for

Olicard 60 retard comes in the form of white, opaque, prolonged-release hard capsules containing sugar pellets.
Olicard 60 retard belongs to the pharmacotherapeutic group: vasodilators in cardiac diseases; nitrates.
Indications for use:
Olicard 60 retard is used to prevent angina pectoris attacks in stable coronary artery disease.

2. Important information before taking Olicard 60 retard

When not to take Olicard 60 retard

Do not take Olicard 60 retard in the following cases:

• hypersensitivity (allergy) to the active substance (isosorbide mononitrate), other nitrates, or any of the other ingredients of this medicine (listed in section 6)
• acute circulatory failure (shock, circulatory collapse)
• cardiogenic shock, if the measures taken did not restore a sufficiently high filling pressure in the heart (left ventricular end-diastolic pressure)
• very low blood pressure (significant hypotension), i.e., with a systolic blood pressure below 90 mmHg

During treatment with Olicard 60 retard, do not take medicines intended for the treatment of erectile dysfunction, containing as an active substance a 5-phosphodiesterase inhibitor, i.e., sildenafil, vardenafil, or tadalafil, as this may cause a significant decrease in blood pressure.

Warnings and precautions

Before starting treatment with Olicard 60 retard, discuss it with your doctor or pharmacist.
Olicard 60 retard is not intended for the treatment of acute heart pain (e.g., acute angina pectoris) and acute myocardial infarction.
Caution should be exercised when taking Olicard 60 retard in the following cases:

• heart muscle disease with reduced heart volume (hypertrophic cardiomyopathy with outflow obstruction), constrictive pericarditis, or cardiac tamponade (filling of the pericardial cavity with blood or other fluid)
• low filling pressures, e.g., in acute myocardial infarction or worsening of left ventricular function (left ventricular failure); avoid decreases in systolic blood pressure below 90 mmHg
• stenosis of the left ventricular valves (aortic and/or mitral valve)
• tendency to circulatory regulation disorders with a decrease in blood pressure (orthostatic circulatory disorders)
• diseases with increased intracranial pressure (so far, only an increase in pressure has been observed after intravenous administration of high doses of nitroglycerin - a chemically similar compound)

Treatment with Olicard 60 retard may cause transient hypoxia and myocardial ischemia in patients with coronary artery disease.
Consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Olicard 60 retard and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
An enhancement of the blood pressure-lowering effect occurs with the use of:

• other vasodilators
• blood pressure-lowering medicines (e.g., β-adrenergic blockers, calcium antagonists, ACE inhibitors)
• medicines used in psychiatric disorders, such as depression, and neuroleptics (used mainly in the treatment of schizophrenia and other psychoses)
• medicines used in the treatment of erectile dysfunction, which contain as an active substance a 5-phosphodiesterase inhibitor, e.g., sildenafil, vardenafil, tadalafil

Olicard 60 retard used concomitantly with dihydroergotamine may increase its blood levels and thus enhance its blood pressure-increasing effect.

Olicard 60 retard with alcohol

Concomitant use of this medicine with alcohol may cause excessive lowering of blood pressure.

Pregnancy, breastfeeding, and fertility

Due to the lack of data on the use of the medicine in pregnant women and the need for special caution in their case, Olicard 60 retard can be taken during pregnancy only on the explicit recommendation of the attending physician. Animal studies do not indicate any direct or indirect harmful effects on pregnancy, embryonic/fetal development, childbirth, or postnatal development at doses corresponding to those used in humans.
During breastfeeding, Olicard 60 retard can be used only on the explicit recommendation of the physician, as it is not known whether the medicine passes into breast milk.

Driving and using machines

During treatment with Olicard 60 retard, especially at the beginning of treatment, when increasing the dose of the medicine, when switching to another product, and when consuming alcohol, dizziness, drowsiness, or fatigue may occur. This should be taken into account when considering driving a vehicle or operating machinery.

Olicard 60 retard contains 261.7 mg of sucrose in one capsule.

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

3. How to take Olicard 60 retard

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally.
Unless your doctor has told you otherwise:
Take 1 capsule of Olicard 60 retard once a day (which corresponds to taking 60 mg of isosorbide mononitrate).
Treatment should be started with low doses of the medicine, gradually increasing them to achieve the desired dose.
Swallow the prolonged-release hard capsules whole, with a sufficient amount of liquid (e.g., a glass of water).
The duration of treatment is determined by the attending physician.
If you feel that the effect of Olicard 60 retard is too strong or too weak, you should immediately consult your doctor or pharmacist.

Taking a higher dose of Olicard 60 retard than recommended

If you have taken a higher dose of Olicard 60 retard than recommended, you should immediately consult your doctor or pharmacist.
Since no cases of overdose with Olicard 60 retard have been reported so far, only possible symptoms related to overdose of the medicine can be described.
Depending on the degree of overdose, a significant decrease in blood pressure (hypotension) with an increase in heart rate, headache, fatigue, dizziness, and a feeling of fainting, hot flashes, nausea, vomiting, and diarrhea may occur.

Missing a dose of Olicard 60 retard

Do not take a double dose to make up for a missed dose.
Continue treatment according to the recommended schedule.

Stopping treatment with Olicard 60 retard

The effectiveness of the treatment may be reduced.

4. Possible side effects

Like all medicines, Olicard 60 retard can cause side effects, although not everybody gets them.
The most commonly observed side effect is headache, which gradually decreases during continued treatment.
Very common (occurred in at least 1 in 10 patients) side effects include:

• headache

Common (occurs in 1 to 10 in 100 patients) side effects include:

• dizziness
• fatigue

Uncommon (occurs in 1 to 10 in 1,000 patients) side effects include:

• hot flashes

The following side effects have been reported with a frequency that cannot be estimated from the available data:

• drowsiness
• increased or newly occurring angina pectoris
• slow heart rate with heart rhythm disorders
• decreases in systolic blood pressure when standing up
• increased heart rate
• fainting, circulatory collapse
• nausea, vomiting
• skin hypersensitivity reactions
• severe skin inflammatory disease (exfoliative dermatitis)

Other instructions:
After administration of Olicard 60 retard, transient hypoxia may occur in the arterial blood due to the displacement of blood to less well-ventilated areas of the lungs.
In patients with coronary artery disease, this may lead to inadequate oxygen supply to the heart muscle.
Ineffectiveness and reduced efficacy of the medicine have been reported in cases of prior use of nitrates. To avoid weakening or loss of the medicine's effect, continuous administration of the preparation in high doses should be avoided.
After the first symptoms of hypersensitivity to Olicard 60 retard appear, the use of the medicine should be discontinued.
In the event of any of the above side effects, you should inform your doctor, who will assess the severity of the complications and decide on the need for further preventive measures.
In some individuals, other side effects may occur during treatment with the medicine. If other side effects occur that are not listed in this leaflet, you should inform your doctor.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 the medicine.

5. How to store Olicard 60 retard

Keep the medicine out of the sight and reach of children.
Store in the original package, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the package after: Expiry date. The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What Olicard 60 retard contains

• The active substance of the medicine is 60 mg of isosorbide mononitrate.
• The other ingredients are: sucrose, corn starch, ethylcellulose, talc. Capsule shell: gelatin, titanium dioxide (E 171).

What Olicard 60 retard looks like and contents of the pack

Olicard 60 retard comes in the form of prolonged-release hard capsules, packaged in blisters of 20 or 50 pieces in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer

Temmler Pharma GmbH
Temmlerstraße 2
35039 Marburg
Germany
Valpharma International S.p.A.
Via G. Morgagni, 2
47864 Pennabilli (RN)
Italy

For more detailed information, please contact the

marketing authorization holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the leaflet:06/2025