OLICARD 40 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Olicard 40 Retard
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
3. What Olicard 40 Retard is and what it is used for
4. Important information before taking Olicard 40 Retard
   1. When not to take Olicard 40 Retard
   2. Warnings and precautions
   3. Olicard 40 Retard with other medicines
   4. Olicard 40 Retard with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to take Olicard 40 Retard
   1. Taking a higher dose of Olicard 40 Retard than recommended
   2. Missing a dose of Olicard 40 Retard
   3. Stopping treatment with Olicard 40 Retard
6. Possible side effects
   1. Reporting side effects
7. How to store Olicard 40 Retard
8. Contents of the pack and other information
   1. What Olicard 40 Retard contains
   2. What Olicard 40 Retard looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information, contact the

Package Leaflet: Information for the Patient

Olicard 40 Retard

40 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Olicard 40 Retard is and what it is used for
• 2. Important information before taking Olicard 40 Retard
• 3. How to take Olicard 40 Retard
• 4. Possible side effects
• 5. How to store Olicard 40 Retard
• 6. Contents of the pack and other information

1. What Olicard 40 Retard is and what it is used for

Olicard 40 Retard is available as white, opaque, prolonged-release hard capsules containing sugar pellets.
Olicard 40 Retard belongs to a group of medicines called vasodilators used in heart diseases; nitrates.
Indications for use:
Olicard 40 Retard is used to prevent angina attacks in stable coronary artery disease.

2. Important information before taking Olicard 40 Retard

When not to take Olicard 40 Retard

Do not take Olicard 40 Retard if you have:

• 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 measures taken have not restored adequate high filling pressure in the heart (left ventricular end-diastolic pressure)
• very low blood pressure (significant hypotension), i.e., systolic blood pressure below 90 mmHg

While taking Olicard 40 Retard, do not take medicines for erectile dysfunction, containing the active substance phosphodiesterase 5 inhibitor, i.e., sildenafil, vardenafil, or tadalafil, as this may cause a significant decrease in blood pressure.

Warnings and precautions

Before starting to take Olicard 40 Retard, discuss it with your doctor or pharmacist.
Olicard 40 Retard is not intended for the treatment of acute heart pain (e.g., acute angina attack) and acute myocardial infarction.
Caution should be exercised when taking Olicard 40 Retard in the following cases:

• heart muscle disease with reduced heart volume (hypertrophic cardiomyopathy with outflow obstruction), constrictive pericarditis, or pericardial tamponade (filling of the pericardial space 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 outflow tract (aortic and/or mitral valve stenosis)
• tendency to disturbances in blood circulation regulation with a decrease in blood pressure (orthostatic circulatory disturbances)
• 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)

Taking Olicard 40 Retard may cause transient hypoxia and myocardial ischemia in patients with coronary artery disease.
Consult your doctor, even if the above warnings refer to past situations.

Olicard 40 Retard with other medicines

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

• other vasodilators
• blood pressure-lowering medicines (e.g., β-adrenergic blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors [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 the active substance phosphodiesterase 5 inhibitor, e.g., sildenafil, vardenafil, tadalafil

Olicard 40 Retard taken with dihydroergotamine may increase its blood levels and thus enhance its blood pressure-increasing effect.

Olicard 40 Retard with alcohol

Taking this medicine with alcohol may cause excessive blood pressure lowering.

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 40 Retard can be taken during pregnancy only on the explicit recommendation of the attending physician. Animal studies do not indicate 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 40 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 40 Retard, especially at the beginning of treatment, when increasing the dose, 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 40 Retard contains 206.4 mg of sucrose in one capsule.
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Olicard 40 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 40 Retard once a day (which corresponds to 40 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 your doctor.
If you feel that the effect of Olicard 40 Retard is too strong or too weak, contact your doctor or pharmacist immediately.

Taking a higher dose of Olicard 40 Retard than recommended

If you have taken more Olicard 40 Retard than recommended, contact your doctor or pharmacist immediately.
Since no cases of overdose with Olicard 40 Retard have been reported so far, only possible symptoms related to overdose can be described.
Depending on the degree of overdose, significant hypotension (low blood pressure) with tachycardia, headache, fatigue, dizziness, and fainting, flushing, nausea, vomiting, and diarrhea may occur.

Missing a dose of Olicard 40 Retard

Do not take a double dose to make up for a forgotten dose.
Continue treatment as prescribed.

Stopping treatment with Olicard 40 Retard

The effectiveness of treatment may be reduced.

4. Possible side effects

Like all medicines, Olicard 40 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 (occurring in at least 1 in 10 patients) side effects include:

• headache

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

• dizziness
• fatigue

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

• flushing

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

• drowsiness
• exacerbation or occurrence of angina pectoris
• slow heart rate with arrhythmias
• 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 taking Olicard 40 Retard, transient decreases in arterial oxygen content may occur 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 nitrate use. To avoid reduced efficacy or loss of effect, avoid continuous administration of high doses of the medicine.
After the first symptoms of hypersensitivity to Olicard 40 Retard, stop taking the medicine.
If you experience any of the above side effects, 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 you experience other side effects not listed in this leaflet, inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olicard 40 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 40 Retard contains

• The active substance is 40 mg of isosorbide mononitrate.
• The other ingredients are: sucrose, corn starch, ethylcellulose, talc. Capsule shell: gelatin, titanium dioxide (E 171).

What Olicard 40 Retard looks like and contents of the pack

Olicard 40 Retard is available as prolonged-release hard capsules, packaged in blisters of 20 or 50 capsules 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 information, 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