OLICARD 40 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
3. Olicard 40 Retard (Оликапд 40 mg)
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Olicard 40 retard and what is it used for
5. Important information before taking Olicard 40 retard
   1. When not to take Olicard 40 retard
   2. Warnings and precautions
   3. Olicard 40 retard and other medicines
   4. Olicard 40 retard with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
6. 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
7. Possible side effects
   1. Reporting side effects
8. How to store Olicard 40 retard
9. 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 in Bulgaria, the country of export:
   4. Manufacturer
   5. Parallel importer:
   6. Repackaged by:
   7. Date of approval of the leaflet: 06.03.2025

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Olicard 40 Retard (Оликапд 40 mg)

40 mg, prolonged-release hard capsules
Isosorbide mononitrate
Olicard 40 retard and Оликапд 40 mg are trade names for the same medicine written in Polish and Bulgarian.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Olicard 40 retard and what is it 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 is Olicard 40 retard and what is it used for

Olicard 40 retard is available as white, opaque, prolonged-release hard capsules containing sugar pellets.
Olicard 40 retard belongs to the pharmacotherapeutic group: vasodilators in cardiac diseases; nitrates.
Indications for use:
Olicard 40 retard is used to prevent angina pectoris 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 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 have not restored a sufficiently high ventricular filling pressure
• very low blood pressure (significant hypotension), i.e., with a systolic blood pressure below 90 mmHg

While taking Olicard 40 retard, do not take medicines intended for the treatment of 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 pectoris) and acute myocardial infarction.
Caution should be exercised when taking Olicard 40 retard in the following cases:

• heart muscle disease with reduced ventricular volume (hypertrophic cardiomyopathy with outflow obstruction), constrictive pericarditis, or pericardial tamponade (filling of the pericardial cavity with blood or other fluid)
• low filling pressures, e.g., in acute myocardial infarction or worsening 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 disorders in the regulation of the circulatory system 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)

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

Olicard 40 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.
The effect of lowering blood pressure is enhanced by the use of:

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

Taking Olicard 40 retard 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 too great a decrease in 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 40 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 40 retard can be used only on the explicit recommendation of the doctor, as it is not known whether the medicine passes into breast milk.

Driving and using machines

While taking Olicard 40 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 machines.
Olicard 40 retard contains 206.4 mg of sucrose in one capsule.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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 taking 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 the attending physician.
If you feel that the effect of Olicard 40 retard is too strong or too weak, you should immediately consult your doctor or pharmacist.

Taking a higher dose of Olicard 40 retard than recommended

If you have taken a higher dose of Olicard 40 retard than recommended, you should immediately consult your doctor or pharmacist.
Since no cases of overdose with Olicard 40 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 accelerated heart rate, headache, fatigue, dizziness, and a feeling of fainting, hot flashes, nausea, vomiting, and diarrhea may occur.

Missing a dose of Olicard 40 retard

Do not take a double dose of the medicine to make up for a missed dose.
Continue treatment as prescribed.

Stopping treatment with Olicard 40 retard

The effectiveness of the 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 (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
• exacerbation or occurrence of angina pectoris
• slow heart rate with heart rhythm disorders
• decreases in systolic blood pressure when standing up
• accelerated heart rate
• fainting, circulatory collapse
• nausea, vomiting
• skin hypersensitivity reactions
• severe skin inflammatory disease (exfoliative dermatitis)

Other instructions:
After taking Olicard 40 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 cause inadequate oxygen supply to the heart muscle.
Ineffectiveness and weakened effect of the medicine have been reported in cases of prior use of nitrates. To avoid weakening or loss of effect of the medicine, continuous administration of the preparation in high doses should be avoided.
After the first symptoms of hypersensitivity to Olicard 40 retard appear, the use of the medicine should be discontinued.
If any of the above side effects occur, the patient should inform their doctor, who will assess the severity of the complications and decide on the need for further preventive measures.
In some people, other side effects may occur during treatment with the medicine. If other side effects occur that are not listed in this leaflet, the patient should inform their doctor.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
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 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Olicard 40 retard contains

• The active substance of the medicine 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 20 or 50 pieces in PVC/Aluminum blisters in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Mylan EOOD
Office building “Serdika offices”
Sitnyakovo Blvd. 48
1505 Sofia, Bulgaria

Manufacturer

Temmler Pharma GmbH
Temmlerstraße 2
35039 Marburg
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 20020121
Parallel import authorization number: 89/25

Date of approval of the leaflet: 06.03.2025

[Information about the trademark]