OLICARD 40 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning!
3. The leaflet should be kept. Information on the immediate packaging in a foreign language.
4. Olicard 40 retard (Оликapд 40 mg)
   1. It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Olicard 40 retard and what is it used for
6. 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
   7. Olicard 40 retard contains 206.4 mg of sucrose in one capsule.
7. 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
8. Possible side effects
   1. Reporting side effects
9. How to store Olicard 40 retard
10. Contents of the packaging and other information
    1. What Olicard 40 retard contains
    2. What Olicard 40 retard looks like and what the packaging contains
    3. Marketing authorization holder in Bulgaria, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 205/17 Date of approval of the leaflet: 17.05.2022

Leaflet attached to the packaging: patient information

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Olicard 40 retard (Оликapд 40 mg)

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

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 packaging and other information

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

Olicard 40 retard is available in the form of white, opaque, prolonged-release hard capsules containing sugar pellets.
Olicard 40 retard belongs to the pharmacotherapeutic group: vasodilators in heart diseases; nitrates.
Indications for use:
Olicard 40 retard is used to prevent angina pectoris attacks in the course of stable coronary artery disease.

2. Important information before taking Olicard 40 retard

When not to take Olicard 40 retard

Olicard 40 retard should not be taken 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 applied treatments have not allowed the restoration of 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 40 retard, medicines intended for the treatment of erectile dysfunction, containing the active substance phosphodiesterase 5 inhibitor, i.e., sildenafil, vardenafil, or tadalafil, should not be taken, as this may cause a significant decrease in blood pressure.

Warnings and precautions

Before starting treatment with Olicard 40 retard, you should 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 using 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 cavity with blood or other fluid),
• low filling pressures, e.g., in acute myocardial infarction or worsening of left ventricular function (left ventricular failure); systolic blood pressure should be avoided below 90 mmHg,
• left ventricular valve stenosis (aortic and/or mitral valve stenosis),
• 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 40 retard may cause transient hypoxia and myocardial ischemia in patients with coronary heart disease.
You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Olicard 40 retard and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
An increase in the blood pressure-lowering effect occurs when using:

• 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 mainly schizophrenia and other psychoses),
• medicines used to treat erectile dysfunction, which contain the active substance phosphodiesterase 5 inhibitor, e.g., sildenafil, vardenafil, tadalafil.

Olicard 40 retard used concomitantly 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 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 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 equivalent 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

During treatment with Olicard 40 retard, especially at the beginning of treatment, when increasing the dose of the medicine, when changing 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 the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.

3. How to take Olicard 40 retard

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The medicine is taken orally.
Unless the doctor recommends otherwise:
Olicard 40 retard is used at a dose of 1 capsule 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.
The hard, prolonged-release capsules should be swallowed whole, washed down 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 a doctor or pharmacist.

Taking a higher dose of Olicard 40 retard than recommended

In case of taking a higher dose of Olicard 40 retard than recommended, you should immediately consult a 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 fainting, flushing, nausea, vomiting, and diarrhea may occur.

Missing a dose of Olicard 40 retard

A double dose of the medicine should not be taken to make up for a missed dose.
Treatment should be continued according to the recommended schedule.

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 out of 100 patients) side effects include:

• dizziness,
• fatigue.

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

• flushing.

The following side effects have been observed 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 administration of 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.
Ineffective and weakened effects 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 medicine 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.
In case of any of the above-mentioned side effects, the attending physician should be informed, who will assess the severity of the complications and decide on the need for further preventive measures.
In some people, during the use of the medicine, other side effects may occur. In case of other side effects not listed in this leaflet, the doctor should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301; Fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Olicard 40 retard

The medicine should be stored in a place invisible and inaccessible to children.
Store at 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, cornstarch, ethylcellulose, talc. Capsule shell: gelatin, titanium dioxide.

What Olicard 40 retard looks like and what the packaging contains

Olicard 40 retard is available in the form of prolonged-release hard capsules, packaged in 20 or 50 pieces, in PVC/Aluminum blisters, in a cardboard box.
For more detailed information, you should 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., No.48, fl. 7
1505 Sofia, Bulgaria

Manufacturer:

Temmler Pharma GmbH
Temmlerstrasse 2
35039 Marburg
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20020121

Parallel import authorization number: 205/17 Date of approval of the leaflet: 17.05.2022

[Information about the trademark]