Olicard 40 retard

Patient Information Leaflet

Caution! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Olicard 40 retard (Olikard 40 mg)
40 mg, prolonged-release hard capsules
Isosorbide mononitrate
Olicard 40 retard and Olikard 40 mg are trade names of the same medicinal product written in
Polish and Bulgarian.
Please read this leaflet carefully before taking this 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 the pharmacotherapeutic group: antianginal agents; nitrates.
Indications:
Olicard 40 retard is used for the prevention of 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:

• an allergy (hypersensitivity) 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 due to heart failure if interventions have not restored adequate cardiac filling pressure (left ventricular end-diastolic pressure)
• very low arterial blood pressure (severe hypotension), i.e. systolic blood pressure below 90 mmHg

While taking Olicard 40 retard, do not take medicines intended for the treatment of erectile dysfunction that contain as the active substance a phosphodiesterase-5 inhibitor, i.e. sildenafil, vardenafil, or tadalafil, as this may cause a significant drop in blood pressure.

Warnings and precautions
Before starting Olicard 40 retard, discuss this with your doctor or pharmacist.

Olicard 40 retard is not intended for the treatment of sudden heart pain (e.g. acute angina attack) or acute myocardial infarction.

Use Olicard 40 retard with caution if you have:

• hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, constrictive pericarditis, or cardiac tamponade (accumulation of blood or other fluid in the pericardial sac)
• low cardiac filling pressures, e.g. in acute myocardial infarction or worsening left ventricular function (left ventricular heart failure); avoid systolic blood pressure falling below 90 mmHg
• stenosis of the left ventricular valves (aortic and/or mitral valve)
• tendency to circulatory regulation disorders when blood pressure drops (orthostatic circulatory disturbances)
• conditions associated with increased intracranial pressure (so far, further increases in pressure have been observed only after intravenous administration of high doses of nitroglycerin – a chemically similar compound)

Olicard 40 retard may cause transient myocardial ischemia and hypoxia in patients with coronary artery disease.

Consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Olicard 40 retard and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

The blood pressure-lowering effect may be enhanced when Olicard 40 retard is taken together with:

• other vasodilating medicines
• antihypertensive medicines (e.g. β-blockers, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors)
• medicines used in psychiatric disorders such as depression, and neuroleptics (used mainly in the treatment of schizophrenia and other psychoses)
• medicines used to treat erectile dysfunction containing a phosphodiesterase-5 inhibitor as the active substance, e.g. sildenafil, vardenafil, tadalafil

Concomitant use of Olicard 40 retard and dihydroergotamine may increase dihydroergotamine blood levels and thereby enhance its blood pressure-raising effect.

Olicard 40 retard and alcohol
Taking this medicine together with alcohol may cause excessive lowering of blood pressure.

Pregnancy, breastfeeding and fertility
Due to lack of data on the use of this medicine in pregnant women and the need for special caution in such cases, Olicard 40 retard should be used during pregnancy only on the explicit recommendation of the attending physician. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic and fetal development, delivery, or postnatal development at doses relevant to humans.

Similarly, during breastfeeding, Olicard 40 retard should be used only on the explicit recommendation of a doctor, as it is unknown whether the drug passes into breast milk.

Driving and operating machinery
During treatment with Olicard 40 retard, especially at the beginning of treatment, when increasing the dose, when switching to another product, or when consuming alcohol concurrently, dizziness, drowsiness, or fatigue may occur. This should be taken into account when considering driving or operating machinery.

Olicard 40 retard contains 206.4 mg of sucrose per capsule.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to take Olicard 40 retard

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The medicine is taken orally.
Unless otherwise advised by the doctor:
Take 1 capsule of Olicard 40 retard once daily (corresponding to 40 mg of isosorbide mononitrate).
Treatment should be initiated with low doses of the medicine, gradually increasing to the desired dose.
The hard capsules with prolonged release must be swallowed whole, with an adequate amount of
fluid (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, consult your doctor or
pharmacist immediately.
Taking more than the recommended dose of Olicard 40 retard
In case of taking more than the recommended dose of Olicard 40 retard, seek immediate advice
from your doctor or pharmacist.
Since no cases of overdose with Olicard 40 retard have been reported to date, only possible
symptoms associated with overdose can be described.
Depending on the degree of overdose, a significant drop in blood pressure (hypotension) with
increased heart rate, headache, fatigue, dizziness and feeling of faintness, hot flushes, 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.
In such a case, continue treatment according to the recommended schedule.
Stopping treatment with Olicard 40 retard
The effectiveness of treatment may be reduced.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The most commonly observed adverse reaction is headache, which gradually decreases during continued treatment.

Very common (occurred in at least 1 out of 10 patients):

• headache

Common (occurs in 1 to 10 out of 100 patients):

• dizziness
• fatigue

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

• hot flushes

The following adverse reactions have been observed at a frequency that cannot be estimated from the available data:

• somnolence
• worsening or occurrence of angina pectoris
• slowing of heart rate with cardiac arrhythmias
• drops in arterial blood pressure upon standing
• increased heart rate
• fainting, circulatory collapse
• nausea, vomiting
• skin hypersensitivity reactions
• severe inflammatory skin disease (exfoliative dermatitis)

Other information:
After administration of Olicard 40 retard, a transient decrease in arterial oxygen content may occur due to blood redistribution to lung areas less filled with air.
In patients with impaired blood flow in the coronary arteries, this may lead to inadequate oxygen supply to the heart muscle.
Reduced efficacy and tolerance of the drug have been reported in cases of prior nitrate use. To avoid diminished or lost drug effect, continuous administration of the preparation in high doses should be avoided.
If the first signs of hypersensitivity to Olicard 40 retard occur, the use of the medicine should be discontinued.
If any of the above-mentioned adverse reactions occur, inform your physician, who will assess the severity of complications and decide on the necessary preventive measures.
In some individuals, other adverse reactions may occur during treatment. If any adverse reactions not listed in this leaflet occur, they should be reported to the physician.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps to increase the knowledge about the safety of the medicine.

5. How to store Olicard 40 retard

Keep this medicine out of 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Olicard 40 retard contains

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

What Olicard 40 retard looks like and contents of the pack
Olicard 40 retard is available as hard, prolonged-release capsules,
packaged in blisters of PVC/Aluminium foil, with 20 or 50 capsules per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, country of export:
Mylan EOOD
Office building „Serdika offices”
Sitnyakovo Blvd. No. 48
1505 Sofia, Bulgaria
Manufacturer
Temmler Pharma GmbH
Temmlerstraße 2
35039 Marburg
Germany
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorisation number in Bulgaria, country of export: 20020121
Parallel import licence number: 89/25