Olicard 60 retard

Package leaflet: Information for the patient

Olicard 60 retard
60 mg, prolonged-release hard capsules
Isosorbide mononitrate
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Olicard 60 retard is and what it is used for
2. What you need to know 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 Olicard 60 retard is and what it is used for

Olicard 60 retard is available as white, opaque prolonged-release hard capsules containing sugar-coated pellets.
Olicard 60 retard belongs to the following pharmacotherapeutic group: vasodilators used in heart diseases; nitrates.
Indications:
Olicard 60 retard is used for the prevention of angina 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 if you have:

• 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 filling pressure in the heart (left ventricular end-diastolic pressure)
• very low arterial blood pressure (significant hypotension), i.e. systolic blood pressure below 90 mmHg

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

Warnings and precautions
Before starting treatment with Olicard 60 retard, discuss this with your doctor or pharmacist.

Olicard 60 retard is not intended for the treatment of acute chest pain (e.g. acute angina attack) or acute myocardial infarction.

Use Olicard 60 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 filling pressures, e.g. in acute myocardial infarction or worsening left ventricular function (left ventricular heart failure); avoid systolic blood pressure dropping below 90 mmHg
• stenosis of the left ventricular valves (aortic valve and/or mitral valve)
• tendency to circulatory regulation disorders when blood pressure drops (orthostatic circulatory disturbances)
• conditions associated with increased intracranial pressure (to date, further increase in pressure has been observed only after intravenous administration of high doses of glyceryl trinitrate – a chemically similar compound)

Treatment with Olicard 60 retard may cause transient myocardial hypoxia and ischemia in patients with coronary artery disease.

Consult your doctor, even if the above warnings refer to conditions you have experienced in the past.

Olicard 60 retard and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.

The blood pressure-lowering effect may be enhanced when Olicard 60 retard is taken together with:

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

Concomitant use of Olicard 60 retard with dihydroergotamine may increase dihydroergotamine blood levels and thereby enhance its blood pressure-raising effect.

Olicard 60 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, Olicard 60 retard should 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 and fetal development, delivery, or postnatal development at doses relevant to humans.

Similarly, during breastfeeding, Olicard 60 retard should be used only on the explicit recommendation of a physician, as it is unknown whether the drug passes into breast milk.

Driving and operating machinery
During treatment with Olicard 60 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. Consider this when deciding whether to drive or operate machinery.

Olicard 60 retard contains 261.7 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 60 retard

This medicine should always be taken according to the instructions given by your doctor. If in doubt,
consult your doctor or pharmacist.
The medicine is taken orally.
Unless otherwise directed by the doctor:
Take 1 capsule of Olicard 60 retard once daily (corresponding to 60 mg of
isosorbide mononitrate).
Treatment should be started with low doses of the medicine, gradually increasing them until the
desired dose is reached.
The prolonged-release hard capsules must be swallowed whole, with an adequate 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 more than the recommended dose of Olicard 60 retard
If more than the recommended dose of Olicard 60 retard has been taken, consult a
doctor or pharmacist immediately.
Since no cases of overdose of Olicard 60 retard have been reported so far,
only possible symptoms associated with overdose can be described.
Depending on the degree of overdose, a significant drop in blood pressure (hypotension)
accompanied by increased heart rate, headache, fatigue, dizziness and lightheadedness,
flushing, nausea, vomiting and diarrhoea may occur.
Missing a dose of Olicard 60 retard
Do not take a double dose to make up for a missed dose.
In such a case, continue treatment according to the prescribed schedule.
Stopping treatment with Olicard 60 retard
The effectiveness of treatment may be reduced.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

The most commonly observed adverse effect is headache, which gradually diminishes 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 effects have been observed with a frequency that cannot be estimated from the available data:

• Somnolence
• Worsening or occurrence of angina pectoris
• Slowing of the heart rate with cardiac rhythm disturbances
• Decrease in blood pressure upon standing
• Accelerated heart rate
• Fainting, circulatory collapse
• Nausea, vomiting
• Skin hypersensitivity reactions
• Severe inflammatory skin disease (exfoliative dermatitis)

Other information:
After administration of Olicard 60 retard, transient reduction in arterial oxygen content may occur due to blood redistribution to lung areas poorly filled with air. In patients with impaired blood flow in the coronary arteries, this may lead to inadequate oxygen supply to the myocardium.
Reduced efficacy or diminished effect of the drug has been reported in cases of prior use of nitrates. To avoid diminished or lost efficacy, continuous administration of the drug in high doses should be avoided.
If the first signs of hypersensitivity to Olicard 60 retard occur, the use of the drug should be discontinued.
In case any of the above-mentioned adverse effects occur, the treating physician should be informed so that the severity of complications can be assessed and appropriate preventive measures decided upon.
In some individuals, other adverse effects not listed here may occur during treatment. If any such adverse effects occur, which are not mentioned in this leaflet, they should be reported to the physician.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Olicard 60 retard

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

6. Contents of the packaging and other information

What Olicard 60 retard contains

• The active substance is 60 mg isosorbide mononitrate.
• The other components are: sucrose, maize starch, ethylcellulose, talc. Capsule coating ingredients: gelatin, titanium dioxide (E 171).

What Olicard 60 retard looks like and contents of the pack
Olicard 60 retard is available as prolonged-release hard capsules, packed in blisters of PVC/Aluminium foil, in cardboard boxes containing 20 or 50 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Poland

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

For further information, contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Poland
Tel. 22 546 64 00