Olicard 40 retard

Package leaflet: Information for the patient

Warning!
Keep this leaflet. Information on the immediate packaging in a foreign language.
Olicard 40 retard (Olikard 40 mg)
40 mg, prolonged-release hard capsules
Isosorbidi mononitras
Olicard 40 retard and Olikard 40 mg are trade names of the same medicinal product written in
Polish and Bulgarian languages.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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, pharmacist, or nurse. See section 4.

Table of contents

1. What Olicard 40 retard is and what it is used for
2. What you need to know 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-coated pellets.
Olicard 40 retard belongs to the following pharmacotherapeutic group: vasodilators used in heart diseases; 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 are allergic (hypersensitive) to the active substance (isosorbide mononitrate), other nitrates, or any of the other ingredients of this medicine (listed in section 6),
• you have acute circulatory failure (shock, circulatory collapse),
• you have cardiogenic shock caused by heart failure, provided that treatment measures have not restored adequate cardiac filling pressure (left ventricular end-diastolic pressure),
• you have 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 containing as 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 treatment with Olicard 40 retard, discuss this with your doctor or pharmacist.
Olicard 40 retard is not intended for the treatment of sudden chest pain (e.g. acute angina attack) or acute myocardial infarction.

Use Olicard 40 retard with caution if you have:

• hypertrophic cardiomyopathy with outflow 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),
• predisposition 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 40 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 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 drugs,
• 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 as active substance a phosphodiesterase-5 inhibitor, e.g. sildenafil, vardenafil, tadalafil.

Concomitant use of Olicard 40 retard with dihydroergotamine may increase dihydroergotamine blood levels and thereby intensify 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 the 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, parturition, or postnatal development at doses relevant for humans.
Similarly, during breastfeeding, Olicard 40 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 40 retard, especially at the beginning of treatment, when increasing the dose, when switching to another product, or when consuming alcohol concomitantly, 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 been previously diagnosed with an 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 doubts, consult
your doctor or pharmacist.
The medicine is taken orally.
Unless otherwise advised by the doctor:
The recommended dose is 1 capsule of Olicard 40 retard once daily (corresponding to 40 mg
of isosorbide mononitrate).
Treatment should be initiated with low doses, gradually increasing them until the desired dose is reached.
The hard, prolonged-release capsules 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, you should
immediately consult your doctor or pharmacist.
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 potential 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 40 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 40 retard
The effectiveness of treatment may be reduced.

4. Possible adverse reactions

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

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

• headache.

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

• dizziness,
• fatigue.

Uncommon (occurs in 1 to 10 in 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 the heart with cardiac rhythm disturbances,
• drops in arterial blood pressure upon standing,
• rapid heartbeat,
• 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 redistribution of blood flow to lung areas poorly ventilated.
In patients with impaired blood flow in the coronary arteries, this may lead to inadequate oxygen supply to the heart muscle.
Reduced or diminished effectiveness of the drug has been reported in cases of prior nitrate use. To avoid diminished or tolerance development, continuous administration of the drug at high doses should be avoided.
If the first signs of hypersensitivity to Olicard 40 retard occur, the use of the drug should be discontinued.
In case any of the above-mentioned adverse reactions occur, the treating physician should be informed, who will assess the severity of complications and decide on 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 reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 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.
• The other ingredients are: sucrose, maize starch, ethylcellulose, talc. Capsule shell composition: gelatin, titanium dioxide.

What Olicard 40 retard looks like and contents of the pack
Olicard 40 retard is available as prolonged-release hard capsules,
packaged in blister packs of 20 or 50 capsules made of PVC/Aluminium, contained in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Bulgarian country of export licence number: 20020121
Parallel import licence number: 205/17