Package leaflet: information for the patient

Neo-Cardiol
124.8 mg, coated tablets
Crataegi folii cum flore extractum spissum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If symptoms worsen or the patient feels worse, contact a doctor.

Table of contents of the leaflet

What Neo-Cardiol is and what it is used for
Important information before taking Neo-Cardiol
How to take Neo-Cardiol
Possible side effects
How to store Neo-Cardiol
Contents of the pack and other information

1. What Neo-Cardiol is and what it is used for

Neo-Cardiol contains a dry extract of hawthorn flowering tops (Crataegi folii cum flore extractum spissum).
This medicinal product exerts a tonic effect on the coronary circulation, increases blood flow in the coronary vessels and myocardium, and enhances the contractile force of the heart muscle (positive inotropic effect).
Indications
A herbal medicinal product used to relieve transient cardiac symptoms of nervous origin (e.g. palpitations, sensation of extra heartbeats due to mild anxiety), after exclusion of serious disorders by a physician.
If there is no improvement or if the patient feels worse, consult a doctor.

2. Information before using Neo-Cardiol

When not to use Neo-Cardiol

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If symptoms do not improve, the illness persists for longer than 6 weeks, or fluid accumulation occurs in the form of leg swelling, medical advice should be sought.
Patients who experience the following symptoms should consult a doctor immediately: chest pain radiating to the arm, upper abdominal pain, neck pain, and shortness of breath.
Caution is advised when administering other drugs used in heart failure or antihypertensive drugs concomitantly, as their effects may be enhanced.

Children and adolescents
Do not use in children and adolescents under 18 years of age.

Neo-Cardiol with other medicines
Concomitant use of other drugs used in heart failure or antihypertensive drugs with Neo-Cardiol may intensify their effects.
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Due to insufficient safety data, Neo-Cardiol should not be used during pregnancy and breastfeeding.
The effect of the medicine on fertility is unknown.

Driving and operating machinery
Neo-Cardiol has no influence on the ability to drive or operate machinery.

Neo-Cardiol contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Neo-Cardiol

This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult a doctor or pharmacist.
Adults
Orally, 2 tablets 3 times daily.
The medicine should be taken regularly for at least 4 - 6 weeks.
Children and adolescents
Do not use in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Neo-Cardiol
Symptoms of overdose are unknown. If a higher than recommended dose has been taken, consult a
doctor or pharmacist.
Missed dose of Neo-Cardiol
Continue treatment as prescribed. Do not take a double dose to make up for a missed dose.
Stopping Neo-Cardiol
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this product may cause side effects, although not everyone will experience them.
No side effects have been reported to date during the use of the medicinal product Neo-Cardiol.
Reporting side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neo-Cardiol

Store below 25°C, in a place out of sight and reach of children.
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. Proper disposal helps protect the environment.

6. Package contents and other information
What Neo-Cardiol contains
The active substance is hawthorn flower and leaf dry extract (Crataegi folii cum flore extractum spissum) (5-6.5:1) – 124.8 mg, extraction solvent – 70% ethanol (V/V).
Excipients: monohydrate lactose, microcrystalline cellulose, potato starch, sodium carboxymethyl starch, magnesium stearate, povidone, Aqua Polish blue 060.13 (hypromellose, talc, miglyol 812, titanium dioxide E 171, indigo carmine E 132, brilliant blue E 133, quinoline yellow E 104).

What Neo-Cardiol looks like and contents of the pack
Neo-Cardiol is a blue, round, film-coated tablet, convex on both sides.
The pack contains 3 PVC/Al blisters with 10 film-coated tablets each, placed together with the package leaflet in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
tel.: +48 71 33 57 225
fax: +48 71 37 24 740
e-mail: [email protected]
For more detailed information, contact the Marketing Authorisation Holder at tel. 71 321 86 04 ext. 123.