Neo-cardiol

Package Leaflet: Information for the Patient

Neo-Cardiol

124.8 mg, coated tablets
Crataegi folii cum flore extractum spissum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If symptoms worsen or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Neo-Cardiol and what is it used for
• 2. Important information before taking Neo-Cardiol
• 3. How to take Neo-Cardiol
• 4. Possible side effects
• 5. How to store Neo-Cardiol
• 6. Package contents and other information

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

Neo-Cardiol contains a thick extract of hawthorn flower (Crataegi folii cum flore extractum spissum).
This medicine tones the coronary circulation, increases blood flow in the coronary vessels and heart muscle, and enhances the strength of heart muscle contractions (positive inotropic effect).

Indications for Use

Phytotherapeutic product used to alleviate transient heart symptoms of nervous origin (e.g., palpitations, feeling of extra heartbeats due to mild anxiety) after ruling out serious conditions by a doctor.
If there is no improvement or you feel worse, consult your doctor.

2. Important Information Before Taking Neo-Cardiol

When Not to Take Neo-Cardiol

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

Warnings and Precautions

If symptoms persist, the disease symptoms last for more than 6 weeks, or there is fluid accumulation in the form of leg edema, consult your doctor.
Patients who experience the following symptoms should immediately consult their doctor: chest pain radiating to the arm, pain in the upper abdomen, pain in the neck area, and shortness of breath.
Caution should be exercised when taking other medicines for heart failure and antihypertensive drugs, as their effects may be enhanced.

Children and Adolescents

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

Neo-Cardiol and Other Medicines

Taking other medicines for heart failure or antihypertensive drugs with Neo-Cardiol may enhance their effects.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking 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 Machines

Neo-Cardiol has no effect on the ability to drive and operate machines.

Neo-Cardiol Contains Lactose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to Take Neo-Cardiol

Always take this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Orally, 2 tablets 3 times a day.
The medicine should be taken systematically for at least 4-6 weeks.
Children and Adolescents
Do not use in children and adolescents under 18 years of age.

Taking a Higher Dose of Neo-Cardiol Than Recommended

Overdose symptoms are not known. If you take more than the recommended dose, consult your doctor or pharmacist.

Missing a Dose of Neo-Cardiol

Continue treatment. Do not take a double dose to make up for the missed dose.

Stopping Neo-Cardiol Treatment

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported with Neo-Cardiol so far.

Reporting Side Effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. 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, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to Store Neo-Cardiol

Store in a temperature below 25°C, out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Neo-Cardiol Contains

The active substance is a thick extract of hawthorn flower (Crataegi folii cum flore extractum spissum) (5-6.5:1) - 124.8 mg, extraction solvent - ethanol 70% (V/V).
The excipients are: lactose monohydrate, microcrystalline cellulose, potato starch, sodium carboxymethyl cellulose, 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 What the Package Contains

Neo-Cardiol is a round, biconvex, blue, film-coated tablet.
The package contains 3 blisters of PVC/Al foil with 10 film-coated tablets each, along with the patient leaflet in a cardboard box.

Marketing Authorization 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: herbapol@herbapol.pl
To obtain more detailed information, contact the marketing authorization holder, tel. 71 321 86 04, ext. 123.

Date of Last Update of the Leaflet: