HELIPICO

Patient Information Leaflet

HeliPico, 27.78 mg/5 ml, syrup
Hederae helicis folii extractum siccum
Please read this leaflet carefully before taking 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 the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if the patient feels worse, consult a physician.

Table of Contents

1. What HeliPico is and what it is used for
2. Important information before taking HeliPico
3. How to take HeliPico
4. Possible side effects
5. How to store HeliPico
6. Contents of the pack and other information

1. What HeliPico is and what it is used for

HeliPico syrup contains dry extract of ivy leaves.
Therapeutic indications
HeliPico syrup is a herbal medicinal product used as an expectorant in productive (wet) cough.

2. Important information before taking HeliPico

When not to take HeliPico:

• if the patient is allergic to ivy leaves, to other plants from the Araliaceae family, or to plants from the Apiaceae family (formerly Umbelliferae), such as anise, caraway, celery, coriander, garden cress, or to anethole, or to any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age due to the risk of worsening respiratory symptoms.

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
Persistent or recurrent cough in children aged 2 to 4 years requires medical diagnosis before starting therapy.
If symptoms of shortness of breath, fever, or purulent sputum occur, consult your doctor or pharmacist.
Concurrent use of antitussive medicines such as codeine or dextromethorphan is not recommended without consulting a doctor.
Caution is advised when administering to patients with gastric mucosal inflammation or gastric ulcer.

Children
HeliPico is contraindicated in children under 2 years of age.

HeliPico and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions have been reported to date.

Pregnancy, breastfeeding and effects on fertility
There are no data on the use of ivy leaf preparations in pregnant or breastfeeding women. HeliPico is not recommended during pregnancy or breastfeeding.
There are no data on the effect of the medicine on fertility.

Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery.

HeliPico contains sorbitol (E420), propylene glycol (E1520), and macrogol glycerol hydroxystearate
The medicine contains 4200 mg of non-crystallizing liquid sorbitol, equivalent to 3024 mg of sorbitol (E420) in each 5 ml of syrup, corresponding to 0.252 bread units.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolize fructose, the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains 150.6 mg of propylene glycol (E1520) in each 5 ml of syrup.
The medicine contains macrogol glycerol hydroxystearate. This may cause indigestion and diarrhoea.
This medicine contains 0.7 mg of alcohol in 5 ml of syrup. The amount of alcohol in each 5 ml of this medicine corresponds to less than 1 ml of beer or less than 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Advice for diabetics
HeliPico syrup does not contain sugar and can be used by diabetics.

3. How to take HeliPico

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is for oral use. An oral dosing syringe with graduated markings to facilitate dosing is supplied with the packaging.

Unless otherwise advised by a doctor, the following dosing regimen should be followed:
Adolescents aged 12 years and over, adults and elderly patients: 5 ml (full oral syringe) two to three times daily, corresponding to a daily dose of 55.56 mg to 83.34 mg of dry extract.
Children aged 6 to 11 years: 2.5 ml of medicine (½ oral syringe) three times daily, corresponding to a daily dose of 41.67 mg of dry extract.
Children aged 2 to 5 years: 1.6 ml of medicine (⅓ oral syringe) three times daily, corresponding to a daily dose of 26.67 mg of dry extract.
Use in children under 2 years of age is contraindicated.

If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

Instructions for using the oral dosing syringe

1. Unscrew the bottle cap (press down and turn counterclockwise).
2. Insert the oral syringe into the adapter located in the neck of the bottle.
3. To fill the oral syringe, turn the bottle upside down, then slowly push the plunger of the oral syringe down to draw the syrup up to the desired mark on the graduated scale.
4. Return the bottle to its upright position and carefully remove the oral syringe by twisting it out of the bottle.
5. Place the tip of the oral syringe into the child's mouth and slowly depress the plunger to gently empty the contents of the syringe.
6. After use, close the bottle by replacing the cap, and wash and dry the oral syringe.

Taking more HeliPico than recommended
Overdose may cause nausea, vomiting, diarrhoea and motor agitation.
In case of overdose, seek immediate medical advice from a doctor, who will recommend appropriate symptomatic treatment.

Missed dose of HeliPico
Do not take a double dose to make up for a missed dose. If a dose has been missed and it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time.

Stopping HeliPico
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Allergic reactions (urticaria, rash, dyspnoea), nausea, vomiting, diarrhoea may occur.
The frequency of adverse reactions is unknown.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, consult a 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store HeliPico

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging. Keep the bottle tightly closed.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The shelf life of the medicine after first opening the bottle is 6 months.
Medicines must 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. Contents of the pack and other information

What HeliPico contains

• The active substance is dry extract of ivy leaves (Hederae helicis folii extractum siccum). 100 ml of syrup contains 555.6 mg of dry extract from Hedera helix L., folium (ivy leaf) (4-8:1). Extraction solvent: ethanol 30% (m/m).
• Other ingredients are: propylene glycol, liquid non-crystallizing sorbitol (E420), macrogol glycerol hydroxystearate, potassium sorbate (E202), citric acid monohydrate, xanthan gum, anise flavour (containing, among others, ethanol, propylene glycol, propanol, natural anise oil), purified water.

What HeliPico looks like and contents of the pack
Brown PET bottle with a polyethylene adapter, polyethylene cap with HDPE, tamper-evident ring, child-resistant closure system, together with an oral dosing syringe, packed in a cardboard box.
Slight cloudiness of the syrup and sedimentation may occur due to the presence of plant components. This does not affect the efficacy of the product.
1 bottle containing 100 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz
tel. 43 829 92 00