Package leaflet: Information for the user

Helituspan APTEO MED 7 mg/ml, syrup
Dry extract of ivy leaves
(Hederae helicis folii extractum siccum)
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient information leaflet or as
directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Leaflet contents

What Helituspan APTEO MED is and what it is used for
Important information before taking Helituspan APTEO MED
How to take Helituspan APTEO MED
Possible side effects
How to store Helituspan APTEO MED
Contents of the pack and other information

1. What Helituspan APTEO MED is and what it is used for

Helituspan APTEO MED syrup is a herbal medicine containing an extract of ivy leaves; it belongs
to the group of expectorant medicines. These medicines are used to help clear mucus and phlegm
from the respiratory tract, thereby providing relief in productive, so-called wet cough in patients
over 2 years of age.
If symptoms do not improve, or if breathing difficulties, fever or pus-containing sputum (phlegm) occur,
you should immediately consult a doctor!
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. Important information before using Helituspan APTEO MED

When not to use Helituspan APTEO MED:

if the patient is allergic to ivy leaf extract, to plants from the Araliaceae family (the botanical family to which ivy belongs), or to any of the other ingredients of this medicine (listed in section 6).

Helituspan APTEO MED should not be given to children

under 2 years of age.

Warnings and precautions
Before starting to take Helituspan APTEO MED, consult a doctor or
pharmacist:

if the patient suffers from gastric irritation (inflammation of the stomach lining) or peptic ulcer disease (stomach ulcers);
if the patient has breathing difficulties, fever, or if pus appears in the sputum.

Children and adolescents
Before administering Helituspan APTEO MED to a child, consult a doctor:

if the child is between 2 and 4 years old and has persistent or recurrent cough.

Helituspan APTEO MED with other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken by the patient.
This also includes medicines available without a prescription.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using any medicine.
The safety of using products containing ivy leaf extracts during pregnancy and breastfeeding has not been confirmed. For this reason, the use of Helituspan APTEO MED is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
There is no evidence that medicinal products containing ivy leaf affect the ability
to drive or operate machinery.
Helituspan APTEO MED contains sorbitol.
This medicine contains 962.5 mg of sorbitol in 2.5 ml of syrup, equivalent to 385 mg/ml.
Sorbitol is a source of fructose. If the doctor has previously informed the patient or his child about intolerance to certain sugars, or if hereditary fructose intolerance—a rare genetic disorder in which a person cannot process fructose—has been diagnosed, consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal disturbances and mild laxative effects.

3. How to use Helituspan APTEO MED

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Helituspan APTEO MED is intended for oral use only. Helituspan APTEO MED should be taken in the morning, at noon, and in the evening, or in the morning and evening.
Shake the bottle vigorously before use.
Use the provided measuring device to administer the dose.
Recommended dose:

Age	Single dose	Daily dose
Children over 2 years to 5 years of age	2.5 ml, corresponding to 17.5 mg of dry extract from ivy leaf	5 ml (2.5 ml twice daily), corresponding to 35 mg of dry
	ivy	extract from ivy leaf
Children from 6 to 12 years of age	5 ml, corresponding to 35 mg of dry extract from ivy leaf	10 ml (5 ml twice daily), corresponding to 70 mg of dry extract from ivy leaf
Adolescents over 12 years of age, adults and elderly persons	5 ml, corresponding to 35 mg of dry extract from ivy leaf	15 ml (5 ml three times daily), corresponding to 105 mg of dry extract from ivy leaf

Patients with renal and (or) hepatic impairment
There are no available data regarding the need for dose reduction in patients with renal and (or) hepatic impairment.
Duration of treatment
If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.
If the patient feels that the effect of Helituspan APTEO MED is too strong or too weak, consult a doctor or pharmacist.
Taking more than the recommended dose of Helituspan APTEO MED
Taking more than the recommended dose of Helituspan APTEO MED may result in nausea, vomiting, diarrhoea, or excessive excitability. In such a case, consult a doctor, showing this leaflet.
Missing a dose of Helituspan APTEO MED
The next dose should be taken according to the usual dosing schedule. Do not take a double dose to make up for a missed dose.
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 everyone will experience them.
The following classification was used to assess the frequency of adverse reactions:
Frequency not known (cannot be estimated from available data):

nausea (feeling sick), vomiting, diarrhoea;
allergic reactions (urticaria, rash, difficulty in breathing, anaphylactic reactions).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in the leaflet, inform a doctor or pharmacist. Adverse reactions may 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 may also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Helituspan APTEO MED

Keep the medicine out of the sight and reach of children.
No special precautions for storage of this medicine are required.
Storage period after opening the bottle: 6 (six) months.
Do not use this medicine after the expiry date stated on the carton. 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 will help protect the environment.

6. Contents of the packaging and other information

What Helituspan APTEO MED contains

The active substance is dry extract of Hedera helix L., folium (ivy leaf). 1 ml of syrup contains 7 mg of dry extract from ivy leaf (5-7.5:1), extraction solvent: ethanol 30% (m/m).
Other excipients: xanthan gum (E415), liquid non-crystallizing sorbitol (E420), monohydrate citric acid (E330), potassium sorbate (E202), flavouring agent "lemon" (cis-citral (neral), trans-citral (geranial), lemon oil and propylene glycol (E1520)), purified water.

What Helituspan APTEO MED looks like and contents of the pack
120 ml of syrup in a dark brown glass bottle or in a dark brown plastic bottle (PET) with a polyethylene screw cap. The pack includes a polypropylene dosing cup with graduations: 2.5 ml, 5 ml, 7.5 ml, 10 ml, 15 ml and 20 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel.: 22 321 62 40
Manufacturer
SOPHARMA AD
16 Iliensko Shosse Str.
Sofia 1220
Bulgaria
This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Хелит успан 7 mg/ml сироп
Latvia: Helituspan 7 mg/ml sīrups
Lithuania: Helituspan 7 mg/ml sirupas
Estonia: Helituspan
Poland: Helituspan APTEO MED