Helituspan Apteo Med

Package Leaflet: Information for the Patient

Helituspan APTEO MED 7 mg/ml, Syrup

Dry extract of ivy leaf
( Hederae helicis folii extractum siccum)

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Helituspan APTEO MED syrup is a herbal medicine containing ivy leaf extract; it belongs to the group of expectorant medicines. These medicines are used to help remove mucus and phlegm from the airways, which in turn provides 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 purulent phlegm occur, consult a doctor immediately!
If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

2. Important information before taking Helituspan APTEO MED

When not to take Helituspan APTEO MED:

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

Do not give Helituspan APTEO MED to children

• under 2 years of age.

Warnings and precautions

Before taking Helituspan APTEO MED, consult a doctor or pharmacist:

• if the patient suffers from gastritis (inflammation of the stomach lining) or peptic ulcer disease (stomach ulcers);
• if the patient has difficulty breathing, has a fever, or has purulent phlegm.

Children and adolescents

Before giving 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 and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The safety of using products containing ivy leaf extract during pregnancy and breastfeeding has not been established. Therefore, Helituspan APTEO MED should not be used during pregnancy and breastfeeding.

Driving and using machines

There is no evidence that medicines containing ivy leaf extract affect the ability to drive or operate machines.

Helituspan APTEO MED contains sorbitol.

This medicine contains 962.5 mg of sorbitol in 2.5 ml of syrup, which corresponds to 385 mg/ml.
Sorbitol is a source of fructose. If the doctor has previously informed the patient that they have an intolerance to some sugars, or if hereditary fructose intolerance (a rare genetic disorder) has been diagnosed, consult a doctor before taking this medicine or giving it to a child.
Sorbitol may cause gastrointestinal disturbances and have a mild laxative effect.

3. How to take Helituspan APTEO MED

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.
In case of 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.
Before use, shake the bottle well.
To dose the medicine, use the measuring cup provided.
Recommended dose:

Patients with kidney and/or liver function disorders
There are no available data on the need to reduce the dose in patients with kidney and/or liver function disorders.
Duration of treatment
If there is no improvement after 7 days or the patient feels worse, they should consult their doctor.
If the patient feels that the effect of Helituspan APTEO MED is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Helituspan APTEO MED than recommended

Taking a higher dose of Helituspan APTEO MED than recommended may result in nausea, vomiting, diarrhea, or excessive restlessness. In such a case, consult a doctor, showing them this leaflet.

Missing a dose of Helituspan APTEO MED

The next dose should be taken according to the previous dosing schedule. Do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following classification has been used to determine the frequency of side effects:

• Frequency not known (cannot be estimated from the available data):
• nausea (feeling sick), vomiting, diarrhea;
• allergic reactions (hives, rash, difficulty breathing, anaphylactic reactions).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Helituspan APTEO MED

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing this medicine.
Shelf life after opening the bottle: 6 months.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 ivy leaf extract (5-7.5:1), extraction solvent: ethanol 30% (m/m).
• Other excipients: xanthan gum (E415), non-crystallizing liquid sorbitol (E420), citric acid monohydrate (E330), potassium sorbate (E202), flavor "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 cap. The pack contains a polypropylene measuring cup with a scale: 2.5 ml, 5 ml, 7.5 ml, 10 ml, 15 ml, and 20 ml.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231
e-mail: [email protected]

Manufacturer

SOPHARMA AD
16 Iliensko Shosse Str.
Sofia 1220
Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 12.2024