Package leaflet: Information for the patient

Herdripsan, syrup
Dry extract of ivy leaves
Hederae helicis folii extractum siccum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient information leaflet or as directed
by the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days (3 days in children), or if the patient feels worse, consult a doctor.

Contents of the leaflet:

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

1. What Herdripsan is and what it is used for

Herdripsan is a herbal medicine containing dry extract of ivy leaves, known by the Latin name
Hedera helix L. It belongs to a group of medicines called expectorants (used to help remove mucus and
phlegm (sputum) from the airways).
Herdripsan is used in the treatment of productive, so-called wet cough.
If there is no improvement after 5 days (3 days in children), or if the patient feels worse, consult a doctor.

2. Important information before using Herdripsan

When not to use Herdripsan

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

Do not use this medicine in children under 2 years of age.
Warnings and precautions
Before using Herdripsan, consult a doctor or pharmacist if:

the patient suffers from gastric irritation (inflammation of the stomach mucosa) or peptic ulcer disease (stomach ulcers);
the patient experiences breathing difficulties, fever, or if blood or pus appears in the sputum. If any of these symptoms occur during treatment with this medicine, consult a doctor.

Children and adolescents
Before administering Herdripsan to a child, consult a doctor:

if the child is between 2 and 4 years of age and has a persistent or recurrent cough.

This medicine should not be used in children under 2 years of age.
Herdripsan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, including those
obtained without a prescription.
Concomitant use of this medicine with antitussive agents (those that suppress the cough reflex and
contain codeine or dextromethorphan) is not recommended without consulting a doctor. If your doctor
has prescribed such a combination, always follow the doctor's instructions exactly.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, you
should consult your doctor or pharmacist before using any medicine.
The safety of using products containing ivy leaf during pregnancy and breastfeeding has not been
confirmed. For this reason, the use of Herdripsan is not recommended during pregnancy and
breastfeeding.
Driving and operating machinery
There is no evidence that medicinal products containing preparations from ivy leaves affect the
ability to drive or operate machinery.
Herdripsan contains sorbitol
This medicine contains 550 mg of sorbitol per ml, which corresponds to 1375 mg of sorbitol in each single
2.5 ml dose or 2750 mg of sorbitol in each single 5 ml dose.
Sorbitol is a source of fructose. If your doctor has informed you that you (or your child) have an
intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI),
a rare genetic disorder in which the body does not break down fructose, speak with your doctor before
taking (or giving to your child) this medicine.
Sorbitol may cause gastrointestinal discomfort and has a mild laxative effect.

3. How to use Herdripsan

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Herdripsan is intended for oral use only.
Herdripsan should be taken in the morning, at noon, and in the evening if administered three times daily, or in the morning and evening if administered twice daily.
It is not recommended to take this product late in the evening, i.e. before going to bed, as expectoration is not desirable at night.
Shake the bottle well before use.
Use the measuring device provided to measure the dose.

Recommended dosage:
Adolescents over 12 years of age, adults and elderly patients
5 ml (35 mg of dry ivy leaf extract) once to three times daily, with a maximum daily dose not exceeding 15 ml (105 mg of dry ivy leaf extract).

Children aged 6 to 11 years
5 ml (35 mg of dry ivy leaf extract) twice daily, with a maximum daily dose not exceeding 10 ml (70 mg of dry ivy leaf extract).

Children aged 2 to 5 years
2.5 ml (17.5 mg of dry ivy leaf extract) twice daily, with a maximum daily dose not exceeding 5 ml (35 mg of dry ivy leaf extract).

If there is no improvement after 5 days (3 days in children), or if the patient feels worse, consult a doctor.
Do not use Herdripsan for longer than one week without consulting a doctor. If symptoms persist beyond one week, consult a doctor.

Overdose of Herdripsan
Taking more than the recommended dose of Herdripsan may result in nausea, vomiting, diarrhoea, or excessive excitability. In such a case, consult a doctor and show them this leaflet.

Missed dose of Herdripsan
Take the next dose 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 experiences them.
The following classification has been used to assess the frequency of adverse reactions:
Frequency unknown (frequency cannot be estimated from the available data)

Allergic reactions (urticaria, skin rash, dyspnoea, anaphylactic reaction)
Nausea, vomiting, diarrhoea.

Reporting suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Herdripsan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required. After first opening, do not store above 25°C.
Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Herdripsan contains

The active substance in Herdripsan is dry extract of ivy leaf. One ml of syrup contains 7 mg of extract (in the form of dry extract) from Hedera helix L. (ivy leaf) (5-7.5:1), extraction solvent: ethanol 30% (m/m).
Other excipients: xanthan gum (E 415), sorbitol liquid, non-crystallizing (E 420), citric acid monohydrate (E 330), potassium sorbate (E 202), lemon flavor FM004156 (cis-citral (neral), trans-citral (geranial), lemon essential oil and propylene glycol (E 1520)), purified water.

What Herdripsan looks like and contents of the pack
Herdripsan is a brownish, clear to slightly turbid syrup with a lemon scent,
packed in a brown glass bottle or a brown PET bottle, closed with a polyethylene cap with a
polyethylene sealing liner and a tamper-evident ring, placed in a cardboard box. The pack includes a polypropylene dosing cup with graduations (2.5 ml; 5 ml; 7.5 ml; 10 ml; 15 ml and 20 ml).
Pack size: 120 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer:
Sopharma AD
16 Iliensko Shosse Str.
1220 Sofia
Bulgaria

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic – Hedemax
Slovakia – Helisolv
Poland – Herdripsan
Romania – Alyssum 7 mg/ml syrup