Herdripsan

Leaflet attached to the packaging: patient information

Herdripsan, syrup

Dry extract of ivy leaves
Hederae helicis folii extractum siccum

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 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 after 5 days (3 days in children) there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Herdripsan and what is it used for

Herdripsan is a herbal medicine containing an extract of ivy leaves, known by the Latin name
Hedera helixL. It belongs to the group of expectorant medicines (used to help remove mucus and phlegm from the respiratory tract).
Herdripsan is used to treat productive cough (so-called wet cough).
If after 5 days (3 days in children) there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Herdripsan

When not to take Herdripsan

• if the patient is allergic to ivy leaf extract or 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 this medicine to children under 2 years of age.

Warnings and precautions

Before taking Herdripsan, consult a doctor or pharmacist if:

• the patient has gastritis (inflammation of the stomach lining) or peptic ulcer disease (stomach ulcers);
• the patient has difficulty breathing, fever, or blood or pus in the phlegm. If any of these symptoms occur while taking this medicine, consult a doctor.

Children and adolescents

Before giving Herdripsan to a child, consult a doctor:

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

Do not give this medicine to children under 2 years of age.

Herdripsan and other medicines

Tell your doctor or pharmacist about all medicines taken recently, including those available without a prescription.
Taking this medicine with cough suppressants (such as codeine or dextromethorphan) is not recommended without consulting a doctor. If a doctor recommends such a combination, always follow the doctor's instructions.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking any medicine.
The safety of using products containing ivy leaf during pregnancy and breastfeeding has not been confirmed. Therefore, it is not recommended to take Herdripsan during pregnancy and breastfeeding.

Driving and using machines

There is no evidence that medicinal products containing ivy leaf extracts affect the ability to drive and use machines.

Herdripsan contains sorbitol

This medicine contains 550 mg of sorbitol in each ml, which corresponds to 1375 mg of sorbitol in each single dose of 2.5 ml or 2750 mg of sorbitol in each single dose of 5 ml.
Sorbitol is a source of fructose. If the doctor has informed the patient that they (or their child) have intolerance to some sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body does not break down fructose, they should talk to their doctor before taking (or giving their child) this medicine.
Sorbitol may cause gastrointestinal upset and has a mild laxative effect.

3. How to take Herdripsan

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Herdripsan is intended for oral use only.
Herdripsan should be taken in the morning, at noon, and in the evening, if taken 3 times a day, or in the morning and evening, if taken 2 times a day.
It is not recommended to take the product late in the evening, i.e., before bedtime, as coughing is not desirable at night.
Before use, shake the bottle well.
The measuring cup provided should be used to dose the medicine.
Recommended dosage:
Adolescents over 12 years of age, adults, and the elderly
5 ml (35 mg of dry ivy leaf extract) 1 to 3 times a day, with a maximum daily dose not exceeding 15 ml (105 mg of dry ivy leaf extract).
Children from 6 to 11 years of age
5 ml (35 mg of dry ivy leaf extract) 2 times a day, with a maximum daily dose not exceeding 10 ml (70 mg of dry ivy leaf extract).
Children from 2 to 5 years of age
2.5 ml (17.5 mg of dry ivy leaf extract) 2 times a day, with a maximum daily dose not exceeding 5 ml (35 mg of dry ivy leaf extract).
If after 5 days (3 days in children) there is no improvement or the patient feels worse, they should contact their doctor.
Do not take Herdripsan for longer than a week without consulting a doctor. If symptoms persist for longer than a week, consult a doctor.

Taking a higher dose of Herdripsan than recommended

Taking a higher dose of Herdripsan 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 Herdripsan

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 taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Herdripsan 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(frequency cannot be estimated from the available data)

• allergic reactions (hives, skin rash, shortness of breath, anaphylactic reaction)
• nausea (feeling sick), vomiting, diarrhea.

Reporting suspected side effects

If any side effects occur, including any side effects not listed in the leaflet, inform a 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 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 the medicine.

5. How to store Herdripsan

Keep the medicine out of the 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 month.
There are no special precautions for storage. 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Herdripsan contains

• The active substance is dry extract of ivy leaf. One ml of syrup contains 7 mg of extract (in the form of dry extract) from Hedera helixL. (ivy leaf) (5-7.5:1), extraction solvent: ethanol 30% (m/m).
• The other excipients are: xanthan gum (E 415), non-crystallizing liquid sorbitol (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 what the pack contains

Herdripsan is a brownish, clear to slightly cloudy syrup with a lemon scent, packaged in a brown glass bottle or brown PET bottle, closed with a polyethylene cap with a polyethylene sealing ring and a guarantee ring, placed in a cardboard box. The packaging includes a polypropylene measuring cup with a scale (2.5 ml; 5 ml; 7.5 ml; 10 ml; 15 ml, and 20 ml).
Pack size: 120 ml.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Hedemax
Slovakia
Helisolv
Poland
Herdripsan
Romania
Alyssum 7 mg/ml syrup

Date of last revision of the leaflet: