Patient Information Leaflet

Hederasal MAX
Hederae helicis folii extractum siccum
52.5 mg, tablets
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has advised.

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 side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after one week, or if you feel worse, consult your doctor.

Table of contents

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

1. What Hederasal MAX is and what it is used for

A herbal medicinal product used as an expectorant in productive (wet) cough.
If there is no improvement after one week, or if you feel worse, consult your doctor.

2. Information before using Hederasal MAX

When not to use Hederasal MAX
If the patient is allergic to the active substance (dry extract of ivy leaves) or to plants from the
Araliaceae family (Araliaceae), or to any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
If shortness of breath, fever, or bloody or purulent sputum occur, consult a doctor or pharmacist.
Caution is advised in patients with gastric irritation or peptic ulcer disease.
The medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, which means the medicine is considered “sodium-free”.

Hederasal MAX and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
No pharmacological interactions with other medicines have been reported so far.
Concomitant use of Hederasal MAX with opioid antitussives such as codeine or dextromethorphan is not recommended without prior consultation with a doctor.

Taking Hederasal MAX with food and drink
For oral administration; take tablet with water. The medicine may be taken with or without food.

Pregnancy and breastfeeding
The safety of use during pregnancy and breastfeeding has not been established. Due to insufficient data, the use of Hederasal MAX is not recommended during these periods.

Driving and using machines
No studies on the effect of Hederasal MAX on the ability to drive or operate machinery have been conducted.

3. How to use Hederasal MAX

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age: 1 tablet twice daily.
Administer orally with water. The medicine may be taken with or without food.
The maximum daily dose of this medicine is 2 tablets.
If symptoms do not improve and persist for longer than one week during treatment, medical advice should be sought.
Use of a higher than recommended dose of Hederasal MAX
Overdose may cause nausea, vomiting, diarrhoea and agitation. In case of overdose, consult a doctor immediately; gastric lavage and/or administration of activated charcoal to reduce drug absorption may be considered.
Missed dose of Hederasal MAX
Do not take a double dose to make up for a missed dose.
Stopping Hederasal MAX
If you have any further questions about use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Hederasal MAX can cause adverse reactions, although not everyone experiences them.
The adverse reactions of the medicine are presented according to organ and system classifications according to MedDRA and frequency of occurrence – frequency unknown (cannot be estimated based on available data).
The following may occur during the use of Hederasal MAX:

Gastrointestinal disorders (nausea, vomiting, diarrhoea) – frequency unknown.
Immune system disorders (allergic reactions: rash, urticaria, dyspnoea, anaphylactic reaction) – frequency unknown.

If other adverse reactions not described above occur, consult a physician or pharmacist.

Reporting of adverse reactions
If any adverse symptoms occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Al. Jerozolimskie 181 C, 02-222 Warsaw, tel. +48 22 492-13-01, fax +48 22 492-13-09), website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Hederasal MAX

Store the medicine at a temperature below 25°C.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hederasal MAX contains
The active substance is dried extract of ivy leaves (Hederae helicis folii extractum siccum).
One tablet contains 52.5 mg of dried extract from Hedera helix L., folium (ivy leaf)
(DER 4-8:1), extraction solvent: ethanol 30% (m/m).
The other ingredients (excipients) are: microcrystalline cellulose (type 102), sodium croscarmellose, aniseed essential oil, colloidal anhydrous silica, magnesium stearate.

What Hederasal MAX looks like and contents of the pack
Hederasal MAX is a round, biconvex, smooth tablet of beige-brown marbled appearance.
Beige-brown streaks on the tablet surface are acceptable.
The pack contains 20 tablets.
2 blisters made of PVC/Aluminium foil, with the patient information leaflet, enclosed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
ul. św. Mikołaja 65/68
50-951 Wrocław
tel: +48 71 33 57 225
fax: +48 71 372 47 40
e-mail: [email protected]

For further information, please contact the Marketing Authorisation Holder: tel. 71 321 86 04 ext. 123
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