Hederasal Max

Leaflet attached to the packaging: patient information

Hederasal MAX
Hederae helicis folii extractum siccum
52.5 mg, tablets

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 advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after a week, contact a doctor.

Table of contents of the leaflet

• 1. What is Hederasal MAX and what is it used for
• 2. Important information before taking Hederasal MAX
• 3. How to take Hederasal MAX
• 4. Possible side effects
• 5. How to store Hederasal MAX
• 6. Package contents and other information

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

A herbal medicine used as an expectorant in the case of productive (wet) cough.
If there is no improvement or the patient feels worse after a week, consult a doctor.

2. Important information before taking Hederasal MAX

When not to take Hederasal MAX

If the patient is allergic to the active substance (dry extract of ivy leaves) and plants of the Araliaceae family or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If shortness of breath, fever, bloody or purulent sputum occur, consult a doctor or pharmacist.
Caution is recommended in patients with gastritis or stomach ulcers.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

Hederasal MAX and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No pharmacological interactions with other medicines have been reported.
Concomitant use of Hederasal MAX with opioid cough suppressants, such as codeine or dextromethorphan, is not recommended without consulting a doctor.

Taking Hederasal MAX with food and drink

Oral administration, swallow the tablet with water. The medicine can be taken with or without food.

Pregnancy and breastfeeding

The safety of using Hederasal MAX during pregnancy and breastfeeding has not been established. Due to the lack of sufficient data, it is not recommended to use the medicine during this period.

Driving and operating machinery

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

3. How to take Hederasal MAX

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years: 1 tablet 2 times a day.
Take orally, swallow with water. The medicine can be taken with or without food.
The maximum daily dose of the medicine is 2 tablets.
If symptoms do not improve and persist for more than a week, consult a doctor.

Taking a higher dose of Hederasal MAX than recommended

Overdose may cause nausea, vomiting, diarrhea, and excitement. In case of overdose, consult a doctor immediately, who may consider gastric lavage and/or administration of activated charcoal to reduce absorption of the medicine.

Missing a dose of Hederasal MAX

Do not take a double dose to make up for a missed dose.

Stopping treatment with Hederasal MAX

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Hederasal MAX can cause side effects, although not everybody gets them.
Side effects are presented according to the MedDRA system organ classification and frequency of occurrence - frequency not known (cannot be estimated from the available data).
During treatment with Hederasal MAX, the following may occur:

• Gastrointestinal disorders (nausea, vomiting, diarrhea) - frequency not known.
• Immune system disorders (allergic reactions: rash, urticaria, shortness of breath, anaphylactic reaction) - frequency not known. If other, unlisted side effects occur, consult a doctor or pharmacist.

Reporting side effects

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

5. How to store Hederasal MAX

Store the medicine at a temperature below 25°C.
Keep the 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 month stated.
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. Package contents and other information

What Hederasal MAX contains

The active substance is dry extract of ivy leaves (Hederae helicis folii extractum siccum).
One tablet contains 52.5 mg of dry extract of Hedera helixL., folium(ivy leaf) (DER 4-8:1), extraction solvent: ethanol 30% (m/m).
Excipients are: microcrystalline cellulose (type 102), sodium croscarmellose, anise essential oil, colloidal silica anhydrous, magnesium stearate.

What Hederasal MAX looks like and what the package contains

Hederasal MAX is a round, biconvex, smooth tablet in a beige-brown color with a marble effect. The occurrence of beige-brown streaks on the surface of the tablets is acceptable.
The package contains 20 tablets.
2 blisters of PVC/Aluminum foil with an informational leaflet in a cardboard box.

Marketing authorization 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]
To obtain more detailed information, contact the marketing authorization holder: tel. 71 321 86 04 ext. 123

Date of last update of the leaflet:

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