Herbion porost islandzki

Package leaflet: Information for the patient

Herbion Iceland Moss, hard tablets
Cetrariae islandicae thallus extractum siccum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if your condition worsens, consult your doctor.

Table of contents of the leaflet

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

1. What Herbion Iceland Moss is and what it is used for

Herbion Iceland Moss contains a dry extract of Iceland moss (Cetraria islandica). It is a
traditional herbal medicinal product recommended for adults and adolescents aged 12 years and older,
as a soothing agent for irritation of the mucous membranes of the throat and oral cavity, and for associated
dry cough.
Herbion Iceland Moss is a traditional herbal medicinal product used for specific indications based solely on long-standing use.

2. Important information before using Herbion Porost Islandzki

When not to use Herbion Porost Islandzki

• if the patient is allergic to extract of Icelandic moss (Icelandic lichen) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Herbion Porost Islandzki, discuss it with your doctor or
pharmacist.

• If breathing difficulties, fever, or appearance of purulent sputum (containing pus) occur, contact your doctor or pharmacist.
• Herbion Porost Islandzki may delay the absorption of other medicines taken at the same time. Do not take any other medicines within half an hour to one hour before or after taking Herbion Porost Islandzki.
• If the condition worsens or does not improve after 7 days of treatment, contact your doctor.

Children and adolescents
Do not use Herbion Porost Islandzki hard pastilles in children under 12 years of age,
because the dose cannot be adjusted for this dosage form. Hard pastilles are not
suitable for children under 6 years of age.
Herbion Porost Islandzki and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interaction of Herbion Porost Islandzki with other medicines has been reported.
Herbion Porost Islandzki with food and drink and alcohol
Do not eat or drink immediately after taking Herbion Porost Islandzki, as the medicine may be removed too quickly from the mucous membranes of the mouth and throat.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Herbion Porost Islandzki is not recommended during pregnancy and breastfeeding due to insufficient data on the use of dry extract of Icelandic moss in pregnant and breastfeeding women.
Driving and operating machinery
No studies have been conducted on the effect on the ability to drive and operate
machinery.
Herbion Porost Islandzki contains isomalt (E 953) and butylated hydroxyanisole (E 320)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine.
Butylated hydroxyanisole (E 320) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Herbion Porost Islandzki

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose for adults and adolescents aged 12 years and older: one tablet eight times daily.
Elderly patients
Dose adjustment is not required.
Renal and/or hepatic impairment
Pharmacokinetic studies have not been conducted.
Method of administration
The tablet should be dissolved in the mouth.
Do not drink or eat immediately after taking Herbion Porost Islandzki, as the medicine may be removed too quickly from the mucous membranes of the mouth and throat.
Duration of treatment
If symptoms persist for longer than 7 days during treatment, consult your doctor or pharmacist.
Taking more Herbion Porost Islandzki than recommended
Do not take more than the recommended dose. No cases of overdose have been reported.
If you forget to take Herbion Porost Islandzki
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 product may cause adverse reactions, although not everyone will experience them.
Frequency unknown (frequency cannot be determined from available data):

• hypersensitivity reaction, usually manifesting as itching, skin redness, breathlessness (shortness of breath), or swelling of the face, lips, and tongue.

If adverse reactions occur, discontinue use of the medicine and consult
your doctor.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your 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 responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Herbion Porost Islandzki

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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 package and other information

What Herbion Porost Islandzki contains

• The active substance is dry extract of Icelandic moss (Cetraria islandica). Each hard pastille contains 3 mg of extract (in the form of dry extract) from Cetraria islandica (L.) Acharius s.l., thallus (Icelandic moss thallus) (30-40:1). Extraction solvent: water.
• Other ingredients are: ascorbic acid (E 300), mannitol (E 421), malic acid (E 296), sucralose (E 955), natural orange flavour, natural citrus flavour (butylated hydroxyanisole (E 320)), turmeric-coloured oil, isomalt (E 953).
• Excipients used in the extract: isomalt (E 953) and colloidal anhydrous silica. See section 2 "Herbion Porost Islandzki contains isomalt (E 953) and butylated hydroxyanisole (E 320)".

What Herbion Porost Islandzki looks like and contents of the pack
Nearly round hard pastille with bevelled edges and a rough surface, yellow to brownish-yellow in colour. Darker specks, lighter spots, air bubbles, and minor edge irregularities may be present. Dimensions of the hard pastille: diameter approximately 19 mm and thickness approximately 8 mm.
Hard pastilles are available in cardboard boxes containing 8, 16, 24, 32 or 40 hard pastilles in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the
responsible entity's representative:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500