Original Timianek i Podbiav

PATIENT INFORMATION LEAFLET: USER INFORMATION

ORIGINAL THYME AND COLTSFOOT

(100 mg + 100 mg)/tablet, hard tablets
Thymi herbae extractum spissum + Tussilaginis farfarae folii extractum spissum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a pharmacist if advice or additional information is needed.
• If any side effects occur, including all possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.
• If after 7 days there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

• 1. What is Original Thyme and Coltsfoot and what is it used for
• 2. Important information before using Original Thyme and Coltsfoot
• 3. How to use Original Thyme and Coltsfoot
• 4. Possible side effects
• 5. How to store Original Thyme and Coltsfoot
• 6. Package contents and other information

1. WHAT IS ORIGINAL THYME AND COLTSFOOT AND WHAT IS IT USED FOR

Traditional herbal medicinal product for use in the indications specified, resulting solely from its long-term use

Original Thyme and Coltsfoot is a traditional herbal medicinal product in the form of tablets with a coating effect. The polysaccharides contained in the preparation create a protective layer that soothes irritations and prevents reflex actions of the throat mucosa, thereby soothing the cough.
Original Thyme and Coltsfoot is a traditional herbal medicinal product used to soothe:
hoarseness, cough associated with a cold, and as an auxiliary in inflammation of the upper respiratory tract mucosa.
If after 7 days there is no improvement or the patient feels worse, you should consult a doctor.

2. IMPORTANT INFORMATION BEFORE USING ORIGINAL THYME AND COLTSFOOT

When not to use Original Thyme and Coltsfoot

• If the patient is allergic (hypersensitive) to thyme herb extract or coltsfoot leaf extract or any of the other ingredients of this medicine listed in section 6.
• If the patient is allergic to other plants of the Asteraceae family (formerly Compositae), such as chamomile, yarrow, or arnica, or Lamiaceae (formerly Labiatae), such as sage.

Warnings and precautions:

• If symptoms do not disappear within a few days (up to a week) of treatment, you should consult a doctor.
• One tablet contains no more than 0.15 µg of pyrrolizidine alkaloids. It is not recommended to exceed the recommended maximum daily dose of 6 tablets, or to use the medicine for a prolonged period, due to the risk of liver damage when the medicine is abused. It is not recommended to use the tablets for too long a period, i.e. no longer than 4 to 6 weeks a year.
• The medicine should not be used in combination with other complex medicines containing coltsfoot leaves or coltsfoot leaf extracts.
• The medicine contains sucrose and glucose. Due to the presence of sugar, the medicine should be used with caution in patients with diabetes.

Children under 12 years:Due to the lack of sufficient data, it is not recommended to use in children under 12 years.

Other medicines and Original Thyme and Coltsfoot

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those that are available without a prescription.
The interaction of Original Thyme and Coltsfoot tablets with other medicines is not known.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult a doctor or pharmacist before using this medicine.
Do not use during pregnancy.
Do not use during breastfeeding.

Driving and using machines

The effect on psychophysical fitness, ability to drive vehicles, and operate machinery is not known.

Important information about some ingredients of Original Thyme and Coltsfoot

If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.
Original Thyme and Coltsfoot contains 1.2 g of glucose and 2.07 g of sucrose per dose. This should be taken into account in patients with diabetes.
The medicine may have a harmful effect on teeth.

3. HOW TO USE ORIGINAL THYME AND COLTSFOOT

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years: suck 1 tablet every 4-6 hours.
Maximum dose: 6 tablets per day.
Children under 12 years: Not recommended.
Original Thyme and Coltsfoot tablets should be sucked slowly, which enhances saliva production, and the saliva moistening the mucous membrane of the mouth and throat reduces the severity of the cough.
Duration of use:
If symptoms do not disappear within a few days (up to a week) of treatment, you should consult a doctor.

Using a higher dose of Original Thyme and Coltsfoot than recommended

Overdose is possible if the maximum daily dose of 6 tablets is exceeded.
Chronic use in a dose above 6 tablets per day (above 1 µg of pyrrolizidine alkaloids) may lead to changes in the liver.

Missing a dose of Original Thyme and Coltsfoot

You should not take a double dose to make up for a missed dose.
You should continue using the medicine without increasing the next dose.

Stopping the use of Original Thyme and Coltsfoot

If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (including anaphylactic shock and angioedema) and gastrointestinal disorders have been observed. The frequency of such side effects is not known.
If you experience any side effects, including all side effects not listed in the leaflet, you should consult a doctor or pharmacist

Reporting side effects.

If you experience any side effects, including all side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 ORIGINAL THYME AND COLTSFOOT

Store in a place out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Original Thyme and Coltsfoot contains

• The active substances of the medicine are: dense water extract of thyme herb (Thymi herbae extractum spissum, DER 3.5-4.5:1) 100 mg and dense water extract of coltsfoot leaf (Tussilaginis farfarae folii extractum spissum, DER 4.5-6.0:1) 100 mg.
• The other ingredients are: sucrose, liquid glucose.

What Original Thyme and Coltsfoot looks like and what the package contains

Original Thyme and Coltsfoot is a brown, flat-cylindrical tablet, slightly convex on both sides, with a characteristic herbal taste and smell; the presence of air bubbles is allowed.
The single package contains 8, 16, 24, or 32 tablets.

Marketing authorization holder

Perrigo Poland Sp. z o.o. [logo of the marketing authorization holder]
ul. Domaniewska 48
02-672 Warsaw
phone: +48 (22) 852 55 51

Manufacturer

Przedsiębiorstwo Produkcyjno-Handlowe „EWA” S.A.
ul. Zamkowy Folwark 9
63-700 Krotoszyn

Date of leaflet approval: August 2024