Original thyme and coltsfoot

ORIGINAL THYME AND COLTSFOOT
(100 mg + 100 mg)/tablet, hard tablets
Thymi herbae extractum spissum + Tussilaginis farfarae folii extractum spissum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should be used as described in the patient leaflet or according to the instructions of a doctor or
pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 7 days or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

1. What Original Thyme and Coltsfoot is and what it is 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. Contents of the package and other information

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

Traditional herbal medicinal product for use in the indications listed, based exclusively on long-standing use
Original Thyme and Coltsfoot is a traditional herbal medicinal product in the form of tablets with a coating action. The mucilaginous polysaccharides contained in the preparation form a protective layer that soothes irritations and suppresses reflex activity of the pharyngeal mucosa, thus relieving cough.
Original Thyme and Coltsfoot is a traditional herbal medicinal product used to soothe:
hoarseness, cough associated with the common cold, and as an adjunctive treatment in catarrhs of the mucous membranes of the upper respiratory tract.
If there is no improvement after 7 days or if the patient feels worse, medical advice should be sought.

2. IMPORTANT INFORMATION BEFORE USING ORIGINAL THYME AND COLTSFOOT

When not to use Original Thyme and Coltsfoot

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

Warnings and precautions:

• If symptoms do not improve within a few days (up to one week) of treatment, consult a doctor.
• One tablet contains no more than 0.15 µg of pyrrolizidine alkaloids. Exceeding the recommended maximum daily dose of 6 tablets or prolonged use of the medicine is not recommended due to the risk of liver damage with excessive use. It is not recommended to use the tablets for too long, i.e. no longer than 4 to 6 weeks per year.
• This medicine should not be used together with other medicinal products containing coltsfoot leaves or extracts of coltsfoot leaves.
• This medicine contains sucrose and glucose. Due to the presence of sugar, the medicine should be used with caution in diabetic patients.

Children under 12 years of age: Due to lack of sufficient data, use in children under 12 years of age is not recommended.
Other medicines and Original Thyme and Coltsfoot
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription.
Interactions between Original Thyme and Coltsfoot tablets and other medicines are not known.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Do not use during pregnancy.
Do not use during breastfeeding.
Driving and operating machinery
The effect on psychophysical performance, ability to drive vehicles and operate machinery is unknown.
Important information about certain ingredients of Original Thyme and Coltsfoot
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this 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 diabetic patients.
The medicine may have harmful effects on teeth.

3. HOW TO USE THE MEDICINAL PRODUCT ORIGINAL TYMIANEK I PODBIAŁ

This medicine should always be used according to the instructions in the patient leaflet or as directed by a physician or pharmacist. In case of doubt, consult a doctor or pharmacist.

Recommended dose:
Adults and adolescents over 12 years of age – suck one tablet every 4–6 hours.
Maximum dose: 6 tablets per day.
Children under 12 years of age: Use is not recommended.

The Original Tymianek i Podbial tablets should be sucked slowly, which enhances saliva secretion. Saliva moistens the mucous membranes of the oral cavity and throat, thereby reducing the intensity of coughing.

Duration of use:
If symptoms do not improve within a few days (up to one week) of treatment, consult a physician.

Use of a higher than recommended dose of Original Tymianek i Podbial
Overdosing is possible if the maximum daily dose of 6 tablets is exceeded.
Chronic use at doses exceeding 6 tablets per day (exceeding 1 µg of pyrrolizidine alkaloids) may lead to liver changes.

Missed dose of Original Tymianek i Podbial
Do not take a double dose to make up for a missed dose. Continue taking the medicine as scheduled without increasing the next dose.

Discontinuation of Original Tymianek i Podbial
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Hypersensitivity reactions (including anaphylactic shock and angioedema) and gastrointestinal disturbances have been observed.
The frequency of these adverse reactions is not known.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, consult a physician or pharmacist.

Reporting of adverse reactions.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE THE MEDICINAL PRODUCT ORIGINAL THYME AND HYSSOP

Keep out of the sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from moisture.
Do not use this medicinal product after the expiry date stated on the packaging after: Expiry
date . The expiry date refers to the last day of the stated month.
Medicinal products must 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 PACKAGE AND OTHER INFORMATION

What Original Tymianek i Podbiał contains

• The active substances are: aqueous extract, dry ( Thymi herbae extractum spissum, DER 3.5-4.5:1 ) 100 mg and aqueous extract, dry from coltsfoot leaf ( Tussilaginis farfarae folii extractum spissum, DER 4.5-6.0:1 ) 100 mg.
• Other ingredients: sucrose, liquid glucose.

What Original Tymianek i Podbiał looks like and contents of the pack
Original Tymianek i Podbiał is in the form of brown, cylindrical flat tablets, slightly convex on both sides, with characteristic herbal taste and odour. The presence of air bubbles is acceptable.
The unit pack contains 8, 16, 24 or 32 pastilles.

Marketing Authorisation Holder
Perrigo Poland Sp. z o.o. [marketing authorisation holder's logo]
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51

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