PECTOSOL

Patient Information Leaflet

PECTOSOL, oral solution concentrate
Extractum liquidum ex: Thymi herba, Lichen islandicus, Hyssopi herba, Saponariae radice
Please read this 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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any 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

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

1. What Pectosol is and what it is used for

Pectosol is a traditional herbal medicine that helps to loosen and expel retained mucus during colds. It contains an aqueous-ethanolic extract from: thyme herb, Icelandic moss, hyssop herb, and soapwort root. It is intended for oral use.

Therapeutic indications
Traditional herbal medicinal product used for:

• inflammatory conditions of the upper respiratory tract,
• difficult expectoration with retained secretions.

The stated indications are based solely on long-standing use.

2. Important information before using Pectosol

When not to use Pectosol

• If the patient is allergic to thyme herb, Icelandic moss, hyssop herb, soapwort root, or plants from the mint family (Lamiaceae), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Pectosol, consult your doctor or pharmacist.
If shortness of breath, fever or purulent sputum occur, contact your doctor or a qualified healthcare professional.

Children
Not recommended for children under 12 years of age due to lack of data.

Pectosol with other medicines
Inform 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.
To date, no cases of interactions between Pectosol and other medicines have been reported.

Pectosol with food, drink and alcohol
To date, no influence of food, drink or alcohol on the effect of Pectosol has been reported.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Due to insufficient data, use during pregnancy and breastfeeding is not recommended.

Driving and operating machinery
The amount of alcohol in this medicine may affect the ability to drive and operate machinery, as it may impair judgment and reaction speed. Use of this medicine before and during travel is not recommended, since the alcohol contained in the medicine may be detected in exhaled air.

Pectosol contains ethanol
This medicine contains 2500 mg of alcohol (ethanol) in each 5 ml of concentrate (7560 mg of alcohol (ethanol) in each 15 ml of concentrate). The alcohol content of this product is equivalent to 63 ml of beer or 26 ml of wine per 5 ml of concentrate (189 ml of beer or 76 ml of wine per 15 ml of concentrate).
The alcohol in this medicine may affect children. Symptoms may include drowsiness and changes in behaviour. It may also affect their ability to concentrate and physical activity.
If the patient has epilepsy or liver problems, he or she should consult a doctor or pharmacist before using this medicine.
The alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, he or she should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, he or she should consult a doctor or pharmacist before using this medicine.

3. How to use Pectosol

This medicine should always be used exactly as described in the 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: take 1 teaspoon of Pectosol (approximately 5 ml) diluted in ½ glass (approximately 125 ml) of water, three times daily.
If symptoms persist for more than 1 week, consult a doctor or qualified healthcare professional.
Use in children
Not recommended for children under 12 years of age due to lack of data.
Use of a higher than recommended dose of Pectosol
There is no data available on overdose.
Missed dose of Pectosol
Do not take a double dose to make up for a missed dose.
If you have any further doubts 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 will experience them.
Hypersensitivity reactions (including one case of anaphylactic shock and one case of Quincke's oedema) and stomach disturbances have been observed. Frequency unknown.
Allergic reactions, abdominal pain, and nausea have been reported.
In rare cases, gastric irritation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
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 enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Pectosol

Keep in closed packaging, at a temperature not exceeding 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Pectosol contains

• 100 g of the medicinal product contains 90 g of liquid extract (1:3) from: Thymus vulgaris L. or Thymus zygis L., herba (thyme herb) / Cetraria islandica (L.) Acharius s.l., thallus (Iceland moss) / Hyssopus officinalis L., herba (hyssop herb) / Saponaria officinalis L., radix (soapwort root) (18/7/3/2). Extraction solvent: ethanol 70% (V/V).
• The other ingredient is: glycerol.

The medicinal product contains 57-63% (V/V) ethanol.

What Pectosol looks like and contents of the pack
Pectosol is a brown-olive liquid (a slight sediment may appear during storage, which is acceptable), with a characteristic odour and taste, contained in an amber glass bottle with a capacity of either 40 g or 90 g.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer
Herbapol Warszawa Sp. z o.o.
ul. Ołówkowa 54, 05-800 Pruszków
„Herbapol-Lublin” S.A.
ul. Diamentowa 25, 20-471 Lublin