Pectosol

Package Leaflet: Information for the Patient

PECTOSOL, Concentrate for Oral Solution

Liquid extract of: Thyme herb, Icelandic moss, Hyssop herb, Soapwort root

Read the Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after 7 days, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Pectosol and what is it used for

Pectosol is a traditional herbal medicinal product used to facilitate expectoration of viscous mucus in the course of a cold. It contains an ethanol-water extract of: thyme herb, Icelandic moss, hyssop herb, and soapwort root. It is intended for oral use.
Indications for use
Traditional herbal medicinal product used in:

• inflammatory conditions of the upper respiratory tract,
• difficult expectoration with viscous mucus.

The mentioned indications are based solely on long-term use.

2. Important information before using Pectosol

When not to use Pectosol

• If you are allergic to thyme herb, Icelandic moss, hyssop herb, soapwort root, or plants of the Lamiaceae family, or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Before starting to use Pectosol, you should discuss it with your doctor or pharmacist.
If you experience shortness of breath, fever, or purulent sputum, you should contact your doctor or a qualified healthcare professional.

Children

It is not recommended to use Pectosol in children under 12 years of age due to the lack of data.

Pectosol and other medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
No interactions between Pectosol and other medications have been reported so far.

Pectosol with food, drink, and alcohol

No effect of food, drink, and alcohol on the action of Pectosol has been reported so far.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medication.
Due to the lack of sufficient data, it is not recommended to use Pectosol during pregnancy and breastfeeding.

Driving and using machines

The amount of alcohol in this medication may affect your ability to drive and use machines, as it may affect your judgment and reaction speed. It is not recommended to use Pectosol before and during travel, as the alcohol contained in the medication may be detected in exhaled air.

Pectosol contains ethanol

This medication contains 2500 mg of alcohol (ethanol) in each 5 ml of concentrate (7560 mg of alcohol (ethanol) in each 15 ml of concentrate). The amount of alcohol in 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 medication may affect children. Symptoms may include: drowsiness and changes in behavior. It may also affect their ability to concentrate and engage in physical activity.
If you have epilepsy or liver problems, you should consult your doctor or pharmacist before using Pectosol.
The alcohol in this medication may change the effect of other medications. If you are taking other medications, you should consult your doctor or pharmacist.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before using this medication.
If you are addicted to alcohol, you should consult your doctor or pharmacist before using this medication.

3. How to use Pectosol

This medication should always be used exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.
Adults and adolescents over 12 years: 3 times a day, take 1 teaspoon of Pectosol (about 5 ml) diluted in ½ glass (about 125 ml) of water.
If symptoms persist for more than 1 week, you should consult your doctor or a qualified healthcare professional.

Use in children

It is not recommended to use Pectosol in children under 12 years of age due to the lack of data.

Using more than the recommended dose of Pectosol

There is no data available on overdose.

Missing a dose of Pectosol

You should not take a double dose to make up for a missed dose.
In case of any further doubts about using this medication, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Pectosol can cause side effects, although not everybody gets them.
Observed hypersensitivity reactions (including one case of anaphylactic shock and one case of Quincke's edema) and stomach disorders. Frequency unknown.
Reported allergic reactions, abdominal pain, and nausea.
In rare cases, stomach irritation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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 181C
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 this medication.

5. How to store Pectosol

Store in closed containers, at a temperature not exceeding 25°C.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
Medications should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Pectosol contains

• -100 g of the medication contains 90 g of liquid extract (1:3) of: Thymus vulgarisL. or Thymus zygisL. ,herba(thyme herb) / Cetraria islandica(L.) Acharius s.l. , thallus(Icelandic moss) / HyssopusofficinalisL. , herba(hyssop herb) / Saponaria officinalisL. , radix(soapwort root) (18/7/3/2). Extractant: ethanol 70% (V/V).
• -The other ingredient is: glycerol.

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

What Pectosol looks like and what the package contains

The medication is a brown-olive liquid (a small sediment is acceptable during storage) with a specific smell and taste, in a colored glass bottle containing 40 g or 90 g of liquid.

Marketing authorization 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

Date of the last update of the leaflet: