Pectolvan

Package Leaflet: Information for the Patient

Pectolvan7 mg/mL, syrup
Dry extract of ivy leaf
( Hederae helicis folii extractum siccum)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Pectolvan and what is it used for
• 2. Important information before taking Pectolvan
• 3. How to take Pectolvan
• 4. Possible side effects
• 5. How to store Pectolvan
• 6. Package contents and other information

1. What is Pectolvan and what is it used for

Pectolvan is a herbal medicine containing ivy leaf extract ( Hedera helixL.); it belongs to the group of expectorant medicines. It helps to remove mucus and phlegm from the lungs and bronchi and makes it easier to cough up.
Pectolvan is used to relieve productive cough (so-called wet cough) in adults, adolescents, and children over 2 years of age.

2. Important information before taking Pectolvan

When not to take Pectolvan:

• if the patient is allergic to ivy leaf extract, to plants of the Araliaceae family or to any of the other ingredients of this medicine (listed in section 6);
• if the patient suffers from hereditary fructose intolerance (a rare genetic disorder in which the person cannot process fructose).

This medicine should not be given to children under 2 years of age, as their breathing problems may worsen.

Warnings and precautions

Before taking Pectolvan, the patient should consult a doctor or pharmacist:

• if the patient has gastritis (inflammation of the stomach lining);
• if the patient has stomach ulcers;
• if the patient is taking cough-suppressing medicines, such as codeine or dextromethorphan.

If the patient experiences difficulty breathing, fever, or pus in the phlegm while taking this medicine, they should inform their doctor or pharmacist.

Children

This medicine should not be given to children under 2 years of age.
If the child is between 2 and 4 years old and has persistent or recurrent cough, a doctor should be consulted before giving Pectolvan.

Pectolvan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No studies have been conducted on the interaction of Pectolvan with other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine is not recommended during pregnancy and breastfeeding due to insufficient data on the use of dry ivy leaf extract in pregnant women and breastfeeding mothers.

Driving and using machines

No studies have been conducted on the effect of Pectolvan on the ability to drive and use machines.
There is no evidence that herbal medicines containing ivy leaf affect the ability to drive and use machines.

Pectolvan contains sorbitol

This medicine contains 385.2 mg of sorbitol in 1 ml of syrup, which corresponds to 963 mg of sorbitol in 2.5 ml of syrup and 1926 mg of sorbitol in 5 ml of syrup.
Sorbitol is a source of fructose. If the doctor has previously informed the patient about intolerance to certain sugars or if the patient has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the person cannot process fructose, they should consult their doctor before taking this medicine or giving it to their child.

3. How to take Pectolvan

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubt, a doctor or pharmacist should be consulted.
Recommended dose:

This medicine is not recommended for patients with kidney or liver function disorders.
Pectolvan is intended for oral use only.
The recommended dose should not be exceeded.
The bottle should be shaken well before use. The medicine should be taken with the measuring spoon provided with the package.
This medicine should not be given to children under 2 years of age.
If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Taking more than the recommended dose of Pectolvan

Taking more than the recommended dose of Pectolvan may result in nausea, vomiting, diarrhea, or excessive restlessness. In such a case, a doctor should be consulted, showing them this leaflet.

Missing a dose of Pectolvan

The next dose should be taken according to the previous dosing schedule. A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Pectolvan can cause side effects, although not everybody gets them.
The following side effects may occur when taking Pectolvan syrup:
Frequency not known (cannot be estimated from the available data):

• Gastrointestinal disorders, such as: nausea, vomiting, diarrhea.
• Allergic reactions, such as: hives, skin rash, shortness of breath, anaphylactic reaction.

In case of an allergic reaction, the use of this medicine should be stopped and a doctor consulted immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 .
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 medicine.

5. How to store Pectolvan

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 25°C.
It should not be stored in the refrigerator or frozen.
This medicine should not be used after the expiry date stated on the carton and bottle after EXP.
The expiry date refers to the last day of the stated month.
After opening the bottle: 90 days.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Pectolvan contains

• The active substance is dry ivy leaf extract ( Hederae helicis folii extractum siccum). One ml of syrup contains 7 mg of dry ivy leaf extract ( Hedera helixL., folium) (4-8:1), extraction solvent: ethanol 30% (m/m). Other excipients: potassium sorbate, sorbitol, xanthan gum, citric acid monohydrate, cherry flavor, purified water. Components of cherry flavor: natural flavoring preparations, natural flavoring substances, other components: propylene glycol, cherry juice concentrate, triacetin, diacetin.

What Pectolvan looks like and what the package contains

Pectolvan syrup is a light brown liquid with a cherry flavor, and a slight sediment may appear.
Pectolvan is available in a package containing a 100 ml brown glass bottle with a white polyethylene cap. A polypropylene measuring spoon is included.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorized for sale in the Member States of the European Economic Area under the following names:

Estonia:
Pectolvan
Poland:
Pectolvan
Date of last revision of the leaflet:May 2025