Pectolvan

Package leaflet: information for the patient

Pectolvan 7 mg/mL, syrup
Dry extract of ivy leaf
( Hederae helicis folii extractum siccum )
Please read the entire leaflet carefully before taking this 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 doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

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

1. What Pectolvan is and what it is used for

Pectolvan is a herbal medicine containing an extract of ivy leaves ( Hedera helix L.); it belongs to
the group of expectorant medicines. It helps remove mucus and phlegm from the lungs and bronchi and facilitates expectoration.
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 using Pectolvan

When not to use Pectolvan:

• if the patient is allergic to ivy leaf extract, to plants of the Araliaceae family (Araliaceae), 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 a person cannot metabolize fructose).

This medicine should not be given to children under 2 years of age, as their breathing problems may worsen.
Warnings and precautions
Before starting treatment with Pectolvan, consult a doctor or pharmacist:

• if the patient suffers from gastric irritation (inflammation of the stomach mucosa);
• peptic ulcer disease (stomach ulcers);
• if the patient is taking cough suppressants such as codeine or dextromethorphan.

If breathing difficulties, fever, or pus in the sputum occur during treatment with this medicine, inform your doctor or pharmacist.
Children
This medicine should not be given to children under 2 years of age.
If a child is between 2 and 4 years old and has a persistent or recurring cough, consult a doctor before administering Pectolvan.
Pectolvan and other medicines
Tell 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.
No studies have been conducted on interactions between Pectolvan and other medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The use of this medicine during pregnancy and breastfeeding is not recommended due to insufficient data on the use of dry ivy leaf extract in pregnant women and nursing mothers.
Driving and operating machinery
No studies have been conducted on the influence of this medicine on the ability to drive or operate machinery.
There is no evidence that medicinal products containing ivy leaf affect the ability to drive or operate machinery.
Pectolvan contains sorbitol
This medicine contains 385.2 mg of sorbitol in 1 ml of syrup, equivalent 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 a doctor has previously informed the patient or his/her child of an intolerance to certain sugars, or if hereditary fructose intolerance—a rare genetic disorder in which a person cannot metabolize fructose—has been diagnosed, consult a doctor before taking the medicine or giving it to a child.

3. How to take Pectolvan

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recommended dose:

It is not recommended to use this medicine in patients with renal and (or) hepatic impairment.
Pectolvan is intended for oral use only.
Do not exceed the recommended dose.
Shake the bottle well before use. The medicine should be taken using the measuring spoon provided in the package.
This medicine is not recommended for children under 2 years of age.
If there is no improvement after 7 days of treatment, or if the patient's condition worsens, consult a physician.
Taking more Pectolvan than recommended
Taking more than the recommended dose of Pectolvan may result in nausea, vomiting, diarrhea, or excessive excitability. In such a case, consult a physician, showing him this leaflet.
If you forget to take Pectolvan
Take the next dose according to the usual dosing schedule. Do not use a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with Pectolvan syrup:
Frequency unknown (cannot be estimated from available data):

• Gastrointestinal disorders such as: nausea, vomiting, diarrhoea.
• Allergic reactions such as: urticaria, skin rash, dyspnoea, anaphylactic reaction.

If an allergic reaction occurs, treatment with this medicine should be discontinued immediately and
medical advice should be sought immediately.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Pectolvan

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not store in a refrigerator or freeze.
Do not use this medicine 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 first opening the bottle: 90 days.
Medicines 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 pack and other information

What Pectolvan contains

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

What Pectolvan looks like and contents of the pack
Pectolvan syrup is a light brown liquid with a cherry taste; slight opalescence may occur.
Pectolvan is available in a pack containing a 100 ml amber glass bottle with a white polyethylene screw cap. A polypropylene dosing spoon is included.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Estonia: Pectolvan
Poland: Pectolvan