Pelafen med

Patient Information Leaflet

Pelafen MED, 20 mg/2.5 ml, syrup
Pelargonii radicis extractum siccum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents:

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

1. What Pelafen MED is and what it is used for

Pelafen MED contains a dry extract of pelargonium root.
Pelafen MED is a traditional herbal medicinal product used for the symptomatic treatment of colds.
The syrup is a traditional herbal medicinal product intended for use in specific indications based solely on long-standing use.
Pelafen MED is intended for use in adults, adolescents, and children aged 3 years and older.
Consult your doctor if there is no improvement after 7 days, or if you feel worse.

2. Important information before using Pelafen MED

When not to use Pelafen MED

• if the patient is allergic to dry extract of pelargonium root or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Pelafen MED, consult your doctor or
pharmacist.
If shortness of breath (difficulty breathing), fever, or coughing up bloody or purulent
secretion occurs, contact your doctor.
In case of symptoms indicating toxic effects on liver cells (such as vomiting, loss of
appetite, abdominal pain, fatigue, yellowing of the skin), discontinue use of the medicine immediately and contact your doctor.
Do not exceed the recommended daily dose.
Children
Due to medical considerations, use in children under 3 years of age is not recommended.
Pelafen MED and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
No studies on interactions have been conducted.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use in pregnant and breastfeeding women is not recommended due to insufficient data.
Driving and operating machinery
The effect of the product on the ability to drive vehicles and operate machinery has not been studied.
Pelafen MED contains liquid maltitol
The medicine contains 893 mg of liquid maltitol (E 965) per single dose (2.5 ml).
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using the medicine.
Pelafen MED contains sorbitol
The medicine contains 625.1 mg of sorbitol (E 420) per single dose (2.5 ml).
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare inherited disorder in which the individual is unable to metabolize fructose, the patient should contact a doctor before taking the medicine or giving it to a child.

3. How to use Pelafen MED

This medicine should always be used exactly as described in this patient information leaflet or
as directed by a doctor or pharmacist. If in doubt, consult your doctor
or pharmacist.
Recommended dose:
Adolescents over 12 years of age, adults and elderly patients:
2.5 ml of syrup three times daily.
Children aged 6 to 11 years:
2.5 ml of syrup twice daily.
Children aged 3 to 5 years:
0.83 ml of syrup three times daily.
Not recommended for children under 3 years of age.
Renal and/or hepatic impairment
There is no data available on the use of Pelafen MED in patients with hepatic and/or renal impairment.
Administration method:
Oral use.
Shake the bottle before use.
Pelafen MED should be administered orally using the oral syringe provided in the package.
Instructions for use of the oral syringe:

1. Insert the syringe into the bottle, immersing only the tip of the syringe into the syrup.
2. Pull back the plunger of the syringe to the graduation mark corresponding to the required dose in milliliters according to the dosing instructions.
3. Remove the syringe from the bottle.
4. Place the tip of the syringe into the patient's mouth and slowly push the plunger to release the medicine.
5. After administration, wash the syringe with warm water and allow it to dry.

Duration of treatment:
If symptoms worsen or do not improve within 7 days of treatment, consult a doctor.
Use of a higher than recommended dose of Pelafen MED
No cases of overdose have been reported.
Missed dose of Pelafen MED
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is given below:
Frequency unknown (cannot be estimated from available data):
Cases of hypersensitivity, anaphylactic reactions, rash, itching, urticaria, angioedema (swelling of subcutaneous tissue areas), nosebleeds, diarrhea, abdominal pain, nausea, vomiting, gum bleeding, hepatotoxicity, and hepatitis have been reported.

Reporting suspected adverse reactions
If any adverse reactions occur, patients should consult a doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet.
Adverse reactions can also be reported directly through the national reporting system.
Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pelafen MED

The medicine should be stored in a place inaccessible and out of sight of children.
The medicinal product does not require special storage conditions. Shelf life after
first opening of the bottle: 3 months. After first opening of the bottle, store below 25°C.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Pelafen MED contains
Active substance:
Each 1 ml of syrup contains 8 mg of extract (as dry extract) (4-25:1) from Pelargonium
sidoides DC and/or Pelargonium reniforme Curt., radix (Pelargonium root); extraction solvent:
ethanol 11% (m/m).
Excipients:
maltodextrin, maltitol liquid (E 965), non-crystallizing liquid sorbitol (E 420), potassium
sorbate (E 202), citric acid (E 330), purified water.

What Pelafen MED looks like and contents of the pack
A dark red liquid with a characteristic odour. The product contains natural ingredients, which may lead to the formation of sediment.
Amber glass bottles of type III, with white HDPE screw cap, with a capacity of 100 ml. The bottles are packed in cardboard boxes containing the patient leaflet and an attached polyethylene and polystyrene oral syringe with a capacity of 5 ml, graduated every 0.5 ml and with additional markings every 0.83 ml.

Marketing Authorisation Holder and Manufacturer
Phytopharm Klęka S.A.
Klęka 1
63-040 Nowe Miasto nad Wartą
Poland
Tel.: +48 61 28 68 000
[email protected]

This medicinal product is authorised in the EEA countries under the following names:
Austria: Pelargonium Phytopharm Sirup
Czech Republic: Pelafen
Estonia: Pelafen
Hungary: Pelafen
Latvia: Pelafen sīrups
Lithuania: Pelafen sirupas
Poland: Pelafen MED
Romania: Pelafen MED 20 mg/2.5 ml syrup
Slovakia: Pelafen sirup

10/2025