Pelafen Med

Leaflet attached to the packaging: patient information

Pelafen MED, 20 mg/ 2.5 ml, syrup

Pelargonii radicis extractum siccum

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including possible side effects not listed in this leaflet, they should inform their doctor or pharmacist.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Pelafen MED and what is it 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 packaging and other information

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

Pelafen MED contains 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 for use in specific indications resulting solely from long-standing use.
Pelafen MED is intended for use in adults, adolescents, and children over 6 years of age.
Consult a doctor if after 7 days there is no improvement or if the patient feels worse.

2. Important information before taking Pelafen MED

When not to take Pelafen MED

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

Warnings and precautions

Before taking Pelafen MED, discuss it with your doctor or pharmacist.
If shortness of breath, fever, coughing up bloody or purulent sputum occurs, contact your doctor.
In case of symptoms of toxic liver damage (such as vomiting, loss of appetite, abdominal pain, fatigue, yellowing of the skin), stop taking the medicine and contact your doctor immediately.

Do not exceed the recommended daily dose.

Children

Due to the lack of sufficient data, it is not recommended to use the medicine in children under 6 years of age.

Pelafen MED and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interaction studies have been conducted.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
It is not recommended to use the medicine in pregnant and breastfeeding women due to the lack of sufficient data.

Driving and using machines

The effect of the product on the ability to drive and use machines has not been studied.

Pelafen MED contains liquid maltitol

The medicine contains 893 mg of liquid maltitol (E 965) in a single dose (2.5 ml).
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Pelafen MED contains sorbitol

The medicine contains 625.1 mg of sorbitol (E 420) in a single dose (2.5 ml).
Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the person is unable to break down fructose, consult your doctor before taking the medicine or giving it to your child.

3. How to take Pelafen MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:

Adolescents over 12 years of age, adults, and the elderly:
2.5 ml of syrup three times a day.
Children from 6 to 11 years of age:
2.5 ml of syrup twice a day.
It is not recommended to use the medicine in children under 6 years of age.
Kidney and/or liver impairment
There are no data on the use of Pelafen MED in patients with liver and/or kidney impairment.
Method of administration:
Oral use.
Shake the bottle before use.
Pelafen MED should be taken orally using the enclosed measuring cup. An appropriate measuring cup with a scale is provided.
Duration of use:
If after 7 days there is no improvement or the patient feels worse, consult a doctor.

Taking a higher dose of Pelafen MED than recommended

No cases of overdose have been reported.

Missing a dose of Pelafen MED

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is given below:
Very rare (may affect up to 1 in 10,000 people):

• mild gastrointestinal disorders (such as diarrhea, abdominal pain, nausea, vomiting, difficulty swallowing), mild bleeding from the gums or nose, and allergic reactions have been reported.

Frequency not known (cannot be estimated from the available data):

• cases of hepatotoxicity (liver damage) have been reported.

Reporting suspected side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system.
Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pelafen MED

Keep the medicine out of the sight and reach of children.
The original sealed package does not require special storage conditions.
Shelf life after first opening the bottle: 3 months. After first opening the bottle, store below 25°C.
Do not use after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Pelafen MED contains

Active substance:
Each ml of syrup contains 8 mg of extract (as dry extract) (4-25:1) from Pelargonium sidoidesDC and/or Pelargonium reniformeCurt., radix (pelargonium root); extraction solvent: ethanol 11% (m/m).
Excipients:
maltodextrin, liquid maltitol (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

Dark red liquid with a characteristic odor. The product contains natural ingredients, which may cause sediment formation.
Bottles made of orange glass type III, with a white HDPE cap, 100 ml. The bottles are packaged in cardboard boxes with a patient leaflet and a measuring cup made of PP, 20 ml.

Marketing authorization holder and manufacturer

Phytopharm Klęka S.A.
Klęka 1
63-040 Nowe Miasto nad Wartą
Poland
tel.: +48 61 28 68 000
fax: +48 61 28 68 529
[email protected]
This medicine is authorized in the EEA member states under the following names:
Austria: Pelargonium Phytopharm Sirup
Poland: Pelafen MED
Romania: Pelafen MED 20 mg/2.5 ml syrup

Date of last revision of the leaflet:

07/2023