Pelafen Med film-coated tablets 30 pcs.

Method and route of administration: Use orally. Unless otherwise directed by a doctor:
Adults and adolescents over 12 years of age: 1 tablet 3 times daily (morning, noon, evening).
Children aged 6 to 12 years: 1 tablet 2 times a day (morning and evening).
Children under 6 years: the product is not recommended for children under 6 years.
Swallow whole, drinking a small amount of water. Do not bite. If, despite the use of the drug, symptoms worsen or do not resolve within 1 week, or if side effects occur, contact your doctor or pharmacist. Do not use Pelafen after the expiration date. Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 65 mm. Width: 119 mm. Depth: 21 mm.
Packaging: Box

One film-coated tablet contains 20 mg of dry extract of Pelargonium sidoides DC, and/or Pelargonium reniforme Curt., radix (geranium root) - Pelargonium radicis extractum, siccum (4-7:1), Extraction solvent: ethanol 14 % (V/V).

Phytopharm Klęka S.A.

Responsible entity:
Phytopharm Klęka S.A.,
Klęka 1
63-040 Nowe Miasto nad Warta,
Poland
phone: +48 61 28 68 000,
fax: +48 61 28 68 529
info@europlant-group.pl

Keep the drug out of sight and reach of children.

Number of units: 30

Recommended: 6 years/years/years

Read the leaflet carefully before taking the drug, as it contains important information for the patient.
Always take this medication as described in the 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 additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist.
- If there is no improvement after 7 days or if the patient feels worse, contact your doctor.

1 What is Pelafen MED and what is it used for?
2. important information before taking Pelafen MED
3. how to take Pelafen MED medicine
4 Possible side effects
5. how to store Pelafen MED drug
6. package contents and other information

Pelafen MED is a herbal medicinal product in the form of film-coated tablets containing dry extract of geranium root.

Traditional herbal medicinal product used in the symptomatic treatment of the common cold.

Pelafen MED is a traditional herbal medicinal product for use for specific indications arising only from long-term use.

This drug should always be used exactly as described in the patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Use orally.

Recommended dose:
Adults and adolescents over 12 years of age: 1 tablet 3 times a day (morning, noon, evening).
Children aged 6 to 12 years: 1 tablet 2 times a day (morning and evening).
Children under 6 years: the product is not recommended for use in children under 6 years.

Pelafen MED is intended for use in adults, adolescents and children 6 years and older.

Swallow whole, drinking a small amount of water. Do not bite.

Do not exceed the recommended dose.


If, despite the use of the drug, symptoms do not resolve within 1 week, contact your doctor or pharmacist.

Use in children
The product is not recommended for use in children under 6 years of age.

Duration of use:
If symptoms persist for more than 7 days despite the use of Pelafen MED, consult a doctor.



Taking more than the recommended dose of Pelafen MED.
No cases of overdose have been reported.

Omission of use of Pelafen MED drug.
Continue with the recommended dosage. Do not use a double dose to make up for a missed dose.

Store the drug out of sight and reach of children.

Do not use this medicine after the expiration date on the package. The expiration date means the last day of the stated month.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.

Like any drug, this medication may cause side effects, although they will not occur in everyone.

Side effects are divided into the following groups according to their frequency of occurrence:

Very common may occur in more than 1 in 10 people
Frequently may affect up to 1 in 10 people
Uncommonly may affect up to 1 in 100 people
Rarely may affect up to 1 in 1,000 people
Very rarely may occur in 1 in 10,000 people
Unknown frequency cannot be determined from available data

Mild gastrointestinal disorders (diarrhea, epigastric pain, nausea, vomiting, difficult swallowing), mild bleeding of the gums or nose, and allergic reactions were observed during the use of Pelafen MED. The incidence was very rare.
Cases of toxic effects on liver cells have also been reported. Their frequency is unknown.

Reporting of side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Avenue 181 C, 02-222 Warsaw,
tel. (22) 49 21 301, fax (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.

What the drug Pelafen MED contains
One film-coated tablet contains 20 mg of dry extract of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (geranium root) - Pelargonium radicis extractum siccum (4-7:1). Extraction solvent: ethanol 14% (V/V).

Excipients included in the tablet:
Extract
Powdered cellulose, colloidal silica anhydrous
Tablet core
Microcrystalline cellulose, colloidal silica anhydrous, magnesium stearate
Tablet shell
Hypromellose, macrogol 6000, iron oxide yellow E172, iron oxide red E 172, titanium dioxide E 171, talc.

What Pelafen MED drug looks like and what the package contains.
Pelafen MED drug comes in the form of reddish-brown, round, bilaterally convex film-coated tablets.
The immediate packaging of Pelafen MED drug is a blister of Aluminum/PVC/PVDC in a cardboard box.
Packaging available: 15, 30 or 45 tablets.
Only selected package sizes may be on the market.

Responsible party
Phytopharm Klęka S.A.
Klęka 1, 63 - 040 Nowe Miasto nad Wartą.
Tel: + 48 61 28 68 000
Fax: + 48 61 28 68 529
info@europlant-group.pl

When not to use Pelafen MED
- If the patient is allergic to the active substance (pelargonium root extract) or any of the other components of this drug (listed in section 6).

Warnings and precautions
Contact your doctor if you experience shortness of breath, fever, expectoration of bloody or purulent secretions, or if your symptoms do not resolve within a week.

Do not exceed the recommended daily dose.


Cases of liver cell toxicity and hepatitis have been reported during use of the drug. If symptoms of hepatotoxicity occur, discontinue use of the drug immediately and contact your doctor.

Patients with renal and/or hepatic insufficiency
There are no data on the use of Pelafen MED in patients with hepatic and/or renal insufficiency.

Children
Due to lack of sufficient data, use in children under 6 years is not recommended.

Pelafen MED and other drugs
Tell your doctor about all medications you are currently or recently taking, as well as medications you plan to take.
So far, no interactions of Pelafen MED with other drugs have been observed.

Pelafen MED with food, drink and alcohol
No data available.

Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.
It is not recommended to use the drug in pregnant or breastfeeding women.

Driving and operating machinery
The effect of the product on the ability to drive and operate machinery has not been studied.