Bionorica Imupret N Oral Drops 50 ml

Use orally, according to the dosage recommended in the drug leaflet.

If there is no improvement after 7 days, or if the patient feels worse, contact your doctor.

The drug is intended for children 2 years and older, adolescents and adults.

Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 112 mm. Width: 40 mm. Depth: 40 mm.
Packaging: box

100 ml of oral drops contains 100 ml of extract (1:38) obtained from: horsetail herb; yarrow herb; valerian root; walnut leaves; dandelion herb; chamomile flowers; oak bark in the ratio (5/4/4/4/4/4/3/2), Extractant: 59% (V/V) ethanol, Contains up to 19.5% (V/V) ethanol.

BIONORICA SE

BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany

Keep out of sight and reach of children.

Recommended: 2 years/years/years

Read the leaflet carefully before using this medication, as it contains important information for the patient.
Always use this medication exactly 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. See section 4.
- If there is no improvement after 7 days, or if the patient feels worse, contact your doctor.

Table of contents of the leaflet
1 What is Imupret N drug and for what purpose it is used.
2. important information before taking Imupret N
3. how to take Imupret N medicine
4 Possible side effects
5. how to store the drug Imupret N
6. package contents and other information

1 What is the drug Imupret N and for what purpose is it used?

Traditionally used at the first signs and during the course of a cold.

Imupret N, is a traditional herbal medicinal product, the indications of which are based solely on long-term use.

If there is no improvement after 7 days or the patient feels worse, contact a doctor.

3 How to take Imupret N medicine?

Always take this drug exactly as described in the patient leaflet or as directed by your doctor. If in doubt, ask your doctor or pharmacist.


Dosage: for severe (acute) cold symptoms - in the first days of treatment:

Children aged 2 to 5 years 10 drops 5-6 times a day (daily dose 50 - 60 drops).
Children aged 6 to 11 years: 15 drops 5-6 times a day (daily dose of 75 - 90 drops).
Adolescents aged 12 years and older and adults: 25 drops 5-6 times a day (daily dose 125 - 150 drops).

The drug should be used according to the dosage given above until the symptoms begin to subside, or are relieved, but for no longer than a week (7 days).

When symptoms begin to subside or become milder, lower the dosage:

A single dose 3 times a day:
Children aged 2 to 5 years 10 drops 3 times a day (daily dose of 30 drops).
Children aged 6 to 11 years 15 drops 3 times a day, (daily dose 45 drops).
Adolescents 12 years and older and adults 25 drops 3 times a day (daily dose 75 drops).

There are insufficient data on dosage in patients with hepatic or renal impairment.

Method of administration:

Orally.
The drug can be taken with a small amount of liquid (for example, with water given in a medicine glass or, in the case of children, in a small spoonful of water).
For easier dosing, the bottle should be held vertically while measuring the drops.

A small precipitate or turbidity may appear during storage.

Duration of treatment:
Imupret N should be used until symptoms have completely resolved, but for no longer than two consecutive weeks (14 days).

In children under 6 years of age, the drug can be used without medical consultation for one week. Longer use requires medical consultation.

Use in children:
Do not give to children under 2 years of age.

Taking more than the recommended dose of Imupret N:
There are no known cases of poisoning.
It is unlikely that the patient's condition will worsen, but if a higher dose of the drug is taken, it is advisable to consult a doctor for further treatment.
The side effects listed in section 4 (below) may worsen.

Omission of taking Imupret N:
If you miss another dose of the drug at the appointed time, do not use a double dose to make up for the missed dose.

Discontinuation of Imupret N:
Discontinuation of Imupret N, oral drops does not cause adverse effects.

If you have any doubts about the use of this drug, ask your doctor or pharmacist.

5 How to store the drug Imupret N?

Store the drug out of sight and reach of children.
Do not use the drug 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 the sewage system or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.

How long can the drops be used after opening the bottle?
After opening the bottle, the shelf life is 6 months.

Storage conditions:
No specific storage conditions.
As with all herbal medicines, Imupret N may develop a slight turbidity or precipitate formed during storage. However, it does not affect the quality of the drug.

4 Possible side effects:

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

The following side effects may occur:

Uncommon (occur in 1 to 100 per 1000 patients):
- Gastrointestinal disorders.

Rare (occur in up to 1 in 1,000 patients):
- Gastrointestinal disorders (such as nausea, vomiting, abdominal pain, heartburn and diarrhea).
- Allergic reactions . (e.g., rash, hives).

Chamomile flower preparations can also cause hypersensitivity reactions in patients allergic to other plants of the Asteraceae family (e.g. mugwort, yarrow, chrysanthemums, daisies) as a result of the so-called cross-allergy.

If hypersensitivity or allergic reactions occur, Imupret N should be discontinued and not used again.

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:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Jerozolimskie Avenue 181 C
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 responsible party.

By reporting side effects, more information on the safety of the drug will be gathered.

6 Package contents and other information:

What does the drug Imupret N, oral drops contain?
The active substance of the drug is an extract composed of:
100 ml of oral drops contains 100 ml of extract (1:38) obtained from:
Equisetum arvense L., herba (horsetail herb) ;
Achillea millefolium L., herba (yarrow herb) ;
Althaea officinalis L., radix (root of goldenrod) ;
Juglans regia L., folium (walnut leaves);
Taraxacum officinale F. H. Wigg., herba (dandelion herb) ;
Matricaria recutita L., flos (chamomile flower) ;
Quercus robur L., Q. petraea (Matt.) Liebl. and Quercus pubescens Willd., cortex (oak bark)
in the ratio (5/4/4/4/4/3/2).

Extraction solvent: 59% [V/V] ethanol.
Contains up to 19.5% (v/v) ethanol.

Information for diabetics:
100 ml of Imupret N, oral drops contains less than 0.6 g of easily digestible carbohydrates.

What does the drug Imupret N, oral drops look like and what does the package contain?

Clear or slightly cloudy, yellow-brown liquid with a chamomile odor and taste, available in narrow-necked bottles of brown glass with a polyethylene dropper and a polypropylene cap with a guarantee ring, placed in a cardboard box.

The printed unit carton contains 1 bottle together with an information leaflet.

Pack sizes:
1 bottle of 50 ml,
1 bottle of 100 ml.

Not all package sizes must be on the market.

Responsible party and manufacturer:

BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Germany
Phone: +49918123190
Fax: +499181231265
E-mail: info@bionorica.de

For more detailed information, please contact the representative of the responsible party:

Bionorica Polska Sp. z o.o.
6B Hrubieszowska St.
01-209 Warsaw
Poland
Tel /Fax: +48 22 886 46 06
e-mail: bionorica@bionorica.pl

2 Important information before taking Imupret N:

When not to take Imupret N:
- if the patient is allergic to the active substances or to any of the excipients (listed in section 6);
- if the patient is allergic to plants of the Asteraceae family Astreacae (formerly Compositae), e.g. common mugwort, yarrow, chrysanthemum, jastris (marguerite), due to possible cross allergies with chamomile flowers.

Warnings and precautions:
If symptoms persist for more than a week or there is difficulty breathing, fever, purulent or bloody sputum, contact your doctor.

Children:
Do not give to children under 2 years of age.


Imupret N and other medications:

Tell your doctor about all medications you are currently or recently taking, as well as medications you plan to take.
There are no studies evaluating the interaction of Imupret N, oral drops with other drugs when administered concurrently. To date, no interactions of Imupret N with other drugs have been reported.
When using products containing oak bark, the absorption of alkaloids and other alkaloid medicinal products may be reduced or blocked.

Use of Imupret N with food and drink:
There are no data on the effect of food and drink on the effect of the drug.

Pregnancy and breastfeeding:
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.

This drug is not recommended for use in pregnant and lactating women due to the lack of studies evaluating the safety of its use, as well as its ethanol content.

Driving and operating machinery:
Imupret N, taken in the recommended doses, has no significant effect on the ability to drive or operate machinery.

Imupret N contains ethanol.
This drug contains 215 mg of alcohol (ethanol) in 25 drops, which corresponds to 156 mg/ml (19.5% v/v). The amount of this drug contained in 25 drops is equivalent to 6 ml of beer or 3 ml of wine. A small amount of alcohol in this drug will not cause any noticeable effects.

There are insufficient data on dosage in patients with hepatic and/or renal impairment.

Imupret N,
oral drops


Extractum compositum ex: Equiseti herba, Millefolii herba, Althaeae radice, Juglandis folio, Taraxaci herba, Matricariae flore, Quercus cortice.