Bionorica Imupret Irrigated Tablets 50 pcs.
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Description
Bionorica Imupret Irrigated Tablets 50 pcs.
Key product features
Acts from the first symptoms of infection (1), Effectively relieves the course of the infection (2,3), Reduces its duration (2,3), 1) CHPL of the medicinal product Imupret® irritants. 2) Vavilova et al. , "Effectiveness and tolerability of Tonsilgon N in the treatment of recurrent upper respiratory tract infections in children: a non-interventional study in Russia," Clinical Phytoscience (2016) 2:6;DOI 10.1186/s40816-016-0020-9. 3) Popovych V et al. "A randomized, open-label, multicenter, comparative study of therapeutic efficacy, safety and tolerability of BNO 1030 extract, containing marshmallow root, chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acutenon-bacterial tonsillitis in children aged 6 to 18 years", Am J Otolaryngol. 2019 Mar - Apr;40(2):265-273.
Description
A cold? Feeling ill?
Imupret®
Imupret® tablets - is a drug for use at any stage of the common cold in adult patients and children over 6 years of age (1).
Imupret® relieves and shortens the time of infection, as it acts on the causes and symptoms of the common cold (2,3).
Imupret® has antiviral and immunomodulatory effects (4).
It can be used as monotherapy or in combination therapy, e.g., with a combination drug that acts temporarily on cold symptoms.
1)CHPL of Imupret medicinal product,
2) Vavilova et al. , "Effectiveness and tolerability of Tonsilgon N in the treatment of recurrent upper respiratory tract infections in children: a non-interventional study in Russia," Clinical Phytoscience (2016) 2:6;DOI 10.1186/s40816-016-0020-9.
3) Popovych V et al. "A randomized, open-label, multicenter, comparative study of therapeutic efficacy, safety and tolerability of BNO 1030 extract, containing marshmallow root, chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acute non-bacterial tonsillitis in children aged 6 to 18 years," Am J Otolaryngol. 2019 Mar - Apr;40(2):265-273.
4) Wosikowski et al. "Imupret inhibits respiratory syncytial virus replication and displays in vitro and in vivo immunomodulatory properties. GA meeting, Münster, 2013, Poster 48".
Imupret®
Imupret® tablets - is a drug for use at any stage of the common cold in adult patients and children over 6 years of age (1).
Imupret® relieves and shortens the time of infection, as it acts on the causes and symptoms of the common cold (2,3).
Imupret® has antiviral and immunomodulatory effects (4).
It can be used as monotherapy or in combination therapy, e.g., with a combination drug that acts temporarily on cold symptoms.
1)CHPL of Imupret medicinal product,
2) Vavilova et al. , "Effectiveness and tolerability of Tonsilgon N in the treatment of recurrent upper respiratory tract infections in children: a non-interventional study in Russia," Clinical Phytoscience (2016) 2:6;DOI 10.1186/s40816-016-0020-9.
3) Popovych V et al. "A randomized, open-label, multicenter, comparative study of therapeutic efficacy, safety and tolerability of BNO 1030 extract, containing marshmallow root, chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acute non-bacterial tonsillitis in children aged 6 to 18 years," Am J Otolaryngol. 2019 Mar - Apr;40(2):265-273.
4) Wosikowski et al. "Imupret inhibits respiratory syncytial virus replication and displays in vitro and in vivo immunomodulatory properties. GA meeting, Münster, 2013, Poster 48".
Storage and use
Use orally, according to the dosage recommended in the drug leaflet. Read the leaflet before using the drug. If there is no improvement after 7 days, contact your doctor. If symptoms do not improve with the use of the product or there are side effects not mentioned in the leaflet, contact your doctor. The drug is intended for children aged 6 years and older, adolescents and adults.
Storage: Store at ambient temperature.
Dimensions: Height: 76 mm. Width: 95 mm. Depth: 28 mm.
Packaging: box
Storage: Store at ambient temperature.
Dimensions: Height: 76 mm. Width: 95 mm. Depth: 28 mm.
Packaging: box
Composition
The drug contains, among others: 1 irritated tablet contains the following powdered active substances: horsetail herb 10,00 mg; yarrow herb 4,00 mg; valerian root 8,00 mg; walnut leaf 12,00 mg; dandelion herb 4, 00 mg; chamomile flower 6,00 mg; oak bark 400 mg, The drug contains, among others: lactose monohydrate, sucrose, glucose
Manufacturer
BIONORICA SE
Manufacturer address
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Safety warning
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Keep out of sight and reach of children.
Number of units
Number of units: 50
Lower age limit
Recommended: 6 years/years/years
General information
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
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 drug and for what purpose it is used.
2. important information before taking Imupret
3. how to take Imupret drug
4 Possible side effects
5. how to store Imupret
6. package contents and other information
Description and use
1 What is Imupret drug and for what purpose it is used.
2. important information before taking Imupret
3. how to take Imupret drug
4 Possible side effects
5. how to store Imupret
6. package contents and other information
1 What is the drug Imupret and for what purpose it is used?
Traditionally used at the first signs and during the duration of a cold.
Imupret, 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.
How to use the drug
Traditionally used at the first signs and during the duration of a cold.
Imupret, 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 drug?
Imupret tablets should be taken as indicated in the package insert or as directed by your doctor. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Unless otherwise indicated by your doctor, the recommended dose is:
Dosage for severe (acute) cold symptoms in the first days of treatment:
Dosage:
Children aged 6 to 11 years 5-6 times a day 1 tablet (daily dose of 5 - 6 tablets).
Adolescents aged 12 years and older and adults 2 tablets 5-6 times a day (daily dose of 10 - 12 tablets ).
Use the product according to the specified dosage until the symptoms begin to subside, or are relieved, but for no longer than a week (7 days).
When symptoms subside or are milder in nature, lower the dosage:
Children aged 6 to 11 years 1 tablet 3 times a day (daily dose of 3 tablets).
Adolescents aged 12 years and older and adults 2 tablets 3 times a day (daily dose of 6 tablets).
There are insufficient data on dosage in patients with liver or kidney dysfunction.
Method of administration:
Oral.
Tablets should be taken whole (not chewed), drinking plenty of liquid (preferably with a glass of water).
Duration of treatment:
Imupret, irritated tablets should be used until symptoms are completely resolved, but for no longer than two consecutive weeks (14 days).
Use in children:
Do not give to children under 6 years of age.
Taking more than the recommended dose of Imupret:
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:
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:
Discontinuation of Imupret drug does not cause adverse effects.
If you have any doubts about the use of this drug, ask your doctor or pharmacist.
How to store the drug
Imupret tablets should be taken as indicated in the package insert or as directed by your doctor. If in doubt, ask your doctor or pharmacist.
Recommended dose:
Unless otherwise indicated by your doctor, the recommended dose is:
Dosage for severe (acute) cold symptoms in the first days of treatment:
Dosage:
Children aged 6 to 11 years 5-6 times a day 1 tablet (daily dose of 5 - 6 tablets).
Adolescents aged 12 years and older and adults 2 tablets 5-6 times a day (daily dose of 10 - 12 tablets ).
Use the product according to the specified dosage until the symptoms begin to subside, or are relieved, but for no longer than a week (7 days).
When symptoms subside or are milder in nature, lower the dosage:
Children aged 6 to 11 years 1 tablet 3 times a day (daily dose of 3 tablets).
Adolescents aged 12 years and older and adults 2 tablets 3 times a day (daily dose of 6 tablets).
There are insufficient data on dosage in patients with liver or kidney dysfunction.
Method of administration:
Oral.
Tablets should be taken whole (not chewed), drinking plenty of liquid (preferably with a glass of water).
Duration of treatment:
Imupret, irritated tablets should be used until symptoms are completely resolved, but for no longer than two consecutive weeks (14 days).
Use in children:
Do not give to children under 6 years of age.
Taking more than the recommended dose of Imupret:
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:
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:
Discontinuation of Imupret drug 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?
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 down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.
Storage conditions:
Do not store at temperatures above 30°C.
Store in the original packaging.
Possible side effects
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 down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.
Storage conditions:
Do not store at temperatures above 30°C.
Store in the original packaging.
4 Possible side effects:
Like any drug, this medication may cause side effects, although not everyone will experience them.
The following side effects may occur:
Uncommon (occur in 1 to 10 per 1000 patients):
- Gastrointestinal disorders.
Unknown frequency (cannot be determined from available data):
- sensitization (allergic) reactions.
Chamomile flower preparations may 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 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.
Package contents and other information
Like any drug, this medication may cause side effects, although not everyone will experience them.
The following side effects may occur:
Uncommon (occur in 1 to 10 per 1000 patients):
- Gastrointestinal disorders.
Unknown frequency (cannot be determined from available data):
- sensitization (allergic) reactions.
Chamomile flower preparations may 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 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 contain?
1 irritated tablet contains the following powdered active substances:
Horsetail herb (Equisetum arvense L., herba) 10.00 mg;
Yarrow herb (Achillea millefolium L., herba) 4.00 mg;
Marshmallow root (Althaea officinalis L., radix) 8.00 mg;
Walnut leaves (Juglans regia L., folium) 12.00 mg;
Dandelion herb (Taraxacum officinale F. H. Wigg., herba) 4.00 mg;
Chamomile flower (Matricaria recutita L., flos) 6.00 mg ;
Oak bark (Quercus robur L., Q. petraea (Matt.) Liebl. ;
Quercus pubescens Willd., cortex ) 4.00 mg.
Excipients: calcium carbonate, glucose monohydrate, spray-dried liquid glucose, potato starch, lactose monohydrate, corn starch, Montana glycol wax, Povidone K25, Povidone K30, virgin castor oil, shellac, dextrin, anhydrous colloidal silica, stearic acid (vegetable origin), sucrose, talc.
Information for diabetics:
1 Imupret tablet contains an average of 0.02 bread units.
What does the drug Imupret, irritated tablets look like and what does the package contain?
Imupret, irritated tablets are packaged in blisters made of PVC/PVDC/Aluminum foil, with 25 tablets
in each blister. The unit printed cardboard box contains 50 tablets
(2 blister packs) or 100 tablets (4 blister packs) along with an information leaflet.
Not all package sizes are necessarily 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 entity:
For more detailed information on this drug, contact the local representative of the responsible entity:
Bionorica Polska Sp. z o.o.
6B Hrubieszowska St.
01 - 209 Warsaw
Poland
Tel /Fax +(48) 22 886 46 06
Email: bionorica@bionorica.pl
Important before use
What does the drug Imupret contain?
1 irritated tablet contains the following powdered active substances:
Horsetail herb (Equisetum arvense L., herba) 10.00 mg;
Yarrow herb (Achillea millefolium L., herba) 4.00 mg;
Marshmallow root (Althaea officinalis L., radix) 8.00 mg;
Walnut leaves (Juglans regia L., folium) 12.00 mg;
Dandelion herb (Taraxacum officinale F. H. Wigg., herba) 4.00 mg;
Chamomile flower (Matricaria recutita L., flos) 6.00 mg ;
Oak bark (Quercus robur L., Q. petraea (Matt.) Liebl. ;
Quercus pubescens Willd., cortex ) 4.00 mg.
Excipients: calcium carbonate, glucose monohydrate, spray-dried liquid glucose, potato starch, lactose monohydrate, corn starch, Montana glycol wax, Povidone K25, Povidone K30, virgin castor oil, shellac, dextrin, anhydrous colloidal silica, stearic acid (vegetable origin), sucrose, talc.
Information for diabetics:
1 Imupret tablet contains an average of 0.02 bread units.
What does the drug Imupret, irritated tablets look like and what does the package contain?
Imupret, irritated tablets are packaged in blisters made of PVC/PVDC/Aluminum foil, with 25 tablets
in each blister. The unit printed cardboard box contains 50 tablets
(2 blister packs) or 100 tablets (4 blister packs) along with an information leaflet.
Not all package sizes are necessarily 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 entity:
For more detailed information on this drug, contact the local representative of the responsible entity:
Bionorica Polska Sp. z o.o.
6B Hrubieszowska St.
01 - 209 Warsaw
Poland
Tel /Fax +(48) 22 886 46 06
Email: bionorica@bionorica.pl
2 Important information before taking Imupret:
When not to take Imupret:
- 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 (formerly Compositae) family.
Warnings and precautions:
If symptoms persist for more than a week or you experience difficulty breathing, fever, purulent or bloody sputum, contact your doctor.
Children:
Do not give to children under 6 years of age.
Imupret drug and other drugs:
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 interactions of Imupret with other drugs when administered concurrently. To date, no interactions of Imupret 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 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 baby, you should consult your doctor or pharmacist before taking this drug.
This drug is not recommended for use in women during pregnancy and lactation due to the lack of studies evaluating the safety of its use.
Driving and operating machinery:
Has not been studied.
Imupret contains glucose, sucrose and lactose.
Patients with rare hereditary disorders of fructose intolerance, glucose-galactose malabsorption syndrome, saccharose-isomaltase deficiency, rare hereditary galactose intolerance or lactase deficiency (Lapp type) should not take Imupret.
One irritated tablet contains approximately 0.020 bread units.
Product identification
When not to take Imupret:
- 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 (formerly Compositae) family.
Warnings and precautions:
If symptoms persist for more than a week or you experience difficulty breathing, fever, purulent or bloody sputum, contact your doctor.
Children:
Do not give to children under 6 years of age.
Imupret drug and other drugs:
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 interactions of Imupret with other drugs when administered concurrently. To date, no interactions of Imupret 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 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 baby, you should consult your doctor or pharmacist before taking this drug.
This drug is not recommended for use in women during pregnancy and lactation due to the lack of studies evaluating the safety of its use.
Driving and operating machinery:
Has not been studied.
Imupret contains glucose, sucrose and lactose.
Patients with rare hereditary disorders of fructose intolerance, glucose-galactose malabsorption syndrome, saccharose-isomaltase deficiency, rare hereditary galactose intolerance or lactase deficiency (Lapp type) should not take Imupret.
One irritated tablet contains approximately 0.020 bread units.
Imupret
irritated tablets
irritated tablets
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