Imupret coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Imupret® coated tablets
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Contents of the leaflet:
- What Imupret is and what it is used for
- What you need to know before taking Imupret
- How to take Imupret
- Possible adverse effects
- Storage of Imupret
- Contents of the pack and other information
1. What Imupret is and what it is used for
Imupret is a traditional herbal medicinal product for the relief of cold symptoms such as sore and irritated throat and dry cough. Its use is based solely on long-standing traditional use.
It is indicated for use in adults, adolescents, and children over 12 years of age.
You should consult a doctor if symptoms worsen or do not improve after 7 days.
Imupret is a traditional herbal medicinal product registered solely on the basis of its long-standing use in this indication.
2. What you need to know before starting to take Imupret
Do not take Imupret
- if you are allergic (hypersensitive) to marshmallow root, chamomile flowers, horsetail stem, walnut leaves, yarrow stem, oak bark, dandelion stem, or to any of the other components of this medicine (listed in section 6).
- if you are allergic (hypersensitive) to plants belonging to the Compositae family.
Warnings and precautions
If you have any doubts about this medicine, consult your doctor or pharmacist before starting to take Imupret.
If symptoms persist or if you experience adverse reactions not mentioned in this leaflet, consult your doctor or pharmacist.
If your symptoms last longer than one week, or if you experience difficulty breathing, fever, or if you cough up mucus containing pus or blood, you must consult your doctor immediately.
Children
Imupret must not be taken by children under 12 years of age.
Taking Imupret with other medicines
There are no available reports on clinical interactions between Imupret and other medicines.
Products containing oak bark may alter the absorption of other medicines containing alkaloids.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
The safety of Imupret during pregnancy and breastfeeding has not been investigated. It is unknown whether the active substances or their metabolites pass into breast milk. Administration of Imupret is not recommended for pregnant or breastfeeding women.
There are no available studies on its effect on fertility.
Driving and using machines
Imupret has no influence on the ability to drive or operate machinery.
Imupret contains glucose, lactose and sucrose.
This medicine contains glucose, lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Imupret
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults, adolescents and children over 12 years: 2 tablets, 3 to 6 times daily.
There is insufficient information available to recommend a specific dose in cases of renal or hepatic impairment.
Method of administration:
The coated tablets should be swallowed whole, without chewing or sucking, with a glass of water or other liquid.
Duration of treatment:
Imupret should not be taken for longer than 2 consecutive weeks.
Please read the information included in the sections: "Warnings and precautions" and "Possible side effects".
If you take more Imupret than you should
No cases of poisoning due to overdose have been reported.
In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the product and the amount ingested.
If you forget to take Imupret
Do not take a double dose to make up for forgotten doses.
If you stop taking Imupret
In general, stopping treatment with this medicine will not cause any harmful effects. If you have any further questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Imupret may produce adverse effects, although not everyone experiences them.
The assessment of possible adverse effects is based on the following frequency classification:
Very common: | affect more than 1 in 10 patients |
Common | affect 1 to 10 in 100 patients |
Uncommon | affect 1 to 10 in 1,000 patients |
Rare | affect 1 to 10 in 10,000 patients |
Very rare | affect less than 1 in 10,000 patients |
Frequency not known | cannot be estimated from the available data |
Possible adverse effects:
Allergic reactions (for example: skin rash) may occur; the frequency of occurrence of these reactions is unknown.
When taking medicines containing chamomile flowers, hypersensitivity reactions may occur, even in individuals with hypersensitivity to other plants of the family Compositae, such as: artemisia, yarrow, chrysanthemum, daisies. These hypersensitivity reactions are due to what is known as cross-reactions.
- Uncommonly: gastrointestinal discomfort may occur.
If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system. By reporting adverse effects, you can help provide more information on the safety of this medicine.
Website: www.notificaRAM.es
5. Storage of Imupret
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Keep the blister in the cardboard carton to protect it from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines or waste containers to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Imupret
Each coated tablet contains the following active substances:
12 mg Juglandis regia L., leaves (Walnut)
10 mg Equisetum arvense L., sterile stems (Horsetail)
8 mg Althaea officinalis L., root (Marshmallow)
6 mg Matricaria recutita L. (Chamomilla recutita (L.) Rauschert), flowers (Chamomile)
4 mg Quercus robur L., Q. petraea (Matt) Liebl and Q. pubescens Willd., bark (Common, sessile and pubescent oak)
4 mg Taraxacum officinale Weber, aerial parts (Dandelion)
4 mg Achillea millefolium L., flowering tops (Yarrow)
The other components are:
Calcium carbonate, glucose monohydrate, liquid glucose, potato starch, lactose monohydrate, corn starch, dextrin, glycol montanic wax, povidone (K25, K30), castor oil, shellac lac (shellac gum), highly dispersed silicon dioxide, stearic acid (of vegetable origin), sucrose, talc.
.
Appearance of the product and contents of the pack
Round coated tablets, white or almost white, biconvex, with a smooth surface.
Pack sizes containing 50 and 100 coated tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Tel.: +49 / 9181 / 231-90
Fax: +49 / 9181 / 231-265
E-mail: [email protected]
Date of the most recent review of this leaflet: December 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/