coated tablets
Please read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet

What Imupret is and what it is used for
What you need to know before taking Imupret
How to take Imupret
Possible side effects
How to store Imupret
Package contents and other information

1. WHAT IMUPRET IS AND WHAT IT IS USED FOR

Imupret is a traditional herbal medicinal product used at the first signs of and during a cold, for example for sore throat, throat irritation, difficulty swallowing, and dry cough.
The product is a traditional herbal medicinal product intended for use in the specific indication based solely on long-term use.
Consult a doctor or qualified healthcare professional if symptoms persist during use of the medicine or if adverse effects mentioned or not mentioned in the package leaflet occur.
Imupret is used for the treatment of children from 6 years of age, adolescents, and adults.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IMUPRET

Do not take Imupret:
If you are hypersensitive (allergic) to the root of marshmallow, chamomile flower, horsetail stem,
walnut leaves, yarrow, oak bark, dandelion herb, or to other plants of the Compositae family, e.g.
artemisia, yarrow, chrysanthemum, daisy, or to any of the other components of this medicinal product (listed in section 6).

Warnings and precautions
You should consult a doctor if symptoms persist for longer than one week or if shortness of breath, fever, purulent or bloody sputum occur.

Children
Use in children under 6 years of age is not recommended due to lack of adequate data and as a general precaution, since the dosage form "coated tablets" is not suitable for children under 6 years of age (risk of accidental ingestion).

Other medicines and Imupret
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted. There are no reports of clinical interactions between Imupret and other medicinal products.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicinal product.
The safety of Imupret during pregnancy has not been established. Use of Imupret during pregnancy is not recommended.
It is unknown whether active substances/metabolites are excreted in breast milk. A risk to the newborn/infant cannot be excluded. Imupret should not be used during breastfeeding.

Driving and using machines
No studies have been performed regarding the effects on the ability to drive vehicles and use machinery.

Imupret contains glucose, lactose and sucrose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.

3. HOW TO TAKE IMUPRET

Take this medicine exactly as described in this leaflet or as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

| Age | Dosage in case of acute symptoms | Dosage after reduction of acute symptoms | |-----|----------------------------------|------------------------------------------| | Children 6–11 years old | 1 coated tablet 5–6 times daily | 1 coated tablet 3 times daily | | Adolescents from 12 years of age and adults | 2 coated tablets 5–6 times daily | 2 coated tablets 3 times daily |

Patients with renal and/or hepatic impairment
Available data are insufficient to provide specific dosing recommendations in cases of reduced renal or hepatic function.

Use in children
Use in children under 6 years of age is not recommended due to lack of adequate data and as a general precaution, since the "coated tablet" formulation is not suitable for children under 6 years of age (risk of accidental ingestion).

Method of administration
For oral use.
Swallow the coated tablets whole, without chewing, preferably with some liquid (e.g. a glass of water).

Duration of treatment
Do not use for longer than 2 consecutive weeks.
If symptoms persist for more than 7 days during treatment, consult a doctor or pharmacist.
It is important to read the information under "Warnings and precautions" and "Undesirable effects".

If you take more Imupret than you should
Cases of overdose have not been reported so far.
If you have taken more Imupret than you should have, inform a doctor. The doctor will decide on the necessary measures.

If you forget to take Imupret
Do not take a double dose to make up for the forgotten dose.

If you stop taking Imupret
Stopping the medicine is usually harmless.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Allergic reactions (e.g. skin rash, urticaria) and gastrointestinal disorders may rarely occur (affecting up to 1 in 1,000 treated individuals).
If you notice these or any other adverse reactions, stop taking the product immediately and consult a doctor.
Reporting of adverse reactions
If you experience any adverse reaction, contact your doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet. You may also report adverse reactions directly via the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IMUPRET

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Storage conditions:
Do not store above 30°C.
Keep blisters in the carton to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater (e.g. in the toilet or sink) or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Imupret contains:
The active substances are:
1 coated tablet contains:
Althaeae radix powder 8 mg
Quercus cortex powder 4 mg
Chamomillae flos powder 6 mg
Taraxaci herba powder 4 mg
Equiseti caulis powder 10 mg
Achilleae flos powder 4 mg
Juglandis folium powder 12 mg

The other components are:
Tablet core: Glucose monohydrate; lactose monohydrate; maize starch; potato starch; colloidal anhydrous silica; stearic acid.
Coating: Calcium carbonate; virgin castor oil; dextrin; glucose liquid; maize starch; montan glycol wax; povidone K25; povidone K30; sucrose; shellac (de-waxed); colloidal anhydrous silica; talc.

Description of the appearance of Imupret and pack contents:
The coated tablets are white to almost white, round, biconvex, with a smooth surface. One coated tablet has a diameter of 8.0 – 8.3 mm.
Pack size: 50 coated tablets.
Pack size: 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt, Germany
Telephone: +49 (0)9181 / 231-90
Fax: +49 (0)9181 / 231-265
Internet: www.bionorica.de
E-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria	Imupret Dragees
Bulgaria	Imupret, coated tablets
Germany	Imupret N Dragees
Greece	Imupret
Italy	Imupret