IMUPRET COATED TABLETS

Introduction

Leaflet:information for the user

Imupret®coated tablets

Read the entire leaflet carefully beforestarting totake this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet:

1. What Imupret is and what it is used for
2. What you need to know before taking Imupret
3. How to take Imupret
4. Possible side effects

5 Conservation of Imupret

1. Package contents and additional information

1. What Imupret is and what it is used for

Imupret is a traditional herbal medicinal product for the relief of symptoms of the common cold such as throat irritation and dry cough. Based exclusively on its traditional use.

It is indicated in adults, adolescents, and children over 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

Imupret is a traditional herbal medicinal product registered solely based on its long experience of use in this indication.

2. What you need to know before taking Imupret

Do not take Imupret

• if you are allergic (hypersensitive) to marshmallow root, chamomile flowers, horsetail stem, walnut leaves, yarrow stem, oak bark, or dandelion stem or to any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to plants that belong to the Compositae family.

Warnings and precautions

If you have doubts about this medication, consult your doctor or pharmacist before starting to take Imupret.

If symptoms persist or adverse reactions appear that are not mentioned in this leaflet, consult your doctor or pharmacist.

For those symptoms that last more than a week or if you experience difficulty breathing, fever, or if you cough up mucus with pus or blood, you should consult a doctor immediately.

Children

Children under 12 years of age should not take Imupret.

TakingImupretwithother medications

There are no reports available on clinical interactions between Imupret and other medications.

Products made with oak bark may alter the absorption of other medications that contain alkaloids.

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

The safety during pregnancy and breastfeeding has not been investigated. It is unknown whether the active substance components or their metabolites pass into breast milk. The administration of Imupret is not recommended in pregnant or breastfeeding women.

There are no available studies on its influence on fertility.

Driving and using machines

It has no influence on the ability to drive and use machinery.

Imupret contains glucose, lactose, and sucrose.

This medication contains glucose, lactose, and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Imupret

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults, adolescents, and children over 12 years of age: 2 tablets, 3 to 6 times a day.

There is not enough information available to recommend a specific dose in case of renal or hepatic function alteration.

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 more than 2 weeks consecutively.

Please read the information included in the sections: "Warnings and precautions" and "Possible side effects".

If you take moreImupretthan you should

There have been no reports of overdose cases.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the product and the amount ingested.

If you forget to takeImupret

Do not take a double dose to make up for forgotten doses

If you stop taking Imupret

In general, stopping the intake of this medication will not produce any harmful effect. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Imupret can cause side effects, although not all people experience them.

The assessment of possible side effects is based on the following frequency classification:

Possible side effects:

Allergic reactions (such as skin rash) may occur; the frequency of these reactions is not known.

When taking medications that contain chamomile flowers, hypersensitivity reactions may occur, even in people with hypersensitivity to other plants of the Compositae family, such as artemisia, yarrow, chrysanthemum, or daisies. These hypersensitivity reactions are due to what is known as cross-reactions.

• Uncommonly: gastrointestinal discomfort may occur.

If you experience side effects, consult your doctor, even if they are side effects not listed in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report it directly through the national reporting system. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Website: www.notificaRAM.es

5. Conservation of Imupret

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep the blister in the cardboard box to protect it from light and moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofImupret

Each coated tablet contains as active ingredients:

12 mg Juglandis regiaL., leaves (Walnut)

10 mg Equisetum arvenseL., sterile stems (Horsetail)

8 mg Althaea officinalisL., root (Marshmallow)

6 mg Matricaria recutitaL. (Chamomilla recutita(L.) Rauschert),flowers (Chamomile)

4 mg Quercus roburL. Q. petraea (Matt)Liebl and Q. PubescensWilld., bark (English oak, sessile oak, and downy oak)

4 mg Taraxacum officinaleWeber,aerial parts (Dandelion)

4 mg Achillea millefoliumL., flowering tops (Yarrow)

The other components are:

Calcium carbonate, glucose monohydrate, glucose liquid, potato starch, lactose monohydrate, corn starch, dextrin, glycerol montanate wax, povidone (K25, K30), castor oil, shellac lacquer (shellac gum), highly dispersed silicon dioxide, stearic acid (of vegetable origin), sucrose, talc.

.

Appearance of the product and package contents

Round, white or almost white, biconvex coated tablets with a smooth surface.

Packaging with 50 and 100 coated tablets

Only some of the package 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 last revision of this leaflet: December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/