Leaflet:information for the user

Imupret®coated tablets

Read this leaflet carefully beforestarting totake this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor orpharmacist.

-Keep this leaflet, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-Ifyou experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this leaflet.See section 4.

-You should consult a doctor if you get worse or do not improveafter 7 days.

1.What isImupretand what it is used for

2.What you need to know beforestarting totakeImupret

3.How to takeImupret

4.Adverse effects

5Storage ofImupret

6.Contents of the package and additional information

Imupretis atraditional medicine based on plants for the relief of symptoms of a cold such as itching and throat irritation and dry cough.

It is indicated for adults, adolescents, and children over 12 years old.

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

Imupretis atraditional medicine based on plants registeredonly based on its long experience of use in this indication.

Do not take Imupret

• if you are allergic (hypersensitive) to marshmallow root, chamomile flowers, horse tail stalk, walnut leaves, milenrama stalk, oak bark, lion's tooth stalk, or 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 any doubts about this medication, consult your doctor or pharmacist before starting to take Imupret.

If symptoms persist or you experience adverse reactions different from those mentioned in this prospectus, consult your doctor or pharmacist.

For 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 must consult your doctor immediately.

Children

Children under 12 years of age should not take Imupret.

Taking Imupret with other medications

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

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

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

Pregnancy, lactation, and fertility

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

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

No studies are available on its influence on fertility.

Driving and operating machinery

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

Imupret contains glucose, lactose, and saccharose.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

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

Administration form:

The coated tablets must be swallowed whole, without chewing or sucking, with a glass of water or other liquid.

Treatment duration:

Imupret should not be taken for more than 2 weeks consecutively.

Please read the information included in the sections: “Warnings and precautions” and “Possible adverse effects”.

If you take moreImupretthan you should

No cases of intoxication due to overdosing have been reported.

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

If you forgot to takeImupret

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Imupret

Generally, interrupting the intake of this medication will not cause any harmful effects. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Imupret may cause adverse effects, although not everyone will experience them.

The evaluation of possible adverse effects is based on the following frequency classification:

Possible Adverse Effects:

Allergic reactions (e.g. skin rash) may occur, but the frequency of these reactions is unknown.

When taking medications containing chamomile flowers, hypersensitivity reactions may occur, even in people with hypersensitivity to other plants in the Compositae family, such as artemisia, calendula, chrysanthemum, and marigold. These hypersensitivity reactions are due to what is known as cross-reactions.

- Infrequently: gastrointestinal discomfort may occur.

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

Reporting Adverse Effects

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

Website: www.notificaRAM.es

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blisterafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C).

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofImupret

Each coated tablet contains as active ingredients:

12 mgEnglish walnut (Juglandis regia)L.,leaves (Walnut)

10 mgEquisetum arvenseL.,sterile stems (Horsetail)

8 mgAlthaea officinalisL.,root (Marshmallow)

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

4 mgQuercus roburL.Q. petraea (Matt)LieblyQ. PubescensWilld., bark (Common, pedunculate and sessile oak)

4 mgTaraxacum officinaleWeber,aerial parts (Dandelion)

4 mgAchillea millefoliumL., flowering tops (Yarrow)

The other components are:

Calcium carbonate, glucose monohydrate, liquid glucose, potato starch, lactose monohydrate, cornstarch, dextrin, glycerol monostearate, povidone (K25, K30), castor oil, shellac (lac resin), highly dispersible silicon dioxide, vegetable stearic acid, sucrose, talc.

.

Appearance of the product and contents of the container

Coated round, white or almost white, biconvex tablets with a smooth surface.

Containers with 50 and 100 coated tablets

Only one of the container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

BIONORICA SE

Kerschensteinerstrasse 11-15

92318 Neumarkt

Germany

Phone: +49 / 9181 / 231-90

Fax: +49 / 9181 / 231-265

Email: [email protected]

Last review date of this leaflet: December 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/