Mituret

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Mituret

Dry extract of ivy leaves
(Hederae helicis folii extractum siccum)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Mituret and what is it used for
• 2. Important information before taking Mituret
• 3. How to take Mituret
• 4. Possible side effects
• 5. How to store Mituret
• 6. Contents of the packaging and other information

1. What is Mituret and what is it used for

Mituret is a herbal medicinal product used as an expectorant in the case of productive (wet) cough. The product contains dry extract of ivy leaves (Hedera helixL., folium).
Mituret is indicated for use in adults, adolescents, and children over 2 years of age.
If after 5 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Mituret

When not to use Mituret:

• if you are allergic to ivy, other plants of the Araliaceaefamily, or any of the other ingredients of the medicine (listed in section 6).
• in children under 2 years of age, as respiratory disorders may worsen in this patient group during the use of secretolytic medicines.

Warnings and precautions

Before taking Mituret, you should discuss it with your doctor in the following cases:

• shortness of breath, fever, or purulent discharge,
• symptoms persisting for more than 5 days,
• taking opioid cough medicines, such as codeine or dextromethorphan,
• stomach inflammation or stomach ulcers.

Children

• Do not use in children under 2 years of age. See the section "When not to use Mituret".
• In the case of persistent or recurrent cough in children from 2 to 4 years of age, you should consult a doctor before using the medicine, and a medical diagnosis should be made before starting treatment.

Mituret and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. No interactions with other medicinal products or other types of interactions have been reported. Systematic interaction studies have not been conducted. Therefore, it cannot be excluded that the effect of other medicinal products may be enhanced or weakened.

Mituret with food, drink, and alcohol

No interactions with food, drink, or alcohol have been observed.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breastfeeding
The safety of use during pregnancy and lactation has not been established. Due to the lack of sufficient data, use during pregnancy and lactation is not recommended.
Fertility
There are no data on the effect on fertility.

Driving and using machines

No studies have been conducted on the effect of the product on the ability to drive and use machines.

Mituret contains:

• 5.55 mg of benzoic acid(E210) per 5 ml, which corresponds to 1.11 mg/ml.
• Lactose. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.
• 1.35 g of sorbitol(E420) per 5 ml, which corresponds to 269.2 mg/ml. Sorbitol is a source of fructose. If you have been diagnosed with an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.

3. How to take Mituret

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Recommended dose:

Mituret is taken orally. The packaging contains a measuring cup to measure the correct dose.
There are insufficient data to provide detailed dosage recommendations in the case of renal and hepatic impairment.
If symptoms do not improve after 5 days of using the medicinal product, you should consult your doctor.

Taking a higher dose of Mituret than recommended

You should immediately inform your doctor or pharmacist if you have taken a higher dose of Mituret than recommended.
Overdose of ivy leaf extracts may cause nausea, vomiting, diarrhea, and excitement. In the case of symptoms of poisoning or overdose, symptomatic treatment is necessary.

Missing a dose of Mituret

You should not take a double dose to make up for a missed dose.

Stopping Mituret treatment

This does not apply.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mituret can cause side effects, although not everybody gets them.
The following side effects have been reported (frequency not known):

• Hypersensitivity reactions, such as hives, rash, shortness of breath, or anaphylactic reaction. Symptoms indicating an anaphylactic reaction include: itching of the skin, hives (similar to nettle rash), redness, swelling of the lips, throat, tongue, hands, and feet, wheezing, hoarseness, nausea, vomiting, abdominal cramps, and in some cases, loss of consciousness.

If you experience hypersensitivity symptoms, you should stop taking Mituret and contact your doctor. In the case of a severe hypersensitivity reaction, you should immediately contact your doctor.

• Gastrointestinal disorders, such as nausea, vomiting, or diarrhea.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Mituret

The medicine should be stored out of sight and reach of children.
After first opening, store in a temperature below 25°C.
Shelf life after first opening: 28 days.
Do not use this medicine after the expiry date stated on the packaging and bottle (after the abbreviation: "EXP"). The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mituret contains

The active substance of the medicine is:
Dry extract of ivy leaves (Hedera helixL., folium). 1 ml of syrup (which corresponds to 1.1 g) contains 5.4 mg of extract (dry) of Hedera helixL., folium(ivy leaf) (5-7.5:1). Extraction solvent: Ethanol 30% (m/m).
The other ingredients are:
Lactose monohydrate, sorbitol (liquid, non-crystallizing, E420), benzoic acid (E210), xanthan gum, ammonium glycyrrhizinate, eucalyptus essential oil (Eucalyptusradiata, Sieber ex DC), and purified water.

What Mituret looks like and contents of the packaging

A clear, green liquid with a characteristic odor in an orange glass bottle with a capacity of 150 ml or 200 ml, with a measuring cup and a child-resistant closure made of plastic.

Marketing authorization holder and manufacturer

Conforma NV
+21 9 228 20 00
Zenderstraat 10
9070 Destelbergen
Belgium

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

BE:
Hedera-Vemedia syrup
DE:
Pulmocap Hedera, syrup
ES:
Hedetus, jarabe
FR:
Hedetus, sirop
LU:
Hedera-Vemedia sirop
NL:
Natterman Hedera, stroop
PL:
Mituret, syrup
PT:
Pulmocap Hedera, xarope

Date of last revision of the leaflet:

12/2024