Mituret

Package leaflet: Information for the patient

Mituret
Dry extract of ivy leaves
(Hederae helicis folii extractum siccum)
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of contents

1. What Mituret is and what it is 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 pack and other information

1. What Mituret is and what it is used for

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

2. Important information before taking Mituret

When not to use Mituret:

• if the patient is allergic to ivy, other plants from the family Araliaceae, or any of the other ingredients of the medicine (listed in section 6).
• in children under 2 years of age, as respiratory disorders may generally worsen in this patient group during treatment with secretolytic medicines.

Warnings and precautions
Before starting to take Mituret, consult a doctor if:

• shortness of breath (difficulty breathing), fever or purulent discharge occur,
• symptoms persist for more than 5 days,
• opioid antitussive medicines such as codeine or dextromethorphan are being taken,
• gastric inflammation or peptic ulcer is present.

Children

• Do not use in children under 2 years of age. See section "When not to use Mituret".
• In case of persistent or recurrent cough in children aged 2 to 4 years, consult a doctor before using the medicine; a medical diagnosis is recommended before starting treatment.

Mituret with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans 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 diminished.

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy and breastfeeding
The safety of use during pregnancy and lactation has not been established. Due to insufficient data, use during pregnancy and lactation is not recommended.

Fertility
No data are available regarding the effect on fertility.

Driving and operating machinery
No studies on the effect of the product on the ability to drive motor vehicles or operate machinery have been conducted.

Mituret contains:

• 5.55 mg of benzoic acid (E210) per 5 ml, equivalent to 1.11 mg/ml.
• lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
• 1.35 g of sorbitol (E420) per 5 ml, equivalent to 269.2 mg/ml. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to the child.

3. How to take Mituret

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:

Mituret is taken orally. The packaging contains a dosing cup for measuring the correct dose.
Available data are insufficient to provide detailed dosage recommendations in the case of
renal or hepatic impairment.
If symptoms do not improve after 5 days of using the medicinal product, consult a doctor.
Taking more than the recommended dose of Mituret
Immediately inform a doctor or pharmacist if more than the recommended dose of the medicine has been taken.
Overdose of ivy leaf extracts may cause nausea, vomiting, diarrhea, and agitation. In case of symptoms of poisoning or overdose, symptomatic treatment is required.
Missed dose of Mituret
Do not take a double dose to make up for a missed dose.
Stopping treatment with Mituret
Not applicable.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported (frequency unknown):

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

If symptoms of hypersensitivity occur, discontinue taking Mituret and contact your doctor. In case of a severe hypersensitivity reaction, seek immediate medical attention.

• Gastrointestinal disturbances such as nausea, vomiting or diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to gather additional information on the safety of the medicine.
Adverse reactions may also be reported to the marketing authorisation holder.

5. How to store Mituret

Keep the medicine out of sight and reach of children.
After first opening, store below 25°C.
Keep out of the reach of children.
Expiry date after first opening: 28 days.
Do not use this medicine after the expiry date stated on the packaging and bottle (marked as "EXP"). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Mituret contains
The active substance in Mituret is:
Dry extract of ivy leaves (Hedera helix L., folium). 1 ml of syrup (corresponding to 1.1 g) contains 5.4 mg
of dry extract from Hedera helix L., folium (ivy leaf) (5–7.5:1). Extraction solvent: Ethanol
30% (m/m).
Other ingredients are:
Monohydrate lactose, sorbitol (liquid, non-crystallizing, E420), benzoic acid (E210), xanthan gum,
ammonium glycyrrhizinate, eucalyptus essential oil (Eucalyptus radiata, Sieber ex DC), and purified water.
What Mituret looks like and contents of the pack
A transparent, green liquid with a characteristic odour, in a 150 ml or 200 ml amber glass bottle with a measuring device and a child-resistant closure made of plastic.
Marketing Authorisation Holder and Manufacturer
Conforma NV
+21 9 228 20 00
Zenderstraat 10
9070 Destelbergen
Belgium
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
BE: Hedera-Vemedia siroop
DE: Pulmocap Hedera, Sirup
ES: Hedetus, jarabe
FR: Hedetus, sirop
LU: Hedera-Vemedia sirop
NL: Natterman Hedera, stroop
PL: Mituret, syrop
PT: Pulmocap Hedera, xarope
12/2024