Edera Dr. Theiss: detailed information

Patient Information Leaflet

Edera Dr. Theiss syrup

Active substance: Dry extract of ivy leaf
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need 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.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet

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

1. What Edera Dr. Theiss is and what it is used for

Edera Dr. Theiss contains dry extract of ivy leaf.
Edera Dr. Theiss is a herbal medicinal product used as an expectorant in the case of productive cough in adults, adolescents, and children from the age of 2 years.
Consult your doctor if you do not feel better or feel worse after 7 days.

2. What you need to know before taking Edera Dr. Theiss

Do not take Edera Dr. Theiss

if you are allergic to ivy, to plants of the Araliaceae family (ivy), or to any of the other ingredients of this medicine (listed in section 6).
in children under 2 years of age due to the risk of worsening respiratory symptoms with secretolytic drugs.

Warnings and precautions

In case of persistent or recurrent cough in children aged between 2 and 4 years, a medical diagnosis is required before treatment.
If you experience breathing difficulties, fever, or purulent mucus (containing pus), you must consult your doctor or a pharmacist.
If symptoms do not improve after 7 days of using the medicine, you must consult a doctor.
It is recommended not to take this medicine together with other cough-suppressant medicines (opioid antitussives such as codeine or dextromethorphan) without medical advice.
If you suffer from stomach problems (gastritis, gastric ulcer), this medicine should be used with caution.
If you have renal insufficiency or hepatic impairment, consult your doctor or pharmacist before taking Edera Dr. Theiss. Data regarding dosage recommendations in these patients are not available.

Other medicines and Edera Dr. Theiss
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No interactions with other medicines or other forms of interaction have been reported for Edera Dr. Theiss.
Interaction studies have not been conducted.
Edera Dr. Theiss with food and drink
Edera Dr. Theiss can be taken regardless of meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Edera Dr. Theiss is not recommended during pregnancy and breastfeeding because data on the use
of dry ivy leaf extract in pregnant women and breastfeeding mothers are insufficient.
Driving and using machines
No studies have been performed to evaluate the effect on the ability to drive vehicles and use machines.
No effects of Edera Dr. Theiss on the ability to drive vehicles and use machines have been reported.
Edera Dr. Theiss contains liquid maltitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
10 ml contain 4 g of liquid maltitol, equivalent to 0.3 bread units. Take this into account if you have
diabetes mellitus. The caloric value of maltitol is 2.3 kcal/g.
Liquid maltitol may have a mild laxative effect.

3. How to take Edera Dr. Theiss

Take this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:

for adults and adolescents over 12 years: 15 ml three times a day.
for children aged 6–11 years: 15 ml twice a day.
for children aged 2–5 years: 10 ml twice a day.

Children under two years of age:
Use is contraindicated.
Use the provided measuring cup to ensure the correct dose.
Patients with renal impairment or hepatic impairment: Due to lack of data, a dosage recommendation cannot be made (see also “Warnings and precautions”).
Edera Dr. Theiss should be taken undiluted and independently of meals.
During the day, while taking Edera Dr. Theiss, you should drink plenty of water or other warm, non-caffeinated beverages.
If symptoms persist for more than one week during treatment with this product, consult your doctor or pharmacist.
If the effect of Edera Dr. Theiss appears too strong or too weak, consult your doctor or pharmacist.
If you take more Edera Dr. Theiss than you should
Do not take higher doses than indicated. Administration of doses exceeding the recommended amount (more than three times the single dose) may cause nausea, vomiting, diarrhoea, and agitation. Please consult a doctor, who will decide on the necessary treatment.
One case has been reported of a 4-year-old child who developed aggression and diarrhoea following accidental ingestion of ivy extract equivalent to 1.8 g of plant-derived substance (equal to 195 ml of Edera Dr. Theiss).
If you forget to take Edera Dr. Theiss
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported. Frequency is unknown.
Allergic reactions have been reported, presenting as hives, skin rashes, breathing difficulties (dyspnoea), and anaphylactic reaction. Frequency is unknown.
If you experience any allergic reaction, stop taking this medicine and consult your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edera Dr. Theiss

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp:". The expiry date refers to the last day of that month.
Do not store above 25°C.
The medicine can be used for up to 6 weeks after first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Edera Dr. Theiss contains

The active substance is dried ivy leaf extract. One ml contains 1.54 mg of extract (as dry extract) from Hedera helix L. folium (ivy leaf) (DER 4-8:1). Extraction solvent: ethanol 30% (m/m).
The other ingredients are potassium sorbate; hydroxyethylcellulose; black currant SD (652281) flavour; liquid maltitol (E 965); citric acid; purified water.

Description of the appearance of Edera Dr. Theiss and package contents
Edera Dr. Theiss is a slightly cloudy yellowish-brown syrup with a characteristic odour (blackcurrant).
Edera Dr. Theiss is available in pack sizes of 100 ml, 200 ml and 250 ml syrup in a brown glass bottle with an attached dosing cup.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Theiss Naturwaren GmbH
Michelinstraße 10
66424 Homburg
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Mucoplant Hustensaft Efeu Sirup
Bulgaria Мукоплант експекторант с бръшлян 154 mg/100 ml, сироп
Croatia Mucoplant sirup od bršljana
Czech Republic Mucoplant proti kašli s břečťanem
Germany Mucoplant Hustensaft Efeu
Hungary Mucoplant Dr. Theiss Borostyán köhögés elleni szirup
Italy Edera Dr. Theiss
Latvia Dr. Theiss efejas sīrups
Lithuania Helixicum sirupas
Poland Mucoplant na kaszel bluszcz
Romania Mucoplant iederă 1,54 mg/ml sirop
Slovakia Mucoplant sirup proti kašľu s brečtanom

Package leaflet: Information for the patient

Ivy Dr. Theiss

Sachet syrup
Dry extract of ivy leaves

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 advised.

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

Contents of this leaflet:

What Ivy Dr. Theiss is and what it is used for
What you need to know before taking Ivy Dr. Theiss
How to take Ivy Dr. Theiss
Possible side effects
How to store Ivy Dr. Theiss
Contents of the pack and other information

1. What Edera Dr. Theiss is and what it is used for

Edera Dr. Theiss contains dried ivy leaf extract.
Edera Dr. Theiss is a herbal medicinal product used as an expectorant in productive cough in adults, adolescents, and children from 6 years of age.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before taking Edera Dr. Theiss

Do not take Edera Dr. Theiss

if you are allergic to ivy, to other plants of the family Araliaceae (ivy family), or to any of the other ingredients of this medicine (listed in section 6).
in children under 2 years of age due to the risk of worsening respiratory symptoms with secretolytic drugs (medicines that promote the production of thin mucus).

Warnings and precautions
Talk to your doctor or pharmacist before taking Edera Dr. Theiss.

If you experience breathing difficulties, fever, or purulent mucus (containing pus), you must consult your doctor or a pharmacist.
If you suffer from stomach problems (gastritis, gastric ulcer), this medicine should be used with caution.

Children
Do not administer this medicine to children under 2 years of age due to the risk of
worsening respiratory symptoms (see "Do not take Edera Dr. Theiss").
Edera Dr. Theiss in sachets is not suitable for use in children under 6 years of age because
the amount of active substance per sachet is not appropriate for this age group. An alternative
pharmaceutical form and dosage (Edera Dr. Theiss Syrup) is available for children under 6 years of age.
Other medicines and Edera Dr. Theiss
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. Interaction studies have not been conducted.
Edera Dr. Theiss with food and drinks
Edera Dr. Theiss can be taken regardless of meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Edera Dr. Theiss is not recommended during pregnancy and breastfeeding because data on the use
of dry ivy leaf extract in pregnant women and breastfeeding mothers are insufficient.
Driving and using machines
No studies have been conducted to evaluate the effect on the ability to drive vehicles or
operate machinery.
Edera Dr. Theiss contains liquid maltitol (containing sorbitol)
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before
taking this medicine.
This medicine contains up to 137 mg of sorbitol in each sachet.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have
an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI),
a rare genetic condition in which a person is unable to metabolize fructose, speak with your
doctor before you (or your child) take or receive this medicine.

3. How to take Edera Dr. Theiss

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:

for adolescents over 12 years of age, adults and elderly: One 5 ml sachet three times a day.
for children from 6 to 11 years of age: One 5 ml sachet twice a day.

Children under 6 years of age:
Edera Dr. Theiss is not suitable for children under 6 years of age (see section "Warnings and precautions") and must not be used in children under 2 years of age (see section "Do not take Edera Dr. Theiss").
Patients with renal or hepatic impairment:
Due to lack of data, a recommended dose cannot be established.
Edera Dr. Theiss should be taken undiluted and independently of meals.
Gently massage the sachet before use.
During the day, drink plenty of water or other warm, caffeine-free beverages while taking Edera Dr. Theiss.
If symptoms persist for more than one week during treatment with this product, consult your doctor or pharmacist.
If you take more Edera Dr. Theiss than you should
Do not take higher doses than indicated. Taking doses exceeding the recommended amount (more than three times the single dose) may cause nausea, vomiting, diarrhoea and agitation. Please consult a doctor, who will decide on the necessary treatment.
One case has been reported of a 4-year-old child who developed aggression and diarrhoea following accidental ingestion of ivy extract equivalent to 1.8 g of plant-derived substance (corresponding to 45 ml, i.e. 9 sachets of Edera Dr. Theiss).
If you forget to take Edera Dr. Theiss
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported. Frequency is not known (frequency cannot be estimated from the available data).
Allergic reactions have been reported, manifesting as urticaria, skin rash, breathing difficulties (dyspnoea), and anaphylactic reaction. Frequency is not known.
If you experience an allergic reaction, stop taking this medicine and consult your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Edera Dr. Theiss

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Edera Dr. Theiss contains

The active substance is dried ivy leaf extract. One sachet (5 ml) contains 33 mg of extract (as dry extract) of Hedera helix L. folium (ivy leaf) (DER 4 - 8 : 1). Extraction solvent: Ethanol 30% (m/m).
The other components are: Potassium sorbate (E 202), hydroxyethylcellulose, blackcurrant flavour SD (652281), maltitol liquid (E 965) (containing sorbitol (E 420)), citric acid, purified water.

Description of the appearance of Edera Dr. Theiss and package contents
Edera Dr. Theiss is a syrup ranging from yellowish-brown to dark brown, slightly cloudy, with a characteristic odour (blackcurrant).
Edera Dr. Theiss is available in 5 ml sachets. Folded cartons containing 15 x 5 ml, 21 x 5 ml and 30 x 5 ml sachets are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Theiss Naturwaren GmbH
Michelinstraße 10
66424 Homburg
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Мукоплант експекторант с Бръшлян Форте, 33 mg сироп в саше
Czech Republic Mucoplant proti kašli s břečťanem forte
Croatia Mucoplant forte sirup od bršljana u vrećici
Italy Edera Dr. Theiss
Hungary Mucoplant Borostyán forte köhögés elleni szirup tasakban
Lithuania Helixicum intens sirupas paketėlyje
Latvia Dr. Theiss efejas forte sīrups paciņā
Poland Mucoplant na kaszel bluszcz forte
Austria Mucoplant Hustensaft Efeu forte Sirup im Beutel
Romania Mucoplant iederă Forte 33 mg sirop în plic
Slovakia Mucoplant sirup vo vrecku proti kašľu s brečtanom forte