HEUMANN

HEUMANN Bronchial Tea Solubifix T

Important notes (mandatory information)

Heumann Bronchialtee Solubifix T, tea infusion powder. Areas of application: traditionally used to support the loosening of mucus in the respiratory tract.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Heumann Bronchialtee Solubifix T, tea infusion powder
Active ingredients: liquorice root dry extract, marshmallow root dry extract, primrose root dry extract, thyme oil
Herbal medicinal product

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you do not feel better or if you feel worse after one week, consult your doctor.
• If you notice any side effects, consult your doctor or pharmacist. This also applies to side effects not listed in this package leaflet.

What this package leaflet contains

1. WHAT IS HEUMANN BRONCHIALTEE SOLUBIFIX T AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HEUMANN BRONCHIALTEE SOLUBIFIX T?
3. HOW SHOULD HEUMANN BRONCHIALTEE SOLUBIFIX T BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEUMANN BRONCHIALTEE SOLUBIFIX T BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEUMANN BRONCHIALTEE SOLUBIFIX T AND WHAT IS IT USED FOR?

Heumann Bronchialtee Solubifix T is a traditional herbal medicinal product. Areas of application: Heumann Bronchialtee Solubifix T is traditionally used to support the loosening of mucus in the respiratory tract. The medicinal product is a traditional medicinal product that is registered exclusively on the basis of many years of use for the area of application.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HEUMANN BRONCHIALTEE SOLUBIFIX T?

You should not take Heumann Bronchialtee Solubifix T if you are hypersensitive (allergic) to anise, anethole, primroses, any of the other active ingredients or any of the other ingredients listed in section 6 of this medicine.

Warnings and precautions

Please talk to your doctor or pharmacist before continuing to take Heumann Bronchialtee Solubifix T if the symptoms worsen while taking the medicine. Medicines containing liquorice root should be used with caution in patients with high blood pressure, kidney, liver or heart disease or low blood potassium levels (hypokalaemia), as these patients may be particularly sensitive to the adverse effects of liquorice root. Concomitant use of diuretics, cardiac glycosides, corticosteroids, laxatives (laxatives) or other medicines that affect electrolyte balance is not recommended (see section "Taking Heumann Bronchialtee Solubifix T with other medicines").

Children and adolescents

There are no adequate studies on the use of this medicine in children and adolescents under 18 years of age. Heumann Bronchialtee Solubifix T should therefore not be used in children and adolescents under 18 years of age.

You should not take Heumann Bronchialtee Solubifix T during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding"). If symptoms persist for more than one week, if you have shortness of breath, fever or purulent or bloody sputum, you should see a doctor immediately.

Taking Heumann Bronchialtee Solubifix T with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Liquorice root may counteract the blood pressure lowering effect of prescribed medicines. Potassium losses can be increased by concomitant intake of liquorice root preparations with certain medicines that increase urinary excretion (e.g. spironolactone, amiloride, triamterene and so-called thiazide or loop diuretics such as hydrochlorothiazide or furosemide), cortisone or cortisone-like substances (adrenal corticosteroids) and laxatives, as well as other medicines that affect electrolyte balance. Potassium deficiency may increase the effect of certain medicines that strengthen the heart muscle (cardiac glycosides) and influence the effect of medicines for heart rhythm disorders. The effect of Heumann Bronchialtee Solubifix T may be increased by concomitant intake of hormonal contraceptives.

Note

The absorption (resorption) of other medicines taken at the same time may be delayed. As a precaution, Heumann Bronchialtee Solubifix T should not be taken V2-I hour before or after taking other medicines.

Taking Heumann Bronchialtee Solubifix T with food, drinks and alcohol

During treatment with Heumann Bronchialtee Solubifix T, you should avoid consuming foods containing liquorice root (e.g. liquorice) at the same time, as this can lead to serious adverse effects such as reduced water excretion by the kidneys, low blood potassium levels, high blood pressure and heart rhythm disorders.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine. There are no adequate studies on the use in pregnancy and breastfeeding. Liquorice root (e.g. also in liquorice) shows mineralocorticoid effects (influencing certain hormones) with prolonged use and higher dosage. Due to the suspicion that the sensitivity to liquorice root is increased by oral contraceptives ("the pill"), it must be considered that a similar effect can be caused by the hormonal changes during pregnancy. Taking the medicine is not recommended for pregnant women. This also means that use is not recommended for women of childbearing age who are not using contraception because of the risk of a possible early pregnancy. It is not known whether the components from the active ingredients or their degradation products pass into breast milk. A risk to breast-fed infants cannot be ruled out. Heumann Bronchialtee Solubifix T should not be taken by breastfeeding women. Animal studies have shown reproductive toxicity (may impair fertility and may harm the unborn child). There are no studies on the effects on fertility.

Driving and using machines

Effects on the ability to drive and use machines are not known so far.

Heumann Bronchialtee Solubifix T contains fructose, glucose and sucrose

This medicine contains fructose, glucose and sucrose. Please only take Heumann Bronchialtee Solubifix T after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Heumann Bronchialtee Solubifix T can be harmful to your teeth (caries).

3. HOW SHOULD HEUMANN BRONCHIALTEE SOLUBIFIX T BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Unless otherwise prescribed, drink 1 cup of tea as hot as possible several times a day. In general, this means 3 - 6 cups of tea daily. Use in children and adolescents under 18 years of age is not recommended (see section "Warnings and precautions").

Note

1 measuring spoon (1.2 g) contains approx. 1 g of carbohydrates, corresponding to 0.09 BE. The calorific value is 2.3 kcal/g.

Method of administration

For oral use. Preparation: Stir 1 measuring spoon with hot water (approx. 150 ml) and sweeten to taste.

Duration of use

Heumann Bronchialtee Solubifix T should not be taken for longer than 4-6 weeks. If symptoms persist for more than 1 week while taking Heumann Bronchialtee Solubifix T, a doctor should be consulted. Please note the information under "1. What is Heumann Bronchialtee Solubifix T and what is it used for?".

If you have taken more Heumann Bronchialtee Solubifix T than you should

If you have taken too much Heumann Bronchialtee Solubifix T, please inform your doctor. He can decide on any necessary measures. High doses lead to a reduction in water and sodium excretion by the kidneys, potassium deficiency, heart rhythm disorders, a non-inflammatory brain disease caused by high blood pressure (hypertensive encephalopathy) and high blood pressure.

If you forget to take Heumann Bronchialtee Solubifix T

If you have taken too little Heumann Bronchialtee Solubifix T or if you have forgotten to take Heumann Bronchialtee Solubifix T, do not take twice the amount next time, but continue taking the medicine as prescribed by your doctor or as described in the dosage instructions.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following category is used for the frequency of side effects: The frequency of the side effects listed below is given as "not known" because the frequency cannot be estimated from the available data. Allergic reactions (respiratory tract, skin) and gastrointestinal complaints may occur. Furthermore, there is a possibility of heart rhythm disorders and a non-inflammatory brain disease caused by high blood pressure (hypertensive encephalopathy). Preparations containing liquorice root (liquorice) can lead to an influence on the mineral metabolism, especially with prolonged use. This manifests itself in the form of retention of sodium and water, loss of potassium with high blood pressure or fluid retention in the tissue, especially when taken together with medicines that strengthen the heart muscle (cardiac glycosides), medicines that increase urinary excretion and laxatives or hormonal contraceptives. A reduction in the potassium content in the blood with muscle weakness and in rare cases loss of myoglobin (red muscle pigment/protein) via the kidneys can occur. If you observe any of the above side effects, especially hypersensitivity reactions (signs such as facial swelling or itchy skin redness), fluid retention in the tissue and muscle weakness, stop taking Heumann Bronchialtee Solubifix T and consult your doctor so that he can decide on the severity and any necessary measures.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD HEUMANN BRONCHIALTEE SOLUBIFIX T BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and container after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Close tightly after use. Note on shelf life after opening the container. Use contents within 6 months after opening the jar.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heumann Bronchialtee Solubifix T contains

1.2 g tea infusion powder (= 1 measuring spoon) contains as active ingredients: 120.0 mg dry extract from liquorice root (3-4:1), extraction agent: water; 65.0 mg dry extract from marshmallow root (7-9:1), extraction agent: water; 10.0 mg dry extract from primrose root (5-7:1), extraction agent: ethanol 60% (m/m); 1.2 mg thyme oil. The other ingredients are: maltodextrin, spray-dried glucose syrup, gum arabic, anise oil, fructose (Ph. Eur.), sucrose (saccharose); colouring agent: ammonia caramel E 150c.

Note

1 measuring spoon of Heumann Bronchialtee Solubifix T contains approx. 1 g of carbohydrates, corresponding to 0.09 BE. Heumann Bronchialtee Solubifix T is gluten-free and can therefore be drunk with chronic disease of the small intestinal mucosa (coeliac disease) and with an intolerance to gluten (domestic sprue).

Contents of the pack

Original pack (OP) with 30 g tea infusion powder (corresponding to approx. 25 cups) + measuring spoon and with 60 g tea infusion powder (corresponding to approx. 50 cups) + measuring spoon.

Pharmaceutical entrepreneur and manufacturer

Winthrop Arzneimittel GmbH
65927 Frankfurt am Main
Telephone: (01 80) 2 02 00 10*
Telefax: (01 80) 2 02 00 11*

*0.06 EUR/call (German landline); max. 0.42 EUR/min (mobile).

Co-distributor

Zentiva Pharma GmbH
65927 Frankfurt am Main

This leaflet was last revised in December 2016.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: traditionally used to support the loosening of mucus in the respiratory tract.