HEUMANN

HEUMANN Bladder and Kidney Tea SOLUBITRAT uro

Important notes (mandatory information)

Heumann Blasen- und Nierentee Solubitrat uro tea infusion powder. Areas of application: for flushing in the case of inflammatory diseases of the urinary tract and as a preventative measure for kidney gravel.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Heumann Blasen- und Nierentee Solubitrat uro tea infusion powder
Active ingredients: dry extract from birch leaves, dry extract from goldenrod herb
Herbal medicinal product for flushing the urinary tract

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as instructed 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 notice any side effects, consult your doctor or pharmacist. This also applies to side effects not listed in this package leaflet.
• If you do not feel better or if you feel worse after 5 days, consult your doctor.

What this package leaflet contains

1. WHAT IS HEUMANN BLASEN– UND NIERENTEE SOLUBITRAT URO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING HEUMANN BLASEN–UND NIERENTEE SOLUBITRAT URO?
3. HOW SHOULD HEUMANN BLASEN– UND NIERENTEE SOLUBITRAT URO BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEUMANN BLASEN– UND NIERENTEE SOLUBITRAT URO BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEUMANN BLASEN- UND NIERENTEE SOLUBITRAT URO AND WHAT IS IT USED FOR?

Herbal medicinal product for flushing the urinary tract. Areas of application: For flushing in the case of inflammatory diseases of the urinary tract and as a preventative measure for kidney gravel. If there is blood in the urine, fever or if the symptoms persist for more than 5 days, it is necessary to consult a doctor.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING HEUMANN BLASEN- UND NIERENTEE SOLUBITRAT URO?

Heumann Blasen- und Nierentee Solubitrat uro must not be taken:

• if you are hypersensitive (allergic) to birch leaves or birch pollen, goldenrod herb or other members of the daisy family or to any of the other ingredients of this medicine listed in section 6,
• if you suffer from diseases in which you must pay attention to reduced fluid intake, such as in the case of severe heart and kidney diseases.

Note

Heumann Blasen- und Nierentee Solubitrat uro should not be used in the case of oedema (water retention in the tissue) as a result of impaired heart or kidney function, since flushing therapy must not be carried out in this case.

Warnings and precautions

If symptoms such as fever, difficulty or painful urination, cramps or blood in the urine occur during the use of Heumann Blasen- und Nierentee Solubitrat uro, you should consult a doctor for advice. Simultaneous treatment with synthetically produced diuretics is not recommended.

Children and adolescents

There is insufficient experience with the use of this medicine in children. Heumann Blasen- und Nierentee Solubitrat uro should therefore not be used in children under 12 years of age.

Taking Heumann Blasen- und Nierentee Solubitrat uro together with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No mutual interactions between Heumann Blasen- und Nierentee Solubitrat uro and other medicines are known to date. There are no studies with Heumann Blasen- und Nierentee Solubitrat uro on possible interactions with other medicines administered at the same time.

Pregnancy and breast-feeding

To date, no evidence of risks during pregnancy and breast-feeding has emerged from the widespread use of birch leaves and goldenrod herb as medicines. The results of experimental studies are not available. Therefore, Heumann Blasen- und Nierentee Solubitrat uro should not be taken during pregnancy and breast-feeding.

Driving and operating machinery

No effects on the ability to drive and operate machinery are known.

3. HOW SHOULD HEUMANN BLASEN- UND NIERENTEE SOLUBITRAT URO BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure.

Dosage

Unless otherwise prescribed by your doctor, the usual dose is: Adults and adolescents aged 12 and over drink a cup of Heumann Blasen- und Nierentee Solubitrat uro 3 to 5 times a day. There are no sufficient studies for children under 12 years of age.

Method of administration

Preparation: Stir 1 measuring spoon of tea infusion powder into hot or warm water (approx. 150 ml) and sweeten to taste. 1 measuring spoon corresponds to 1.2 g of tea infusion powder.

Note

Ensure that you drink plenty of fluids during the flushing therapy with Heumann Blasen- und Nierentee Solubitrat uro.

Duration of use

Goldenrod herb and birch leaf preparations are traditionally used over a period of 2 to 4 weeks. However, please note the information in the section "Areas of application" and in the section "What side effects are possible?". Please talk to your doctor or pharmacist if you have the impression that the effect of Heumann Blasen- und Nierentee Solubitrat uro is too strong or too weak.

If you have taken more Heumann Blasen- und Nierentee Solubitrat uro than you should

If you have taken more than you should, please inform a doctor. He/she can decide on any necessary measures. Cases of poisoning have not been reported. However, it is to be expected that the symptoms described under "Side effects" will occur more frequently.

If you forget to take Heumann Blasen- und Nierentee Solubitrat uro

Do not take double the amount the next time, but continue taking the medicine as described in the package leaflet or as prescribed by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Heumann Blasen- und Nierentee Solubitrat uro can cause side effects, although not everybody gets them.

The following frequency information is used to assess side effects:
Very common:	more than 1 in 10 users
Common:	1 to 10 users in 100
Uncommon:	1 to 10 users in 1,000
Rare:	1 to 10 users in 10,000
Very rare:	fewer than 1 user in 10,000
Not known:	frequency cannot be estimated from the available data.

Gastrointestinal complaints (nausea, vomiting, diarrhoea) and hypersensitivity reactions (itching, rash, hives, allergic rhinitis) may occur. The frequency is not known. If you observe any of the side effects listed above, inform a doctor, if necessary, so that he/she can decide on the severity and any necessary measures. Heumann Blasen- und Nierentee Solubitrat uro must not be taken again at the first signs of a hypersensitivity reaction.

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, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD HEUMANN BLASEN- UND NIERENTEE SOLUBITRAT URO 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 container and the folding box after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions Store in the original container. Keep Heumann Blasen- und Nierentee Solubitrat uro tightly closed in order to protect the contents from moisture. Note on shelf life after first opening: Heumann Blasen- und Nierentee Solubitrat uro can be stored for 3 months after first opening the container. The contents must not be used 3 months after opening the jar.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heumann Blasen- und Nierentee Solubitrat uro contains

The active ingredients are dry extract from birch leaves and dry extract from goldenrod herb. 1.2 g of tea infusion powder (= 1 measuring spoon) contains: Dry extract from birch leaves (4-8 :1) 224 mg, extraction agent: water; dry extract from goldenrod herb (4-7 :1) 250 mg, extraction agent: water. The other ingredients are: maltodextrin, ammonia caramel (E 150 c), orange flavouring, caramel flavouring, saccharin sodium, bitter fennel oil.

Notes

Heumann Blasen- und Nierentee Solubitrat uro is also suitable for diabetics. One measuring spoon (= 1.2 g) of the tea infusion powder contains approx. 0.69 g of carbohydrates, corresponding to 0.06 BE. Heumann Blasen- und Nierentee Solubitrat uro is gluten-free and can therefore be drunk in the case of coeliac disease and non-tropical sprue.

A medical device (1 measuring spoon) is enclosed with this medicine. Manufacturer: Winthrop Arzneimittel GmbH 65927 Frankfurt am Main.

What Heumann Blasen- und Nierentee Solubitrat uro looks like and contents of the pack

Pack with 30 g of tea infusion powder (corresponding to approx. 25 cups) plus measuring spoon and pack with 60 g of tea infusion powder (corresponding to approx. 50 cups) plus 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*

Co-distributor

Zentiva Pharma GmbH
65927 Frankfurt am Main

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

This package leaflet was last revised in October 2014.

Source: Information from the package leaflet
Status: 10/2017
Areas of application: for flushing in the case of inflammatory diseases of the urinary tract and as a preventative measure for kidney gravel.