SINUPRET

SINUPRET Juice

Important notes (mandatory information)

Sinupret Saft, syrup. Areas of application: for improving symptoms of acute inflammation of the paranasal sinuses. Warning: Contains 8% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sinupret Saft, syrup for oral use for children aged 2 and over and adults
Active ingredients: gentian root cut, vervain cut, garden sorrel herb cut, elderflowers picked, cowslip flowers with calyx cut
Herbal medicinal product

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, to achieve the best possible treatment results, Sinupret Saft must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 7 – 14 days, you must consult a doctor.
• If any of the listed side effects affect you significantly or you notice side effects that are not listed in this leaflet, please inform your doctor or pharmacist.

This leaflet contains

1. WHAT IS SINUPRET SAFT AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING SINUPRET SAFT?
3. HOW TO TAKE SINUPRET SAFT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SINUPRET SAFT?
6. FURTHER INFORMATION

1. WHAT IS SINUPRET SAFT AND WHAT IS IT USED FOR?

Sinupret Saft is a herbal medicinal product for inflammation of the paranasal sinuses. Sinupret Saft is used to improve symptoms of acute inflammation of the paranasal sinuses.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING SINUPRET SAFT?

Sinupret Saft must not be taken if you are hypersensitive (allergic) to gentian root, vervain, garden sorrel herb, elderflowers, cowslip flowers or any of the other ingredients of this medicine (other ingredients are listed under section 6 Further information).

Special care must be taken when taking Sinupret Saft

If symptoms persist for more than 7 -14 days or recur periodically, a doctor must be consulted.

Children

The medicine should not be used in children under 2 years of age. There are currently no sufficient studies on the use of Sinupret Saft in children under 2 years of age.

When taking Sinupret Saft with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Interactions with other medicines are not known to date.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Like all medicines, Sinupret Saft should only be used during pregnancy and breast-feeding after careful consideration of the benefits and risks by the doctor. Due to the alcohol content, Sinupret Saft should only be taken during pregnancy and breast-feeding if it is not possible to take Sinupret, film-coated tablets.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Sinupret Saft

The medicine contains 8% alcohol by volume.

This medicine contains maltitol solution

Please only take Sinupret Saft after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 7.0 ml contains 5.5 g maltitol solution corresponding to approx. 0.35 bread units (BU). If you are on a diabetic diet, you should take this into account. The calorific value is 2.3 kcal/g maltitol solution. Maltitol solution can have a slightly laxative effect.

3. HOW TO TAKE SINUPRET SAFT?

Always take Sinupret Saft exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Age	Single dose	Total daily dose
Children under 2 years	Not intended for use.
Children aged 2 – 5 years	2.1 ml = 2.5 g	6.3 ml = 7.5 g (3 times 2.1 ml)
Children aged 6 –11 years	3.5 ml = 4.2 g	10.5ml = 12.6 g (3 times 3.5 ml)
Adults and adolescents aged 12 and over	7.0 ml = 8.4 g	21.0 ml = 25.2 g (3 times 7.0 ml)

Method of administration

Dose with the enclosed measuring cup and take Sinupret Saft 3 times a day (morning, noon and evening) undiluted or in a little water. If necessary, you can rinse with liquid (no alcohol), preferably a glass of drinking water. Sinupret Saft can be taken with food, with drinks or independently of meals. If you have a sensitive stomach, you should take Sinupret Saft after meals. Shake before use!

Duration of use

The duration of use is, unless otherwise prescribed: 7 -14 days. If there is no improvement by then, please consult a doctor.

If you have taken more Sinupret Saft than you should

If you have taken more Sinupret Saft than you should, please notify a doctor. They can decide on any necessary measures. The side effects listed below may occur more frequently.

If you forget to take Sinupret Saft

If you accidentally take too little or forget to take Sinupret Saft, do not take double the amount the next time, but continue taking Sinupret Saft as prescribed by your doctor or as described in the leaflet.

If you stop taking Sinupret Saft

Stopping Sinupret Saft is generally harmless.

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, Sinupret Saft can have side effects, although not everybody gets them.

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

Significant side effects or signs to watch out for, and measures to take if you are affected

Gastrointestinal complaints (including stomach pain, nausea) may occur occasionally. Hypersensitivity reactions of the skin (rash, redness, itching) may occur occasionally. Severe allergic reactions (swelling of the lips, tongue and throat and/or larynx with airway narrowing (angioedema), shortness of breath, swelling of the face) may also occur. The frequency is not known. At the first signs of a hypersensitivity reaction, Sinupret Saft must not be taken again. If side effects occur, the preparation should be discontinued and a doctor consulted. They can decide on the severity and any further measures that may be necessary.

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 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 on the safety of this medicine.

5. HOW TO STORE SINUPRET SAFT?

Do not store above 30°C. Keep out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container (label). The expiry date refers to the last day of the month. Note on shelf life after opening or preparation: Shelf life after opening: 6 months.

6. FURTHER INFORMATION

What Sinupret Saft contains

100 g (83.3 ml) Sinupret Saft contains 34.5 g of an extract (1:38.5) from 0.9 g of a mixture of gentian root, vervain, garden sorrel herb, elderflowers, cowslip flowers with calyx (1:3:3:3:3);1. Extraction agent: Ethanol 59% by volume, 2. - 4. Extraction agent: purified water. Contains 8% alcohol by volume. The other ingredients are: maltitol solution, cherry flavour.

What Sinupret Saft looks like and contents of the pack

Sinupret Saft is available in packs of 100 ml (NI) syrup. Sinupret Saft is a light brown, clear, viscous syrup. Slight clouding or flocculation may occur during storage, but this does not affect the effectiveness of the preparation.

Pharmaceutical entrepreneur and manufacturer

BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 231-90
Fax: 09181 231-265
Internet: www.bionorica.de
E-mail: info@bionorica.de

Co-distributor

PLANTAMED Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 231-0
Fax: 09181218-50

This leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 11/2017
Areas of application: for improving symptoms of acute inflammation of the paranasal sinuses. Warning: Contains 8% alcohol by volume!