SINUPRET

SINUPRET drops

Important notes (mandatory information)

Sinupret drops. Areas of application: for acute and chronic inflammation of the paranasal sinuses. Warning: Contains 19% 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 drops for use in children aged 2 years and over and adults
Active ingredients: gentian root cut, vervain cut, garden sorrel herb cut, elderflowers raked, primrose flowers with calyx cut

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

• Keep the package leaflet. You may want to read it again later.
• Ask your 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 side effects listed occur to a significant extent or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This leaflet contains

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

1. WHAT ARE SINUPRET DROPS AND WHAT ARE THEY USED FOR?

Sinupret drops is a herbal medicine for inflammation of the paranasal sinuses. Sinupret drops are used for acute and chronic inflammation of the paranasal sinuses.

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

Sinupret drops must not be taken if you are hypersensitive (allergic) to gentian root, vervain, garden sorrel herb, elderflowers, primrose 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 drops

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

Children

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

When taking Sinupret drops with other medicines

Please tell 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 drops 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 drops should only be taken during pregnancy and breast-feeding if it is not possible to take Sinupret, coated tablets.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Sinupret drops

This medicine contains 19% (V/V) alcohol.

3. HOW TO TAKE SINUPRET DROPS?

Always take Sinupret drops exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

• Children aged 2 – 5 years: Single dose 15 drops, corresponding to 0.9 ml, total daily dose 45 drops (3 times 15), corresponding to 2.7 ml.
• Children aged 6 — 11 years: Single dose 25 drops, corresponding to 1.5 ml, total daily dose 75 drops (3 times 25), corresponding to 4.5 ml.
• Adults and adolescents aged 12 years and over: Single dose 50 drops, corresponding to 3.0 ml, total daily dose 150 drops (3 times 50), corresponding to 9.0 ml.

Method of administration

Sinupret drops can be taken with a little liquid (e.g. a glass of water), if necessary - e.g. to mask the bitter taste for children. Sinupret drops can be taken with food, with drinks or independently of meals. If you have a sensitive stomach, it is best to take Sinupret drops after meals. Hold the bottle upright to remove. Slight clouding or flocculation may occur during storage, but this does not affect the effectiveness of the preparation. 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 drops than you should

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

If you forget to take Sinupret drops

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

If you stop taking Sinupret drops

Discontinuing Sinupret drops 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 drops 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) and severe allergic reactions (swelling of the lips, tongue and throat and/or larynx with airway narrowing (angioedema), shortness of breath, swelling of the face) can occur rarely. At the first signs of a hypersensitivity reaction, Sinupret drops must not be taken again. If side effects occur, the preparation should be discontinued and a doctor consulted. He 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 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 provide more information on the safety of this medicine.

5. HOW TO STORE SINUPRET DROPS?

Do not store above 25°C. Keep out of reach of children. Do not use the 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 3 months.

6. FURTHER INFORMATION

What Sinupret drops contain

The active ingredients are: The active ingredient is an extract of gentian root, vervain, garden sorrel herb, elderflowers, primrose flowers with calyx. 100 g Sinupret drops contain: 29 g extract (drug/extract ratio 1 : 11) from gentian root, cut; vervain, cut; garden sorrel herb, cut; elderflowers, raked; primrose flowers with calyx, cut; (1:3:3:3:3) Extraction agent: Ethanol 59% (V/V) Contains 19% alcohol by volume. The other ingredients are: Purified water.

Diabetic note

Sinupret drops do not contain any relevant countable bread units (BUs).

What Sinupret drops look like and contents of the pack

Sinupret drops are available in packs of 100ml (N3), 200ml (2x100ml) and 300ml (3x100ml) drops for oral administration, liquid. Sinupret drops are a clear, yellow-brown liquid.

Pharmaceutical entrepreneur and manufacturer

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

Co-distribution

PLANTAMED Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 231-0
Telefax: 09181 218-50

This package leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for acute and chronic inflammation of the paranasal sinuses. Warning: Contains 19% alcohol by volume!