SINUPRET

SINUPRET coated tablets

Important notes (mandatory information)

Bionorica Sinupret coated tablets. Areas of application: for acute and chronic inflammation of the paranasal sinuses.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bionorica Sinupret coated tablets for use in children from 6 years of age and adults
Active ingredients: powdered vervain, powdered gentian root, powdered garden sorrel herb, powdered elderflowers, powdered primrose flowers with calyx
Herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Sinupret 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 package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

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

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

Sinupret is a herbal medicinal product for inflammation of the paranasal sinuses. Sinupret is used for acute and chronic inflammation of the paranasal sinuses.

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

Sinupret 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

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 6 years of age. There are no sufficient studies on the use of Sinupret in children under 6 years of age to date.

When taking Sinupret 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 should only be used during pregnancy and breast-feeding after careful consideration of the benefits and risks by the doctor.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Sinupret

This medicine contains the sugars glucose, lactose, sucrose and sorbitol. Please only take Sinupret after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE SINUPRET?

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

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

• Children aged 6 –11 years: Single dose 1 coated tablet, total daily dose 3 coated tablets (3 times 1 coated tablet).
• Adults and adolescents aged 12 years and over: Single dose 2 coated tablets, total daily dose 6 coated tablets (3 times 2 coated tablets).

Method of administration

Sinupret is swallowed 3 times a day (morning, noon, evening) whole with a little liquid (e.g. a glass of water). Sinupret can be taken with food, with drinks or independently of meals. If you have a sensitive stomach, you should take Sinupret after meals.

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 than you should

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

If you forget to take Sinupret

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

If you stop taking Sinupret

Discontinuing Sinupret 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 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 (skin rash, skin redness, itching) and severe allergic reactions (swelling of the lips, tongue and throat and/or larynx with airway narrowing (angioedema), shortness of breath, facial swelling) can occur rarely. At the first signs of a hypersensitivity reaction, Sinupret must not be taken again. If side effects occur, the preparation should be discontinued and a doctor consulted. He/she 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?

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 or blister pack. The expiry date refers to the last day of the month.

6. FURTHER INFORMATION

What Sinupret contains

The active ingredients are: 1 coated tablet contains the following active ingredients: powdered vervain 18 mg, powdered gentian root 6 mg, powdered garden sorrel herb 18 mg, powdered elderflowers 18 mg, powdered primrose flowers with calyx 18 mg. The other ingredients are: calcium carbonate (E 170); chlorophyll powder 25% (E 141); dextrin; Eudragit E 12.5; gelatine; glucose syrup; indigo carmine, E 132, aluminium hydroxide; potato starch; lactose monohydrate; maize starch; light magnesium oxide; montanglycol wax; riboflavin (E 101); refined castor oil; sucrose (saccharose); shellac; highly dispersed silicon dioxide; sorbitol; stearic acid; talc; titanium dioxide (E 171).

Diabetic information

One coated tablet contains an average of 0.01 bread units (BU).

What Sinupret looks like and contents of the pack

Packs of 50 (N2) coated tablets, 2 blisters with 25 coated tablets each. Packs of 100 (N3) coated tablets, 4 blisters with 25 coated tablets each. Packs of 200 coated tablets, 8 blisters with 25 coated tablets each. Hospital pack of 1,000 (20 x 50) coated tablets. Sinupret coated tablets are green, round, biconvex with a smooth surface.

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(5)bionorica.de

Co-distributor

Plantamed Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 231-0
Fax: 09181 21850

This package leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 10/2017
Areas of application: for acute and chronic inflammation of the paranasal sinuses.