SINUPRET

SINUPRET forte coated tablets

Important notes (mandatory information)

Sinupret forte 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

Sinupret forte coated tablets for use in adolescents aged 12 years and over and adults
Active ingredients: powdered vervain, powdered gentian root, powdered garden sorrel herb, powdered elderflowers, powdered cowslip flowers with calyx
Herbal medicinal product

Read all of this leaflet carefully because it contains important information for you.This medicinal product is available without a prescription. However, Sinupret forte must be used as directed in order to be as effective as possible.

• Keep this 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 here affect you severely or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

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

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

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

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

Sinupret forte 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 medicinal product (other ingredients are listed under section 6 Further information).

Special care must be taken when taking Sinupret forte

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

Children

The medicinal product should not be used in children under 12 years of age. There are no sufficient studies on the use of Sinupret forte in children under 12 years of age to date.

When taking Sinupret forte with other medicinal products

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicinal products. Like all medicinal products, Sinupret forte 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 necessary.

Important information about certain other ingredients of Sinupret forte

This medicinal product contains the sugars glucose, lactose, sucrose and sorbitol. Please only take Sinupret forte after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE SINUPRET FORTE?

Always take Sinupret forte 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: Adults and adolescents aged 12 years and over: Single dose 1 coated tablet, total daily dose 3 coated tablets (1 coated tablet 3 times a day).

Method of administration

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

Duration of use

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

If you have taken more Sinupret forte than you should

If you have taken more Sinupret forte 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 forte

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

If you stop taking Sinupret forte

Discontinuing Sinupret forte is generally harmless.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicinal products, Sinupret forte can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate 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, swelling of the face) can occur rarely. At the first signs of a hypersensitivity reaction, Sinupret forte must not be taken again. If side effects occur, the preparation should be discontinued and a doctor should be 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 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 medicinal product.

5. HOW TO STORE SINUPRET FORTE?

Do not store above 30°C. Keep medicinal products out of the reach of children. Do not use this medicinal product 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 forte contains

The active ingredients are: 1 coated tablet contains the following active ingredients: powdered vervain 36 mg, powdered gentian root 12 mg, powdered garden sorrel herb 36 mg, powdered elderflowers 36 mg, powdered cowslip flowers with calyx 36 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; montan glycol wax; riboflavin (E 101); refined castor oil; sucrose (saccharose); shellac; highly dispersed silicon dioxide; sorbitol; stearic acid; talc; titanium dioxide (E 171). Diabetics note: One coated tablet contains an average of 0.03 bread units (BU).

What Sinupret forte looks like and contents of the pack

Sinupret forte coated tablets are green, round, biconvex with a smooth surface.

Packs of 20 (N1) coated tablets, 1 blister with 20 coated tablets. 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. Hospital pack with 500 (10 x 50) coated tablets.

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-distributor

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

This leaflet was last revised in September 2014.

Source: Information from the package leaflet
Version: 11/2017
Areas of application: for acute and chronic inflammation of the paranasal sinuses.