SINUPRET

SINUPRET extract coated tablets

Important notes (mandatory information)

Sinupret extract coated tablets. Areas of application: for acute, uncomplicated 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 extract coated tablets for use in adolescents aged 12 years and over and adults
Active ingredients: dry extract from a mixture of gentian root, primrose flowers, sorrel herb, elderflowers and vervain
Herbal medicinal product

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

• 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 package leaflet contains

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

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

Sinupret extract is a herbal medicinal product for inflammation of the paranasal sinuses. Sinupret extract is used for acute, uncomplicated inflammation of the paranasal sinuses.

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

Sinupret extract must not be taken if you have existing stomach and duodenal ulcers or if you are hypersensitive (allergic) to gentian root, vervain, sorrel herb, elderflowers, primrose flowers or any of the other ingredients of the medicinal product (other ingredients see section 6 Further information).

Special care must be taken when taking Sinupret extract

If you have symptoms that last longer than 7-14 days, worsen or recur periodically, if you have nosebleeds, severe pain, purulent nasal discharge, visual disturbances, asymmetry of the midface or eyes or numbness in the face, you should consult a doctor, as these symptoms or findings are generally considered serious warning signs for all forms of rhinosinusitis that require specialist examination and urgent treatment. Special care is required when taking the product if you have known stomach inflammation and if you have a sensitive stomach. It is best to take Sinupret extract after meals and with a glass of water.

Children

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

When taking Sinupret extract with other medicinal products

No systematic interaction studies have been performed. Therefore, an increase or decrease in the effect of other medicinal products cannot be ruled out. Please inform 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.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicinal products. As a precaution, Sinupret extract should be avoided during pregnancy. It is not known whether the active ingredients of Sinupret extract pass into breast milk. You should therefore not use Sinupret extract while breast-feeding.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Sinupret extract

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

3. HOW TO TAKE SINUPRET EXTRACT?

Always take Sinupret extract 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: Adults and adolescents aged 12 years and over take 1 coated tablet 3 times a day. The product is not intended for use in children under 12 years of age. There are no sufficient data for specific dosage recommendations in the case of impaired renal/hepatic function.

Method of administration

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

If you have taken more Sinupret extract than you should, please inform a doctor. They can decide on any necessary measures. The side effects listed below (e.g. nausea, stomach pain, diarrhoea) may occur more frequently.

If you forget to take Sinupret extract

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

If you stop taking Sinupret extract

Discontinuing Sinupret extract is generally harmless.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Significant side effects or signs to watch out for, and measures to be taken if affected

Common side effects (1 to 10 out of 100 people treated)

Gastrointestinal complaints e.g. nausea, flatulence, diarrhoea, dry mouth, stomach pain.

Uncommon side effects (1 to 10 out of 1000 people treated)

Hypersensitivity reactions of the skin (e.g. rash, redness, itching), dizziness.

Not known (frequency cannot be estimated from the available data)

Severe allergic reactions (swelling of the lips, tongue and throat and/or larynx with airway narrowing, shortness of breath, swelling of the face). At the first signs of a hypersensitivity reaction, Sinupret extract must not be taken again.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any 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 to provide more information on the safety of this medicinal product.

5. HOW TO STORE SINUPRET EXTRACT?

Do not store above 30°C. Keep the medicinal product out of the reach of children. Do not use the medicinal product after the expiry date which is stated on the folding box or blister pack. The expiry date refers to the last day of the month.

6. FURTHER INFORMATION

What Sinupret extract contains

Composition: 1 coated tablet contains: Active ingredient: 160.00 mg dry extract (3-6:1) from gentian root, primrose flowers, sorrel herb, elderflowers, vervain (1:3:3:3:3) 1. Extraction agent: Ethanol 51%. The other ingredients are: Spray-dried gum arabic, calcium carbonate, carnauba wax, cellulose powder, microcrystalline cellulose, chlorophyll powder 25% (E140), dextrin, glucose syrup, hypromellose, indigo carmine, aluminium salt (E 132), magnesium stearate, maltodextrin, riboflavin (E 101), highly dispersed silicon dioxide, highly dispersed hydrophobic silicon dioxide, sucrose, stearic acid, talc, titanium dioxide (E 171).

Diabetic information

One coated tablet contains an average of 0.026 creditable bread units (BU). Sinupret extract is gluten- and lactose-free.

What Sinupret extract looks like and contents of the pack

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

Packs of 20 (N1) coated tablets, 2 blisters each containing 10 coated tablets.
Packs of 40 coated tablets, 4 blisters each containing 10 coated tablets.
Hospital pack of 400 (10 × 40) 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 package leaflet was last revised in October 2015.

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