Sinuherb Coated Tablets
Package Leaflet: Information for The User
Sinuherb® Coated Tablets
Gentian root (Gentiana lutea L.)
Verbena herb (Verbena officinalis L.)
Sorrel herb (Rumex acetosa L.)
Elder flower (Sambucus nigra L.)
Primula flower with calyces (Primula veris L.)
Read all of this leaflet carefully because it contains important information for you.
This is medicine is available without a prescription. However, you still need to take Sinuherb® carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 7 days.
• If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or healthcare practitioner.
In this leaflet:
1. What Sinuherb® is and what it is used for
2. Before you take Sinuherb®
3. How to take Sinuherb®
4. Possible side effects
5. How to store Sinuherb®
6. Further information
1. What Sinuherb® is and what it is used for
Sinuherb® is a traditional herbal medicinal product containing gentian root, verbena herb, sorrel herb, elder flower, and primrose flower with sepals. For full details see section 6. Sinuherb® is a traditional herbal medicinal product used to relieve the symptoms of nasal congestion and sinusitis. This use is based on traditional use only.
2. Before you take Sinuherb®
This product is not suitable for children under 12 years of age.
2.1 Do not take Sinuherb® if you are
• allergic to gentian, verbena, sorrel, elder flower, primrose or any primula species
• allergic to any of the other ingredients (see section 6)
• under 12 years of age
• pregnant or breast feeding
Tell your doctor before you take this product if you have an intolerance to some sugars (see section 2.6).
2.2 Take special care with Sinuherb®
If your symptoms last for more than 7 days or get worse you must see your doctor.
If your symptoms come back again you must see your doctor.
This product contains Primula and patients who have a stomach ulcer or inflammation of the stomach lining should see their doctor before starting to take this product.
2.3 Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.
2.4 Pregnancy and breast-feeding
Do not take this product if you are pregnant or breast feeding because there is no evidence that it is safe to do so.
2.5 Driving and using machines
Sinuherb® is not likely to affect your ability to drive or use machines.
2.6 Important information about some of the ingredients of Sinuherb®
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this product. Each tablet contains 145 mg sucrose and 3.924 mg glucose.
3. How to take Sinuherb®
Remember to always take this medicine with a glass of water. The tablets should be swallowed whole and not chewed. You should check with your doctor, pharmacist or healthcare practitioner if you are not sure.
3.1 How much Sinuherb® to take
The usual treatment time is 7 days.
If your symptoms worsen or persist for more than 7 days, see your doctor or pharmacist.
If shortness of breath, fever, blood stained or coloured sputum occurs, see your doctor.
3.2 Adults, the elderly and children over 12 years of age
One tablet three times each day.
Children under 12 years of age
Do not give to children under 12 years of age.
Do not exceed the stated dose.
3.3 If you take more Sinuherb® than you should
If you have accidentally taken 2 or 3 tablets together this usually will not have any side effects. Continue to take the usual dose at the usual time.
If you have accidentally taken a lot of this medicine you may get more side effects or any side effects may get worse. You must talk to your doctor.
3.4 If you forget to take Sinuherb®
Continue to take your usual dose at the usual time. Never take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, please ask your doctor, pharmacist or healthcare practitioner.
4. Possible side effects
Like all medicines, Sinuherb® can cause side effects, although not everybody gets them.
Stomach pain, nausea or feeling sick are uncommon (affect less than 1 in 100 people, but more than 1 in 1000 people).
Allergic reactions (such as skin rashes, itching and reddening hives), severe allergic reactions (such as swelling of the skin due to fluid , shortness of breath and swelling of the face) may occur rarely (affect less than 1 in 1000 people, but more than 1 in 10,000 people).
Irregular heartbeat and itching may occur rarely with products containing Gentian root. Also headache has been reported with Gentian root. The frequency is not known.
5. How to store Sinuherb®
Keep out of the reach and the sight of children.
Do not use the tablets after the expiry date on the carton and the blister strip. The expiry date is the last day of that month. Do not store above 30° C. Keep them in the blister package until it is time to take them.
Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
6. Further Information What Sinuherb® contains
Each coated tablet contains:
12 mg Gentian root (Gentiana lutea L.),
36 mg Verbena herb (Verbena officinalis L.), 36 mg Sorrel herb (Rumex acetosa L.),
36 mg Elder flower (Sambucus nigra L.),
36 mg Primula flower with calyces (Primula veris L.).
The other ingredients are:
Tablet core: colloidal anhydrous silica, cellulose powder, maltodextrin, croscarmellose sodium, magnesium stearate (vegetable).
Tablet coating: hypromellose, sucrose, talc, calcium carbonate, tragacanth, acacia, titanium dioxide E 171, anhydrous glucose, shellac, white beeswax, carnauba wax.
What Sinuherb® looks like and contents of the pack
Sinuherb® is a white, convex, round, coated tablet. Sinuherb® comes in blister packs of 20, 40 or 60 tablets. Not all packs may be marketed.
Traditional Herbal Registration Holder and Manufacturer
Traditional Herbal Registration Holder
Grunwalder Gesundheitsprodukte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany.
Stop taking this product immediately if you experience any allergic reactions.
Making medicines safer:
Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
Manufacturer
Schaper & Brummer GmbH & Co. KG, BahnhofstraUe 35, 38259 Salzgitter, Germany.
This leaflet was last revised in September 2015.
THR 18457/0019
Certification Mark
