Sinuxol coated tablets Extracts of Golden Gentian Root, Golden rod Flower, Gorse Herb, Elder flower, and ironwort Herb
What Sinuxol Is And What It Is Used For
Herbal medicine is used for the treatment of acute, uncomplicated sinusitis with symptoms such as
- Runny nose
- Nasal congestion
- Headache
- Facial pain
- Pressure over the face in adults
What You Need To Know Before Taking Sinuxol
Do Not Take Sinuxol:
- If you are allergic (hypersensitive) to the active substances or any other ingredient in this medicine (listed in section 6)
- If you have or have had stomach ulcers.
Warnings And Precautions
- Serious hypersensitivity reactions may occur. Stop taking Sinuxol and contact a doctor immediately if you experience any of the following symptoms:
- Swelling of the face, tongue, or throat, difficulty swallowing
- Hives
- Difficulty breathing. These types of reactions may require emergency hospital care. See also section 4.
- Talk to your doctor if you develop nosebleeds, fever, severe pain, persistent snot, impaired vision, one-sided swelling of the center of the face or eyes, or numbness in the face. These symptoms are generally seen as serious warning signs of those forms of sinusitis that require examination by a medical specialist and urgent medical treatment.
- Talk to your doctor if symptoms persist after 7-14 days, worsen or recur frequently.
- Patients with known gastritis (gastric catarrh) or a sensitive stomach should be especially careful when taking this medicine. You should preferably take Sinuxol after a meal and with a glass of water.
Children And Young People
Not recommended for children and adolescents under 18 years due to lack of sufficient data.
Other Medicines And Sinuxol
The effect of simultaneous intake of other drugs has not been studied. Therefore, it cannot be ruled out that the effect of other drugs can be strengthened or weakened.
When contacting a doctor or other healthcare professional, remember to mention that you are taking or have recently taken this over-the-counter medicine.
Pregnancy And Breastfeeding
In the absence of sufficient data, use during pregnancy is not recommended.
In the absence of sufficient data, during breastfeeding Sinuxol uses is not recommended.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving Ability And Use Of Machinery
Sinuxol may have some effect on the ability to drive and use machines in patients who experience the possible side effect of dizziness (see section 4).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Sinuxol Contains Glucose And Sucrose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Information for diabetics:
- One coated tablet contains on average 0.3 g of degradable carbohydrates.
How To Take Sinuxol
- Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- The recommended sinuxol tablet dosage is:
- Adults: 1 coated tablet 3 times daily.
- There are insufficient data for specific dosage recommendations for patients with impaired renal or hepatic function.
- Sinuxol uses for children and adolescents
- Use in children and adolescents under 18 years of age is not recommended due to insufficient data.
- Method of administration:
- Sinuxol is swallowed whole with a little liquid (eg a glass of water) 3 times a day (morning, noon, and evening). If you have a sensitive stomach, you should preferably take Sinuxol after meals.
- Treatment time:
- Unless otherwise prescribed, the medicine should be taken for 7–14 days. Consult a doctor if symptoms persist after treatment.
If You Have Taken Too Much Sinuxol
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If You Forget To Take Sinuxol
Do not take a double dose to make up for a missed dose, but continue to take Sinuxol as prescribed by your doctor or as described in this leaflet.
If You Stop Taking Sinuxol
It is harmless to stop taking Sinuxol.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Side Effects Of Sinuxol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects of sinuxol ( may affect up to 1 in 10 users):
- Stomach and intestinal problems, e.g.
- Nausea
- Flatulence
- Diarrhea
- Dry mouth
- Stomach ache
Uncommon side effects ( may affect up to 1 in 100 users):
- Local hypersensitivity reactions (e.g. rash, redness, itching of the skin or eyes)
- Severe allergic reactions (swelling of the lips, tongue, and throat, and/or larynx with narrowing of the airways, Shortness of breath, facial swelling).
- Dizziness
Stop taking Sinuxol if you develop signs of an allergic/hypersensitivity reaction.
How To Store Sinuxol
- Store at a maximum of 30°C.
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton and blister after Ug.dat and EXP respectively. The expiration date is the last day of the specified month.
Contents Of The Packaging And Other Information
Contents declaration
- The active substance per tablet is:160 mg of dry extract of Gentiana lutea L. (gold gentian) root, Primula veris L. (gold viva) flower, Rumex Crispus L. (buckthorn) herb, Sambucus nigra L. (elder) flower and Verbena Officinalis L. (ironwort) herb, corresponding to 480-960 mg of dried plant material of golden gentian root (37-74 mg), goldenrod flower (111-222 mg), mugwort herb (111-222 mg), elderflower (111-222 mg) and ironwort herb (111 -222 mg).1st extractant: ethanol 51% (w/v)/59% (v).
- Other ingredients are sucrose; talc; calcium carbonate (E 170); microcrystalline cellulose; maltodextrin; cellulose powder; hypromellose; dextrin; spray-dried acacia; hydrophobic colloidal silica; hydrophobic anhydrous silica; titanium dioxide (E 171); liquid glucose; magnesium stearate; stearic acid; chlorophyll powder 25% (contains chlorophyll-copper complex E 141); indigo carmine aluminum lacquer paint (contains indigo carmine E 132 and aluminum hydroxide); carnauba wax; riboflavin (E 101).
Appearance And Package Sizes Of The Medicine
- Packs of 20 coated tablets: 2 blister cards each containing 10 coated tablets.
- Packs of 40 coated tablets: 4 blister cards each containing 10 coated tablets.
- Not all pack sizes may be marketed.
- Sinuxol is green, round, biconvex, coated tablets with a smooth surface.
Marketing Authorization Holder And Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Phone: +49 9181 23190
Fax: +49 9181 231265
Email: info@bionorica.de
This medicine is approved in the European Economic Area under the names:
AUSTRIA Sinupret intense, überzogene Tablette
BULGARIA Синупрет экрастат обвити таблекти
CROATIA Sinupret acute obložene tablete
CZECH REPUBLIC Sinupret acute
GERMANY, LUXEMBOURG Sinupret extract, überzogene Tablette
DENMARK Linux
ESTONIA Sinupret extract coated tableted
LATVIA Sinupret ekstrats 160 mg otālkotās tablets
Lithuania
POLAND Sinupret extract, tabletki drażowane
ROMANIA Sinupret acute drajeuri
SWEDEN Sinuxol
SLOVENIA Sinupret exera obložene tablete
SLOVAKIA Sinupret Acute , obaléné tablety