coated tablets
Powdered golden gentian, powdered Primula species (primrose and/or primrose), powdered Rumex species (meadow sorrel, mountain sorrel, clematis, spinach sorrel, mugwort, and/or sorrel), powdered elderberry, and powdered ironwort
What Sinupret is and what it is used for
Sinupret is herbal medicine for the relief of symptoms in the nose and its sinuses during colds.
What you need to know before taking Sinupret
Do not take Sinupret
- if you are allergic to the active substances or any of the other ingredients in Sinupret (listed in section 6).
- if you have a stomach ulcer.
Warnings and precautions
Serious hypersensitivity reactions may occur. Stop taking Sinupret and contact your doctor immediately if you experience any of the following symptoms: swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing. These types of reactions may require emergency hospital care. See also section 4.
If you have gastritis (stomach catarrh) or a sensitive stomach, you should be especially careful when using this medicine. Sinupret should preferably be taken after meals with a glass of water.
If the symptoms in the nose and sinuses last longer than 2 weeks, get worse, recur often, and/or are followed by fever and coughing up long mucus, you should contact a doctor.
Children
Not recommended for children under 6 years of age as there is a lack of sufficient data.
Other medicines and Sinupret
When contacting a doctor or other healthcare professional, remember to mention that you are taking or have recently taken this over-the-counter medicine.
The effect of simultaneous intake of other drugs has not been studied.
Pregnancy, breastfeeding, and fertility
In the absence of sufficient data, use during pregnancy or breastfeeding is not recommended.
The drug’s possible effect on fertility has not been studied.
Driving ability and use of machinery
Sinupret has no or negligible effect on the ability to drive and use machines.
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.
Sinupret contains glucose, lactose, sucrose and sorbitol.
If you have an intolerance to some sugars, you should talk to your doctor before using this medicine.
How to use Sinupret
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults, elderly, and adolescents from 12 years of age: 2 tablets 3 times daily.
Children 6–11 years: 1 tablet 3 times daily.
Mode of administration
The tablets should be swallowed whole with a little liquid (eg a glass of water), after meals.
Treatment time
Sinupret should not be used for longer than 2 weeks. See section 2.
Use for children and adolescents
Not recommended for children under 6 years of age.
If you have used too much Sinupret
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 use Sinupret
Do not take a double dose to make up for a missed tablet.
If you stop using Sinupret
It is harmless to stop taking Sinupret.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stomach problems (eg stomach cramps and nausea) are uncommon.
Hypersensitivity reactions in the skin (eg rash, redness, itching ) are rare.
Allergic reactions such as angioedema, shortness of breath and facial edema (swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing) have been reported (occurring in an unknown number of users). This type of reaction may require urgent hospital care, see also section 2.
How Sinupret should be stored
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 tablet map after “Expiry date.”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances in 1 coated tablet are:
6 mg powdered golden gentian ( Gentiana lutea L.), root, corresponding to 6 mg dried root,
18 mg powdered Primula species (primrose ( Primula veris L.) and/or primrose ( Primula elatior L. Hill)), flower, corresponding to 18 mg dried flowers,
18 mg of powdered Rumex species (meadow sorrel ( Rumex acetosa L.), mountain sorrel ( Rumex acetosella L.), snowdrop ( Rumex obtusifolius L.), spinach drop ( Rumex patientia L.), mug drop ( Rumex Crispus L.) and/or large sorrel ( Rumex thyrsiflorus Fingerh.)), herb, equivalent to 18 mg dried herb,
18 mg powdered elder ( Sambucus nigra L.), flower, equivalent to 18 mg dried flowers,
18 mg of powdered iron herb ( Verbena Officinalis L.), herb, corresponding to 18 mg of dried herb.
- Other ingredients are:
Sucrose, talc, lactose monohydrate, calcium carbonate, potato starch, corn starch, dextrin, colloidal anhydrous silica, stearic acid, titanium dioxide (color E171), liquid glucose, gelatin, indigo carmine aluminum lacquer (color E132), shellac, light magnesium oxide, sorbitol, basic butylated methacrylate copolymer, montan glycol wax, riboflavin (E101), castor oil, chlorophyllin-copper complex (E141).
Appearance and package sizes of the medicine
Sinupret is a sugar-coated, green, round, biconvex tablet with a smooth surface and a sweet taste. The coated tablet has a diameter of 8.1 – 8.3 mm.
Sinupret is available in packs of 50, 100, and 200 tablets.
Not all pack sizes may be marketed.
Bionorica SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Telephone +49-9181-23190
Fax +49-9181-231265