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Product Name: Boiron Sinuphyl Film-Coated Tablets
Purpose:
- Herbal medicine for treating acute inflammation of the paranasal sinuses in adults.
Physical Description:
- Tablet Appearance: Green, round, biconvex, film-coated.
- Surface: Smooth.
- Packaging: Box of 20 tablets.
Active Ingredients:
- Native dry extract (3-6:1) from:
- Gentian root (Gentiana lutea L.)
- Primrose flowers (Primula veris L.)
- Curly sorrel (Rumex crispus L.)
- Elderflower (Sambucus nigra L.)
- Verbena (Verbena officinalis L.)
- Extraction Ratio: 1:3:3:3:3.
- Ethanol 51% (m/m)*S as the first extraction agent.
- Each tablet contains 160 mg of native dry extract.
Other Ingredients:
- Sucrose, talc, calcium carbonate (E170), microcrystalline cellulose, maltodextrin, powdered cellulose, hypromellose, dextrin, spray-dried acacia, anhydrous hydrophobic silica, titanium dioxide (E171), liquid glucose, vegetable magnesium stearate, stearic acid, chlorophyll powder 25% (copper-chlorophyllin E141), indigotine aluminum lake (indigotine E132 and aluminum hydroxide), carnauba wax, riboflavin (E101).
Dosage & Administration:
- Recommended for Adults: 1 tablet, 3 times a day.
- Maximum: 3 tablets per day.
- Treatment Duration: 7 to 14 days.
- Administration: Swallow with water, after meals. Do not chew.
Precautions & Warnings:
- Do not use if allergic to any ingredients or if you have/had a peptic ulcer.
- Consult a doctor if symptoms persist or worsen after 1-2 weeks, or if you experience severe symptoms like fever, nosebleeds, severe pain, vision problems, or numbness.
- Not recommended for children and adolescents under 18.
- Avoid during pregnancy and breastfeeding.
- Consult a doctor before use if you have sugar intolerance or are diabetic (0.3 g digestible carbohydrates per tablet).
- May affect driving and machine operation.
Side Effects:
- Common (1 in 10): Abdominal pain, nausea, diarrhea, bloating, vomiting.
- Uncommon (1 in 100): Rash, skin redness, itching, severe allergic reactions. Discontinue if hypersensitivity occurs.
Storage:
- Store out of sight and reach of children, below 30° C.
Please read the following full disclosure before buying or taking this product.
PRODUCT CHARACTERISTICS SUMMARY
ANSM - Updated on: 09/11/2021
- NAME OF THE MEDICINAL PRODUCT
SINUPHYL, film-coated tablet
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
1 film-coated tablet contains:
160.00 mg of native dry extract (3-6:1) of gentian root (Gentiana lutea L.), primrose flowers (Primula veris L.), curly dock (Rumex crispus L.), elderflower (Sambucus nigra L.), vervain (Verbena officinalis L.) (1:3:3:3:3)
1st extraction agent: 51% ethanol (m/m)
Excipients with known effect:
Glucose syrup 3.141 mg
Sucrose 133.736 mg
For the complete list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Film-coated tablet
The film-coated tablets are green in color, round, biconvex with a smooth surface. The film-coated tablet has a diameter of 11.0 – 11.9 mm.
- CLINICAL DATA
4.1. Therapeutic indications
Herbal medicine used to treat uncomplicated acute inflammations of the paranasal sinuses (acute uncomplicated rhinosinusitis) in adults.
4.2. Dosage and method of administration
Dosage
Adults: 1 film-coated tablet 3 times a day (maximum 3 film-coated tablets per day).
There is insufficient data regarding specific dosage recommendations in case of renal/hepatic insufficiency.
Pediatric population
This medicine is contraindicated in children and adolescents under 18 years of age.
Method of administration
The film-coated tablets should be swallowed without chewing. Take this medicine with a little liquid, e.g., with a glass of water.
Unless otherwise indicated, the duration of use of the medicine is 7 to 14 days. Please note the information in the section “Special warnings and precautions for use.”
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1.
Gastroduodenal ulcer.
4.4. Special warnings and precautions for use
In patients with known gastritis and those with a sensitive stomach, particular care is required when taking this medicine. It is preferable to take SINUPHYL after meals with a glass of water.
If symptoms persist for more than 7 to 14 days, worsen, or reoccur periodically and/or if the patient has a fever, nosebleeds, severe pain, purulent nasal discharge, vision problems, asymmetrical numbness of the mid-face, eyes, or face, differential diagnosis and medical treatment are necessary.
SINUPHYL is contraindicated in patients with rare hereditary disorders such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
Information for diabetics:
A film-coated tablet contains an average of 0.3 g of digestible carbohydrates.
Pediatric population
Use is not recommended in children and adolescents under 18 years due to lack of sufficient data.
Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows for continuous monitoring of the benefit/risk balance of the medicinal product. Health professionals report any suspected adverse effects via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
No cases of poisoning due to SINUPHYL have been observed to date.
In case of overdose, the aforementioned adverse effects (e.g., nausea, abdominal pain, diarrhea) may be more intense.
Treatment of poisonings:
In case of symptoms of poisoning or overdose, symptomatic treatment is necessary.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: other cold preparations, ATC code: R05X
Clinical efficacy:
The efficacy of SINUPHYL has been evaluated in patients with acute viral rhinosinusitis in a randomized, placebo-controlled clinical study. The primary efficacy endpoint was the mean Major Symptom Score (MSS) at the end of treatment. Treatment with SINUPHYL showed clinically significant differences in mean MSS compared to placebo. SINUPHYL relieved symptoms two days earlier than placebo.
5.2. Pharmacokinetic properties
There are no studies on the pharmacokinetics and bioavailability.
5.3. Preclinical safety data
Chronic toxicity
In multiple dose studies, SINUPHYL dry extract was orally administered to dogs (39 weeks) and rats (26 weeks). In the dog study, the No Observed Adverse Effect Level (NOAEL) was 320 mg dry extract/kg body weight, which is equivalent to 22 times the equivalent human dose. In the rat study, the NOAEL was 320 mg dry extract/kg body weight. This is equivalent to 7 times the equivalent human dose.
Genotoxicity
No mutagenic/genotoxic potential was detected when SINUPHYL dry extract was tested in vitro in the Salmonella typhimurium reverse mutation test (AMES) and in the mouse lymphoma test, as well as in the rat micronucleus test (in vivo).
Reproductive toxicology
No effects on fertility, embryofetal development, perinatal and postnatal development, and no teratogenic effects were observed after administration of Sinupret oral drops or Sinupret film-coated tablets in different species (rat and rabbit).
In a Segment II study on reproductive toxicity in rabbits, embryofetal development was not affected and no teratogenic effects were observed after administration of SINUPHYL dry extract up to the maximum daily dose of 800 mg dry extract/kg body weight tested, corresponding to 32 times the safety margin based on the recommended equivalent dose for humans.
Carcinogenicity
No carcinogenicity studies have been conducted.
No photosafety studies have been conducted.
- PHARMACEUTICAL DATA
6.1. List of excipients
Sucrose
Talc
Calcium carbonate (E170)
Microcrystalline cellulose
Maltodextrin
Cellulose, powdered
Hypromellose
Dextrin
Acacia, spray-dried
Silica, colloidal hydrophobic
Silica, anhydrous hydrophobic
Titanium dioxide (E171)
Glucose, liquid
Magnesium stearate [vegetable]
Stearic acid
Chlorophyllin 25% powder (contains copper-chlorophylline E 41)
Indigotine aluminum lake (contains indigotine E132 and aluminum hydroxide)
Carnauba wax
Riboflavin (E101)
6.2. Incompatibilities
No known incompatibilities.
6.3. Shelf life
2 years
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of outer packaging
SINUPHYL is available in blister packs (PVC/PVDC/Aluminium).
Each blister pack contains 10 film-coated tablets.
The following presentations are available:
Presentation of 20 film-coated tablets
Presentation of 40 film-coated tablets
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
No special requirements for disposal.
- MARKETING AUTHORIZATION HOLDER
BIONORICA SE KERSCHENSTEINERSTRASSE 11-15 92318 NEUMARKT GERMANY
- MARKETING AUTHORIZATION NUMBER(S)
· 34009 302 360 3 1: 20 tablets in blister packs (PVC/PVDC/Aluminium).
· 34009 302 360 4 8: 40 tablets in blister packs (PVC/PVDC/Aluminium).
- DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization: {DD month YYYY}
- DATE OF REVISION OF THE TEXT
[to be completed later by the holder]
{DD month YYYY}
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DISPENSING
Medicine not subject to medical prescription.
