Boiron Sinuphyl Tablets 20 Tablets

Description

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

1. NAME OF THE MEDICINAL PRODUCT

SINUPHYL, film-coated tablet

2. 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.

3. 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.

4. 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.

4.5. Interactions with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy, and lactation

Pregnancy

There are no data on the use of SINUPHYL in pregnant women. Animal studies have not shown direct or indirect harmful effects concerning reproductive toxicity (see section 5.3). For safety reasons, the use of SINUPHYL should be avoided during pregnancy.

Breastfeeding

It is unknown whether the active substances in SINUPHYL are excreted in human breast milk. A risk to the breastfed child cannot be excluded. SINUPHYL should not be used during breastfeeding.

Fertility

There are no data on the effects of SINUPHYL on human fertility. Animal studies have not shown any effects of Sinupret film-coated tablets and Sinupret oral drops on fertility (see section 5.3).

4.7. Effects on the ability to drive and use machines

SINUPHYL may have a minor influence on the ability to drive and use machines in patients experiencing possible adverse effects such as dizziness (see section 4.8).

4.8. Adverse effects

Like all medicines, SINUPHYL can cause side effects.

The profile of adverse effects is based on two placebo-controlled clinical studies involving 455 and 386 adult patients, and partially on reports and studies concerning similar products (the liquid extract drops and powdered plant substances in tablet form are made from the same plant substances).

The following frequency categories are used to evaluate adverse effects:

· Very common (≥ 1/10)

· Common (≥ 1/100 to < 1/10)

· Uncommon (≥ 1/1,000 to < 1/100)

· Rare (≥ 1/10,000 to < 1/1,000)

· Very rare (<1/10,000)

· Frequency not known (cannot be estimated from the available data)

Gastrointestinal disorders

Common: gastrointestinal disorders such as abdominal pain, nausea, diarrhea, bloating, vomiting

Immune system disorders

Uncommon: local hypersensitivity reactions such as rash, erythema, skin or eye pruritus, and systemic allergic reactions such as angioedema, dyspnea, facial swelling.

Nervous system disorders

Uncommon: dizziness

Reporting of suspected adverse reactions