SUMMARY OF PRODUCT CHARACTERISTICS
ANSM – Last updated: 30/07/2024
IN THIS ANNEX, THE TERM “MARKETING AUTHORISATION” IS TO BE UNDERSTOOD AS “REGISTRATION OF A TRADITIONAL HERBAL MEDICINAL PRODUCT” AND THE TERM “AUTHORISATION” AS “REGISTRATION”.
1. NAME OF THE MEDICINAL PRODUCT
SINUFIX, soft capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lemon (Citrus limon (L.) Burman fil.) (essential oil from peel/pericarp) .................................... 11.4 mg
Thyme (Thymus vulgaris L. or Thymus zygis L.) (essential oil from aerial parts) ............... 11.4 mg
Peppermint (Mentha x piperita L.) (essential oil from fresh aerial parts) ................................. 11.4 mg
Per one soft capsule.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Soft capsule.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Traditional herbal medicinal product used for the symptomatic treatment of the common cold.
Use is reserved for the specified indication exclusively on the basis of long-standing use.
SINUFIX, soft capsule is indicated in adults.
4.2. Posology and method of administration
Posology
Adults: 1 soft capsule 3 times daily.
Paediatric population
Use in children and adolescents under 18 years of age is not recommended (see section 4.4).
Method of administration
Oral use.
Swallow the capsule whole, without chewing, with a large glass of water.
Duration of treatment
5 days.
If symptoms persist beyond 5 days of use, a doctor or pharmacist must be consulted.
4.3. Contraindications
Hypersensitivity to the active substances, to extracts from the following botanical genera Citrus, Thymus, Mentha, or to any of the excipients listed in section 6.1.
Due to the presence of terpene derivatives, this medicinal product is contraindicated in patients with a history of epilepsy and/or seizures.
Due to the presence of peppermint essential oil, this medicinal product is contraindicated:
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in liver diseases,
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in gallstones, cholangitis, or other biliary tract disorders,
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in achlorhydria.
4.4. Special warnings and precautions for use
Follow the recommended dose and treatment duration.
In the event of fever, breathing difficulties, purulent sputum, or worsening symptoms during use, a doctor must be consulted.
This product contains terpene derivatives which, at excessive doses, may cause:
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seizure-type events in infants and children,
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respiratory pauses and collapse in infants.
Patients with heartburn or hiatal hernia may sometimes experience worsening of symptoms after taking peppermint essential oil. Treatment must be discontinued in these patients.
Peppermint essential oil should be used with caution in people with inflammation or ulceration of the gastrointestinal tract.
Paediatric population
In the absence of sufficient data in this population, use in children and adolescents under 18 years of age is not recommended.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
This medicinal product contains terpene derivatives. There are no or limited data on the use of terpene derivatives in pregnant women.
SINUFIX, soft capsule is not recommended during pregnancy, and in women of childbearing potential not using contraception.
Breast-feeding
There are no data on the excretion into breast milk of the essential oil components contained in SINUFIX and/or their metabolites. A risk to newborns/infants cannot be excluded.
This medicinal product must not be used during breast-feeding.
Fertility
No fertility data are available.
4.7. Effects on ability to drive and use machines
Effects on the ability to drive and use machines have not been studied.
4.8. Undesirable effects
Due to the presence of essential oils and if the indication or recommended doses are not followed:
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risk of seizures in children,
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possibility of digestive disorders, in particular stomach pain (gastralgia),
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risk of contact allergy or allergic reactions.
Contact allergy to peppermint oil has been reported in patients with intra-oral symptoms associated with burning mouth syndrome, recurrent oral ulceration, or a lichenoid reaction. Frequency is unknown.
Allergic reactions to menthol have been reported, including headache, bradycardia, muscle tremors, ataxia, anaphylactic shock, and erythematous skin rash. Frequency is unknown.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres – Website: https://signalement.social-sante.gouv.fr/.
4.9. Overdose
Overdose may cause severe gastrointestinal symptoms (such as nausea, diarrhea, rectal ulceration), central nervous system disorders (such as seizures, ataxia, loss of consciousness), urinary disorders, and cardiac rhythm disturbances, probably due to the presence of menthol.
In the event of massive overdose, treatment consists of gastric lavage and symptomatic treatment.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Not applicable.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
The in vitro genotoxicity study conducted with Sinufix, soft capsule showed no mutagenic effect in the Ames test.
No carcinogenicity studies or reproduction and development toxicity studies have been performed.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Medium-chain triglycerides (RSPO: Roundtable on Sustainable Palm Oil).
Capsule shell composition: bovine gelatin, glycerol, water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at a temperature not exceeding 30°C.
6.5. Nature and contents of container
15 soft capsules in blisters (PVC/PVDC/Aluminium) in a cardboard carton.
6.6. Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
SYLVEOS SAS
12 Avenue de la Grande Armée
75017 Paris
France
8. MARKETING AUTHORISATION NUMBER(S)
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34009 302 303 1 2: 15 soft capsules in blisters (PVC/PVDC/Aluminium) in a cardboard carton.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[To be completed later by the holder]
10. DATE OF REVISION OF THE TEXT
[To be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Non-prescription medicinal product.
