SUMMARY OF PRODUCT CHARACTERISTICS
ANSM – Updated on: 23/05/2024
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NAME OF THE MEDICINAL PRODUCT
CYSTINE B6 BAILLEUL, film-coated tablet
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QUALITATIVE AND QUANTITATIVE COMPOSITION
L-cystine........................................................................................................................... 500.0 mg
Pyridoxine hydrochloride.................................................................................................. 50.0 mg
Per film-coated tablet.
Excipient with known effect:
Each tablet contains 6.16 mg of propylene glycol.
For the full list of excipients, see section 6.1.
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PHARMACEUTICAL FORM
Film-coated tablet, yellow, shiny, lenticular.
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CLINICAL PARTICULARS
4.1. Therapeutic indications
· Adjunct treatment of disorders of the skin appendages (fragile nails and hair).
· Adjunct treatment of corneal healing disorders.
4.2. Posology and method of administration
Posology:
4 tablets per day in two doses, to be taken with meals, for one month.
If there is no improvement after one month of treatment, medical advice must be sought.
Method of administration:
Oral use.
The tablets must be swallowed with a large glass of water.
Paediatric population:
No data are available.
4.3. Contraindications
· Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
· Cystinuria.
4.4. Special warnings and precautions for use
Precautions for use
This medicine must not be used for a prolonged period.
Particular attention should be paid when taking several products containing vitamin B6.
This medicine contains 6.16 mg of propylene glycol per tablet.
4.5. Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data or there are limited data on the use of CYSTINE B6 BAILLEUL in pregnant women.
Animal studies are insufficient to conclude on reproductive toxicity. CYSTINE B6 BAILLEUL is not recommended during pregnancy.
Breast-feeding
As vitamin B6 passes into breast milk and due to the high amounts of pyridoxine present in CYSTINE B6 BAILLEUL, its use during breast-feeding is not recommended.
Fertility
Effects on male fertility were observed in an animal study. The relevance of these effects in humans is unknown.
4.7. Effects on ability to drive and use machines
CYSTINE B6 BAILLEUL, film-coated tablet has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
According to the system organ class, undesirable effects are listed below by frequency using the following categories: 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); not known (cannot be estimated from the available data).
Not known:
Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, photosensitivity, hypertrichosis, acne
Immune system disorders: hypersensitivity reactions
Nervous system disorders: peripheral neuropathies mainly of the sensory type have been reported after high doses and/or prolonged use of vitamin B6.
Gastrointestinal disorders: abdominal pain, flatulence, abdominal distension, diarrhoea.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres – Website: www.signalement-sante.gouv.fr
4.9. Overdose
Peripheral neuropathies mainly of the sensory type have been reported after high doses and/or prolonged use of vitamin B6.
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PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: OTHER VITAMIN PREPARATIONS, COMBINATIONS, ATC code: A11JC
Supply of cystine, a sulphur-containing amino acid formed by two cysteine monomers, found mainly in the keratin of skin appendages, and of vitamin B6, a factor in the utilisation of cystine.
An in vitro study evaluating the influence of nutrition on the formation of human hair follicles showed that the follicle growth rate, protein synthesis and hair fibre diameter depend on the presence of cysteine. Indeed, a decrease in cysteine concentration in hair follicle cultures leads to a dose-dependent decrease in the growth rate and in the diameter of the fibres produced.
A study measuring cystine in the hair bulb and hair shaft in healthy volunteers showed incorporation of cystine into the hair bulb. These results were not correlated with any potential clinical improvement.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
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PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium carboxymethylcellulose, talc, microcrystalline cellulose (Avicel PH 102), magnesium stearate, sepifilm LP 010 (hypromellose, microcrystalline cellulose, stearic acid), sepisperse AP 3083 yellow (propylene glycol, hypromellose, titanium dioxide (E171), quinoline yellow (E104)), carnauba wax.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of container
Boxes of 20, 60 or 120 tablets in blisters (PVC/aluminium).
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
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MARKETING AUTHORISATION HOLDER
Laboratoires Bailleul S.A.
14/16 avenue Pasteur
L-2310 Luxembourg
LUXEMBOURG
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MARKETING AUTHORISATION NUMBER(S)
· 34009 316 698 8 3: 20 tablets in blisters (PVC/aluminium).
· 34009 369 522 1 8: 60 tablets in blisters (PVC/aluminium).
· 34009 380 189 3 6: 120 tablets in blisters (PVC/aluminium).
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[to be completed later by the marketing authorisation holder]
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DATE OF REVISION OF THE TEXT
[to be completed later by the marketing authorisation holder]
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DOSIMETRY
Not applicable.
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INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND SUPPLY
Medicinal product not subject to medical prescription.
