Solacy Adult Nasopharyngeal Disorders - 45 Capsules

1. Ingredients Per capsule: l-Cystine – 72.6 mg Precipitated sulphur – 22.0 mg Coated vitamin A acetate* – of which retinol: 1650 IU Saccharomyces cerevisiae yeast** – 77.40 mg *Crystallised vitamin A acetate (500,000 IU/g), gelatine, sucrose, corn starch, antioxidant (butylhydroxytoluene) **Top-fermented, rinsed and dried Saccharomyces cerevisiae Excipient with known effect: Sucrose For a full list of excipients, see section 4.1. 2. Product Information 2.1. Therapeutic IndicationsTo supplement symptomatic treatment of cold-like conditions (particularly bronchitis and ear, nose and throat infections). For adult use. 2.2. Directions for Use and DosageTake 3 capsules a day for 3 months. Swallow whole with water. Take capsules at meals. 2.3. Contra-indicationsDo NOT use if you are allergic to any of this medicine's ingredients. 2.4. Warnings and Precautions for Use– Contains vitamin A. Use with caution if taking another vitamin A product. – Due to the presence of sucrose, do not use if you are fructose-intolerant (this is a rare, inherited disorder). 2.5. Interactions with Other Medicines and Other SubstancesNo clinically significant interactions based on data currently available. 2.6. Pregnancy and Breast-FeedingIf you are pregnant: – Vitamin A has teratogenic effects in several animal species. – In humans, heavy doses of vitamin A have been known to cause congenital defects in some cases. – The lack of authoritative epidemiological study, combined with unreliable case reporting, makes it difficult to provide an accurate measurement of the risk of congenital defects. – You are therefore advised to limit your medicinal vitamin A intake to 5000 IU per day. If you are breast-feeding: If vitamin A is consumed in large quantities, your baby will be at risk of excessive dose. You are therefore advised to limit your medicinal vitamin A intake to 5000 IU per day. 2.7. Driving and Operating Machinery:This medicine is not believed to impair your ability to drive or operate machinery safely. 2.8. Possible Side EffectsIsolated cases of cutaneous allergic reaction have been reported. 2.9. Excessive DoseMassive overdose may cause hypervitaminosis A. 3. Pharmacodynamic Properties – Pharmacotherapeutic Group: Nutrition of respiratory mucous membrane (R: Respiratory System) – Mixture of sulphur, vitamin A and yeasts formulated to ease inflammation of the respiratory mucosa. – In addition, vitamin A has immuno-stimulating properties. 4. Pharmaceutical Information 4.1. ExcipientsMagnesium stearate Capsule shell: Gelatine, titanium dioxide (E171) 4.2. Shelf Life2 years 4.3. Storage InstructionsKeep below 30°C. 4.4. Packaging– Thermoformed blister-packs (composition: PVC/PE/PVDC/aluminium) of 15 capsules each. – Packs of 45 or 90 capsules. 5. Marketing Authorisation Holder LABORATOIRES GRIMBERG 19, RUE POLIVEAU 75005 PARIS FRANCE 6. Marketing Authorisation No. – 317 395-9: 45 capsules in thermoformed blister-packs (composition: PVC/PE/PVDC/aluminium) – 355 722-3: 90 capsules in thermoformed blister-packs (composition: PVC/PE/PVDC/aluminium) 7. Prescription and Delivery Conditions Non-prescription medicine